Gas Insufflator

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K221995 Device Name Gas Insufflator Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> <span> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over The Counter Use (21 CFR 801 Subpart C) </span> </div> | > Prescription Use (Part 21 CFR 801 Subpart D) ver-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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. {4}------------------------------------------------ ## 4. 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. # 5. Indications for 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. # 6. Comparison of the technological characteristics | Comparison<br>Items | Subject Device | Predicate Device | Verdict | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------| | 510(K) No. | K221995 | K161554 | \ | | Product Name | Gas Insufflator | ENDOFLATOR 40, model UI4000 | \ | | Regulation<br>No. | 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 {5}------------------------------------------------ | K221995 | |---------| | 3 / 5 | | | | | 3 / 5 | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Indications<br>for Use | The Gas Insufflator is designed to use<br>carbon dioxide gas to insufflate the<br>abdominal cavity, so as to generate and<br>maintain pneumoperitoneum, expand<br>the surgical field and keep sufficient<br>space during diagnostic and therapeutic<br>laparoscopic procedures. | The ENDOFLATOR 40 are used to<br>create and/or to distend a cavity in the<br>following diagnostic and therapeutic<br>interventions:<br>• Laparoscopy<br>• Pediatric Laparoscopy<br>• Endoscopy of the Lower<br>Gastrointestinal Tract:<br>(e.g., TEO, colonoscopy)<br>• Endoscopic Vessel Harvesting | Similar | | Distension<br>Medium | CO2 | CO2 | Same | | Indicated<br>Population | Adult and Pediatric | Adult and Pediatric | Same | | Modes | Adult mode,<br>Child mode | High Flow,<br>Pediatrics | Same | | Maximum<br>Flow Rate | Adult: 40 L/min<br>Pediatric: 15 LPM | High flow: 40 LPM (ENDOFLATOR<br>40)<br>Pediatric: 15 LPM | Same | | Maximum<br>Pressure | Adult: 30 mmHg<br>Pediatric: 15 mmHg | High flow: 30 mmHg<br>Pediatric: 15 mmHg | Same | | Overpressure<br>Action | Intra-abdominal pressure exceeds the<br>set value 5mmHg and continuously<br>exceeds 5s: visual and audible alarm<br>followed by pressure relief after 5<br>seconds | Pediatric:<br>Intra-abdominal<br>pressure >0.1 x set pressure + 2.5<br>mmHg for 3 sec (max 4 mmHg)<br>High flow: Intra-abdominal<br>pressure >0.05 x set pressure + 3.5<br>mmHg for 3 sec (max 5 mmHg)<br>Visual and audible alarms followed by<br>pressure relief after 5 seconds | Similar | | Gas Supply<br>Shortage<br>Action | At < 10 bar, informational signal<br>At < 3 bar, visual warning<br>At <1 bar, visual and audible alarm and<br>gas supply stopped/insufflation<br>deactivated. | At < 10 bar, informational signal<br>At <1 bar, visual and audible alarm and<br>gas supply stopped/insufflation<br>deactivated | Similar | | Over<br>Temperature<br>Protection | None, no heating available | >41°C<br>Heating 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ 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.