NON-REBREATHING 'T' (BE 117)

K973066 · Instrumentation Industries, Inc. · CBP · Feb 3, 1998 · Anesthesiology

Device Facts

• Record ID: K973066
• Device Name: NON-REBREATHING 'T' (BE 117)
• Applicant: Instrumentation Industries, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Feb 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2

Indications for Use

The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer.

Device Story

BE 117 Non-Rebreathing 'T' is a respiratory accessory used with a spirometer. Device features two side ports, each containing a single check valve. Principle of operation: valves ensure unidirectional gas flow; inhaled gas enters through proximal port; exhaled gas exits through distal port. Prevents backflow of gas toward source. Used in clinical settings by healthcare providers to facilitate accurate spirometry measurements in spontaneously breathing patients. Benefits include prevention of rebreathing and maintenance of unilateral breathing circuit integrity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable 'T' connector featuring two integrated check valves. Designed for integration into respiratory circuits with spirometers. Mechanical operation; no energy source required. Materials and sterilization methods not specified.

Indications for Use

Indicated for spontaneously breathing patients requiring unilateral gas flow during respiratory monitoring or spirometry to prevent backflow toward the gas source.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1998 FEB

Ms. Lori Zuravleff QA/RA Manager Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102

Re : K973066 BE 117 Non-rebreathing 'T' Requlatory Class: II (two) Product Code: СВР Dated: August 15, 1997 Received: August 18, 1997

Dear Ms. Zuravleff:

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 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, Druq, 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 reqistration, 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 requlations 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 Requlation (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 requlations.

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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 requlation (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.qov/cdrh/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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## INDICATION FOR USE STATEMENT

- BE 117 Non-Rebreathing 'T' Device:
- This is a 'T' containing a single check valve in each of two side ports causing inhaled Summary: gas to be delivered through proximal port and exhaled gas to be released through distal port.

The reusable BE 117 Non-Rebreathing 'T' is designed for use with a spontaneously breathing patient where "back flow" must be avoided The 'T's are designed to prevent the flow of gas back toward the source and ensure unilateral breathing. The BE 117 'T' is intended to be used with a spirometer.

Lou Burlingoff
Signature

Lori Zuravleff Typed Name

. Rng

(Division Sign-Off) Division of Cardiovascular, Respiratory, January 27, 1998 Date

and Neurological Devices K973066 510(k) Number_

> K973066 Premarket notification (510(k)) number

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