(123 days)
Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.
Indications For Use:
- A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
- A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.
Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121
This document is an FDA 510(k) clearance letter for a medical device and does not contain the acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "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..."
This means the device was cleared based on its substantial equivalence to a predicate device, not on new clinical trials or detailed performance studies with acceptance criteria as one would find in a clinical trial report. The FDA is acknowledging that the device is similar enough to existing, legally marketed devices that it can be marketed without requiring new, extensive proof of safety and efficacy.
Therefore, I cannot extract the requested information from the provided text as it is not present.
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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 features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Michael A. Leagre King Systems Corporation 15011 Herriman Blvd. Noblesville, IN 46060
K983817 Re: Breathing Circuit Bacterial Filter with Heat and Moisture Exchanger, Models MS-101, MS-111 and MS-121 Regulatory Class: II (two) Product Code: 73 CAH Dated: February 10, 1999 Received: February 16, 1999
Dear Mr. Leagre:
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 leqally 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 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 regulations.
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Page 2 - Mr. Michael A. Leagre
This letter will allow you to beqin 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) 594-4648. 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section #3
Device name: Bacterial/Viral filter and HME combination device.
Product numbers: MS-101, MS-111, MS-121
Intended use for all models is the same. Different products are offered for variations in size. Specifically, MS-101 is for use in pediatric cases; MS-111 and VIS-121 are for use in cases where a larger dead space is not a concern for the physician.
Indications For Use:
-
- A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
-
- A Heat and Moisture Exchanger (HME) is a device intended to be positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia and ventilator care.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark Warner
Prescription Use (Per 21 CFR 858.5260) OR
Over-The-Counter Use ------
(Optional Format 1-2-96)
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number.
§ 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).