Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Device Description

Nasal-Aire Criticial Care is ventilator interface accessory intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Nasal-Aire Critical Care consists of a soft nosepiece with two exhaust ports and two soft nasal cannula for fitting into the nasal openings. Connected on each side of the nosepiece is a length of tubing. The two lengths of tubing are joined at the opposite ends by a "Y"-shaped coupling, forming a loop with the nosepiece at one end and the "Y" coupling at the other. At the base of the "Y" coupling is a port for connection of the Nasal-Aire Critical Care to a positive pressure ventilation device. The Nasal-Aire Critical Care is compatible with any positive pressure ventilator containing a 22mm connection. Nasal-Aire Critical Care will be offered in various sizes designed for a comfortable and compliant fit for a wide variety of nare sizes.

AI/ML Overview

The provided document is a 510(k) summary for the Nasal-Aire Critical Care device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria or performance metrics directly comparable to what is typically found in AI/ML device studies.

Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/ML device study), is largely not present in this regulatory document. This document outlines functional equivalence to existing devices through comparison of attributes.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for performance metrics in the way one would see for an AI/ML diagnostic or prognostic device (e.g., target sensitivity, specificity). Instead, it relies on a comparison of attributes of the "Nasal-Aire Critical Care (Subject device)" against several "Predicate devices" to demonstrate substantial equivalence.

The "performance" here is described in terms of functional attributes and intended use. The table below summarizes the comparison, which serves as the basis for demonstrating that the device is "as safe and effective as the predicate devices."

Attribute	Nasal-Aire Critical Care(Subject device)	Predicate Devices (Composite from listed predicates)
Intended Use	Intended for use with CPAP or Bi-Level device to provide noninvasive ventilation for the treatment of respiratory insufficiencies or obstructive sleep apnea.	Similar intended uses, including non-invasive treatment for respiratory insufficiency and/or obstructive sleep apnea with CPAP/bi-level therapy.
Intended Environment	Hospital/Institutional Use: Yes	Hospital/Institutional Use: Yes
Offered in Various sizes	Yes	Yes (for interfaces)
Intended for Single Patient Use	Yes	Yes (for interfaces, some predicates indicated "No, multiple patient" for full mask series, but the Nasal-Aire is single-use)
Provided Non-Sterile	Yes	Yes (for interfaces)
Compatible with 22mm ventilator connection	Yes	Yes
Treatment delivered through Nasal Passages	Yes	Yes (for interfaces; one predicate mentions "Yes and mouth")
Pressure delivery	3-35 cm H2O: Yes	3-35 cm H2O: Yes
Allows for pressure monitoring	Yes	Yes
Intended Population	Adult	Adult
Patient Contact Material	Silicone	Silicone
Interface: Tubing Length	7"	Varies (15/18" for one predicate, unknown for others; 7" is within reasonable range for such a device compared to longer ventilator tubing)
Latex Free	Yes	Yes (where specified)

Acceptance Criteria (Implied): The implied acceptance criteria are the attributes and performance characteristics of the predicate devices. The "study" (or rather, the justification for substantial equivalence) involved demonstrating that the Nasal-Aire Critical Care met or was comparable to these attributes.

Sample sizes 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 in the 510(k) summary. Given that this is a physical medical device (ventilator interface) and not an AI/ML software device, the concept of "test set" in the context of data validation is not applicable in the way it would be for AI/ML. The "study" mentioned ("Biocompatability requirements and functional testing") would involve laboratory tests and potentially limited human factor testing, but details on sample sizes or data provenance are not included in this summary.
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 and is not typically relevant for a 510(k) submission for a physical device like a ventilator interface. "Ground truth" in the context of expert consensus is specific to diagnostic AI/ML algorithms, not general medical devices. Functional testing would rely on engineering standards and measurement accuracy, not expert consensus on interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided and is not relevant for this type of device submission. Adjudication methods are specific to processes involving human interpretation outcomes for establishing ground truth, typically in AI/ML validation.
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. MRMC studies are specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This device is a physical ventilator interface, not an AI/ML assistant, so such a study would not apply.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This question is specific to AI/ML algorithms and is not applicable to a physical medical device like the Nasal-Aire Critical Care.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the functional and biocompatibility testing mentioned, the "ground truth" would be established by scientific and engineering standards, not expert consensus, pathology, or outcomes data in the sense used for AI/ML or clinical trials. For instance, biocompatibility testing would adhere to ISO standards, and functional testing would involve measuring parameters against predefined specifications (e.g., pressure delivery, connection compatibility). The document states "Biocompatability requirements and functional testing relative to the intended use of the Nasal-Aire Critical Care have been satisfactorily completed," implying compliance with relevant standards.
The sample size for the training set
This information is not provided and is not applicable. There is no "training set" for a physical device in the way there is for an AI/ML algorithm.
How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

JAN 1 4 2004

K031896

510(k) SUMMARY OF SAFETY AND EFFECTIVENE

Submitter's Name:	InnoMed Technologies Inc.
Submitter's Address:	506 Garden St. Greensburg PA 15601 USA
Telephone Number:	(724) 838-7880
Fax Number:	(724) 838-7886
Contact Person:	Frank Pelc
Date:	October 17, 2003
Proprietary Name:	Nasal-Aire Critical Care
Classification:	Class II, 1. CFR 868.5895 MNT 2. 868.5905 BZD
Classification Name:	1. Ventilator, Continuous, Non-Life Supporting2. Accessory to Continuous Ventilator
Predicate Devices:	K982454, BiPAP Vision Ventilatory Support Systemand Whisper Swivel exhalation port as cleared with usefor this ventilator; Manufacturer: Respironics Inc.
	K003075, Knightstar 330 Ventilator and BreezeSleepgear Interface with Nasal Pillows Assembly asinterface recommended for use by the manufacturerwith this ventilator; Manufacturer: Puritan-Bennett.
	K022465, Nasal-Aire II, Innomed Technologies
	K023244, Mirage Full Face Mask Series, ResMed, Inc.

Device Description - Nasal-Aire Criticial Care is ventilator interface accessory intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

{1}------------------------------------------------

Substantial Equivalence - Biocompatability requirements and functional testing relative to the intended use of the Nasal-Aire Critical Care have been satisfactorily completed to show that it is as safe and effective as the predicate devices.

The table below, comparing the Nasal-Aire Critical Care to predicate devices, shows that it is comparable to other devices cleared for similar intended use.

Attribute	Nasal-Aire CriticalCare (Subject device)	KnightStar 330Ventilator w/BreezeInterface	Mirage Full FaceMask Series	Vision VentilatorSystem w/WhisperSwivel
Intended Use	Intended for use withCPAP or Bi-Level deviceto provide noninvasiveventilation for thetreatment of respiratoryinsufficiency orobstructive sleep apnea.	Non-invasively treatspontaneously breathingpatients weighing 30kg ormore who suffer fromrespiratory insufficiencyand/or obstructive sleepapnea.	Intended for multiplepatient use for adultpatients prescribedcontinuous positiveairway pressure(CPAP) and bi-leveltherapy.	Intended to augmentthe breathing ofspontaneouslybreathing adult patientssuffering fromrespiratory failure,respiratoryinsufficiency, orobstructive sleepapnea.
IntendedEnvironment:Hospital/InstitutionalUse	Yes	Yes	Yes	Yes
Offered in Varioussizes	Yes	Yes (interface)	Yes	No
Intended for SinglePatient Use	Yes	Yes (interface)	No, multiple patient	Yes (interface)
ProvidedNon-Sterile	Yes	Yes (interface)	Yes	Yes (interface)
Compatible with22mm ventilatorconnection	Yes	Yes	Yes	Yes
Treatment deliveredthrough NasalPassages	Yes	Yes (interface)	Yes and mouth	N/A
CPAP Swivel

Yes (interface)

Yes

Connection

Yes

Comparison of Features

{2}------------------------------------------------

・

Attribute	Nasal-Aire CriticalCare (Subject device)	KnightStar 330Ventilator w/BreezeInterface	Mirage Full FaceMask Series	Vision VentilatorSystem w/WhisperSwivel
Pressure delivery3-35 cm H2O	Yes	Yes	Yes	Yes
Allows for pressuremonitoring	Yes	Yes	Yes	Yes
Intended Population	Adult	Adult	Adult	Adult
Patient ContactMaterial	Silicone	Silicone	Silicone	N/A
Interface: TubingLength	7"	15/18"	unknown	N/A
Latex Free	Yes	Yes	Yes	N/A

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three wing-like shapes extending upwards.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

InnoMed Technologies Incorporated Mr. Frank Pelc Director, Regulatory Affairs Northeast Division 506 Garden Street Greensburg, Pennsylvania 15601

Re: K031896

Trade/Device Name: Nasal-Aire Critical Care Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: MNS, BZD Dated: October 18, 2003 Received: October 21, 2003

Dear Mr. Pelc:

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.

{4}------------------------------------------------

Page 2 - Mr. Pelc

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,

Charles

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number:

Applicant: InnoMed Technologies

Device Name: Nasal-Aire Critical Care

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109)

Prescription Use

Over-the counter Use

fAul

Anesthesiology, General Hospital, Infection Control, Dent

510(k) Number: K031896

Regulation Number and Section

§ 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).