EVA15

K202799 · Palliare , Ltd. · HIF · Oct 21, 2020 · Obstetrics/Gynecology

Device Facts

• Record ID: K202799
• Device Name: EVA15
• Applicant: Palliare , Ltd.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Oct 21, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1730
• Device Class: Class 2

Intended Use

The EVA15 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 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Device Story

EVA15 Insufflator is a microprocessor-controlled device used in operating rooms or endoscopy suites to distend body cavities and evacuate surgical smoke. It accepts compressed CO2 and air as inputs. The device operates via a digital pressure regulation system for CO2 delivery and a venturi method for smoke evacuation. It features three modes: Continuous Flow (0-15 SLPM), Intermittent Pressure Insufflation (targeted pressure, max 12 SLPM), and Continuous Pressure Insufflation (targeted pressure, max 40 SLPM). The device is operated by clinicians; output is delivered via a sterile, single-use tube set connected to a trocar. By maintaining cavity pressure up to 15 mmHg, it facilitates endoscopic instrument use and improves visualization by clearing smoke, potentially benefiting patients by enabling safer, more efficient minimally invasive procedures.

Clinical Evidence

No clinical data. Bench testing only; performance data from the predicate device were leveraged as the subject device is identical in design.

Technological Characteristics

Microprocessor-controlled insufflator; digital pressure regulation; venturi-based smoke evacuation. Powered by AC (100-240V). Uses compressed CO2 and air. Dimensions: 160x130x330mm; weight: 5.5kg. User interface: membrane panel. Sterile, single-use EtO-sterilized tube set. Connectivity: standard trocar luer connection.

Indications for Use

Indicated for patients undergoing diagnostic or therapeutic endoscopic and laparoscopic procedures requiring cavity distension (abdomen, rectum, colon, esophagus, stomach, or thoracic cavity) 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

• Palliare EVA15 (K193520)

Submission Summary (Full Text)

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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.

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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. 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) K202799

Device Name EVA15 Insufflator

Indications for Use (Describe)

The EVA15 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 15 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

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

| <div> <span> <b>Prescription Use (Part 21 CFR 801 Subpart D)</b> </span> </div> |
|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| Date Prepared: | 21-Oct-20 |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Submitter: | Palliare Ltd.<br>Galway Business Park, Dangan<br>Galway H91 P2DK, Ireland<br>Tel - + 353-91-516362 |
| Official Contact: | John O'Dea, Ph.D., Director |
| Submission Correspondent: | Paul Dryden<br>ProMedic, LLC |
| Proprietary or Trade Name:<br>Common/Usual Name: | EVA15 Insufflator<br>CO2 insufflator |
| Regulation Number:<br>Regulation Name:<br>Product Code:<br>Regulatory Class: | 21 CFR 884.1730<br>Laparoscopic insufflator<br>HIF, FCX<br>Class II |
| Predicate Device: | K193520 - Palliare EVA15 |

510(k) Summary

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 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.

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).

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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 CO2into 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.

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# 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<br>(Laparoscopic Insufflator).<br>Product Code HIF (Class II) | 21 C.F.R. § 884.1730 (Laparoscopic<br>Insufflator), Product Code HIF,<br>FCX (Class II) | Similar |
| Fundamental<br>scientific<br>technology | Digital insufflation pressure<br>regulation system using<br>compressed CO2 gas. Venturi<br>smoke evacuation. | Digital insufflation pressure<br>regulation system using compressed<br>CO2 gas. Venturi smoke evacuation. | Same |
| Patient<br>connection | Standard Trocar luer connection | Standard Trocar luer connection | Same |
| Indications for<br>Use | The EVA15 Insufflator is<br>intended for use in diagnostic<br>and/or therapeutic endoscopic and<br>laparoscopic procedures to<br>distend the abdomen,<br>colon or thoracic cavity with up<br>to 15 mmHg pressure, by filling it<br>with gas and to evacuate surgical<br>smoke. | The EVA 15 Insufflator is intended<br>for use in diagnostic and/or<br>therapeutic endoscopic and<br>laparoscopic procedures to distend<br>the abdomen, rectum, colon,<br>esophagus, stomach or thoracic<br>cavity with up to 15 mmHg<br>pressure, by filling it with gas and to<br>evacuate surgical smoke. | Similar |
| Gas Delivery<br>Modes | Fixed Flow<br>Intermittent Pressure (Standard)<br>Insufflation<br>Continuous Pressure Insufflation | Fixed Flow<br>Intermittent Pressure (Standard)<br>Insufflation<br>Continuous Pressure Insufflation | Same |
| Smoke<br>Evacuation | Available in all modes. Operates<br>continuously or may be activated<br>on/off using foot pedal. | Available in all modes. Operates<br>continuously or may be activated<br>on/off using foot pedal. | Same |
| 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<br>Sterilization | EtO | EtO | Same |
| User Interface | Membrane Panel | Membrane Panel | Same |

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# 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.