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

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 or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. 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:

Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per minute (SLPM)
Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

The tubeset is a sterile, single-use product. The tubeset is made of PVC and polyethylene. The A VA 15 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.

AI/ML Overview

The provided text describes the EVA15 Insufflator, a medical device, and its 510(k) submission to the FDA. However, it does not contain information about a study involving AI assistance for human readers, nor does it detail a study for an AI algorithm's standalone performance. The document focuses on the substantial equivalence of the EVA15 Insufflator to a predicate device (SurgiQuest AirSeal iFS System) based on non-clinical performance testing of mechanical and electrical aspects.

Therefore, many of the requested details, especially those related to AI model evaluation (like sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable or present in this document.

Here's an analysis of the available information based on your request:

Acceptance Criteria and Device Performance (Bench Testing Summary):

The document provides a summary of non-clinical performance testing. The "acceptance criteria" are generally stated as "predefined acceptance criteria" without specific numerical thresholds, and the "reported device performance" is a qualitative statement that the device met these criteria.

Category	Acceptance Criteria (Stated)	Reported Device Performance (Stated)
Bench Testing
Pressure delivery accuracy	Predefined acceptance criteria	Device met criteria
Flow delivery accuracy	Predefined acceptance criteria	Device met criteria
Simulated Leak	Predefined acceptance criteria	Device met criteria under conditions
Smoke Evacuation	Predefined acceptance criteria	Device met criteria
Smoke Evacuation Filter	Predefined acceptance criteria	Device met criteria
Software Validation	Adherence to Guidance for Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)	Software was validated
Electrical / EMC
Electrical Safety	Requirements of IEC 60601-1 standards	Device met requirements
EMC	Requirements of IEC 60601-1-2:2014	Device met requirements
Sterility & Aging
Tubeset Sterilization	ISO 11135:2014/Amd.1:2018 Annex E (Half cycle)	Validated
Shelf-life	ISO 10993-7:2008/Amd 1:2019, ASTM D4169-16, ASTM F1886 (visual), ASTM F2096 (leak), ASTM F88 (seal), ASTM F-1980-16 (aging)	Supported 1 year

Information Not Available in the Document:

Sample size used for the test set and the data provenance: The document details bench testing, which implies a test set, but it does not specify the sample size (e.g., number of units tested, number of simulated scenarios). It also does not discuss data provenance in the sense of patient data (e.g., country of origin, retrospective/prospective), as this is a physical device rather than an AI/imaging diagnostic.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as the testing involves objective measurements of pressure, flow, and filtration, not expert human interpretation for establishing ground truth like in medical imaging.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for engineering bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is for a medical device (insufflator) approval, not an AI diagnostic/assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device's performance testing consists of physical measurements against engineering specifications and validated standards (e.g., pressure readings, flow rates, filtration efficiency).
The sample size for the training set: Not applicable as this is not an AI/machine learning model that undergoes training.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 23, 2020

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

Re: K193520

Trade/Device Name: EVA15 Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: June 23, 2020 Received: June 25, 2020

Dear Paul 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.

{1}------------------------------------------------

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 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-regulatoryinformation/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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 R. Roberts, Ph.D. Acting 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

{2}------------------------------------------------

{3}------------------------------------------------

510(k) Summary

Submitter:	Palliare Ltd.Galway Business Park, DanganGalway H91 P2DK, Ireland
Official Contact:	John O'Dea, Ph.D., DirectorTel: +353-91-516362Email: jodea@palliare.com
Contact Person name:	Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704
Date Prepared:	July 21, 2020
Proprietary or Trade Name:Regulation number:Regulation Name:Regulatory Class:Product Code:	EVA15 Insufflator21 CFR 884.1730Laparoscopic InsufflatorClass IIHIF
Predicate Device:	K172516 - SurgiQuest AirSeal iFS System

The predicate devices has no been subject to a design-related recall.

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 or thoracic cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA15 Insufflation is intended to use in hospital. 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:

Flow Mode (1) delivers a fixed flow, settable between 0 and 15 standard liters per ● minute (SLPM)
. Pressure Modes (2) -
- Intermittent Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 12 SLPM (i.e. no more than 12 SLPM will be delivered during intermittent pressure insufflation).
- Continuous Pressure Insufflation a pressure is targeted, but the flow delivered o in targeting that pressure is capped at 40 SLPM (i.e. no more than 40 SLPM will be delivered during continuous pressure insufflation).

{4}------------------------------------------------

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.

Indications for Use:

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

{5}------------------------------------------------

Table 1 - Comparison - Subject vs. Predicate
----------------------------------------------	--	--	--

	Subject Device: EVA15 Insufflator(K193520)	Predicate Device: SurgiQuest AirSeal iFS System(K172516)	Comparison
Manufacturer	Palliare Ltd.	SurgiQuest Inc. (Acquired by ConMed Co. in 2015)
Classification	21 C.F.R. § 884.1730 (LaparoscopicInsufflator), Product Code HIF	21 C.F.R. § 884.1730 (Laparoscopic Insufflator),Product Code HIF, GCJ	Same
Fundamentalscientifictechnology	Digital insufflation pressureregulation system using compressedCO2 gas. Venturi smoke evacuation.	Digital insufflation pressure regulation system usingcompressed CO2 gasSmoke evacuation using custom trocar generatingnegative pressure	Similar
Patient connection	Standard Trocar luer connection	Customized trocar	Similar - each connectsto cavity using a trocar
Indications for Use	The EVA15 Insufflator is intended foruse in diagnostic and/or therapeuticendoscopic and laparoscopicprocedures to distend the abdomen,colon or thoracic cavity with up to 15mmHg pressure, by filling it with gasand to evacuate surgical smoke.	The SurgiQuest AirSeal® iFS System is intended for usein diagnostic and/or therapeutic endoscopic proceduresto distend a cavity by filling it with gas, to establish andmaintain a path of entry for endoscopic instruments andto evacuate surgical smoke.It is indicated to facilitate the use of variousthoracoscopic and laparoscopic instruments by fillingthe abdominal or thoracic cavity with gas to distend it,by creating and maintaining a gas sealed obstruction-free instrument path and by evacuating surgical smoke.This instrument can also be used to insufflate the rectumand colon to facilitate endoscopic observation, diagnosisand treatment. The trocar of the AirSeal® iFS System isindicated for use with or without visualization.	Similar except thesubject device does notinclude a trocar.
	Subject Device: EVA15 Insufflator	Predicate Device: SurgiQuest AirSeal iFS System(K172516)	Comparison
Gas DeliveryModes	Fixed FlowIntermittent Pressure (Standard)InsufflationContinuous Pressure Insufflation	Intermittent Pressure (Standard and Smoke Evac Modes)InsufflationContinuous Pressure Insufflation (Airseal Mode)	SimilarSubject device also hasa fixed flow mode
Smoke Evacuation	Available in all modes. Operatescontinuously or may be activatedon/off using foot pedal.	Available in Airseal (continuous pressure) and SmokeEvacuation modes. Operates continuously.	Similar
Flow Range	0-40 SLPM	0-40 SLPM	Same
Pressure Range	7-15 mmHg	5-20 mmHg	SimilarSubject device has asmaller range
Accessories	Tubeset	Tubeset, Custom Trocar	Similar
Dimensions	160x130x330mm	420x220x470mm	SimilarSubject is smaller
Weight	5.5kg	26.0kg	SimilarSubject is smaller
Power Source	AC 100-240V	AC 100/115/230V	Similar
TubesetSterilization	EtO	EtO	Same
User Interface	Membrane Panel	Touchscreen	Similar

{6}------------------------------------------------

Discussion of Differences

The differences in technological characteristics do not raise different questions of safety and effectiveness when compared to the predicate.

{7}------------------------------------------------

Summary of Non-clinical Performance Testing

The subject devices comply with voluntary standards for electrical safety, and electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:

Bench

. Static condition
- Pressure and flow delivery accuracy; the device was demonstrated to meet o predefined acceptance criteria regarding pressure and flow
Dynamic condition ●
- o Simulated leak; the device was demonstrated to meet predefined acceptance criteria under simulated leak conditions
- Smoke evacuation; the device was demonstrated to meet predefined acceptance o criteria regarding smoke evacuation
. Efficiency of Smoke Evacuation Filter; the device was demonstrated to meet predefined acceptance criteria regarding the smoke evacuation filter

Software was validated per Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.

Electrical / EMC

. Electrical Safety
- o IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) IEC 60601-1-8: 2012 o

The device was demonstrated to meet the requirements of the standard.

EMC
- IEC 60601-1-2:2014 o

The device was demonstrated to meet the requirements of the standard.

Sterility and Aging Effect

Sterilization of the tubeset is via EtO and was validated per ISO 11135:2014/Amd.1:2018 Annex E, Half cycle approach. In addition, testing to ISO 10993-7:2008/Amd 1:2019, ASTM D4169-16, ASTM F1886 (visual inspection), ASTM F2096 (leak detection), ASTM F88 (seal strength) and ASTM F-1980-16 (aging) supported a shelf-life of 1 year.

Substantial Equivalence Conclusion

The performance testing described above demonstrate that the subject device is as safe and effective as the predicate device and supports a determination of substantial equivalence.

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.