K Number

Device Name

Insufflator

Manufacturer

Scivita Medical Technology Co., Ltd.

Date Cleared

2023-05-16

(239 days)

Product Code

HIF

Regulation Number

884.1730

Intended 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

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K030837

Reference Devices

K153513

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions a "microprocessor-controlled" device and standard software validation, but there is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML.

Therapeutic

No
The device is intended to facilitate the use of a laparoscope by distending the peritoneal cavity with gas, which is an intraoperative function but does not directly treat a disease or condition.

Diagnostic

No
The device's intended use is to fill the peritoneal cavity with gas to distend it for laparoscopic procedures, which is a therapeutic or facilitative function, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components such as housing, power supply, pressure reducers, venting system, fluid sensor, gas heater, setting keys, and display elements, in addition to the software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it." This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
Device Description: The device is described as a CO2 insufflator used to distend the peritoneal cavity. This is a surgical/procedural device, not a device designed to analyze biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This insufflator's function is purely mechanical/procedural.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HIF

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peritoneal cavity

Indicated Patient Age Range

Pediatric mode, adult mode and bariatric mode

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

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
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.
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
Overpressure alarm test
Set pressure output

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030837

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K153513

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below that.

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.

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

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

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)02
High 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.

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 FLOW
INSUFFLATOR F108	Insufflator
FM134
50L
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 a
device intended to
facilitate the use of the
laparoscope by filling the
peritoneal cavity with
gas to distend it.	The 40L High Flow
Insufflator F108 with
low flow mode is a
device intended to
facilitate the use of the
laparoscope by filling
the peritoneal cavity
with gas to distend it.	The device Insufflator
50L FM134 is a CO2
insufflator intended
for use during
diagnostic and/or
therapeutic
endoscopic
procedures to distend
a cavity by filling it
with gas. The
Standard, Pediatric
and Bariatric
operating modes of
the device are
indicated to fill and
distend a peritoneal
cavity with gas during
a laparoscopic	Same

			procedure. The
Pediatric operating
mode is specifically
indicated for pediatric
laparoscopic
procedures. The
Vessel Harvesting
operating mode is
indicated for use
during endoscopic
vessel harvesting
procedures to create a
cavity along the
saphenous vein or
radial artery.
Configuration	Insufflator (housing,
power supply, pressure
reducers, venting system,
fluid sensor, gas heater,
various setting keys and
display elements), high
pressure tube and
pneumoperitoneum tube	Housing, power
supply, pressure
reducers, a venting
system, a fluid sensor,
a gas heater, various
setting keys and
display elements	Casing, world power
supply, pressure
reducers, venting
system, redundant
pressure pressure
measurement, fluid
sensor, gas heater,
software controlled
graphical user
interface (GUI) touch
screen and various
setting keys and
display elements	Different
Mechanism of
Action	Microprocessor
controlled CO2
insufflator	Microprocessor
controlled CO2
insufflator	Microprocessor
controlled CO2
insufflator	Same
ITEM	Subject Device	Predicate Device K030837	Reference Device K153513	Remark
Product	Insufflator	40 L HIGH FLOW
INSUFFLATOR F108	Insufflator 50L
FM134	/
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:
1-10mmHg
Adult 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

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

	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 wire
Pneumoperitoneum 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

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 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.