VENTLAB BACTERIAL FILTER, MODEL BF100

K030271 · Ventlab Corp. · CAH · Jul 7, 2003 · Anesthesiology

Device Facts

• Record ID: K030271
• Device Name: VENTLAB BACTERIAL FILTER, MODEL BF100
• Applicant: Ventlab Corp.
• Product Code: CAH · Anesthesiology
• Decision Date: Jul 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5260
• Device Class: Class 2

Intended Use

The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.

Device Story

Ventlab Bacterial Filter BF100 is a disposable, single-patient-use device designed for integration into respiratory breathing circuits. It functions as a mechanical barrier to filter particulate matter from the gas stream. Used in clinical settings where respiratory support is provided; operated by healthcare professionals. The device benefits patients by reducing the risk of cross-contamination and particulate exposure within the breathing circuit. It is intended for a maximum duration of 24 hours before disposal.

Clinical Evidence

Bench testing only.

Technological Characteristics

Disposable bacterial/viral filter for respiratory breathing circuits. Single-patient use, 24-hour limit. Mechanical filtration principle. No electronic components, software, or energy source.

Indications for Use

Indicated for use in respiratory breathing circuits for filtration of particulate matter in patients requiring respiratory support. Single patient use, limited to 24 hours.

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

JUL 0 7 2003

Mr. Robert M. Kelly Director RA/QA Ventlab Corporation 2934 Highway 601 North Mocksville, NC 27028

Re: K030271

Trade/Device Name: Ventlab Bacterial Filter BF 100 Regulation Number: 21 CFR 868.5260 Regulation Name: Breathing Circuit Bacterial Filter Regulatory Class: II Product Code: CAH Dated: April 29, 2003 Received: April 30, 2003

Dear Mr. Kelly:

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.

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

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Page 2 -- Mr. Robert M. Kelly

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Susan Kunn

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use:

510k Number : K030271

Applicant: Ventlab Corporation

Device Name: Ventlab Bacterial Filter BF100

The BF100 Disposable Bacterial/Viral Filter is intended for use within respiratory breathing circuits where filtration of particulate matter is desired. Each filter is broading of single patient use for up to 24 hours, and is not intended for reuse.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use_

fHW.t.h.

Seneral Hospital.

510(k) Number: K030271