(33 days)
The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP. The Aura™ CPAP Patient Interface has three significant components: 1) Headgear Assembly, 2) Nasal Seal Assembly, and 3) Tubing and Adjustment Assembly. The Headgear Assembly holds the device Tubing and Adjustment Assembly, and the Nasal Seal Assembly in place on the user's head. The Headgear Assembly is adjustable by the user. The Nasal Seal Assembly is made from a silicone material which connects to the Tubing and Adjustment Assembly. The Nasal Seal Assembly provides the airflow pathway to the user's nasal openings. The Tubing and Adjustment Assembly connects to the CPAP System. The Tubing and Adjustment Assembly passes the constant air pressure of the CPAP System to the Nasal Seal Assembly. The Tubing and Adjustment Assembly allows the positioning of the Nasal Seal Assembly for the comfort of the user. The Tubing and Adjustment Assembly allows for the positions of the Nasal Seal Assembly in both dimensions: away from the face and in the vertical direction.
This document is a 510(k) premarket notification for the Aura™ CPAP Patient Interface. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, MRMC studies, training set details) are not explicitly present in the provided text.
Based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Implied) |
|---|---|
| Intended Use Equivalence | The Aura™ CPAP Patient Interface functions as an accessory to CPAP devices for treating Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy, which is consistent with the intended use of the predicate devices. |
| Technological Equivalence | The device has three significant components (Headgear, Nasal Seal, Tubing/Adjustment Assembly) which are functionally equivalent to components found in similar nasal CPAP masks. |
| Safety and Effectiveness | Laboratory testing and compliance with standards were provided. No new questions of safety or effectiveness are raised compared to predicate devices. (Specific performance metrics are not detailed). |
| Material Equivalence | The Nasal Seal Assembly is made from silicone material, which is a common and accepted material for such devices. (Performance details not provided explicitly). |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "Laboratory and standards compliance" being provided, suggesting a bench study or testing against recognized standards rather than a clinical human test set with a specific sample size.
- Data Provenance: Not explicitly stated, given the nature of the submission focusing on substantial equivalence based on technical specifications and standards compliance, rather than a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. Ground truth in the context of device performance for substantial equivalence is typically established through engineering specifications, material testing, and compliance with industry standards, not by expert consensus on clinical cases in the way an AI diagnostic algorithm might be evaluated.
4. Adjudication method for the test set:
- Not applicable/Not mentioned. Adjudication methods are relevant for clinical studies involving human interpretation or challenging diagnoses, which is not the primary focus of this 510(k) submission.
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:
- No. An MRMC comparative effectiveness study was not done. This device is a physical medical accessory (CPAP mask), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- The ground truth in this context is based on engineering specifications, material properties, laboratory testing against recognized standards (e.g., biocompatibility, pressure performance, leak rates for CPAP masks), and functional equivalence to legally marketed predicate devices. It does not involve expert consensus on clinical cases or pathology reports in the manner of a diagnostic device.
8. The sample size for the training set:
- Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical medical accessory.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an algorithm, there is no training set or ground truth established in that manner.
{0}------------------------------------------------
SEP - 8 2004
Image /page/0/Picture/2 description: The image shows the word "AEIOMed" in a stylized font. A curved line extends from the bottom left of the "A" to the top right of the "d", visually connecting the letters. The word appears to be a logo or brand name, possibly for a company or product.
1313 5" St. SE Suite 205 Minneapolis, MN 55414 Ph: 612-455-0550 Fax: 612-455-0551
Summary of Safety and Effectiveness
Company Name: AEIOMed, Inc. 1313 5th Street SE, Suite 205 Minneapolis, MN 55414
Dave Markovich, Senior Director of Operations Contact:
(612) 455-0550 Phone:
Fax: (612) 455-0551
Summary Date: August 4, 2004
Aura™ CPAP Patient Interface Trade Name:
Common Name: CPAP Accessory: Nasal CPAP Mask
Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator
Predicate Devices:
| 510(k) Number: | K022465 |
|---|---|
| Manufacture: | Innomed Technologies |
| Trade Name: | Nasal-Aire II™ |
| 510(k) Number: | K033759 |
| Manufacture: | Respironics, Inc. |
| Trade Name: | ComfortLite™ |
Description of Device 1.0
The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP.
{1}------------------------------------------------
The Aura CPAP Patient Interface is initially used under the direct supervision of a trained medical professional. The Aura CPAP Patient Interface function and applications may be reviewed in a clinical setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
Intended Use 2.0
The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
3.0 Technology
The Aura™ CPAP Patient Interface has three significant components:
-
- Headgear Assembly,
-
- Nasal Seal Assembly, and
-
- Tubing and Adjustment Assembly.
The Headgear Assembly holds the device Tubing and Adjustment Assembly, and the Nasal Seal Assembly in place on the user's head. The Headgear Assembly is adjustable by the user.
The Nasal Seal Assembly is made from a silicone material which connects to the Tubing and Adjustment Assembly. The Nasal Seal Assembly provides the airflow pathway to the user's nasal openings.
The Tubing and Adjustment Assembly connects to the CPAP System. The Tubing and Adjustment Assembly passes the constant air pressure of the CPAP System to the Nasal Seal Assembly. The Tubing and Adjustment Assembly allows the positioning of the Nasal Seal Assembly for the comfort of the user. The Tubing and Adjustment Assembly allows for the positions of the Nasal Seal Assembly in both dimensions: away from the face and in the vertical direction.
{2}------------------------------------------------
Conclusions 4.0
The Aura™ CPAP Patient Interface is substantially equivalent to the predicate devices. Laboratory and standards compliance were provided to support the Aura™ CPAP Patient Interface. No new questions of safety or effectiveness are raised.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2004
AEIOMed, Incorporated C/O Mr. Gary Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K042130
Trade/Device Name: Aura™ CPAP Patient Interface Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: August 4, 2004 Received: August 6, 2004
Dear Mr. Syring:
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. Syring
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,
Shin-Lin, Ph.D.
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
510(k) Number (if known): _
Device Name: Aura™ CPAP Patient Interface
Indications for Use:
The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Qun Suliom
Page 1 of 1
(Division Sign-Off) (Division Sign-Othesiology, General Hospital, Division Control, Dental Devices
510(k) Number
§ 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).