The subject device consists of an insufflator, a high pressure tube and a pneumoperitoneum tube. The insufflator is a microprocessor-controlled CO2 insufflator that consists of the following major components and features: housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, various setting keys and display elements. The insufflator is not intended to enter the field and cannot be sterilized. The pneumoperitoneum tube shall be cleaned, disinfected, and sterilized prior to subsequent use.

AI/ML Overview

The provided document is a 510(k) summary for an Insufflator (K222812), intended to facilitate the use of a laparoscope by distending the peritoneal cavity with gas. It primarily focuses on demonstrating substantial equivalence to a predicate device (K030837) and a reference device (K153513) through non-clinical performance testing.

Based on the provided information, here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a table of "acceptance criteria" for specific performance metrics in a pass/fail format alongside the device's reported performance. Instead, it lists the standards and the types of comparative non-clinical performance testing performed, implying that meeting these standards and showing comparable performance to the predicate device would be the acceptance criteria.

However, we can infer some criteria from the "General Comparison" table (Table 2) and the "Performance Specifications" in Table 3 (which is incomplete in the provided text).

Aspect / Category	Acceptance Criteria (Implied / Inferred)	Reported Device Performance (Subject Device K222812)	Comments / Comparison to Predicate
Set Pressure Range	Pediatric mode: 1-10mmHg; Adult/Bariatric: 1-30mmHg (matching reference device)	Pediatric mode: 1-10mmHg; Adult and bariatric mode: 1-30mmHg	Different from predicate (1-30mmHg) but aligns with capabilities of the reference device.
Accuracy of Pressure	≤ ± 2mmHg (comparable to predicate's ±1mmHg or within acceptable limits)	± 2mmHg	Different from predicate (±1mmHg). This difference is not stated to raise safety concerns.
Set Gas Flow Range	1-50L/min (matching reference device)	1-50L/min	Different from predicate (1-40L/min) but matches reference device.
Overpressure Warning	Warning initiated when actual pressure is >3mmHg above nominal pressure	When actual pressure is >3mmHg above nominal pressure, the overpressure warning is initiated	Different from predicate (>4mmHg). Subject device has a tighter warning threshold.
Gas Supply Warning	Warning when cylinder <15 bar or central supply <2 bar	When gas cylinder pressure falls below 15 bar or central gas supply pressure falls below 2 bar, injection will be interrupted, device warning initiated.	Specific thresholds provided, comparable functionality to predicate.
Contamination Warning	Interruption and warning on fluid penetration	When fluid penetrates into the device through the pneumoperitoneum tube joint, the gas injection will be interrupted, device warning initiated.	Same as predicate.
Venting Defect Warning	Interruption and warning on venting defect	When the device vents defect, the gas injection will be interrupted, device warning initiated.	Present in subject device, not specified for predicate.
Heater Defect Warning	Interruption and warning when gas temp > 41°C	When the gas temperature is greater than 41°C, the gas injection will be interrupted, device warning initiated.	Different from predicate (>42°C). Subject device has a slightly lower warning threshold.
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same as predicate and reference device.
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Same as predicate and reference device.
Software V&V	In accordance with relevant FDA guidance	Test results demonstrated software function met requirements	Performed for Major Level of Concern software.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "non clinical tests were conducted" and "comparative performance testing was also conducted on the subject and predicate devices." However, it does not specify the sample sizes used for these tests. The tests are non-clinical, meaning they involve lab testing of the devices themselves, not patient data. Therefore, questions of country of origin of data or retrospective/prospective are not applicable for this non-clinical submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable as the studies are entirely non-clinical performance and safety tests of a medical device (insufflator). There is no "ground truth" to be established by clinical experts for a test set in the context of this 510(k) submission.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above. Non-clinical engineering tests do not involve expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (insufflator) and relies on non-clinical performance and safety testing. There are no human readers or cases involved in the presented studies.

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

This question is not applicable in the traditional sense for this device. The device is hardware with embedded software, not an AI algorithm performing diagnostic or therapeutic functions needing standalone performance evaluation in the context of AI/ML. The software verification and validation were performed as an integral part of the device's functionality.

7. The Type of Ground Truth Used:

As the studies are non-clinical performance tests, the "ground truth" would be established by:

Engineering specifications and standards: Adherence to standards like IEC 60601-1, IEC 60601-1-2, ASTM D4169, AAMI TIR 30, AAMI TIR 12, ISO 15883-2, ISO 17665-1, ISO 14971, and IEC 60601-2-18.
Expected physical and functional performance: Measured parameters like flow rate, pressure accuracy, temperature, and warning thresholds are compared against design specifications and the performance of the predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an insufflator, not a machine learning or AI model that requires a training set of data. The software within the device is likely deterministic control software, subject to standard software verification and validation, not machine learning model training.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable as there is no training set mentioned or implied for this device.

Summary

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May 16, 2023

Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K222812 Trade/Device Name: Insufflator Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF Dated: April 14, 2023 Received: April 14, 2023

Dear Diana Hong:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K222812

Device Name Insufflator

Indications for Use (Describe)

The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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

The assigned 510(k) Number: _ K222812

1. Date of Preparation: 05/12/2023
1. Sponsor Identification

Scivita Medical Technology Co., Ltd. No. 8, Zhong Tian Xiang, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R. CHINA.

Establishment Registration Number: 3020746799.

Contact Person: Ruqin Wu Position: Regulation Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Subject Device

Trade Name: Insufflator Common Name: Laparoscopic Insufflator

Classification Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF (Insufflator, Laparoscopic) Regulation Number: 21 CFR 884.1730 Review Panel: Obstetrics/Gynecology

Indications for Use:

The Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

Device Description:

System name	Component name	Model
Insufflator	Insufflator	SL101, SL102
	Pneumoperitoneum tube	IL-QFH02, IL-QF02
	High pressure tube	High pressure Tube for Central Gas supply:IL-GY(G)02, IL-GY(E)02, IL-GY(A)02High pressure Tube for Gas Cylinder:IL-GY02

Table 1. System Configuration

The SL101 insufflator has the gas heating function, while the SL102 insufflator does not have the gas heating function. And the IL-QFH02 pneumoperitoneum tube has the gas heating function, while the IL-QF02 pneumoperitoneum tube does not have the gas heating function. The high pressure tube is provided in two types, connected to Central Gas supply and to Gas Cylinder. The high pressure tube for Central Gas supply can be available in 3 models, IL-GY(G)02, IL-GY(E)02, IL-GY(A)02; while the high pressure tube for Gas Cylinder can only be available in IL-GY02 model.

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5. Identification of Predicate Devices

Predicate Device 510(k) Number: K030837 Trade/Device Name: 40 L HIGH FLOW INSUFFLATOR F108

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

Reference Device 510(k) Number: K153513 Trade/Device Name: Insufflator 50L FM134

6. Summary of Technological characteristics

ITEM	Subject Device	Predicate Device	Reference Device	Remark
Product	Insufflator	K030837	K153513	/
		40 L HIGH FLOWINSUFFLATOR F108	InsufflatorFM13450L
Product Code	HIF	HIF	HIF, OSV	Same
Regulation No.	21 CFR 884.1730	21 CFR 884.1730	21 CFR 884.1730	Same
Class	II	II	II	Same
Indications for Use	The Insufflator is adevice intended tofacilitate the use of thelaparoscope by filling theperitoneal cavity withgas to distend it.	The 40L High FlowInsufflator F108 withlow flow mode is adevice intended tofacilitate the use of thelaparoscope by fillingthe peritoneal cavitywith gas to distend it.	The device Insufflator50L FM134 is a CO2insufflator intendedfor use duringdiagnostic and/ortherapeuticendoscopicprocedures to distenda cavity by filling itwith gas. TheStandard, Pediatricand Bariatricoperating modes ofthe device areindicated to fill anddistend a peritonealcavity with gas duringa laparoscopic	Same

			procedure. ThePediatric operatingmode is specificallyindicated for pediatriclaparoscopicprocedures. TheVessel Harvestingoperating mode isindicated for useduring endoscopicvessel harvestingprocedures to create acavity along thesaphenous vein orradial artery.
Configuration	Insufflator (housing,power supply, pressurereducers, venting system,fluid sensor, gas heater,various setting keys anddisplay elements), highpressure tube andpneumoperitoneum tube	Housing, powersupply, pressurereducers, a ventingsystem, a fluid sensor,a gas heater, varioussetting keys anddisplay elements	Casing, world powersupply, pressurereducers, ventingsystem, redundantpressure pressuremeasurement, fluidsensor, gas heater,software controlledgraphical userinterface (GUI) touchscreen and varioussetting keys anddisplay elements	Different
Mechanism ofAction	Microprocessorcontrolled CO2insufflator	Microprocessorcontrolled CO2insufflator	Microprocessorcontrolled CO2insufflator	Same
ITEM	Subject Device	Predicate Device K030837	Reference Device K153513	Remark
Product	Insufflator	40 L HIGH FLOWINSUFFLATOR F108	Insufflator 50LFM134	/
Operating Modes	Pediatric mode, adult mode and bariatric mode	Veress operating mode, High Flow operating mode	Standard, Pediatric and Bariatric operating mode	Different
Set Pressure Range	Pediatric mode:1-10mmHgAdult mode and bariatric mode: 1-30mmHg	1-30mmHg	/	Different
Accuracy of Pressure	$\pm$ 2mmHg	$\pm$ 1mmHg	/	Different
Set Gas Flow Range	1-50L/min	1-40L/min	1-50L/min	Different
Power Supply	100-240V, 50/60Hz	100-240V, 50/60Hz	/	Same
Weight	About 8.2kg	About 7kg	/	Different
Dimension (W x H x D)	267mm x 395mm x 134mm	267mm x 138mm x 410mm	/	Different
Overpressure warning function	Has the overpressure warning function;When the actual pressure is > 3 mmHg above the nominal pressure, the overpressure warning is initiated.	Has the overpressure warning function;When the actual pressure is > 4 mmHg above the nominal pressure, the overpressure warning is initiated.	/	Different
Gas supply warning function	When gas cylinder pressure falls below 15 bar or central gas supply pressure falls below 2 bar, injection will be interrupted, device warning initiated.	When gas cylinder pressure falls below 15 bar or central gas supply pressure is too low, injection will be interrupted, device warning initiated.	/	Different
Contamination warning function	When the fluid penetrates into the device through the pneumoperitoneum tube joint, the gas injection will	When the fluid penetrates into the device through the pneumoperitoneum	/	Same

Table 2. General Comparison

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	Table 3. Performance and Safety Comparison
--	--------------------------------------------	--	--

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	be interrupted, device warning initiated.	tube joint, the gas injection will be interrupted, device warning initiated.
Venting defect warning function	When the device vents defect, the gas injection will be interrupted, device warning initiated.	/	/	Different
Heater defect warning function	When the gas temperature is greater than 41°C, the gas injection will be interrupted, device warning initiated.	When the gas temperature is greater than 42°C, the gas injection will be interrupted, device warning initiated.	/	Different
Material	Insufflator: The shell material is steel plate, and the front panel is resin composite material.High Pressure Tube: Synthetic rubber, double braided steel wirePneumoperitoneum Tube: Silicone, SUS304, PSU	Host: The outer surface is steel plate and resin.Tube: Silicone, PSU, Special steel	/	Different
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Same

The differences between the subject and predicate devices do not raise different questions of safety or effectiveness.

1. Summary of Non-Clinical Performance Testing
  Non clinical tests were conducted to verify that the subject device met all design specifications as was same/similar to the predicate device and reference device. The test results demonstrated that the subject device complies with the following standards:
A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences

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A IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
AAMI TIR 30: 2011/ (R) 2016 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
AAMI TIR 12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
ISO 15883-2:2006 Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
A ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 14971: 2019 Medical devices - Application of risk management to medical devices
IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

The software verification and validation for software with a Major Level of Concern were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.

The following comparative performance testing was also conducted on the subject and predicate devices:

Compensation of leakages
Flow rate
Gas temperature
Overpressure release time
A Overpressure alarm test
Set pressure output
1. Summary of Clinical Testing

No clinical study is included in this submission.

9. Conclusion

The results of nonclinical testing demonstrate that the subject devices are as safe and effective as the predicate device to support a substantial equivalence determination.

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.