VADI MANUAL RESUSCITATOR

K030864 · Vedi Corp. · BTM · Jan 30, 2004 · Anesthesiology

Device Facts

• Record ID: K030864
• Device Name: VADI MANUAL RESUSCITATOR
• Applicant: Vedi Corp.
• Product Code: BTM · Anesthesiology
• Decision Date: Jan 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The VADI Manual Resuscitator is designed for use as an adjunct to artificial respiration and cardiopulmonary resuscitation. The Resuscitator can be used to ventilate the aphonic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

Device Story

VADI Manual Resuscitator is a handheld device used as an adjunct to artificial respiration and cardiopulmonary resuscitation (CPR). It provides ventilation and/or oxygen delivery to aphonic or spontaneously breathing patients. The device is available in three models sized by patient weight: infant (≤ 10 kg), child (10-30 kg), and adult (> 30 kg). It is intended for use by healthcare professionals in clinical settings. The device operates manually to deliver air or oxygen to the patient's airway.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual resuscitator; handheld form factor; available in infant, child, and adult sizes based on patient weight. Non-powered, mechanical device.

Indications for Use

Indicated for artificial respiration and cardiopulmonary resuscitation in aphonic or spontaneously breathing patients. Infant model: patients ≤ 10 kg. Child model: patients 10-30 kg. Adult model: patients > 30 kg.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized human figures or waves, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN S 0 2004

Vedi Corporatioin c/o Dr. Eric Luo Lodestar Products, Inc. 6833 Saint Lawrence Street Plano, Texas 75024

Re: K030864

Trade/Device Name: Vedi Manual Resuscitator Regulation Number: 868.5915 Regulation Name: Emergency Manual Ventilator (Resuscitator) Regulatory Class: II Product Code: BTM Dated: January 15, 2004 Received: January 16, 2004

Dear Dr. Luo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becaled a was the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the encreased of the enactment date of the Medical Device interstate conments, or to tvay 20, 1978, are cases and Amendments, of to devices and nave ocon (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmetic 110 (Pro) ............................................................................................................................... approval appreation (1 Mr.). - Four . - Four . - The general controls provisions of the Act include controls provisions of the Fet. "The genting of devices, good manufacturing practice, requiremond for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) offect If your device is classified (sec above) into controls. Existing major regulations affecting (PMA), II may be subject to such additional votibeans, Title 21, Parts 800 to 898. In the Federal your device can be found in the Code of Peceral regaring your device in the Federal Register.

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Page 2 - Dr. Eric Luo

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that PDA s Issualice of a babetannes with other requirements
mean that FDA has made a determination that your device for Fodard agencies mean that FDA has made a deceminations administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by stights to residential of the Act of ally receial statutes and regarsments, including, but not limited to: registration You music colliply with an the Act 3 required and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), labolity (21 Crising (21 CFR Part 820), and if requirements as set form in the quality systems (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) I his letter will anow you to begin manceming your and equivalence of your device to a premarket notification. The PDA miding of casements
legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your device of [phone]. Also, please note the regulation please contact the Office of Comphanes are (s. ) - ) - >>>>>>>> Part 807.97). You
entitled, "Misbranding by reference to premarket notification the Ast from the entified, "Misoranumig by reference to premairs on your responsibilities under the Act from the may obtain offer general million of your copyright of your Assistance at its toll-free DIVIsion of Sman 2011 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Cluts
Shiu-Liang, Ph.D.

Chiu Lin, Ph.D. 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 Statement

510(k) Number (if known): K030860 4

Device Name: VADI Manual Resuscitator

Indications for Use:

The VADI Manual Resuscitator is designed for use as an adjunct to artificial respiration and cardiopulmonary resuscitation. The Resuscitator can be used to ventilate the aphonic patient and to augment ventilation and/or oxygen delivery to the spontaneously breathing patient. The infant model is intended for patients weighing up to 10 kg, the child model is intended for patients weighing between 10 and 30 kg, and the adult model is intended for patients weighing more than 30 kg.

Prescription Use √
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use --
(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K030864 (Optional Format 3-10-98)

(Posted July 1, 1998)