(108 days)
No
The device description focuses on mechanical components (Headrest, Nasal Seal, Tubing) and their function in delivering CPAP therapy. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies described relate to cleaning and disinfection, not algorithmic performance.
No.
The device is described as an "accessory to continuous positive airway pressure (CPAP) devices," which are the therapeutic devices. This device's function is to hold the tubing and nasal seal in place and provide an airflow pathway, not to deliver therapy itself.
No
The device is described as a "reusable accessory" to CPAP devices used for treating Obstructive Sleep Apnea. Its function is to hold a nasal seal and tubing in place to deliver air pressure, not to diagnose a condition.
No
The device description explicitly lists three physical components: Headrest, Nasal Seal, and Tubing, and describes their physical functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Headrest® with Nasal Seal is an accessory to a CPAP device. Its function is to deliver air pressure to the user's nasal passages for the treatment of Obstructive Sleep Apnea. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is for the treatment of Obstructive Sleep Apnea by applying CPAP therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they facilitate the delivery of air pressure. There is no mention of sample collection, analysis, or diagnostic results.
Therefore, the Headrest® with Nasal Seal is a medical device used for therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Headrest® with Nasal Seal is a reusable accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
Product codes
BZD
Device Description
The Headrest® with Nasal Seal 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 Headrest® with Nasal Seal is initially used under the direct supervision of a trained medical professional. The Headrest® with Nasal Seal function and applications are applied in a clinical or home setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
The Headrest® with Nasal Seal has three significant components:
- l) Headrest,
-
- Nasal Seal, and
-
- Tubing.
The Headrest holds the device Tubing and the Nasal Seal in place on the user's head. The Headrest is adjustable by the user. The Nasal Seal is made from a silicone material which connects to the Headrest. The Nasal Seal provides the airflow pathway to the user's nasal openings. The Tubing connects to the CPAP System. The Tubing and Headrest pass the constant air pressure of the CPAP System to the Nasal Seal. The Headrest allows the positioning of the Nasal Seal for the comfort of the user.
- Tubing.
The Headrest and Nasal Seal are reusable components. The Tubing is single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Headrest® with Nasal Seal is initially used under the direct supervision of a trained medical professional. The Headrest® with Nasal Seal function and applications are applied in a clinical or home setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
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)
Performance of the Headrest and Nasal Seal after 30 cleaning and disinfection exposures to Cidex® OPA indicated both components continued to meet specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 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 font is simple and sans-serif, with a modern and clean appearance. The word is in all caps.
1313 5" St. SE Suite 205 Minneapolis, MN 55414 Ph: 612-455-0550 Fax: 612-455-0551
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510(k) Summary
Company Name: AEIOMed, Inc. 1313 5th Street SE, Suite 205 Minneapolis, MN 55414
Contact: Gary Payment, Director of Quality Assurance
Phone: (612) 455-0564
Fax: (612) 455-0551
Summary Date: October 22, 2007
Trade Name: Reusable Headrest® with Nasal Seal
Common Name: CPAP Accessory: Nasal CPAP Mask
Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator
Predicate Devices:
510(k) Number: K042130 Manufacture: AEIOMed, Inc. Trade Name: CPAP Patient Interface
510(k) Number: K042403 Manufacture: ResMed Ltd. Mirage Swift™ Trade Name:
1.0 Description of Device
The Headrest® with Nasal Seal 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 Headrest® with Nasal Seal is initially used under the direct supervision of a trained medical professional. The Headrest® with Nasal Seal function and
1
applications are applied in a clinical or home setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.
2.0 Intended Use
The Headrest® with Nasal Seal is a reusable 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 Headrest® with Nasal Seal has three significant components:
- l) Headrest,
-
- Nasal Seal, and
-
- Tubing.
The Headrest holds the device Tubing and the Nasal Seal in place on the user's head. The Headrest is adjustable by the user. The Nasal Seal is made from a silicone material which connects to the Headrest. The Nasal Seal provides the airflow pathway to the user's nasal openings. The Tubing connects to the CPAP System. The Tubing and Headrest pass the constant air pressure of the CPAP System to the Nasal Seal. The Headrest allows the positioning of the Nasal Seal for the comfort of the user.
The Headrest and Nasal Seal are reusable components. The Tubing is single patient use.
Performance of the Headrest and Nasal Seal after 30 cleaning and disinfection exposures to Cidex® OPA indicated both components continued to meet specifications.
4.0 Conclusions
The reusable Headrest with Nasal Seal is substantially equivalent to the predicate devices. Laboratory testing and guidance document compliance were provided to support the reusable Headrest with Nasal Seal Instructions for cleaning and disinfection, and performance after cleaning and disinfection. No new questions of safety or effectiveness are raised.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEb -8 2008
AEIOMed, Incorporated C/O Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K072993
Trade/Device Name: Reusable CPAP Patient Interface Regulation Number: 21 CFR 868,5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: February 1, 2008 Received: February 4, 2008
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.
3
Page 2 - Mr. Syring
Please be advised that FDA's issuance of a substantial equivalence determination does not mcan 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 (OS) 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 (240) 276-0115. 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/industry/support/index.html.
Sincerely yours,
Ching-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
4
Indications for Use 510(k) Number (if known): _ K 0 7 2 9 93
Device Name: Reusable CPAP Patient Interface
Indications for Use:
The Headrest® with Nasal Seal is a reusable accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
Prescription Use X (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)
signature
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K072993