(209 days)
No
The device description and summary of performance studies focus on the physical components and functional testing of a ventilator interface accessory, with no mention of AI or ML capabilities.
Yes.
The device is intended to treat respiratory insufficiencies or obstructive sleep apnea, which are medical conditions, classifying it as a therapeutic device.
No
The device is a ventilator interface accessory used to provide noninvasive ventilation, not to diagnose a condition. Its function is to deliver therapy, not to identify or characterize disease.
No
The device description clearly outlines physical components (soft nosepiece, nasal cannula, tubing, "Y"-shaped coupling, 22mm connection) and its function as a disposable interface, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide noninvasive ventilation for respiratory insufficiencies or obstructive sleep apnea. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description details a physical interface for delivering positive pressure ventilation to the nasal passages. It does not describe any components or processes for analyzing biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in the body.
- Providing information for diagnosis, monitoring, or screening.
The device is clearly described as a ventilator interface accessory used for delivering therapy.
N/A
Intended Use / Indications for Use
Nasal-Aire Critical 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 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.
Product codes
MNT, BZD, MNS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal passages
Indicated Patient Age Range
Adult
Intended User / Care Setting
Hospital settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K982454, K003075, K022465, K023244
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
JAN 1 4 2004
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 Supporting |
- Accessory to Continuous Ventilator |
| Predicate Devices: | K982454, BiPAP Vision Ventilatory Support System
and Whisper Swivel exhalation port as cleared with use
for this ventilator; Manufacturer: Respironics Inc. |
| | K003075, Knightstar 330 Ventilator and Breeze
Sleepgear Interface with Nasal Pillows Assembly as
interface recommended for use by the manufacturer
with 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.
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.
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 Critical
Care (Subject device) | KnightStar 330
Ventilator w/Breeze
Interface | Mirage Full Face
Mask Series | Vision Ventilator
System w/Whisper
Swivel |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for use with
CPAP or Bi-Level device
to provide noninvasive
ventilation for the
treatment of respiratory
insufficiency or
obstructive sleep apnea. | Non-invasively treat
spontaneously breathing
patients weighing 30kg or
more who suffer from
respiratory insufficiency
and/or obstructive sleep
apnea. | Intended for multiple
patient use for adult
patients prescribed
continuous positive
airway pressure
(CPAP) and bi-level
therapy. | Intended to augment
the breathing of
spontaneously
breathing adult patients
suffering from
respiratory failure,
respiratory
insufficiency, or
obstructive sleep
apnea. |
| Intended
Environment:
Hospital/Institutional
Use | Yes | Yes | Yes | Yes |
| Offered in Various
sizes | Yes | Yes (interface) | Yes | No |
| Intended for Single
Patient Use | Yes | Yes (interface) | No, multiple patient | Yes (interface) |
| Provided
Non-Sterile | Yes | Yes (interface) | Yes | Yes (interface) |
| Compatible with
22mm ventilator
connection | Yes | Yes | Yes | Yes |
| Treatment delivered
through Nasal
Passages | Yes | Yes (interface) | Yes and mouth | N/A |
| CPAP Swivel | | | | |
Yes (interface)
Yes
Yes
Connection
Yes
Comparison of Features
2
・
:
| Attribute | Nasal-Aire Critical
Care (Subject device) | KnightStar 330
Ventilator w/Breeze
Interface | Mirage Full Face
Mask Series | Vision Ventilator
System w/Whisper
Swivel |
|-----------------------------------|----------------------------------------------|----------------------------------------------------|---------------------------------|-------------------------------------------------|
| Pressure delivery
3-35 cm H2O | Yes | Yes | Yes | Yes |
| Allows for pressure
monitoring | Yes | Yes | Yes | Yes |
| Intended Population | Adult | Adult | Adult | Adult |
| Patient Contact
Material | Silicone | Silicone | Silicone | N/A |
| Interface: Tubing
Length | 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:
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.
(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