IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00

K022062 · Impact Instrumentation, Inc. · MOD · May 6, 2003 · Anesthesiology

Device Facts

• Record ID: K022062
• Device Name: IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
• Applicant: Impact Instrumentation, Inc.
• Product Code: MOD · Anesthesiology
• Decision Date: May 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.

Device Story

The Impact Universal Single-Limb Portable Ventilator Circuit is a disposable accessory for ventilators with a single-limb interface. It consists of tubing, connectors, and an exhalation valve. The device functions as a conduit to deliver breathing gases from the ventilator to the patient during inhalation and to vent gases to the atmosphere during exhalation. It is intended for use in clinical settings where mechanical ventilation is required for adult and pediatric patients. The device is a passive mechanical component; it does not perform data processing or clinical analysis.

Clinical Evidence

Bench testing only. Biological qualification safety tests performed per ISO 10993 (Parts 1, 5, 12) and USP 25. Performance testing conducted in accordance with ASTM F-1100, Table 2.

Technological Characteristics

Disposable ventilator circuit comprising tubing, connectors, and exhalation valve. Materials evaluated per ISO 10993 and USP 25; Ethylene-Vinyl Acetate Copolymers (21 CFR 177.1350). Tested per ASTM F-1100. Passive mechanical device; no energy source, software, or connectivity.

Indications for Use

Indicated for adults and medium-to-large pediatric patients requiring mechanical ventilation via a single-limb circuit interface.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Predicate Devices

• Allegiance Healthcare Corporation, Catalog Number 1755 (K801875), Airlife™ Universal Portable Volume Ventilator Circuit (Dual Limb)

Submission Summary (Full Text)

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## IMPACT Instrumentation, Inc.

:

27 Fairfield Place, West Caldwell, NJ 07006 P.O. Box 508, West Caldwell, NJ 07007-0508

# MAY 0 6 2003

#### SMDA REQUIREMENTS - ABBREVIATED 510(k)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Impact, Universal Single-Limb, Portable Ventilator Circuit

Impact Instrumentation, Inc.

West Caldwell, New Jersey 07006

Manufacturer:

27 Fairfield Place West Caldwell, New Jersey 07006 Regulatory Affairs Contact: Mr. Leslie H. Sherman P.O. Box 508

Telephone:

973.882.1212

27 Fairfield Place

P.O. Box 508

Facsimile:

. .

973.882.4993

Date Summary Prepared:

March 4, 2003 (Amended from June 20, 2002)

Trade Name:

Common Name:

Classification Name:

1. 1

: Product Code:

Classification:

Predicate Device:

Impact, Universal Single-Limb, Portable Ventilator Circuit

Ventilator circuit

Accessory to Continuous Ventilator per 21 CFR 868.5895 and the state of the states

MOD

Class II

Allegiance Healthcare Corporation, Catalog Number 1755 (K801875), Airlife™ Universal Portablo Volume Ventilator Circuit (Dual Limb).

4-1

.

electro-medical techni

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#### Description:

#### Intended Use:

### Substantial Equivalence:

Summary of Testing

The Impact, Universal Single-Limb, Portable Ventilator Circuit is comprised of disposable connectors, tubing and exhalation valve. It is intended for use with adults and medium-to-large pediatric patients.

Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators Having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.

The Impact, Universal Single-Limb, Portable Ventilator Circuit is substantially equivalent to the Allegiance Healthcare Corporation, Catalog Number 1175, Airlife™ Universal Portable Volume Ventilator Circuit in that:

- the intended use is the same
the performance attributes are the same

Materials used in the fabrication of the Impact, Universal Single-Limb, Portable Ventilator Circuit were evaluated through biological qualification safety tests as outlined in:

ISO 10993 Part 1 "Biological Evaluation of Medical Devices",

ISO 10993 Part 5 "Tests for in vitro cytotoxicity",

ISO 10993 Part 12 "Sample Preparation and Reference Materials".

USP 25 "Biological Reactivity Tests, in vivo -Classification of Plastics", and

21 CFR 177.1350 "Ethylene-Vinyl Acetate Copolymers" In addition, the Impact, Universal Single-Limb, Portable Ventilator Circuit was tested in accordance with industry recognized test methods contained in ASTM F-1100, Table 2, and was found to be acceptable for its intended use.

Proposed Labeling

Previously supplied.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines representing hair or clothing.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 0 6 2003

Mr. Leslie H. Sherman President Impact Instrumentation, Incorporated 27 Fairfield Place West Caldwell, New Jersey 07006

Re: K022062

Trade/Device Name: Impact, Universal Single-Limb, Ventilator Circuit Regulation Number: 868.5895 Regulation Name: Accessory to Continuous Ventilator Regulatory Class: II Product Code: MOD Dated: February 6, 2003 Received: February 7, 2003

Dear Mr. Sherman:

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.

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Page 2 - Mr. Sherman

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 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), 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,

Saser Roose

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

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# K022062

Statement of Indications for Use

Impact Universal Single-Limb Ventilator Circuit is intended for use in conjunction with ventilators having a single-limb circuit interface. The ventilator circuits are used as a means by which to transfer breathing gases from a ventilator to a patient (inhalation) and from a patient to atmosphere (exhalation). The device is intended for use with adults and medium to large pediatric patients.

Prescription Use Only \/ -

S. Lise M. Pinto

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_K022062