Nasal-Aire is intended for use as an accessory to respiratory ventilators. Ventilation is indicated for patients who require mechanical assistance with breathing.

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.

The Nasal-Aire cannot exhaust exhaled air therefore this device must be used with a ventilator that contains an active exhalation valve or with an intentional leak port added into the breathing circuit

Device Description

Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use.

The Nasal-Aire accessory and associated tubing is intended for use in delivering ventilation to patients. The device consists of a hollow silicone elastomer under nose strip with molded nasal insert sleeves made from silicone elastomer. The under nose strip is fitted bilaterally with 3/8" Tygon® tubing which serves as conduits for ventilation. The tubing is joined to form a single ventilation conduit by a silicone elastomer "Y" coupling. The system is completed by the "Y" coupling connected to an adapter for connection to the main ventilators supply line. When the device is worn by the patient the under nose strip is positioned across the patient's upper lip and the silicone nasal inserts are inserted in the patient's nares. The tubing drapes over the patient's ears in the manner of standard nasal cannulae used for administering oxygen with the "Y" coupling positioned in front of the patient.

AI/ML Overview

This document describes the Nasal-Aire™ ventilator accessory and its clearance through the 510(k) process, which relies on demonstrating substantial equivalence to a predicate device. It does not contain an acceptance criteria table with reported device performance in the way one would typically see for an AI/ML device or a device requiring specific performance metrics against a defined standard.

Instead, the performance evaluation for this medical device focuses on safety and functionality sufficient to demonstrate equivalence for its intended use as a ventilator accessory.

Here's an attempt to extract and infer the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" given the nature of a 1999 510(k) summary for a ventilator accessory.

Acceptance Criteria and Study for Nasal-Aire™ Ventilator Accessory

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k) Summary)	Reported Device Performance
Primary Safety Aspect	Negligible unintended leakage of respiratory gases	"In vivo tests with healthy subjects ventilated with up to 2 Liters at inspiration rates of 100Lpm confirmed that unintended leakage was negligible and did not adversely impact the effectiveness of the device."
Biocompatibility	Meet FDA G95-1 and ANSI/AAMI/ISO 10993 (Part 1) for surface devices (limited skin contact <24 hours) and mucosal membrane contact.	"The materials of which the device is manufactured are all standard medical grade materials with an established history of safe clinical use in similar therapeutic respiratory devices...Patient contacting materials used in the device are specified to meet the biocompatibility requirements..." (Implicitly met through material selection and compliance claim)
Material Safety	Use of standard medical grade materials with an established history of safe clinical use.	"The materials of which the device is manufactured are all standard medical grade materials with an established history of safe clinical use in similar therapeutic respiratory devices."
Functional Design	Compatibility with non-continuous ventilation devices.	"Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices." (Demonstrated suitability for intended use described)
Ease of Use/Comfort	Simple manipulation and comfortable fit.	"The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use." (Claim based on design and materials)

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The text states "A limited clinical study was conducted using the device to assess unintended leakage of respiratory gases during clinical use. In vivo tests with healthy subjects..." The exact number of healthy subjects is not specified.
Data Provenance: The study was "in vivo" (on living subjects). The location or country of origin is not specified, but it's likely in the USA given the FDA application. The study appears to be prospective as it involved testing the device on subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not Applicable. This type of device evaluation (for a physical medical accessory) does not typically involve expert consensus for "ground truth" in the same way an AI/ML diagnostic device would. Performance was directly measured (e.g., leakage).

4. Adjudication Method for the Test Set:

Not Applicable. As there's no "ground truth" established by experts or human readers to adjudicate, this concept does not apply to this device's testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. An MRMC study is relevant for diagnostic or interpretive devices involving human readers. This is a ventilator accessory, and its effectiveness was evaluated based on physical performance parameters like leakage and biocompatibility.

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

Not Applicable. This is a physical medical device, not an algorithm or software.

7. The type of ground truth used:

For the leakage study, the "ground truth" was the direct measurement of unintended leakage during ventilation.
For biocompatibility, the "ground truth" was compliance with established material safety standards (FDA Blue Book Memorandum G95-1 and ANSI/AAMI/ISO Standard 10993 (Part 1)).

8. The sample size for the training set:

Not Applicable. This device does not use machine learning or AI, so there is no training set.

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

Not Applicable. This device does not use machine learning or AI, so there is no training set or ground truth for it.

Summary Context:

This 510(k) summary (from 1999) describes a physical medical device. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended (minimal leakage, comfortable fit), uses safe and compatible materials, and is substantially equivalent to a legally marketed predicate device (The Monarch® Mini Mask). The studies mentioned are primarily focused on physical performance and material safety, not on diagnostic accuracy or AI performance.

Summary

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XI. 510(K) Summary

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Breathing Technologies Corp. Submitted By: 1909 Tebeau Street Waycross, GA 31501

Date Prepared: November 16, 1999

Telephone: 912-285-0576 E-mail: btech@accessatc.net

Contact Person: Tom Wood, CEO
Device Name: Ventilator accessory mask, Ventilator nasal mask Ventilator nasal insert (common names)

Ventilator Accessory (classification names)

Nasal-Aire™ (proprietary trade name)

Predicate Device: The Monarch® Mini Mask manufactured by Respironics, Inc. Cleared for market by 510(k) #K945938

Indications for Use and Description of Subject Device:

Nasal-Aire is intended for use as an accessory to respiratory ventilators. Nasal-Aire is a nasal insert with attached tubing for connection with non-continuous ventilation devices. The simplicity of the Nasal-Aire design allows easy manipulation of the device. Soft, pliable silicone is used for the nasal insert portion of the device facilitates a comfortable fit of the device when in use. Ventilation is indicated for patients who require mechanical assistance with breathing.

A limited clinical study was conducted using the device to assess unintended leakage of respiratory gases during clinical use. In vivo tests with healthy subjects ventilated with up to 2 Liters at inspiration rates of 100Lpm confirmed that unintended leakage was negligible and did not adversely impact the effectiveness of the device,

The materials of which the device is manufactured are all standard medical grade materials with an established history of safe clinical use in similar therapeutic respiratory devices. Patient contact with all materials includes mucosal membrane contact for limited contact duration. The patient contacting materials used in the device are specified to meet the biocompatibility requirements identified in the FDA's Blue Book Memorandum G95-1 and in ANSI/AAMI/ISO Standard 10993 (Part 1) for both surface devices with limited skin contact of less than 24 hours and surface with limited duration mucosal membrane contact.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 26 1999

Mr. Tom Wood Breathing Technologies, Corp. 1909 Tebeau Street Waycross, GA 31501

Re : K990659 Nasal-Aire Regulatory Class: II (two) Product Code: 73 BZD Dated: Undated Received: September 16, 1999

Dear Mr. Wood:

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 regulation (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 regulatory 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 - Mr. Tom Wood

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 regulation 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,

Anale d. Carey

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Celia 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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Nasal Aire by Breathing Technologies

Intended Use

Nasal Aire is an accessory to positive pressure ventilation devices (e.g. CPAP, Bi-level). It may also be used in respiratory insufficiencies if the patient can tolerate the excess dead space.

Carole Cury
Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K9906 510(k) Number

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prescription use

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).