The Omniflator® Model 6630 CO₂ Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6600. The 6630 has an adjustable gas flow rate from 0-30 LPM. The unit shall have direct patient pressure monitoring which can be used by attaching the direct patient monitoring tubing set to the Omniflator's® patient monitoring connector and subsequently into a cannula or trocar after initial insufflation has been achieved. The user has an option to utilize CO2 from a central supply or E-Cylinder tank.

AI/ML Overview

The provided documents describe a Laparoscopic Insufflator, Omniflator® 6630 (K973447), which received 510(k) clearance from the FDA in 1998. The primary purpose of this medical device submission is to demonstrate substantial equivalence to previously marketed devices, not to present a study proving the device meets acceptance criteria in the way this request typically defines it for AI/ML performance studies.

Therefore, many of the requested elements for an AI/ML performance study are not applicable to this traditional medical device submission. The focus here is on design, materials, and intended use as compared to existing technology, rather than on algorithm performance against a ground truth.

Here's an attempt to address the prompt based on the available information, noting where information is not present due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (for substantial equivalence)	Reported Device Performance (as stated in submission)
Design: Similar to predicate devices.	Omniflator® Model 6630 incorporates front panel controls similar to current Omniflator® Model #6600.
Materials: Non-toxic and previously used in medical devices.	All materials are non-toxic and have been previously used to manufacture other medical devices.
Intended Use: Gas distention of the abdomen for diagnostic and/or operative laparoscopy.	Used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.
Adjustable Gas Flow Rate: Within a specified range.	Adjustable gas flow rate from 0-30 LPM.
Patient Pressure Monitoring: Capability for direct monitoring.	Unit shall have direct patient pressure monitoring… by attaching direct patient monitoring tubing set.
CO2 Source Options: Central supply or E-Cylinder tank.	User has an option to utilize CO2 from a central supply or E-Cylinder tank.
Substantial Equivalence: Demonstrate equivalence to currently marketed devices (e.g., Snowden - Pencer).	Northgate's 6630 Insufflator/tubing sets are substantially equivalent in design, materials, and intended use to other currently marketed devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use, not on a performance study using a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth for an AI/ML algorithm's performance is established or described in these documents. The "ground truth" equivalent would be the existing characteristics and performance of the predicate devices.

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

Not applicable. No test set or expert adjudication is described for algorithm performance.

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

Not applicable. This device is a laparoscopic insufflator, not an AI-assisted diagnostic tool.

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

Not applicable. This relates to an AI/ML algorithm, which is not what this device is.

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

For the purpose of substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices based on their historical use and regulatory clearances. This is assessed by the FDA against the new device's specifications.

8. The sample size for the training set

Not applicable. No training set for an AI/ML algorithm is described.

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

Not applicable. No training set or associated ground truth is described.

Summary for this specific device (Omniflator® 6630):

The provided documents are for a 510(k) submission for a non-AI/ML medical device. The "acceptance criteria" discussed are related to demonstrating substantial equivalence to existing, legally marketed predicate devices, rather than the performance metrics of a novel algorithm. The "study" proving these criteria are met is the comparison presented by the manufacturer (Northgate Technologies, Inc.) to the FDA, detailing the device's design, materials, and intended use in relation to established predicates. The FDA's review and clearance (K973447) signifies their agreement with the claim of substantial equivalence.

Summary

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SEP 3 0 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name: Laparoscopic Insufflator

Omniflator® 6630 Proprietary Name:

Classification: CLASS II

Materials:

All materials used to manufacture the Northgate Technologies Inc. Omniflator® Model 6630 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.

Description:

Substantial Equivalence:

Northgate's 6630 Insufflator/tubing sets are substantially equivalent in design, materials, and intended use to other currently marketed devices. Other manufacturers of similar devices are Snowden - Pencer.

Intended Use:

The Nortech® 6630 Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 3 0 1998

Mr. Casey Kurek Regulatory Manager Northgate Technologies, Inc. 600 Church Road Elgin, IL 60123

Re: K973447 Nortech Omniflator® 6630 Dated: July 14, 1998 Received: July 16, 1998 Regulatory Class: II

21 CFR 884.1730/Procode: 85 HIF

Dear Mr. Kurek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmam.n.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Labels	Values
510(k) Number (if known):	K973447

Corve active Lake

OMNIFLATOR® 6630 Device Name:

Indications For Use:

THE NORTECH OMNIFLATOR® 6630 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

Casey Kurek 9.8.97

C. Kufek, Regulatory Manager

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

David C. Hegmon
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K973447

(Optional Format 1-2-96)

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.