INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)

K970959 · Instrumentation Industries, Inc. · BTM · Jun 13, 1997 · Anesthesiology

Device Facts

• Record ID: K970959
• Device Name: INSTANT FLOW VAVLE (FLOWMETER, POLE, RAIL, WALL MOUNT)
• Applicant: Instrumentation Industries, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Jun 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

On/Off control of oxygen flow when using a resuscitator bag. For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve. On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.

Device Story

BE 3000 Series Instant Flow Valves provide mechanical on/off control for oxygen delivery systems. Device connects to external flowmeter and resuscitator/hyperinflation bag. Operation: lifting bag from valve arm triggers immediate oxygen flow; replacing bag on arm stops flow. Eliminates manual flowmeter adjustment by clinician during resuscitation. Used in clinical settings by healthcare personnel. Benefits include rapid oxygen delivery initiation and simplified workflow during patient ventilation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical flow control valve. Dimensions/materials not specified. Standalone device; no software or electronic components. Manual operation via bag-actuated lever mechanism.

Indications for Use

Indicated for neonatal, pediatric, and adult patients requiring oxygen delivery via resuscitator/hyperinflation bags. Used for on/off control of oxygen flow.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 13 1997

Ms. Lori Zuravleff
Instrumentation Industries, Inc.
2990 Industrial Boulevard
Bethel Park, Pennsylvania 15102

959
Re: K970599
* Instant Flow Valves
Regulatory Class: II (two)
Product Code: 73 BTM
Dated: March 14, 1997
Received: March 17, 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, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 - Ms. Lori Zuravleff

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/dsmamain.html".

Sincerely yours,


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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BE 3000 Series

# INDICATION FOR USE STATEMENT

Device: BE 3000 Series Instant Flow Valves

Summary: On/Off control of oxygen flow when using a resuscitator bag.

For use with hyperinflation bag (not included) weighing ~3 ounces - 4 pounds (90 - 1814 grams). The use of these sizes of bags typically range from neonatal, pediatric to adult care. The valves are intended to be used with a flowmeter (not included) which controls the flow of oxygen to the valve.

On/off oxygen action is controlled by lifting/replacing bag on arm of valve. Immediate oxygen flow is provided when bag is lifted from arm (preventing personnel from having to turn oxygen on). Oxygen flow is stopped when bag is replaced.


Lori Zuravleff
Typed Name

March 14, 1997
Date

K970959
Premarket notification (510(k)) number

prescription 430
✓
over-the-counter use


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