THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

Device Description

The CO, Gas Warmer II Unit is designed to be used in conjunction with an insufflator to provide continuous non-adjustable heating of gas to a laparoscopic instrument. The CO2 Gas Warmer II Unit is comprised of a control unit and reusable heat exchanger and power cords.

AI/ML Overview

The provided text describes a medical device, the Northgate Technologies Inc. CO2 Gas Warmer II, and its regulatory clearance based on substantial equivalence. It does not contain information about acceptance criteria or a study demonstrating device performance against specific criteria in the way typically seen for AI/ML-driven devices or those requiring extensive clinical studies to prove effectiveness.

The clearance is based on substantial equivalence to predicate devices. This means that instead of conducting new performance studies to meet new acceptance criteria, the manufacturer demonstrated that their device is as safe and effective as a device already legally marketed.

Therefore, most of the requested information about acceptance criteria and performance studies is not applicable to this type of regulatory submission in the way the questions are framed for AI/ML or efficacy-proving studies.

Here's a breakdown based on the provided text:

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

Acceptance Criteria: The implicit acceptance criterion for this device, based on the provided document, is that it warms gas to a range of 95-105°F / 35-40.5°C. This is stated as the "Indications For Use" and is the essential function described. There are no other performance metrics or specific thresholds (e.g., accuracy, sensitivity, specificity, or response time) explicitly mentioned as acceptance criteria for regulatory clearance.
Reported Device Performance: The document does not provide a specific performance study or test results demonstrating that the CO2 Gas Warmer II achieves this temperature range. The substantial equivalence argument implies that it does achieve this, or would be expected to, based on the design, materials, and intended use being similar to already-cleared devices.

Acceptance Criteria (Implicit from Indications for Use)	Reported Device Performance
Warms gas to 95-105°F / 35-40.5°C	Not explicitly reported in the provided text, but implied to meet this by substantial equivalence.

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. The provided document is a 510(k) clearance letter and a summary of safety and effectiveness, which relies on substantial equivalence. It does not describe a clinical or performance study with a test set.

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. There was no test set or ground truth established for this type of submission.

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

Not applicable. There was no test set.

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 an insufflator accessory, not an AI-driven diagnostic or assistive tool for human readers.

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

Not applicable. This device is hardware for warming gas, not an algorithm.

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

Not applicable. No ground truth in the context of diagnostic performance was established or required for this 510(k) submission. For warming devices, "ground truth" would typically refer to measured temperature in design validation, but this specific data is not in the provided documents.

8. The sample size for the training set

Not applicable. As a hardware device cleared through substantial equivalence, there is no "training set" in the machine learning sense.

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

Not applicable. See point 8.

Summary

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SEP 1 7 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

Insufflator, Laparoscopic Accessory Common/Usual Name:

CO., Gas Warmer II Proprietary Name:

Classification: Class II

Materials:

All materials used to manufacture the Northgate Technologies Inc. CO3 Gas Warmer II Unit are non-toxic and have been previously used to manufacture other medical devices.

Description:

Substantial Equivalence:

Northgate's CO2 Gas Warmer II Unit which is comprised of a control unit/heat exchanger and power cords are substantially equivalent in design, materials, and intended use to numerous currently marketed devices. Other manufacturers of similar devices are Snoden Pencer and Wisap.

Intended Use:

The Nortech CO2 Gas Warmer II Unit shall be used as a means of supplying warm gas for the distention of the abdomen for diagnostic and/or operative laparoscopy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Mr. Casey Kurek Requlatory Manager Northgate Technologies Incorporated 600 Church Road Elgin, IL 60123

Re: K992381 CO2 Gas Warmer II Dated: August 16, 1999 Received: August 19, 1999 Requiatory Class: Il 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 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). 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 II (Special Controls) or 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 requlation (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 531 through 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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Page 1 of 1

Confidential

510(k) Number (if known

K992381

Device Name:

CO2 Gas Warmer II

Indications For Use:

THE NORTECH GAS WARMER II IS INDICATED FOR WARMING GAS (95-1059F/35-40.5°C) USED FOR THE DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND/OR OPERATIVE LAPAROSCOPY.

Cury Kurek
C. Kurek, Regulatory Manager

C. Kurek, 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
X
(Per 21 CFR 801.109)

Over-the-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992381

(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.