The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.

Device Description

The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W).

The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode.

The Gas Insufflator is for professional healthcare environment use.

AI/ML Overview

The provided text describes the acceptance criteria and the study conducted for the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Gas Insufflator (K221995).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance testing rather than specific "acceptance criteria" in a tabular format with corresponding reported performance. However, the "Comparison of the technological characteristics" table (Table 1) acts as a de-facto acceptance criteria by demonstrating similarity or equivalence to the predicate device. The "Bench Performance testing" section lists tests conducted to demonstrate performance and safety features.

Acceptance Criteria (Implied from comparison and performance testing)	Reported Device Performance (from "Bench Performance testing" and "Comparison" section)
General Intended Use	The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures. (Same as predicate)
Distension Medium	CO2 (Same as predicate)
Indicated Population	Adult and Pediatric (Same as predicate)
Modes	Adult mode, Child mode (Similar to predicate's High Flow, Pediatrics)
Maximum Flow Rate	Adult: 40 L/min, Pediatric: 15 L/min (Same as predicate: High flow: 40 LPM, Pediatric: 15 LPM)
Maximum Pressure	Adult: 30 mmHg, Pediatric: 15 mmHg (Same as predicate: High flow: 30 mmHg, Pediatric: 15 mmHg)
Overpressure Action	Intr-abdominal pressure exceeds the set value 5mmHg and continuously exceeds 5s: visual and audible alarm followed by pressure relief after 5 seconds (Similar to predicate's overpressure action for Pediatric and High flow modes)
Gas Supply Shortage Action	At < 10 bar, informational signal; At < 3 bar, visual warning; At <1 bar, visual and audible alarm and gas supply stopped/insufflation deactivated. (Similar to predicate)
Electrical Safety & EMC	Complies with IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18:2009, IEC 60601-1-8:2006 + A2:2020.
Software Verification & Validation	Conducted and documented, considered a "Major" level of concern.
Sterility & Aging Effect (for Tubing Set)	Validated per ISO 11135:2014, EO limit per ISO 10993-7:2008, packaging integrity per ASTM D4169-16. Supported a shelf-life of 2 years (ASTM F1886/F1886M-16, ASTM F88/F88M-15, ASTM F1929-15, ASTM F-1980-16).
Bench Performance (Static Condition)	Accuracy of gas pressure in normal and insufficient air supply conditions tested. Accuracy of flow rate in normal and insufficient air supply conditions tested.
Bench Performance (Dynamic Condition)	Accuracy of gas pressure with continuous leak of 1, 3, 5, 7, and 10 L/min tested. Accuracy of gas pressure with transient leak of 32 L/min tested.
Bench Performance (Safety Features)	Gas consumption display, Overpressure protection, Low/high gas supply protection tested.

2. Sample size used for the test set and the data provenance:

The document describes bench testing, software validation, sterility testing, and electrical safety/EMC testing. There is no mention of a "test set" in the context of patient data or clinical studies. The testing is performed on the device itself or its components (e.g., insufflation tubing set). Therefore, "sample size" in terms of patient data and "data provenance" (country of origin, retrospective/prospective) are not applicable here as this is a medical device clearance for a Gas Insufflator, not an AI/diagnostic software.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a Gas Insufflator, not a diagnostic device requiring expert interpretation for ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the same reasons as above.

5. 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:

This information is not applicable as the device is a Gas Insufflator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a physical medical device (Gas Insufflator), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for this device's performance is established by engineering and regulatory standards (e.g., IEC, ISO, ASTM) and pre-defined performance specifications related to pressure, flow rate, safety alarms, and electrical characteristics. For example, the accuracy of gas pressure is measured against a known standard.

8. The sample size for the training set:

This information is not applicable as the device is a Gas Insufflator, not an AI/machine learning model that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 28, 2023

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Guofang Ma QA&RA Director No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area Zonghan Subdistrict Cixi. Zhejiang 315300 CHINA

Re: K221995

Trade/Device Name: Gas Insufflator Regulation Number: 21 CFR 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: February 18, 2023 Received: February 23, 2023

Dear Guofang Ma:

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

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statutes and regulations administered by other Federal agencies. 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-regulatory-information/postmarketing-safety-reportingcombination-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 Roberts -S

Jason 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) K221995

Device Name Gas 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)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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K221995 Page 1 of 5

K221995 1 / 5

510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter Information

● 510(k) Submitter:

Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. No.1 Xinxing Yilu Road, Emerging Industrial Cluster Area, Zonghan Subdistrict, Cixi City, Zhejiang, 315300, China

Contact
Guofang Ma QA&RA Director Telephone: +86-010-64117355-8108 Fax: +86-010-64117355-8167 Email: QARA@surgnova.com
Date Prepared: Mar 28, 2023

2. Device Information

Trade/Proprietary Name: Gas Insufflator Common Name: Gas Insufflator Classification Name: Laparoscopic Insufflator Classification Number: 21 CFR 884.1730 Product Code: HIF (Insufflator, Laparoscopic) Regulatory Class: Class II

3. Predicate Device

510(k) Number: K161554 Trade/Device Name: ENDOFLATOR 40, Model UI4000 Classification Name: Laparoscopic Insufflator Classification Number: 21 CFR 884.1730 Product Code: HIF, OSV, FCX Regulatory Class: Class II

The predicate device has not been subject to a design related recall.

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4. Device Description

The Gas Insufflator is for professional healthcare environment use.

5. Indications for use

6. Comparison of the technological characteristics

ComparisonItems	Subject Device	Predicate Device	Verdict
510(K) No.	K221995	K161554	\
Product Name	Gas Insufflator	ENDOFLATOR 40, model UI4000	\
RegulationNo.	21 CFR 884.1730	21 CFR 884.1730	Same
Classification	II	II	Same
Product Code	HIF	HIF, OSV, FCX	Same
Intended use	The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during laparoscopic diagnosis and/or surgical treatment.	CO2 insufflators and their accessories are used to create and/or to distend a cavity during diagnostic or therapeutic endoscopic interventions.	Same

Table 1 Comparison of subject and predicate device technological characteristics

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K221995
3 / 5

			3 / 5
Indicationsfor Use	The Gas Insufflator is designed to usecarbon dioxide gas to insufflate theabdominal cavity, so as to generate andmaintain pneumoperitoneum, expandthe surgical field and keep sufficientspace during diagnostic and therapeuticlaparoscopic procedures.	The ENDOFLATOR 40 are used tocreate and/or to distend a cavity in thefollowing diagnostic and therapeuticinterventions:• Laparoscopy• Pediatric Laparoscopy• Endoscopy of the LowerGastrointestinal Tract:(e.g., TEO, colonoscopy)• Endoscopic Vessel Harvesting	Similar
DistensionMedium	CO2	CO2	Same
IndicatedPopulation	Adult and Pediatric	Adult and Pediatric	Same
Modes	Adult mode,Child mode	High Flow,Pediatrics	Same
MaximumFlow Rate	Adult: 40 L/minPediatric: 15 LPM	High flow: 40 LPM (ENDOFLATOR40)Pediatric: 15 LPM	Same
MaximumPressure	Adult: 30 mmHgPediatric: 15 mmHg	High flow: 30 mmHgPediatric: 15 mmHg	Same
OverpressureAction	Intra-abdominal pressure exceeds theset value 5mmHg and continuouslyexceeds 5s: visual and audible alarmfollowed by pressure relief after 5seconds	Pediatric:Intra-abdominalpressure >0.1 x set pressure + 2.5mmHg for 3 sec (max 4 mmHg)High flow: Intra-abdominalpressure >0.05 x set pressure + 3.5mmHg for 3 sec (max 5 mmHg)Visual and audible alarms followed bypressure relief after 5 seconds	Similar
Gas SupplyShortageAction	At < 10 bar, informational signalAt < 3 bar, visual warningAt <1 bar, visual and audible alarm andgas supply stopped/insufflationdeactivated.	At < 10 bar, informational signalAt <1 bar, visual and audible alarm andgas supply stopped/insufflationdeactivated	Similar
OverTemperatureProtection	None, no heating available	>41°CHeating is turned off	Different

The Gas Insufflator has the same general intended use. According to above comparison results, difference in technological characteristics do not raise different questions of safety and effectiveness.

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K221995 4 / 5

7. Summary of Non-Clinical Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

The Gas Insufflator has been designed and tested as follows:

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Gas Insufflator in accordance to the following standards:

IEC 60601-1:2005 + A1:2012
IEC 60601-1-2:2014
IEC 60601-2-18:2009
IEC 60601-1-8:2006 + A2:2020

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "Major" level of concern.

Sterility and Aging Effect

Sterilization of the tubing set is via EO and was validated per ISO 11135:2014, Half cycle approach, the EO limit was validated per ISO 10993-7:2008, and the packaging integrity was validated per ASTM D4169-16. In addition, testing to ASTM F1886/F1886M-16 (visual inspection), ASTM F88/F88M-15 (seal strength), ASTM F1929-15 (dye penetration) and ASTM F-1980-16 (aging) supported a shelf-life of 2 years.

Bench Performance testing

The Gas Insufflator was tested to demonstrate the performance including safety features. Tests were conducted in both Adult and Child modes. Full ranges of pressure and flow rates were tested:

Static condition .
- . Accuracy of gas pressure in normal and insufficient air supply conditions
- Accuracy of flow rate in normal and insufficient air supply conditions .
Dynamic condition
- Accuracy of gas pressure with continuous leak of 1, 3, 5, 7, and 10 L/min .
- Accuracy of gas pressure with transient leak of 32 L/min .
Gas consumption display
Safety features

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K221995 ર | ટ

Overpressure protection
Low/high gas supply protection

8. Conclusion

The non-clinical test results described above demonstrate that the subject device is as safe and effective as the predicate device. Therefore, the subject device is substantially equivalent to the predicate.

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.