K Number
K012485
Device Name
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
Manufacturer
Date Cleared
2001-10-09

(68 days)

Product Code
Regulation Number
868.5260
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit. - A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care. - ventifator care. Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.
Device Description
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More Information

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No
The document describes a passive mechanical filter and heat/moisture exchanger, with no mention of AI, ML, or any computational processing of data.

No
The breathing circuit bacterial filter and HME are intended to remove particulates and warm/humidify gases, which are supportive functions for patients during anesthesia or ventilator care, but they do not directly treat a disease or medical condition.

No
The device described, a breathing circuit bacterial filter and A heat and moisture exchanger (HME), is intended to remove particulate matter, warm, and humidify gases for a patient during anesthesia or ventilator care. It performs a therapeutic or supportive function rather than diagnosing a condition.

No

The device description and intended use clearly describe a physical breathing circuit bacterial filter and heat and moisture exchanger (HME), which are hardware components. There is no mention of software as the primary or sole component of the device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device as a breathing circuit bacterial filter and/or a heat and moisture exchanger (HME). These functions relate to filtering and conditioning gases breathed by a patient, which are actions performed in vivo (within the living body) or on gases that will be introduced in vivo.
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing samples from the human body (blood, urine, tissue, etc.).
    • Providing information about a physiological state, health, disease, or congenital abnormality.
    • Being used for diagnosis, monitoring, or screening.

The device's function is mechanical and physical (filtering and humidifying gases) within the breathing circuit, not analytical or diagnostic based on biological samples.

N/A

Intended Use / Indications for Use

  • A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases of a 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 or ventilator care.
  • Each All-Round® filter or HME/filter is intended for adult patients whose respiratory status will not be compromised by the dead space.

Product codes

73 CAH

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

adult patients

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

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Reference Device(s)

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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/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

OCT - 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Charles A. Burt King Systems Corporation 15011 Herriman Boulevard Noblesville, IN 46060

Re: K012485

MS-140 All Round® Enhanced Performance Filter MS-141 All Round® Enhanced Performance Filter Angled MS-142 All Round® HME/ Enhanced Performance Filter MS-143 All Round® HME/ Enhanced Performance Filter Angled Regulation Number: 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II (two) Product Code: 73 CAH Dated: July 30, 2001 Received: August 2, 2001

Dear Mr. Burt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Charles A. Burt

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,

N. Dark Tille

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section #3

KO12485

Device name: MS-140 All-Round® Enhanced Performance Filter MS-140 All-Round® Enhanced Performance Filter Angled MS-141 All-Round® HME / Enhanced Performance Filter MS-142 All-Round® HME / Enhanced Performance Filter Angled

Intended Use:

  • A breathing circuit bacterial filter is a device that is intended to remove 1. microbiological and particulate matter from the gases of a breathing circuit.
  • A heat and moisture exchanger (HME) is a device intended to be 2. positioned over a tracheotomy or tracheal tube to warm and humidify by passive means gases breathed in by a patient during anesthesia or ventilator care.
  • ventifator care.
    Each All-Round® filter or HME/filter is intended for adult patients 3. whose respiratory status will not be compromised by the dead space.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 868.5260)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012485