(315 days)
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 comprised of disposable connectors, tubing and exhalation valve.
The provided text describes the Impact, Universal Single-Limb, Portable Ventilator Circuit and its substantial equivalence to a predicate device. However, it does not contain information about "acceptance criteria" and "device performance" in the format of a table with numerical values, nor does it detail a study that explicitly demonstrates the device meets specific acceptance criteria in the way typically found for AI/ML-based medical devices.
The document focuses on demonstrating substantial equivalence for a physical medical device (a ventilator circuit). This involves showing that the new device has the same intended use and performance attributes as a legally marketed predicate device. The performance attributes are evaluated through biological qualification safety tests and industry-recognized test methods.
Therefore, many of the requested elements for an AI/ML device study are not applicable or not present in this document. I will extract the information that is available and indicate where the requested information is not provided.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with numerical performance metrics for the device. Instead, it refers to general compliance with safety and performance standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Safety | 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"21 CFR 177.1350 "Ethylene-Vinyl Acetate Copolymers" |
| Functional Performance | Tested in accordance with industry recognized test methods contained in ASTM F-1100, Table 2, and found to be acceptable for its intended use. Performance attributes are stated to be the same as the predicate device (Allegiance Healthcare Corporation, Catalog Number 1755, Airlife™ Universal Portable Volume Ventilator Circuit). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data for an AI/ML device. The testing described involves material and functional performance of the device itself, not a dataset for an algorithm. Therefore, information on sample size for a test set, country of origin, or retrospective/prospective nature is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for a physical device's performance is typically established through adherence to engineering specifications and performance standards, not expert consensus on data.
4. Adjudication method for the test set
Not applicable. There is no "test set" or adjudication process described as would be relevant for an AI/ML device's output.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical ventilator circuit, not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies and human reader improvement with AI are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
The "ground truth" equivalent for this device is based on compliance with established international and national standards for medical device materials and functional performance. This includes:
- Biological qualification safety tests (ISO 10993, USP 25, 21 CFR 177.1350)
- Industry-recognized test methods (ASTM F-1100, Table 2)
- Demonstration of performance attributes being the same as the predicate device.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it is not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
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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
: 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.
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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 (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
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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
§ 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).