EVA15 insufflator

K222901 · Palliare , Ltd. · HIF · Jan 27, 2023 · Obstetrics/Gynecology

Device Facts

• Record ID: K222901
• Device Name: EVA15 insufflator
• Applicant: Palliare , Ltd.
• Product Code: HIF · Obstetrics/Gynecology
• Decision Date: Jan 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EVA 15 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 25 mmHg pressure, by filling it with gas and to evacuate surgical smoke.

Device Story

EVA15 Insufflator is a microprocessor-controlled device for endoscopic/laparoscopic procedures; used in OR or endoscopy suites by clinicians. Inputs: compressed CO2 gas (50 psi) and air. Operation: digital pressure regulation system delivers CO2 to distend body cavities (up to 25 mmHg, 40 SLPM flow); venturi-based vacuum system evacuates surgical smoke. Output: controlled gas delivery and smoke removal. Features: foot pedal control, disposable tubeset with ID chip for usage tracking/validation. Benefits: maintains cavity distension while clearing smoke, improving visualization. Healthcare providers use membrane panel to set parameters; device ensures safe pressure limits via software-controlled regulation.

Clinical Evidence

Bench testing only. Performance testing verified pressure accuracy, simulated leak response, and smoke evacuation efficiency within the 25 mmHg range. Software verification confirmed the device correctly reads the tubeset ID chip to enforce usage limits.

Technological Characteristics

Microprocessor-controlled insufflator; digital pressure regulation; venturi-based smoke evacuation. Dimensions: 160x130x330mm; Weight: 5.5kg. Power: 100-240V AC. Gas: 50 psi CO2/air. Connectivity: ID chip in disposable tubeset connector. Sterilization: EtO for tubeset. User interface: membrane panel.

Indications for Use

Indicated for patients undergoing laparoscopic or endoscopic procedures requiring cavity distension via gas insufflation 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 (K202799)

Reference Devices

• World of Medicine Model FM134 (K153513)
• Tubeset (K193520)
• Tubeset (K202922)

Submission Summary (Full Text)

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

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.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <span></span> | <span></span> |
| <div></div> | <div></div> |
| <span></span> | <span></span> |
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> 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.<br>Galway Business Park, Dangan<br>Galway H91 P2DK, Ireland<br>Tel - [phone] | |
| Official Contact: | John O'Dea, Ph.D., Director |
| Submission Correspondent: | Paul Dryden<br>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 |
| 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:

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.

## 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:<br>EVA15 Insufflator - K202799 | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer | Palliare | Palliare | Same |
| Classification | 21 C.F.R. § 884.1730 ( <i>Laparoscopic Insufflator</i> )<br>Product Code HIF, FCX (Class II) | 21 C.F.R. § 884.1730 ( <i>Laparoscopic Insufflator</i> )<br>Product Code HIF, FCX (Class II) | Same |
| Fundamental<br>scientific<br>technology | Digital insufflation pressure regulation system<br>using compressed CO2 gas. Venturi smoke<br>evacuation. | Digital insufflation pressure regulation system<br>using compressed CO2 gas. Venturi smoke<br>evacuation. | Same |
| Patient<br>connection | Standard Trocar luer connection | Standard Trocar luer connection | Same |
| Indications for<br>Use | The EVA 15 Insufflator is intended for use in<br>diagnostic and/or therapeutic endoscopic and<br>laparoscopic procedures to distend the abdomen,<br>rectum, colon, esophagus, stomach or thoracic<br>cavity with up to 25 mmHg pressure, by filling it<br>with gas and to evacuate surgical smoke. | The EVA 15 Insufflator is intended for use in<br>diagnostic and/or therapeutic endoscopic and<br>laparoscopic procedures to distend the abdomen,<br>rectum, colon, esophagus, stomach or thoracic<br>cavity with up to 15 mmHg pressure, by filling it<br>with gas and to evacuate surgical smoke. | Similar except extension of<br>pressure range |
| Gas Delivery<br>Modes | Intermittent Pressure (Standard) Insufflation<br>Continuous Pressure Insufflation | Fixed Flow<br>Intermittent Pressure (Standard) Insufflation<br>Continuous Pressure Insufflation | Fixed flow not offered in<br>proposed product |
| Smoke<br>Evacuation | Available in all modes. Operates continuously<br>or may be activated on/off using foot pedal. | Available in all modes. Operates continuously or<br>may 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 the<br>reference K153515 |
| Accessories | Tubeset | Tubeset | Same as cleared under<br>K193520 and K202922<br>except for addition of ID Chip |
| Use limitation<br>of tube set | 48 hours due to ID Chip | Labeling was disposable but nothing prevented<br>continued use | Addition of ID chip |
| | Proposed Device: EVA15 Insufflator | Predicate:<br>EVA15 Insufflator - K202799 | Comparison |
| 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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