BREATHING CIRCUIT BACTERIAL FILTER

• K Number: K973797
• Device Name: BREATHING CIRCUIT BACTERIAL FILTER
• Manufacturer: KING SYSTEMS CORP.
• Date Cleared: 1998-03-12 ( 157 days)
• Product Code: CAH
• Regulation Number: 868.5260
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: K121026

Intended Use

A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Device Description

Breathing Circuit Bacterial Filter

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a "Breathing Circuit Bacterial Filter" and discusses regulatory aspects, not performance studies or acceptance criteria for a device.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
6. If a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 1998

Mr. Bruce E. Green King Systems Corporation 15011 Herriman Boulevard Noblesville, IN 46060

Re: K973797 Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: January 7, 1998 Received: January 8, 1998

Dear Mr. Green:

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 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 EFR 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.

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Page 2 - Mr. Bruce E. Green

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), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the requlation 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callabrin, Ph.D.

Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the words "KING SYSTEMS" in large, bold, sans-serif font. Below that, in a smaller font, is the word "CORPORATION". The text is all in black and the background is white. The words are stacked on top of each other.

Revised February 3, 1998

510(K) #K973797

Device Name: Breathing Circuit Bacterial Filter

Indications For Use:

A bacterial filter is indicated for use when the care provider desires to protect the patient, care provider, equipment, or all three from the transference of bacteria or virus through the breathing circuit. This filter is provided only in combination with a King Systems Universal F2™ breathing circuit. Within this combination the overall intended use is to administer medical gases and/or anesthetic gases to a patient during anesthesia for inhalation, or medical gases to a patient during respiratory care inhalation.

Suan E. Free

Bruce E. Green Regulatory Affairs Manager

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on of Cardiovascular, Respiratory, Surological Devices 19737 (k) Number _

Prescriptions use $\checkmark$

TC

1501 1 HERRIMAN BOULEVARD / NOBLESVILLE, IN 46060 PHONE [phone] FAX [phone] E-Mail: [e-mail] World Wide Web: www.kingsystems.com

Regulation Number and Section

§ 868.5260 Breathing circuit bacterial filter.

(a)
Identification. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.(b)
Classification. Class II (performance standards).