October 21, 2020

Palliare Ltd.
℅ Paul E. Dryden
Consultant
Palliare Ltd. c/o ProMedic Consulting, LLC
131 Bay Point Dr. NE
St. Petersburg, FL 33704

Re: K202799
Trade/Device Name: EVA15 Insufflator
Regulation Number: 21 CFR§ 884.1730
Regulation Name: Laparoscopic Insufflator
Regulatory Class: II
Product Code: HIF, FCX
Dated: September 21, 2020
Received: September 23, 2020

Dear Paul E. Dryden:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies.

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.18
Silver Spring, MD 20993
www.fda.gov
K202799 - Paul E. Dryden Page 2

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related
adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for
combination products (see https://www.fda.gov/combination-products/guidance-regulatory-
information/postmarketing-safety-reporting-combination-products); good manufacturing practice
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current
good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jason Roberts -S
Jason R. Roberts, Ph.D.
Assistant Director
DHT3B: Division of Reproductive,
Gynecology and Urology Devices
OHT3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure
 K202799
Page 1 of 4

510(k) Summary

Date Prepared: 21-Oct-20

Submitter: Palliare Ltd.

Galway Business Park, Dangan
Galway H91 P2DK, Ireland
Tel - + 353-91-516362

Official Contact: John O’Dea, Ph.D., Director

Submission Correspondent: Paul Dryden

ProMedic, LLC

Proprietary or Trade Name: EVA15 Insufflator

Common/Usual Name: CO2 insufflator

Regulation Number: 21 CFR 884.1730

Regulation Name: Laparoscopic insufflator
Product Code: HIF, FCX
Regulatory Class: Class II

Predicate Device: K193520 – Palliare EVA15

The predicate device has not been subject to a design-related recall.

Modification:

The indications for use for the subject device have been modified from that of the predicate to include
specific reference to insufflation of the rectum, esophagus, and stomach. There are no proposed design
changes in this 510(k). The subject device remains identical in design to the predicate.

Device Description:

The EVA15 insufflator is intended for use in diagnostic and/or therapeutic endoscopic and
laparoscopic procedures to distend a cavity by filling it with gas and to evacuate surgical smoke. It is
indicated to facilitate the use of various endoscopic and laparoscopic instruments by filling the
abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15
Insufflator is used in an operating room or endoscopic suite. It consists of the following major
components: (1) a micro-processor-controlled insufflation and smoke evacuation unit and (2) a
disposable tube set.

There are 3 operating modes:

(a) Continuous Flow (similar to a traditional endoscopic insufflator) – delivers a fixed flow between
0 and 15 standard liters per minute (SLPM)

(b) Intermittent Pressure Insufflation (similar to traditional laparoscopic insufflation) – a pressure

is targeted, but the flow delivered in targeting that pressure is limited to 12 SLPM (i.e. no
more than 12 SLPM will be delivered during intermittent pressure insufflation).

(c) Continuous Pressure Insufflation – a pressure is targeted, but the flow delivered in targeting
that pressure is limited to 40 SLPM (i.e. no more than 40 SLPM will be delivered during
continuous pressure insufflation).

Page 1 of 4
 K202799
Page 2 of 4

510(k) Summary

The tube set is a sterile, single-use product. The EVA15 Insufflator is an active medical device,
nonsterile and reusable and is intended to insufflate a body cavity up to 15mmHg and with up to
40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2
and air gas supplies to supply the pneumatic circuitry for insufflation and smoke evacuation
respectively.

Principle of Operation:

The operating principle employs 2 methods:

(A) A digital insufflation pressure regulation system using compressed CO2 gas to deliver CO2 into
the patient cavity to be insufflated at the direction and control of the physician and

(B) The use of a venturi method to create a vacuum to evacuate any smoke created during the
procedure.

Patient Population:

Patient undergoing laparoscopic or endoscopic procedures in which insufflation may be helpful

Environment of use:

Operating room or endoscopy suite.

Indications for Use:

The EVA15 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic and
laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic
cavity with up to 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

A comparison of Technological Characteristics of the subject and predicate devices are presented in
Table 1 below.

Page 2 of 4
 K202799
Page 3 of 4

K202799
510(k) Summary
Table 1 – Comparison – Subject vs. Predicate

Predicate: Subject Device: Comparison

EVA15 Insufflator - K193520 EVA15 Insufflator
Manufacturer Palliare Palliare Same

Classification 21 C.F.R. § 884.1730 21 C.F.R. § 884.1730 (Laparoscopic Similar

(Laparoscopic Insufflator), Insufflator), Product Code HIF,
Product Code HIF (Class II) FCX (Class II)
Fundamental Digital insufflation pressure Digital insufflation pressure Same
scientific regulation system using regulation system using compressed
technology compressed CO2 gas. Venturi CO2 gas. Venturi smoke evacuation.
smoke evacuation.
Patient Standard Trocar luer connection Standard Trocar luer connection Same
connection
Indications for The EVA15 Insufflator is The EVA 15 Insufflator is intended Similar
Use intended for use in diagnostic for use in diagnostic and/or
and/or therapeutic endoscopic and therapeutic endoscopic and
laparoscopic procedures to laparoscopic procedures to distend
distend the abdomen, the abdomen, rectum, colon,
colon or thoracic cavity with up esophagus, stomach or thoracic
to 15 mmHg pressure, by filling it cavity with up to 15 mmHg
with gas and to evacuate surgical pressure, by filling it with gas and to
smoke. evacuate surgical smoke.
Gas Delivery Fixed Flow Fixed Flow Same
Modes Intermittent Pressure (Standard) Intermittent Pressure (Standard)
Insufflation Insufflation
Continuous Pressure Insufflation Continuous Pressure Insufflation
Smoke Available in all modes. Operates Available in all modes. Operates Same
Evacuation continuously or may be activated continuously or may be activated
on/off using foot pedal. on/off using foot pedal.
Flow Range 0-40 SLPM 0-40 SLPM Same

Pressure Range 7-15 mmHg 7-15 mmHg Same

Accessories Tubeset Tubeset Same

Dimensions 160x130x330mm 160x130x330mm Same

Weight 5.5kg 5.5kg Same

Power Source 100-240V 100-240V Same

Tubeset EtO EtO Same

Sterilization
User Interface Membrane Panel Membrane Panel Same

Page 3 of 4
 K202799
Page 4 of 4

K202799
510(k) Summary
Discussion of Differences:

The differences in indications between the subject device and the predicate do not constitute a
new intended use.

The subject and predicate device have the same technological characteristics.

Summary of Non-clinical Performance Testing:

As the subject device is identical in design to the predicate, performance data from the predicate
device were leveraged to support the performance of the subject device.

Substantial Equivalence Conclusion:

The difference in indications between the subject device and the predicate do not constitute a new
intended use. The subject and predicate device have the same technological characteristics.
Therefore, the subject device is as safe and effective as the predicate device.

Page 4 of 4