(50 days)
Not Found
No
The summary describes a standard CPAP mask and its features, with no mention of AI or ML technology.
Yes
The device is a CPAP mask, which is used to deliver continuous positive airway pressure therapy, a common treatment for sleep apnea and other respiratory conditions. The "Intended Use" explicitly states it's for "CPAP/VPAP therapy" under a physician's direction, indicating its therapeutic purpose.
No
The device is a CPAP mask, which is a therapeutic device used for delivering CPAP/VPAP therapy. It does not perform any diagnostic function such as identifying, assessing, or monitoring a disease or condition. Its purpose is to deliver therapy, not to diagnose.
No
The device description clearly outlines physical components like masks, valves, and headgear, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for patients who have been prescribed CPAP/VPAP therapy. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on features related to comfort, seal, and positioning for delivering therapy. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used for delivering respiratory therapy, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The GaleMed CPAP masks are intended to be used in a home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.
Product codes (comma separated list FDA assigned to the subject device)
BZD
Device Description
The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Full face and Nasal style
- . Integral anti-asphyxia valve
- Headgear for attachment .
- . Single use disposable and Single patient, multi-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
Adults
Intended User / Care Setting
home, hospital or institutional environment
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)
Comparative testing for safety and efficacy: Flow vs. Leak / Pressure Dead space
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.
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
GaleMed CPAP mask
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 26-Sept-07
| 87, Li-gong, 2nd Road | ||
|---|---|---|
| Wu-jia, I-Lan, 268, Taiwan | ||
| Tel – 011-3-990-8618 | ||
| Official Contact: | ||
| Thomas Loescher | NOV 】 6 200 | |
| Proprietary or Trade Name: | ||
| CPAP masks | ||
| Common/Usual Name: | ||
| Patient interface for use with CPAP systems | ||
| Classification Name: | ||
| BZD - 868.5905 | Ventilator. non-continuous (respirator), accessory | |
| Device: | ||
| CPAP masks | ||
| Predicate Devices: | ||
| Hsiner Co., Ltd. - K063268 |
Device Description:
The proposed CPAP masks incorporate a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use.
- . Full face and Nasal style
- . Integral anti-asphyxia valve
- Headgear for attachment .
- . Single use disposable and Single patient, multi-use
| Indications for Use: | The GaleMed CPAP masks are intended to be used in a home,
hospital or institutional environment for patients who have been
prescribed CPAP/VPAP therapy. This device is intended to be
used under the specific direction of a physician. Disposable and
Single patient, multi-use styles. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Population: | Adults with OSA |
| Environment of Use: | Hospitals, Home, sub-acute care settings |
| Contraindications: | None |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 26-Sept-07
Comparative table:
| Features | Predicate Hsiner
K063268 | Proposed Device |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Indications for use | The Hsiner CPAP masks are
intended to be used in a home,
hospital or institutional environment
for patients who have been
prescribed CPAP/VPAP therapy.
This device is intended to be used
under the specific direction of a
physician. Disposable and Single
patient, multi-use styles. | Identical |
| Environment of Use | Home, Hospital, Sub-acute
Institutions | Same |
| Patient Population | Adult | Same |
| Contraindications | None | None |
| Single patient,
Multi-use | Yes | Yes |
| Components | Headgear
Anti-asphyxia valve | Headgear
Anti-asphyxia valve |
| Anti-asphyxia valve | Yes | Yes |
| Materials | Polycarbonate
Silicone | Identical K063268 |
| Comparative testing
for safety and
efficacy | Flow vs. Leak / Pressure
Dead space | Identical |
Differences Between Other Legally Marketed Predicate Devices:
The proposed device is identical to the predicate device, K063268.
There are no differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.
NOV 1 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Galemed Corporation C/O Mr. Paul Dryden President ProMedic, Incorporated 3460 Pointe Creek Court, # 102 Bonita Springs, Florida 34134-2015
Re: K072755
Trade/Device Name: CPAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: September 26, 2007 Received: September 27, 2007
Dear Mr. Dryden:
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. Dryden
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 (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,
Neil R.C. dyl
for
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 Statement
Page 1 of 1
(To be assigned) 510(k) Number: CPAP mask Device Name: The GaleMed CPAP masks are intended to be used in a Indications for Use: home, hospital or institutional environment for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be used under the specific direction of a physician. Disposable and Single patient, multi-use styles.
Prescription Use XX (Part 21 CFR 801 Subpart D) 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)
Müll Thul
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________