(111 days)
The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.
The provided 510(k) summary (K120920) describes the acceptance criteria and the study that proves the device meets them.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 17510-2:2007) | Reported Device Performance |
|---|---|
| Resistance to flow | Well below the requirement |
| CO₂ rebreathing | Well below the requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data. The performance evaluation was conducted according to technical standards (ISO 17510-2). The document indicates "No clinical test was performed for this device." Therefore, there is no sample size for a clinical test set, nor data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable as no clinical study or ground truth established by experts was performed for the performance evaluation. The evaluation was based on engineering measurements against a technical standard.
4. Adjudication Method for the Test Set
Not applicable as no clinical study or expert adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The device is a physical medical device (CPAP masks), not an AI-assisted diagnostic or imaging device, so this type of study is not relevant.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical medical device, not an algorithm. The performance evaluation was conducted on the physical properties of the masks.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation was established by the technical requirements and thresholds defined in ISO 17510-2: "Sleep apnea breathing therapy-Part 2: Masks and application accessories." This is a set of engineering standards, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.
8. Sample Size for the Training Set
Not applicable. The device is a physical medical device; there is no "training set" like there would be for a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as point 8.
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K120920 510(k) Summary 13.
In accordance with 21 CFR section 807.92 Hsiner is submitting the following 510(k) summary.
Date: 07/11/2012 13.1.
13.2. 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
Name of Device 13.3.
Proprietary Names:
-
- Hsiner Pediatric CPAP Silicone Nasal Masks
-
- Hsiner Nasal Pillow Mask
Common Name: CPAP Mask Classification Name: Noncontinuous ventilator (IPPB)
Product Code: BZD Regulation Number: 868.5905 Device Class 2
Substantially equivalent to: 13.4.
This submission compares the Hsiner extension devices to Hsiner's CPAP/VPAP Masks (K K063268) in addition to the following predicate devices;
- Hsiner Pediatric CPAP Silicone Nasal Mask to the Hsiner CPAP/VPAP Nasal Masks 1. (K063268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224),
- Hsiner Nasal Pillow Mask to Repironics' GoLife Nasal Mask (K102502). 2.
Comparison to Predicate Devices 13.5.
There are no technological differences between these devices.
13.5.1. Design, Materials and Intended Use
The Hsiner CPAP Silicone Nasal Mask and Hsiner Nasal Pillow Mask devices, accessories, attachments, principles of operation and materials are all essentially equivalent to predicate devices already cleared by FDA. The Hsiner, ResMed and Respironics devices operate on the same principles and have the same intended use.
13.6. Description of the device
Hsiner's Pediatric CPAP Silicone Nasal Mask and Hsiner's Nasal Pillow Mask are both product line extensions to their existing line of CPAP interface devices for the application of CPAP/VPAP therapy.
Modified 07/11/2012
1:
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Intended Use of the Device 13.7.
-
- Hsiner Pediatric CPAP Silicone Nasal Masks: - The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
-
- Hsiner Nasal Pillow Mask: The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. This device is intended to be use under the specific direction of a physician.
Clinical-Performance Evaluations 13.8.
No clinical test was performed for this device
Performance Evaluation 13.9.
The performance test protocols for Hsiner's line extensions follow appropriate sections of ISO 17510-2 (2007): "Sleep apnea breathing therapy-Part 2: Masks and application accessories."
-
- Hsiner's Pediatric CPAP Silicone Nasal Mask was found to be well below the resistance to flow and CO2 rebreathing requirement identified in ISO 17510-2.
- Hsiner's Nasal Pillow Mask was found to be well below the resistance to flow and CO2 2. rebreathing requirement identified in ISO 17510-2.
13.10. Conclusion
- · Performance evaluation concludes that all the devices meet the requirements associated with ISO 17510-2 "Sleep apnea breathing therapy-Part 2: Masks and application accessories" and that there are no significant differences in resistance to flow and CO2. rebreathing.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the left side of the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
JUL 16 2012
Hsiner Company C/O Mr. Tom Shanks MD Ventures 29201 Via Norte Temecula, California 92591
Re: K120920
Trade/Device Name: Hsiner CPAP Nasal Pillow Mask, Hsiner Pediatric CPAP Silicone Nasal Masks Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 29, 2012 Received: July 2, 2012
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
For
Anthony D. Watson. B.S., M.S., M.B.A. 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 :
Hsiner CPAP Nasal Pillow Mask Device Name:
Indications for Use:
The Hsiner Nasal Pillow Mask is intended to be use patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 120920 Page 1 of 1
Modified 07/11/2012
Page 17
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Indications for Use
510(k) Number:
Hsiner Pediatric CPAP Silicone Nasal Masks Device Name:
Indications for Use:
The Hsiner Pediatric CPAP Silicone Nasal Mask is intended to be use with patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in a home, hospital or institutional environments. 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) ·
BELOW THIS LINE-CONTINUE ON (PLEASE DO NOT WRITE ANOTHER PAGE IF NEEDED)
Office of Device Evaluation (ODE) Page 1 of 1 Concurrence of CDRF
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Modified 07/11/2012
Page 15
§ 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).