BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)

K983817 · King Systems Corp. · CAH · Mar 1, 1999 · Anesthesiology

Device Facts

• Record ID: K983817
• Device Name: BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
• Applicant: King Systems Corp.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit. 2. 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 Story

Combination bacterial/viral filter and heat and moisture exchanger (HME) for breathing circuits. Device placed in-line with tracheotomy or tracheal tubes. Passive operation: captures heat and moisture from exhaled gases to warm/humidify inhaled gases; filters microbiological and particulate matter from breathing circuit gases. Used in clinical settings (anesthesia/ventilator care) by healthcare professionals. Benefits include reduced risk of contamination and maintenance of airway humidity/temperature.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Combination bacterial/viral filter and passive HME. Dimensions vary by model (MS-101, MS-111, MS-121). Mechanical filtration and passive heat/moisture exchange. No electronic components or software.

Indications for Use

Indicated for patients requiring anesthesia or ventilator care. MS-101 is for pediatric use; MS-111 and MS-121 are for use where larger dead space is not a concern.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [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/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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K983817

## 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:

- 1. A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
- 2. 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.