The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

Device Description

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.

For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.

The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

AI/ML Overview

This document is a 510(k) summary for the Nasal-Aire II Pediatric device, which is an accessory to positive pressure ventilation devices. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested items related to acceptance criteria and specific study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text for the Nasal-Aire II Pediatric device.

The document states that "functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices." However, it does not detail what specific functional tests were performed, what the acceptance criteria for those tests were, or what the reported performance was.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot provide. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Nasal-Aire II Pediatric. It broadly claims "functional testing" shows it is "as safe and effective as the predicate devices," but no details are given.

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

Cannot provide. No information about a specific test set, its sample size, or data provenance is mentioned.

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)

Cannot provide. No ground truth establishment for a test set is discussed.

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

Cannot provide. No information on adjudication methods is present.

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

Cannot provide. This is a medical device (nasal cannula), not an AI/imaging device that would typically involve human readers or MRMC studies.

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

Cannot provide. This device is a passive accessory and does not involve an algorithm.

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

Cannot provide. No ground truth is discussed beyond the general assertion that functional testing supports safety and effectiveness.

8. The sample size for the training set

Cannot provide. No training set is mentioned as this is not an AI/machine learning device.

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

Cannot provide. No training set or ground truth establishment for a training set is mentioned.

Summary of available information related to equivalence:

Device Trade Name: Nasal-Aire II Pediatric
Common/Usual Name: Accessory to Non-Continuous Ventilator
Predicate Devices:
- K060105: Kidsta Mask System (ResMed)
- K022465: Nasal-Aire II (Innomed Technologies Inc. - likely the original version from which this pediatric version was modified)
- K002001: Breeze Sleepgear with Nasal Pillows (Puritan Bennett Corp.)
- K072993: Reusable Headrest® with Nasal Seal (AEIOMed, Inc.)
- Unknown K number: Infant Nasal CPAP Set (Hudson RCI)
Conclusion on Equivalence (from the submission): The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.
Intended Use (as stated by FDA in the letter): The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. Intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

This 510(k) summary focuses on demonstrating that the new pediatric version of the Nasal-Aire II maintains the same safety and effectiveness as already cleared predicate devices through design similarity and general functional testing, rather than presenting a performance study against specific, novel acceptance criteria.

Summary

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

Premarket Notification 510(k) Section 5 - 510(k) Summary

Attachment 4

Nasal-Aire II Pediatric

11090004

Image /page/0/Picture/3 description: The image shows the logo for InnoMed Technologies. The logo consists of a triangle made up of smaller triangles on the left, followed by the company name "InnoMed" in a bold, sans-serif font. Below the company name, the word "Technologies" is written in a smaller font.

6601 Lyons Road, Suites B1-B4 Coconut Creek, FL 33073 Tel (561) 208-3778 Fax (888) 280-6607 E-mail - Imagil!@mergenetsolutions.com

510(k) Summary

NOV - 5 2009

Company Name: InnoMed Technologies, Inc. 6601 Lyons Rd. Suites B1-B4 Coconut Creek, FL 33073

Official Contact: Linda Magill Director of Quality and Regulatory Affairs

Telephone: (561) 208-3778

Fax: (888) 280-6607

Summary Date: March 20, 2009

Device Trade Name: Nasal-Aire II Pediatric

Common/Usual Name: Accessory to Non-Continuous Ventilator

Classification Name: Non-Continuous (Respirator) Ventilator (21 CFR 868.5905, Product Code BZD)

Predicate Devices:

510(k) Number: K060105
Manufacturer: ResMed
Trade Name: Kidsta Mask System
510(k) Number: K022465
Manufacturer: Innomed Technologies Inc.
Trade Name: Nasal-Aire II
510(k) Number: K002001
Manufacturer: Puritan Bennett Corp.
Trade Name: Breeze Sleepgear with Nasal Pillows
510(k) Number: K072993
Manufacturer: AEIOMed, Inc.
Trade Name: Reusable Headrest® with Nasal Seal

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

510(k) Number: unknown Manufacturer: Hudson RCI Trade Name: Infant Nasal CPAP Set

Device Description:

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

Intended Use:

The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP. Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

Technology:

The Nasal-Aire II Pediatric has three significant components:

Silicone Cannula with Nasal Inserts and Exhalation Ports
Tubing with a 'Y' shaped swivel coupling .
Headgear .

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

Nasal-Aire II Pediatric is designed for patient comfort to facilitate patient compliance so that maximum benefit of the prescribed therapy can be derived. The headgear is adjustable by the user. Five different sizes of the cannula are available for a comfortable fit and a good seal. The swivel coupling connects to the ventilation device. The cannula provides the airflow pathway to the user's nasal openings.

Conclusion

The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Linda Magill Director of Quality and Regulatory Affairs Innomed Technologies, Incorporated /RespCare, Incorporated 6601 Lyons Road, Suites B1-B4 Coconut Creek, Florida 33073

NOV - 5 2009

Re: K090804

Trade/Device Name: Nasal-Aire II Pediatric Interface Accessory to Positive Pressure · Ventilation Device

Regulation Number: 21 CFR 868.5905

Regulation Name: Noncontinuous Ventilator IPPB Regulatory Class: II Product Code: BZD Dated: October 15, 2009 Received: October 16, 2009

Dear Ms. Magill:

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 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 - Ms. Magill

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nh foc

Susan Runner, D.D.S., M.A. Acting Division 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

(To be assigned) 510(k) Number:

Device Name:

Nasal-Aire II Pediatric Interface Accessory to Positive Pressure Ventilation Device

Indications for Use: .

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulten

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K090804

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).