SLEEVED FILTER

K010040 · King Systems Corp. · CAH · Mar 9, 2001 · Anesthesiology

Device Facts

• Record ID: K010040
• Device Name: SLEEVED FILTER
• Applicant: King Systems Corp.
• Product Code: CAH · Anesthesiology
• Decision Date: Mar 9, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Indications for Use

The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

Device Story

The Sleeved Filter/HME is a respiratory accessory designed to minimize gross contamination within breathing circuits. It functions by providing a protective sleeve over the patient-end connection of the circuit. Used in clinical settings, it is operated by healthcare professionals (physicians, nurses, or respiratory therapists) during mechanical ventilation or anesthesia delivery. By acting as a physical barrier, the device reduces the risk of environmental or patient-derived contamination entering the breathing circuit, thereby supporting infection control protocols and potentially improving patient safety during respiratory support.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

The device is a mechanical accessory consisting of a filter or HME (Heat and Moisture Exchanger) integrated with a protective sleeve. It is designed for use in breathing circuits. No specific materials, energy sources, or software components are described.

Indications for Use

Indicated for use in patients requiring breathing circuit support to reduce gross contamination by covering the patient end of the circuit with a protective sleeve.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2001

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

K010040 Re: Sleeved Filter or Sleeved HME/Filter Regulatory Class: II (two) Product Code: CAH Dated: December 27, 2000 Received: January 5, 2001

Dear Mr. Burt:

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, 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

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Page 2 - Mr. Charles A. Burt

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.

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 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 regulation 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,

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

Device name: Sleeved Filter, Sleeved HME/Filter.

Intended Use:

The Sleeved Filter or Sleeved HME/Fitter is used to reduce gross contamination on breathing circuits by covering the patient end of a breathing circuit with a protective sleeve.

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)

Klaus Roberts MD 3/7/11

Division of Cardiovascular & Respiratory Devices