EVA 15 Insufflator

K193520 · Palliare , Ltd. · HIF · Jul 23, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K193520
• Device Name: EVA 15 Insufflator
• Applicant: Palliare , Ltd.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jul 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

EVA15 Insufflator is a microprocessor-controlled device for hospital use; provides cavity distension and surgical smoke evacuation during endoscopic/laparoscopic procedures. Inputs: compressed CO2 gas and air. Operation: digital pressure regulation system delivers CO2 to distend cavity; venturi method creates vacuum for smoke evacuation. Three modes: Fixed Flow (0-15 SLPM), Intermittent Pressure (capped at 12 SLPM), and Continuous Pressure (capped at 40 SLPM). Operated by clinicians via membrane panel; connects to patient via standard trocar luer connection. Output: controlled gas flow and smoke removal. Benefits: maintains surgical field visibility and cavity distension; facilitates instrument use. Device is reusable; includes sterile, single-use PVC/polyethylene tubeset.

Clinical Evidence

Bench testing only. Evaluated pressure and flow delivery accuracy under static and dynamic (simulated leak) conditions. Validated smoke evacuation performance and filter efficiency. Confirmed electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2). Sterilization (EtO) and shelf-life (1 year) validated per ISO 11135, ISO 10993-7, and ASTM standards (D4169, F1886, F2096, F88, F1980). No clinical data provided.

Technological Characteristics

Microprocessor-controlled insufflator; dimensions 160x130x330mm; weight 5.5kg. Materials: PVC and polyethylene (tubeset). Power: AC 100-240V. Gas: compressed CO2 and air. Sensing/Actuation: digital pressure regulation and venturi vacuum. Connectivity: standalone. Sterilization: EtO (tubeset). Standards: IEC 60601-1, IEC 60601-1-8, IEC 60601-1-2, ISO 11135, ISO 10993-7.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic endoscopic and laparoscopic procedures requiring cavity distension (abdomen, colon, or thoracic) and surgical smoke evacuation.

Regulatory Classification

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.

Predicate Devices

• SurgiQuest AirSeal iFS System (K172516)

Submission Summary (Full Text)

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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.

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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 (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 ([e-mail]) or phone [phone] 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

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#### 510(k) Summary

| Submitter: | Palliare Ltd.<br>Galway Business Park, Dangan<br>Galway H91 P2DK, Ireland |
|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea, Ph.D., Director<br>Tel: [phone]<br>Email: [e-mail] |
| Contact Person name: | Paul Dryden<br>ProMedic, LLC<br>131 Bay Point Dr NE<br>St. Petersburg, FL 33704 |
| Date Prepared: | July 21, 2020 |
| Proprietary or Trade Name:<br>Regulation number:<br>Regulation Name:<br>Regulatory Class:<br>Product Code: | EVA15 Insufflator<br>21 CFR 884.1730<br>Laparoscopic Insufflator<br>Class II<br>HIF |
| 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).

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

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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:

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.

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

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

| | Subject Device: EVA15 Insufflator<br>(K193520) | Predicate Device: SurgiQuest AirSeal iFS System<br>(K172516) | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Manufacturer | Palliare Ltd. | SurgiQuest Inc. (Acquired by ConMed Co. in 2015) | |
| Classification | 21 C.F.R. § 884.1730 (Laparoscopic<br>Insufflator), Product Code HIF | 21 C.F.R. § 884.1730 (Laparoscopic Insufflator),<br>Product Code HIF, GCJ | Same |
| Fundamental<br>scientific<br>technology | Digital insufflation pressure<br>regulation system using compressed<br>CO2 gas. Venturi smoke evacuation. | Digital insufflation pressure regulation system using<br>compressed CO2 gas<br>Smoke evacuation using custom trocar generating<br>negative pressure | Similar |
| Patient connection | Standard Trocar luer connection | Customized trocar | Similar - each connects<br>to cavity using a trocar |
| Indications for Use | The EVA15 Insufflator is intended for<br>use in diagnostic and/or therapeutic<br>endoscopic and laparoscopic<br>procedures to distend the abdomen,<br>colon or thoracic cavity with up to 15<br>mmHg pressure, by filling it with gas<br>and to evacuate surgical smoke. | The SurgiQuest AirSeal® iFS System is intended for use<br>in diagnostic and/or therapeutic endoscopic procedures<br>to distend a cavity by filling it with gas, to establish and<br>maintain a path of entry for endoscopic instruments and<br>to evacuate surgical smoke.<br>It is indicated to facilitate the use of various<br>thoracoscopic and laparoscopic instruments by filling<br>the abdominal or thoracic cavity with gas to distend it,<br>by creating and maintaining a gas sealed obstruction-<br>free instrument path and by evacuating surgical smoke.<br>This instrument can also be used to insufflate the rectum<br>and colon to facilitate endoscopic observation, diagnosis<br>and treatment. The trocar of the AirSeal® iFS System is<br>indicated for use with or without visualization. | Similar except the<br>subject device does not<br>include a trocar. |
| | Subject Device: EVA15 Insufflator | Predicate Device: SurgiQuest AirSeal iFS System<br>(K172516) | Comparison |
| Gas Delivery<br>Modes | Fixed Flow<br>Intermittent Pressure (Standard)<br>Insufflation<br>Continuous Pressure Insufflation | Intermittent Pressure (Standard and Smoke Evac Modes)<br>Insufflation<br>Continuous Pressure Insufflation (Airseal Mode) | Similar<br>Subject device also has<br>a fixed flow mode |
| Smoke Evacuation | Available in all modes. Operates<br>continuously or may be activated<br>on/off using foot pedal. | Available in Airseal (continuous pressure) and Smoke<br>Evacuation modes. Operates continuously. | Similar |
| Flow Range | 0-40 SLPM | 0-40 SLPM | Same |
| Pressure Range | 7-15 mmHg | 5-20 mmHg | Similar<br>Subject device has a<br>smaller range |
| Accessories | Tubeset | Tubeset, Custom Trocar | Similar |
| Dimensions | 160x130x330mm | 420x220x470mm | Similar<br>Subject is smaller |
| Weight | 5.5kg | 26.0kg | Similar<br>Subject is smaller |
| Power Source | AC 100-240V | AC 100/115/230V | Similar |
| Tubeset<br>Sterilization | EtO | EtO | Same |
| User Interface | Membrane Panel | Touchscreen | Similar |

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# Discussion of Differences

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

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## 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.