V*CARE MANUAL RESUSCITATOR

K012842 · Ventlab Corp. · BTM · Sep 18, 2001 · Anesthesiology

Device Facts

• Record ID: K012842
• Device Name: V*CARE MANUAL RESUSCITATOR
• Applicant: Ventlab Corp.
• Product Code: BTM · Anesthesiology
• Decision Date: Sep 18, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to The V"Care Manual Resusciator with Dult In Frossale Inchier of reversible apnea, commonly associated with cardiopulmonary arrest.

Device Story

V*Care Manual Resuscitator is a manual ventilation device equipped with an integrated pressure monitor. It is used by clinicians to provide manual ventilation to patients suffering from reversible apnea or cardiopulmonary arrest. The device allows the operator to deliver breaths while simultaneously monitoring airway pressure to ensure appropriate ventilation levels. It is intended for use in clinical settings where manual resuscitation is required.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual resuscitator with integrated pressure monitoring system. Device is classified as Class II, product code 73 BTM, under regulation 868.5915.

Indications for Use

Indicated for patients experiencing reversible apnea, commonly associated with cardiopulmonary arrest.

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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SEP 1 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marge Walls-Walker Ventlab Corporation 3934 Highway 601 North Mocksville, NC 27028

Re: K012842

V*Care Manual Resuscitator with Built in Pressure Monitor Regulation Number: 868.5915 Regulation Name: Manual Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: August 20, 2001 Received: August 23, 2001

Dear Ms. Walls-Walker:

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

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## Page 2 - Ms. Marge Walls-Walker

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 [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" (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 [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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## Attachment 2 Indications for Use Statement

**510(k) Number** K012842

Device Name V*Care Manual Resuscitator with Built in Pressure Monitor

## Indications for Use

The V*Care Manual Resuscitator with Built-in Pressure Monitor's intended use is to The V"Care Manual Resusciator with Dult In Frossale Inchier of reversible apnea, commonly associated with cardiopulmonary arrest.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CQRH, Office of Device Evaluation (ODE) Prescription Use X OR Over-The-Counter Use_ (Per 21 CFR 801.109)

Dak Th
Division of Cardiovascular & Respiratory Devices
510(k) Number K012842