1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX

K014115 · Portex, Inc. · BTM · Feb 27, 2002 · Anesthesiology

Device Facts

• Record ID: K014115
• Device Name: 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX
• Applicant: Portex, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Feb 27, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.

Device Story

1st Response Manual Resuscitator is a disposable, single-patient-use emergency manual ventilator. Device consists of a compressible plastic bag with inlet and patient-end valve assemblies. Inlet valve connects to bag, expandable tube, or flexible tube reservoirs to collect oxygen overflow. Patient-end valve features 15 mm ID x 22 mm OD connector, exhalation port, and swivel mechanism. Optional configurations include breathing masks, PEEP valves (5-20 cm H2O range), exhalation filters, and oropharyngeal airways. Operated by healthcare providers in emergency settings to deliver manual ventilation. Provider compresses bag to deliver gas; valves regulate flow and exhaust. PEEP valve uses springs and silicone diaphragm to maintain positive end-expiratory pressure. Device provides respiratory support to patients in distress, potentially stabilizing oxygenation and ventilation.

Clinical Evidence

Bench testing only. Performance and specifications verified against ASTM F920 (Minimum Performance and Safety Requirements for Resuscitators), ISO 8382 (Resuscitators intended for use with humans), and ISO 5356-1 (Anaesthetic and respiratory equipment - Conical connectors).

Technological Characteristics

Disposable manual resuscitator; plastic compressible bag; silicone rubber diaphragm in PEEP valve; 15mm/22mm connectors. Complies with ASTM F920, ISO 8382:1988, and ISO 5356-1:1987. PEEP valve adjustable 5-20 cm H2O. Non-powered, manual operation.

Indications for Use

Indicated for patients with body mass of 25 kg (55 lbs) or more suffering from respiratory distress requiring pulmonary-assist/respiratory support.

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.

Predicate Devices

• 1st Response Manual Resuscitators, Cat. No. 008000, 008003, and 008006 (K992057)

Submission Summary (Full Text)

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K014115

Image /page/0/Picture/1 description: The image shows a logo for a company or brand named "PORTEX". The logo is in black and white and features the word "PORTEX" in a white, sans-serif font. The word is set against a black background that is shaped like a rounded rectangle. The logo has a simple and modern design.

FEB 2 7 2002

#### Portex, Inc.

10 Bowman Drive Keene NH 03431-0724 USA Tel: [phone] www.portexusa.com

## K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### 510(K) SUMMARY:

#### COMPANY INFORMATION:

Portex Inc 10 Bowman Drive Keene, NH 03431 [phone] Contact: Timothy J. Talcott Director of Regulatory Compliance

#### PREPARATION DATE OF SUMMARY:

December 12, 2001

#### TRADE NAME:

1* Response Manual Resuscitator

#### COMMON NAME:

Manual Resuscitator

### PRODUCT CLASS/CLASSIFICATION:

Class II, 73 BTM, 21 CFR 868.5915

#### PREDICATE DEVICE(S):

- Portex, Inc., Ft. Myers Florida, 1* Response Manual Resuscitators, Cat. No. 008000, 008003, and 008006, (K992057).

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#### DESCRIPTION:

The 14 Response manual resuscitator is a disposable, single use emergency manual ventilator. It is intended for single patient use only.

Each device consists of a plastic compressible ventilator bag fitted with control valves at each of the two ends. The inlet valve, opposite the patient end, allows entry of fresh gas into the compressible ventilator bag. The valve blocks escape of fresh gas from the ventilator bag during its compression. Attached to this valve are one of three types of reservoirs; bag reservoir, expandable tube reservoir, or flexible length tube reservoir. These reservoirs serve to collect an overflow of oxygen when a supplemental oxygen supply is used.

The patient end of the ventilator bag is fitted with a second valve assembly. This valve consists of a 15 mm ID x 22 mm OD patient connector and exhalation port. The patient port has a swivel feature to allow the care provider to move the bag around the patient, as needed.

Standard configurations of the device are provided with or without a breathing mask and with or without a PEEP valve. Special configurations are available which could include; pre-attached components, exhalation filter, varying lengths of oxygen lines, varying sizes of breathing masks, and oropharyngeal airways (Berman and Guedel).

The breathing mask consists of a clear flexible cone that features a 22 mm ID port and a clear tacky cushion that contacts the patient's face. The PEEP valve features a 30 mm ID port and a knob to allow the care provider the ability to adjust the amount of PEEP. The PEEP valve can be adjusted from 5-20 cm H2O and uses two springs and a silicone rubber diaphragm to regulate the exhaust pressure.

#### INDICATIONS FOR USE:

The 1st Response Manual Resuscitator is a pulmonary-assist device intended to provide respiratory support to patients suffering from respiratory distress. It is intended for use on patients with a body mass of 25 kg (55 lbs) or more.

#### TECHNICAL CHARACTERISTICS:

The device has the same technical characteristics as the device we have authorization to market under premarket notification K992057.

#### NON-CLINICAL DATA:

Performance and specifications of the modified device are consistent with all requirements for this device type specified by: ASTM 920; Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans. ISO 8382:1988 (E) Resuscitators intended for use with humans, and ISO 5356-

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1: 1987 - Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets.

## CONCLUSION:

The comparison to the predicate device demonstrates that the proposed device is safe and effective and is substantially equivalent to the predicate device.

Very truly yours,

PORTEX, INC.

Timothy Rales

Timothy J. Talobtt Director of Regulatory Compliance

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2002

Mr. Timothy J. Talcott Portex, Inc. 10 Bowman Drive Keene, NH 03431-0724

Re: K014115

1ª Response Manual Resuscitator Regulation Number: 868.5915 Regulation Name: Ventilator, Emergency Manual (Resuscitator) Regulatory Class: II (two) Product Code: 73 BTM Dated: December 12, 2001 Received: December 14, 2001

Dear Mr. Talcott:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments, or to conimered proc to rias 2011-11-11 accordance with the provisions of the Federal Food, Drug, de necs that have occh require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, morelore, mances of the Act include requirements for annual registration, listing of general controls provision 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 rr your de rio to such additional controls. Existing major regulations affecting your device can may of subject to back as a sublimations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Timothy J. Talcott

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 cormply 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 Oivision 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,

Dola Tuth

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# B: INTENDED USE OF DEVICE

## PROPOSED INDICATIONS FOR USE:

Page 1 of 1

510(k) Number (if known): צווארצות אירוש 510(k)

Device Name: 1st Response Manual Resuscitator

Indications For Use:

The 14 Response Manual Resuscitator is a pulmonary-assist device intended to The I " Respiratory support to patients suffering from respiratory distress. It is provide respiratory bappell to tha body mass of 25 kg (55 lbs) or more.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | | |
|--------------------------------------------------------|-----------------------|-------------------------|--|
| Division of Cardiovascular & Respiratory Devices | | | |
| 510(k) Number | K014113 | | |
| Prescription Use | <div> ✓ </div> | OR Over-The-Counter Use | |