STURDY MANUAL RESUSCITATOR

K032596 · Sturdy Industrial Co., Ltd. · BTM · Aug 5, 2004 · Anesthesiology

Device Facts

• Record ID: K032596
• Device Name: STURDY MANUAL RESUSCITATOR
• Applicant: Sturdy Industrial Co., Ltd.
• Product Code: BTM · Anesthesiology
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without additional oxygen. The child model is intended for patients more than 10kg and less than 30kg. The adult model is intended for patients more than 30kg.

Device Story

Manual resuscitator device providing controlled or assisted ventilation to patients; operates via manual compression of a self-inflating bag; delivers ambient air with optional supplemental oxygen; used by clinicians in emergency or clinical settings; provides respiratory support to patients unable to breathe adequately; benefits include restoration of ventilation and oxygenation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual resuscitator; self-inflating bag design; provides ventilation with ambient air or supplemental oxygen; classified as a manual emergency ventilator (Product Code BTM).

Indications for Use

Indicated for manually-powered controlled or assisted ventilation in patients requiring respiratory support. Adult model for patients >30kg; child model for patients 10-30kg.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

AUG - 5 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sturdy Industrial Company Limited C/O Dr. Eric Luo Lodestar Products, Incorporated 6833 Saint Lawrence Street Plano, Texas 75024

Re: K032596

Trade/Device Name: STURDY Manual Resuscitator Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: June 29, 2004 Received: June 30, 2004

Dear Dr. Luo:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becatermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to devises 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 approvisions of the Act. The general controls provisions of the Act include condiols provisions of the vistration, 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 (1 MA), it may of back of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Luo

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 mean that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal states and equirements, including, but not limited to: registration 1 ou must comply with and 07); labeling (21 CFR Part 801); good manufacturing practice and fisting (21 CF rear on 7), and 1007), and ity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality aion 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) This letter whilanon yourse of substantial equivalence of your device to a premarket notification. - The PDF mails 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), If you desire specific at ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may ovean outer generational 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,

Chiu Liu, 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): __K032596

Device Name: STURDY Manual Resuscitator

Indications for Use:

The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted The STORD T Manual Resusetator 15 Intendout 16 The child model is intended for patients wore than ventillation with ambient an with of without addit only only in the edult model the more than 30kg.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 807 Subpart C) | |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K032596

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