PVC AND SILICONE MANUAL RESUSCITATORS

K051177 · David Medical Products Co.,Ltd · BTM · Aug 29, 2005 · Anesthesiology

Device Facts

• Record ID: K051177
• Device Name: PVC AND SILICONE MANUAL RESUSCITATORS
• Applicant: David Medical Products Co.,Ltd
• Product Code: BTM · Anesthesiology
• Decision Date: Aug 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

Device Story

Manual resuscitators (PVC and Silicone models) provide emergency lung ventilation to patients with inadequate breathing. Device consists of a manual bag-valve-mask system operated by healthcare providers or trained personnel in emergency settings. Operation involves manual compression of the bag to deliver air/oxygen to the patient's airway. Output is mechanical ventilation support. Device is intended for use in clinical or emergency environments to assist patient respiration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual resuscitator available in PVC or Silicone materials. Device is a non-powered, manually operated bag-valve-mask system. No software, electronics, or energy source required.

Indications for Use

Indicated for individuals with inadequate breathing requiring emergency lung ventilation.

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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Public Health Service

AUG 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David Lu Official Correspondent David Medical Products Company Limited No. 88, Fuda Road, Ludu Taicang, Suzhou, Jiangsu, CHINA 215412

Re: K051177

Trade/Device Name: PVC Manual Resusciator, DA-00131, DA-00132, DA-00133; Silicone Manual Resusciator, DA-00171, DA-00172, DA-00173 Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: August 20, 2005 Received: August 26, 2005

Dear Mr. Lu:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to actived Cosmetic Act (Act) that do not require approval of a premarket the Fouch application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provided by an an 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 Cc :1trols) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can oo found in the announcements concerning your device in the Federal Register.

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Page 2 - Mr. Lu

Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be advisod that I D11 o lobalization that your device complies with other requirements modi that I Dr mas made a aves and regulations administered by other Federal agencies. of the Act of any I ederal can its requirements, including, but not limited to: registration 1 ou must comply with and art any, labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 067), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality is a 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 feter will anon yourse bogan and equivalence of your device of your device to a premairer notified.com - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 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 not to read in [phone]. Also, please note the regulation 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 other 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/industry/support/index.html.

Sincerely yours,

Syvette y. Michael Davis.

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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David Medical Products ( SUZHOV) Co., Ltd. Address: No. 88, Fuda Rd. Ludu, Taicang, Suzhou, Jiangsu, CHINA 215412 Tel: [phone] Fax: [phone] E-mail: [e-mail] http:// www.triad-orthopedic.com.tw

## Indications for Use

510 (K) NUMBER ( IF KNOW ):_ ] くのS//フフ

DEVICE NAME: PVC Manual Resusciator, DA-00131, DA-00132, DA-00133;

Silicone Manual Resusciator, DA-00171, DA-00172, DA-00173

## INDICATIONS FOR USE:

To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

Prescription Use V (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: | K051177 |

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