The Airlife Heated Ventilator and Anesthesia Breathing Circuits are comprised of disposable connectors, tubing, and heating wire assemblies. The circuits are for infant, pediatric and adults.

AI/ML Overview

The provided text is a 510(k) summary for the Airlife® Heated Ventilator and Anesthesia Breathing Circuits. It focuses on establishing substantial equivalence to a predicate device based on intended use and performance attributes. The document does not contain the detailed information required to describe acceptance criteria, a specific study proving device performance against those criteria, or the methodology for a clinical study involving human readers or ground truth establishment.

Here's a breakdown of what is available and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics with numerical thresholds. The summary mentions "performance attributes are similar" to the predicate, implying that the device should perform comparably, but no specific criteria or targets are reported.
Reported Device Performance: Not detailed in the provided text. The document states:

"All materials used in the fabrication of the Airlife® Heated Ventilator and Anesthesia Breathing Circuits were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices". These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use."
This describes testing for materials and states they were found "acceptable," but it doesn't provide performance data for the device itself (e.g., heating efficiency, temperature control, flow resistance).

Therefore, a table cannot be constructed from the provided information.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided. The text describes material testing but does not mention a "test set" in the context of a clinical or performance study with a specific sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. There is no mention of a "test set" requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. There is no mention of a "test set" or an adjudication process.

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:

This information is not provided. The device is a heated breathing circuit, not an AI-assisted diagnostic tool, so an MRMC study involving human readers and AI is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided. The device is a physical medical device, not an algorithm, so this type of study is not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided as there is no mention of a study requiring ground truth. The "testing" mentioned pertains to biological safety and industry-recognized methods for materials, not clinical outcomes or expert-adjudicated data.

8. The sample size for the training set:

This information is not provided. There is no mention of a "training set" as this device is not a machine learning model.

9. How the ground truth for the training set was established:

This information is not provided as there is no mention of a "training set" or ground truth for it.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on intended use and material safety, not on specific performance criteria or clinical study results with detailed methodologies. The context is a medical device from 1999, which aligns with less extensive reporting requirements for performance studies at that time compared to modern AI/diagnostic device submissions.

Summary

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K993833

DEC 1 0 1999

Image /page/0/Picture/2 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

SMDA REQUIREMENTS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Heated Ventilator and Anesthesia Breathing Circuits

Manufacturer:	Allegiance Healthcare Corporation1660 Iowa AvenueRiverside, CA 92507
Regulatory Affairs Contact:	Sharon Robbins1500 Waukegan Road MPWMMcGaw Park, IL 60085
Telephone:	(847) 785-3311
Date Summary Prepared:	September, 1999
Common Name:	Airlife® Heated Ventilator and AnesthesiaBreathing Circuits
Classification:	Class II per 21CFR § 868. 5270
Predicate Device:	Isothermal Heated Ventilator and AnesthesiaBreathing Circuits.
Description:	The Airlife Heated Ventilator and AnesthesiaBreathing Circuits are comprised of disposableconnectors, tubing, and heating wireassemblies. The circuits are for infant, pediatricand adults.

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Image /page/1/Picture/0 description: The image shows the word "Allegiance" in a bold, sans-serif font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in black and the background is white.

Allegiance Healthcare Corporation 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

SMDA REQUIREMENTS (continued)

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Airlife® Heated Ventilator and Anesthesia Breathing Circuits

Intended Use:	Breathing system heaters are defined as a devicethat is intended to warm breathing gases beforethey enter a patient's airway.
Substantial Equivalence:	The Airlife® Heated Ventilator and AnesthesiaBreathing Circuits are substantially equivalent tothe Isothermal Heated Ventilator and AnesthesiaBreathing Circuits in that:- the intended use is the same- the performance attributes are thesimilar
Summary of testing:	All materials used in the fabrication of the Airlife®Heated Ventilator and Anesthesia Breathing Circuitswere evaluated through biological qualification safetytests as outlined in ISO 10993 Part-1 "BiologicalEvaluation of Medical Devices". These materialsalso were tested in accordance with industryrecognized test methods and were found to beacceptable for the intended use.

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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 & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1999

Ms. Sharon Robbins Allegiance Heathcare Corporation 1500 Waukegan Road McGaw Park, IL 60085-6787

Re: K993833 Airlife® Heated Ventilator and Anesthesia Breathing Circuits Requlatory Class: II (two) Product Code: 73 BZE November 10, 1999 Dated: Received: November 12, 1999

Dear Ms. Robbins:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sharon Robbins

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Juano H Westerhausen for

elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image contains the word "Allegiance" in a bold, stylized font. To the left of the word is a graphic of a plus sign made up of small dots. The word is in all capital letters, and the font is sans-serif.

Allegiance Healthcare Corporation 1500 Waukegan Road
McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.785.2461

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510(k) Number (if known):	Unknown K993833
Device Name:	Airlife® Heated Ventilator and AnesthesiaBreathing Circuits
Indications For Use:	Breathing system heaters are defined as a devicethat is intended to warm breathing gases beforethey enter a patient's airway.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use (Per 21 CFR 801.109)	X
	or
Over-The Counter Use

Division Sign-Off
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K993833

Regulation Number and Section

§ 868.5270 Breathing system heater.

(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).