The EVA 15 Insufflator is intended for use in diagnostic endoscopic and laparoscopic procedures to distend the abdomen, rectum, colon, esophagus, stomach or thoracic cavity with up to 25 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 instruments by filling the abdominal cavity or rectum with gas to distend it, and by evacuating surgical smoke. The EVA 15 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.

The laparoscopic 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 25mmHg and with up to 40 SLPM instantaneous flow. The EVA15 is powered by AC and uses compressed 50 psi CO2 and air gas supply the pneumatic circuitry for insufflation and smoke evacuation respectively.

AI/ML Overview

This document describes the 510(k) submission for the EVA15 Insufflator, emphasizing the modifications and the non-clinical testing performed to demonstrate substantial equivalence to its predicate device (K202799 - Palliare EVA15).

Here’s a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the device met its acceptance criteria, which were the "same acceptance criteria as applied to the predicate" (K202799). However, specific numerical acceptance criteria are not detailed for all tests. The performance reported indicates successful completion of these tests.

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Pressure Range	Maximum Pressure Delivery	Up to 25 mmHg (New Indications for Use)	Device successfully delivers up to 25 mmHg pressure.
Non-clinical Testing	Static condition - Pressure accuracy	(Not explicitly detailed, but implied to be within acceptable limits for the predicate device)	Demonstrated that the subject device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness.
	Dynamic condition - Simulated leak	(Not explicitly detailed, but implied to be within acceptable limits for the predicate device)	Demonstrated that the subject device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness.
	Dynamic condition - Smoke evacuation	(Not explicitly detailed, but implied to maintain cavity pressure during evacuation for the predicate device)	Demonstrated that the subject device met its acceptance criteria, including evacuating surgical smoke without loss of cavity pressure. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness.
ID Chipset Functionality	Reading chip for correct tubeset and use time	Correctly read chip to determine presence of chipset and identity of tubeset; enforce 48-hour use limit.	Software verification and validation confirmed the EVA 15 insufflator could read the connector chip correctly to determine the presence of the chipset and the identity of the tubeset, and implicitly enforce the 48-hour use limitation.
Safety Valve	Spring pressure relief valve performance	(Not explicitly detailed, but implied to function correctly as a safety measure)	Verification of the spring pressure relief valve performance was performed and the device met its acceptance criteria. This performance is considered sufficient to demonstrate substantial equivalence and does not present different questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in terms of subject data (e.g., patient data for an AI algorithm). The testing described is non-clinical performance testing of the device itself (hardware and software). Therefore, specific sample sizes for a data-driven test set are not applicable here. The provenance of any data used for testing (e.g., country of origin, retrospective/prospective) is not mentioned as the testing focuses on device function.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable as the document describes non-clinical performance testing of a medical device (an insufflator), not an AI algorithm that requires expert-established ground truth from images or patient data.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or mentioned. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for an insufflator device.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study of the device was performed in the form of non-clinical testing (static and dynamic conditions). This is not an "algorithm only" study in the typical AI context; rather, it refers to the performance of the integrated device system. The document states: "Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria... Testing included: Static condition (Pressure accuracy), Dynamic condition (Simulated leak, Smoke evacuation)."

7. Type of Ground Truth Used

The "ground truth" for this device's performance testing would be the engineering specifications and established functional requirements for insufflators. For example, pressure accuracy would be compared against a calibrated standard, and smoke evacuation effectiveness against predefined thresholds. It's not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

This information is not applicable as the device is a hardware/software system, not a machine learning or AI algorithm that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

Summary

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January 27, 2023

Palliare Ltd. % Paul Dryden President/Consultant for Strata ProMedic Consulting, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704

Re: K222901

Trade/Device Name: EVA15 Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, FCX Dated: December 20, 2022 Received: December 20, 2022

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.

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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 (OS) 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 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

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Indications for Use

510(k) Number (if known) K22901

Device Name EVA15 Insufflator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)



Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary Page 1 of 4

Date Prepared:	26-Jan-23
Palliare Ltd.Galway Business Park, DanganGalway H91 P2DK, IrelandTel - +353-91-516362
Official Contact:	John O'Dea, Ph.D., Director
Submission Correspondent:	Paul DrydenProMedic, 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
Predicate Device:	K202799 - Palliare EVA15
Common/Usual Name:	CO2 insufflator
Regulation Number:	21 CFR 884.1730
Regulation Name:	Laparoscopic insufflator
Product Code:	HIF, FCX

Modification:

Updated maximum pressure delivered to 25 mmHg, the ability to select two insufflation pressures and select using the foot pedal, and a chip identifier in the tubeset connectors.

Device Description:

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:

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

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510(k) Summary Page 2 of 4

cavity with up to 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Patient Population:

Patients undergoing laparoscopic or endoscopic procedures in which insufflation may be helpful.

Environments of use:

Operating room or endoscopy suite.

Table 1 is a comparison - Subject Device vs. the Predicate, K202799 - Palliare EVA15.

Substantial Equivalence Discussion

The EVA15 insufflator has the same general intended use and indications, technological characteristics, and principles of operation as the predicate Palliare EVA 15, K202799.

Intended Use/ Indications for Use

The proposed modifications to the indications for use are to extend the pressure delivery range from 15 mmHg to 25 mmHg

Technological Characteristics

The modification does not change the technological characteristics.

Principles of Operation

The EVA15 Insufflator principle of operation remains unchanged to the predicate.

Non-clinical Testing

Performance testing of the insufflator in the revised pressure range demonstrated that the subject device met its acceptance criteria, the same acceptance criteria as applied to the predicate. Testing included:

Static condition .
- Pressure accuracy .
Dynamic condition ●
- Simulated leak
- Smoke evacuation

The addition of the ID Chipset to the disposable tubeset connector is to ensure that the correct tubeset is used and to limit the time the disposable tubeset may be used. Software verification and validation was performed to test that the EVA 15 insufflator could read the connector chip correctly to determine the presence of the chipset and the identity of the tubeset. Verification of the spring pressure relief valve performance was performed.

Substantial Equivalence Conclusion

The EVA15 with the modified performance and addition of the ID chip in the tubeset remain to have the same intended use and similar indications, technological characteristics and principles of operation.

This difference does not present different questions of safety or effectiveness than the predicate device because CO2 is delivered to the surgical field at a maximum 25 mmHz, which is lower than other marketed devices e.g., K153513 - World of Medicine Model FM134, and smoke is evacuated without loss of cavity pressure as with the currently cleared EVA15- K202799. The results of non-clinical performance testing demonstrate that the subject device is as safe and effective as the predicate. Thus, the EVA15 Insufflator is substantially equivalent to the Palliare EVA 15, cleared under K202799.

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Table 1 – Comparison – Subject vs. Predicate

	Proposed Device: EVA15 Insufflator	Predicate:EVA15 Insufflator - K202799	Comparison
Manufacturer	Palliare	Palliare	Same
Classification	21 C.F.R. § 884.1730 ( Laparoscopic Insufflator )Product Code HIF, FCX (Class II)	21 C.F.R. § 884.1730 ( Laparoscopic Insufflator )Product Code HIF, FCX (Class II)	Same
Fundamentalscientifictechnology	Digital insufflation pressure regulation systemusing compressed CO2 gas. Venturi smokeevacuation.	Digital insufflation pressure regulation systemusing compressed CO2 gas. Venturi smokeevacuation.	Same
Patientconnection	Standard Trocar luer connection	Standard Trocar luer connection	Same
Indications forUse	The EVA 15 Insufflator is intended for use indiagnostic and/or therapeutic endoscopic andlaparoscopic procedures to distend the abdomen,rectum, colon, esophagus, stomach or thoraciccavity with up to 25 mmHg pressure, by filling itwith gas and to evacuate surgical smoke.	The EVA 15 Insufflator is intended for use indiagnostic and/or therapeutic endoscopic andlaparoscopic procedures to distend the abdomen,rectum, colon, esophagus, stomach or thoraciccavity with up to 15 mmHg pressure, by filling itwith gas and to evacuate surgical smoke.	Similar except extension ofpressure range
Gas DeliveryModes	Intermittent Pressure (Standard) InsufflationContinuous Pressure Insufflation	Fixed FlowIntermittent Pressure (Standard) InsufflationContinuous Pressure Insufflation	Fixed flow not offered inproposed product
SmokeEvacuation	Available in all modes. Operates continuouslyor may be activated on/off using foot pedal.	Available in all modes. Operates continuously ormay be activated on/off using foot pedal.	Same
Flow Range	0-40 SLPM	0-40 SLPM	Same
Pressure Range	Up to 25 mmHg	7-15 mmHg	Different but similar to thereference K153515
Accessories	Tubeset	Tubeset	Same as cleared underK193520 and K202922except for addition of ID Chip
Use limitationof tube set	48 hours due to ID Chip	Labeling was disposable but nothing preventedcontinued use	Addition of ID chip
	Proposed Device: EVA15 Insufflator	Predicate:EVA15 Insufflator - K202799	Comparison
Dimensions	160x130x330mm	160x130x330mm	Same
Weight	5.5kg	5.5kg	Same
Power Source	100-240V	100-240V	Same
TubesetSterilization	EtO	EtO	Same
User Interface	Membrane Panel	Membrane Panel	Same

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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.