K Number
K022062
Device Name
IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
Date Cleared
2003-05-06

(315 days)

Product Code
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
The Impact, Universal Single-Limb, Portable Ventilator Circuit is comprised of disposable connectors, tubing and exhalation valve.
More Information

Not Found

No
The summary describes a passive ventilator circuit comprised of tubing and connectors, with no mention of AI/ML terms or functionalities.

No.
The device is a ventilator circuit used to transfer breathing gases, not to treat a medical condition or disease itself.

No
The device is a ventilator circuit used to transfer breathing gases, not to diagnose a medical condition.

No

The device description explicitly states it is comprised of disposable connectors, tubing, and an exhalation valve, which are physical hardware components.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is used to transfer breathing gases between a ventilator and a patient. This is a direct interaction with the patient's respiratory system, not an analysis of samples taken from the body.
  • Device Description: The description lists components like connectors, tubing, and an exhalation valve, which are typical for a respiratory circuit.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on in vitro testing.
  • Performance Studies: The performance studies focus on material safety and functionality related to gas transfer, not diagnostic accuracy or analytical performance.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ventilator circuit does not fit that description.

N/A

Intended Use / 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.

Product codes

MOD

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adults and medium to large pediatric patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K801875

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 868.5895 Continuous ventilator.

(a)
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.(b)
Classification. Class II (performance standards).

0

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

1

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.

2

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.

3

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

4

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