The Omniflator® Model 7640 CO, Gas Insufflator incorporates front panel controls similar to our current Omniflator® Model #6630/6600. The 7640 has an adjustable gas flow rate from 0-40 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 CO, from a central supply or E-Cylinder tank.

AI/ML Overview

The provided text is a 510(k) summary for the Nortech Omniflator® 7640 Laparoscopic Insufflator. It describes the device, its intended use, and states that it is substantially equivalent to legally marketed predicate devices.

However, this document does not contain information about:

Specific acceptance criteria for device performance (numerical thresholds for accuracy, precision, etc.).
A study proving the device meets acceptance criteria.
Sample sizes for test or training sets.
Data provenance.
Number/qualifications of experts or ground truth establishment methods.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone algorithm performance studies.
Type of ground truth used.

The document is a regulatory submission demonstrating substantial equivalence to existing devices, which is a different type of evaluation than a study proving performance against specific acceptance criteria. The substantial equivalence relies on the device being similar in design, materials, and intended use to previously cleared devices.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text.

Summary

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5 1999 FEB

Image /page/0/Picture/1 description: The image shows the word "NORTECH" in a bold, sans-serif font. The word is white against a black background, and there is a thick black line above and below the word. To the left of the word is a thick black vertical bar. The image has a slightly grainy texture, which may be due to the image quality or the printing process.

K983326

SUMMARY OF SAFETY AND EFFECTIVENESS

Common/Usual Name: Laparoscopic Insufflator

Proprietary Name: Omniflator® 7640

Classification: CLASS II

Materials:

All materials used to manufacture the Northgate Technologies Inc. Ominflator® Model 7640 and tubing sets are non-toxic and have been previously used to manufacture other medical devices.

Description:

Substantial Equivalence:

Northgate's 7640 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® 7640 Insufflator shall be used for gas distention of the abdomen for diagnostic and/or operative laparoscopy.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K983326 Nortech Omniflator® 7640 Laparsocopic Insufflator Dated: December 30,1998 Received: December 31, 1998 Regulatory Class: II 21 CFR 884.1730/Procode: 85 HIF

5 1999 FEB

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

Dear Ms. 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). 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 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 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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), piease contact the Uffice 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,

t. Daniel G. Schultz, M.D.

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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510(k) Number (if known

K983326

CONF .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

THE NORTECH OMNIFLATOR® 7640 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE LAPAROSCOPY.

Casey Kurek
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
(Per 21 CFR 801.109)

Over-the-Counter Use

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

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.