(116 days)
Not Found
No
The 510(k) summary describes a CPAP/VPAP mask, which is a passive device for delivering air pressure. There is no mention of AI, ML, image processing, or any other computational technology that would suggest the use of AI/ML. The description focuses on the physical function of the mask.
No
The device is a CPAP/VPAP mask, which is an accessory used in CPAP/VPAP therapy. It does not provide therapy itself but rather administers the therapy prescribed by a physician.
No
The device, Hsiner CPAP/VPAP Masks, is described as being used to "administer various aerosol treatments" and is for patients who have "been prescribed CPAP/VPAP therapy." This indicates it is a treatment delivery device, not a device used to diagnose a medical condition.
No
The device description clearly states it is a CPAP/VPAP mask, which is a physical hardware component used in respiratory therapy. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for administering CPAP/VPAP therapy to patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a mask used to administer aerosol treatments. This aligns with a respiratory therapy device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is the defining characteristic of an IVD.
Therefore, the Hsiner CPAP/VPAP mask is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.
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
Home, hospital or Institutional environments
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K002465, K961915, K000705, K991648
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Hsiner Company CPAP Masks 510(k) Submission
8. 510(k) Summary
.....
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
8.1. Submitter Information
Hsiner Company, LTD No. 13, Tyan Shin St., Taya Hsiang Taichung Hsien, Taiwan, ROC
Phone: +886-4-25664306
Registration No .: 3003862188 Owner/Operator No .: 9053474
8.2. Name of Device
| Proprietary Name: | CPAP/VPAP Masks |
|---|---|
| Common Name: | CPAP Mask |
| Classification Name: | Noncontinuous ventilator (IPPB) |
| Product Code: | BZD |
| Regulation Number: | 868.5905 |
| Device Class: | 2 |
Substantially equivalent to: 8.3.
- . Respironics ComfortFull Full-Face CPAP Mask (K002465, K961915)
- Respironics Comfort Select Nasal CPAP Mask (K000705, K991648) .
8.4. Description of the device
The Hsiner CPAP/VPAP Masks is used to administer various aerosol treatments in both the homecare and hospital settings.
8.5. Intended Use of the Device
The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.
8.6. Comparison to Predicate Devices
The Hsiner CPAP/VPAP Masks is equivalent in design, materials and performance to the Predicate devices. All the predicate devices utilize the same principles of operation and have the same intended use
FEB 2 3 2007
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird is a circular inscription that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hsiner Company, Limited C/O Mr. Tom Shanks Principal MDVentures 29201 Via Norte Temecula, California 92591
Re: K063268
Trade/Device Name: Hsiner CPAP/VPAP Masks Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: February 5, 2007 Received: February 8, 2007
Dear Mr. Shanks:
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.
FEB 2 3 2007
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.
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Page 2 - Mr. Shanks
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 (240) 276-0120. 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 vours.
Clive
Chih-Ling Liu, 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
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Indications for Use
510(k) Number (K052811):
Hsiner CPAP/VPAP Masks Device Name:
Indications for Use:
The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mihail Mihail
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