(308 days)
The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
The Pioneer U121 Series CPAP operates using standard AC Power from a wall outlet. This U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motordriven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit. The pressurized air is delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. This device only requires minimal cleaning and periodic dealer service checks to ensure optimum performance.
This looks like a 510(k) premarket notification for a Continuous Positive Airway Pressure (CPAP) device, not an AI/ML medical device. Therefore, a significant portion of the requested information (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not provided in this type of submission for this kind of device.
However, I can extract the available information related to acceptance criteria and performance as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device meets specifications | The results of the testing confirm that the device meets specifications. |
| Substantially equivalent to predicate device (Invacare Polaris CPAP System K982242) | The Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the Invacare Polaris CPAP System (K982242). |
| Operates using standard AC Power | Operates using standard AC Power from a wall outlet. |
| Delivers continuous positive air pressure to the upper airway | Delivers continuous positive air pressure to the upper airway. |
| Intended for treating adult Obstructive Sleep Apnea (OSA) in the home | Indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home. |
| Not intended for life support | Not intended for life support. |
| Does not provide patient monitoring capabilities | Do not provide any patient monitoring capabilities. |
| Microprocessor-based control system for pressure regulation | A microprocessor based control system. Controls the pressure of air delivered by monitoring the speed of motor-driven blower. |
| Filtration of air | Air, which penetrates through the filter, is directed to the motor-driven blower. |
| Delivery via flexible tubing (22 mm internal diameter) and standard nasal mask with exhaust port | Delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. |
| Minimal cleaning and periodic dealer service checks required | Only requires minimal cleaning and periodic dealer service checks to ensure optimum performance. |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. For a traditional mechanical device like a CPAP, performance testing typically involves engineering and functional validation against design specifications and established standards, rather than testing on clinical patient "test sets" in the way an AI/ML algorithm would be. The focus is on the device's physical function and safety.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth, in the context of expert consensus, is typically for diagnostic interpretation tasks, which is not relevant for this CPAP device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are used in studies involving human interpretation or clinical endpoints, not for the functional testing of a CPAP machine.
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. This is a mechanical CPAP device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI effectiveness are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a mechanical CPAP device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device would be its adherence to engineering specifications, safety standards, and functional performance metrics (e.g., pressure delivery accuracy, flow rate, noise levels, etc.) as demonstrated through laboratory and bench testing. These are compared against the predicate device's established performance and recognized standards for CPAP machines.
8. The sample size for the training set:
- Not applicable / Not provided. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. As there is no AI/ML component, there is no training set or associated ground truth establishment.
In summary, the provided document describes a traditional medical device (CPAP) and its premarket notification. The "study" referenced in the acceptance criteria is performance testing against engineering specifications and a comparison to a predicate device to establish substantial equivalence, rather than a clinical trial or algorithm validation study.
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MAY 1 0 2005
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
"510(k) SUMMARY"
| 9.1 Trade/Proprietary Name: | Pioneer U121 Series CPAP |
|---|---|
| 9.2 Common/Usual Name: | CPAP(Continuous Positive Airway Pressure)and the control control control controlled to the consideration of the consideration of the consistent of the contribution of the contribution of the contribution of the cont |
- 9.3 Classification Name:
Ventilator, Noncontinuous (Respirator)
Comparison to Currently Marketed Devices 9.4
The Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the Invacare Polaris CPAP System (K982242).
9.5 Device Description
The Pioneer U121 Series CPAP operates using standard AC Power from a wall outlet. This U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motordriven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit.
The pressurized air is delivered to the patient via a flexible tubing, 22 mm internal diameter, and a standard nasal mask with an exhaust port. This device only requires minimal cleaning and periodic dealer service checks to ensure optimum performance.
9.6 Indications for Use
The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
Technological Characteristics 9.7
This Pioneer U121 Series CPAP consists of a motor-driven blower and a microprocessor based control system. The air, which penetrates through the filter, is directed to the motor-driven blower for pressure lift, and then the pressurized air is delivered to the nozzle, located at the front end of this unit. The microprocessor controls the pressure of air delivered by monitoring the speed of motor-driven blower. This technology is well established and has been used in other legally marketed products. There are no major technological differences.
Performance Data 9.8
The results of the testing confirm that the device meets specifications and is substantially equivalent to the predicate device.
9.9 Conclusion
Based on the design, performance specifications and testing and intended use, the Merits Health Products Pioneer U121 Series CPAP are substantially equivalent to the currently marketed device.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing left and has three stripes on its wings.
MAY 1 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Chao Merits Health Products Company Limited 9 Road 36, Taichung Industrial Park Taichung, TAIWAN, R.O.C.
Re: K041823
Trade/Device Name: Pioneer U121 Series CPAP Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: April 18, 2005 Received: April 21, 2005
Dear Mr. Chao:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have to rown a your 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to devices that has the Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval upprovision (1 the Act. The general controls provisions of the Act include controls provibrons of the sixtration, 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 (FMR), it may be subjoct to back adding Federal Regulations, Title 21, Parts 800 to 898. In your device ear oe roundsh further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Chao
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 yours,
SM Schui Om,D.
Chiú 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
K041823 * 10(k) File Number:
Merits Health Products Pioneer U121 Series CPAP Device Name:
Indications For Use:
The Pioneer U121 Series CPAP are indicated for treating the adult, suffering from Obstructive Sleep Apnea (OSA), in the home by delivering continuous positive air pressure to the upper airway. The devices are not intended for life support nor do they provide any patient monitoring capabilities.
ﺒ
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 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)
Ques Sul
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K0918
PAGE 1 of ___
§ 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).