(157 days)
Not Found
Not Found
No
The summary describes a bacterial filter for a breathing circuit and contains no mention of AI, ML, or related concepts.
No.
The device is a bacterial filter, which is a component of a breathing circuit used to protect against the transfer of bacteria or viruses. While it is part of a system that administers medical gases, the filter itself is primarily a protective and preventative component, not directly therapeutic in nature.
No
Explanation: The device, a bacterial filter, is used to protect from the transference of bacteria or viruses and to administer medical gases. There is no indication that it is used to diagnose a disease or condition.
No
The device is described as a "Bacterial Filter" and is provided in combination with a "breathing circuit," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter bacteria and viruses from breathing circuits during the administration of medical gases. This is a function performed in vivo (on or within a living patient) as part of a medical procedure, not in vitro (outside the body) for the purpose of diagnosing a condition.
- Device Description: It's described as a "Breathing Circuit Bacterial Filter," which aligns with its function in a breathing circuit.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device's function is to prevent the spread of microorganisms within a breathing circuit, which is a supportive function during medical gas administration, not a diagnostic test.
N/A
Intended Use / 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.
Product codes
73 CAH
Device Description
Breathing Circuit Bacterial Filter
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
care provider
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
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 (301) 594-4648. 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 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 (800) 638-2041 or (301) 443-6597 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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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
11 ision Sign-Off)
on of Cardiovascular, Respiratory, Surological Devices 19737 (k) Number _
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1501 1 HERRIMAN BOULEVARD / NOBLESVILLE, IN 46060 PHONE 317-776-6823 1-800-642-5464 FAX 317-776-6827 E-Mail: kingsystems@iquest.net World Wide Web: www.kingsystems.com