1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR

K023793 · Portex, Inc. · BTM · Feb 11, 2003 · Anesthesiology

Device Facts

• Record ID: K023793
• Device Name: 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
• Applicant: Portex, Inc.
• Product Code: BTM · Anesthesiology
• Decision Date: Feb 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 1st Response Pediatric 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 between 10 kg (22 lbs) and 40 kg (88 lbs).

Device Story

1st Response Pediatric 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 manages fresh gas entry and prevents escape during compression; includes bag or tube reservoirs for supplemental oxygen overflow. Patient-end valve features 15mm ID x 22mm OD connector, exhalation port, manometer port, and pressure-limiting valve (PLV). Swivel patient port allows clinician maneuverability. Optional configurations include face mask, disposable manometer, PEEP valve, or exhalation filter. Operated by healthcare providers in emergency settings to provide manual respiratory support. Output is delivered gas volume to patient; clinical decision-making relies on provider assessment of patient respiratory distress. Benefits include immediate manual ventilation support for pediatric patients.

Clinical Evidence

Bench testing only. Performance and specifications verified against ASTM 920 (Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans), ISO 8382:1988 (Resuscitators intended for use with humans), and ISO 5356-1:1987 (Anaesthetic and respiratory equipment - Conical connectors).

Technological Characteristics

Disposable plastic compressible bag; inlet/outlet valve assemblies; 15mm ID x 22mm OD patient connector; pressure-limiting valve (PLV); manometer port. Complies with ASTM 920, ISO 8382, and ISO 5356-1. Manual operation; no energy source required. Single-patient use.

Indications for Use

Indicated for patients with respiratory distress weighing between 10 kg (22 lbs) and 40 kg (88 lbs) requiring pulmonary 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

• Portex, Inc., 1st Response Manual Resuscitators, Cat. No. S500, 8503, 8506, 8520 and 8520B

Submission Summary (Full Text)

{0}------------------------------------------------

K023793

Image /page/0/Picture/1 description: The image shows the date February 11, 2003. The text is in a simple, sans-serif font. The date is written in the format of month, day, and year. The text is slightly faded, suggesting that the image may be a scan or a photograph of an older document.

#### Portex, Inc.

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

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

#### 510(K) SUMMARY:

#### COMPANY INFORMATION:

Portex Inc 10 Bowman Drive Keene, NH 03431 [phone] Contact: Cynthia Engelhardt Technical Writer, Regulatory Affairs

#### PREPARATION DATE OF SUMMARY:

February, 10, 2003

#### TRADE NAME:

1st Response Pediatric 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. S500, 8503, 8506, 8520 and 8520B.

{1}------------------------------------------------

#### DESCRIPTION:

The 18 Response Pediatic 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 two types of reservoirs; bag reservou or tube 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, exhalation port, manometer port and a pressure-limiting valve (PLV). 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 face mask. Special configurations are available which include a disposable manometer, PEEP valve with adapter, or exhalation filter.

#### INDICATIONS FOR USE:

The 1ª Response Pediatric 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 between 10 kg (22 lbs) and 40 kg (881bs).

#### TECHNICAL CHARACTERISTICS:

: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The device has the same technical characteristics found in either the adult device we have authorization to market under premarket notification K014115 or the same technical characteristics found in the pediatric device we have authorization to market under premarket notification K991861.

#### 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 5356-1: 1987 - Anaestheric and respiratory equipment - Conical connectors - Part 1; Cones and sockets.

{2}------------------------------------------------

## 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.

Cynthia Engelhardt Technical Writer, Regulatory Affairs

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a traditional symbol of medicine, with three intertwined snakes around a staff. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2003

Ms. Cindy Engelhardt Portex, Incorporated 10 Bowman Drive Keene. New Hampshire 03431

Re: K023793

Trade/Device Name: 1st Response Pediatric Manual Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Resuscitator Regulatory Class: II (two) Product Code: 73 BTM Dated: November 12, 2002 Received: November 13, 2002

Dear Ms. Engelhardt:

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 comply with all the Act's requirements, including, but not limited to: registration

{4}------------------------------------------------

Page 2 - Ms. Cindy Engelhardt

and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please contact the Office of Compliance at [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 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,

Suser Rumpa

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

# B: INTENDED USE OF DEVICE

# PROPOSED INDICATIONS FOR USE:

Page 1 of 1

510(k) Number (if known): Homous KO23793

Device Name: 1* Response Pediatric Manual Resuscitator

Indications For Use:

The 1st Response Pediatric 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 between 10 kg (22 lbs) and 40 kg (88 lbs).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use*\$\qquad\$OR Over-The-Counter Use*