(36 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The P & F POWERED WHEELCHAIR, HC-510 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
The provided text describes a 510(k) premarket notification for a powered wheelchair, the P & F POWERED WHEELCHAIR, HC-510. The 510(k) pathway demonstrates substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics like sensitivity, specificity, or reader improvement.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" in the typical sense of a medical device performance study (e.g., target true positive rate for an AI diagnostic). Instead, the acceptance criteria for a 510(k) submission are demonstration of substantial equivalence to a predicate, which includes similar:
- Intended use
- Device technology and principles of operation
- Performance (if applicable, through non-clinical testing)
- Safety and effectiveness
The "reported device performance" is primarily qualitative and comparative in nature, focusing on how the new device matches the predicate.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance |
|---|---|
| Intended Use | "The intended use between the two devices is the same." (Provides mobility to persons restricted to a seated position) |
| Device Characteristics (Mainframe) | Mainframes are fixed. Materials meet strength and fatigue tests; similar material aspects. Mainframes are similar. |
| Device Characteristics (Dimensions/Weight) | Overall dimensions are similar. The new device is heavier than the predicate device. |
| Device Characteristics (Functional) | Weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and incline degree are all the same. Back upholstery material is also the same fabric. |
| Device Characteristics (Electronic Systems) | Electronic systems between two devices are from the same suppliers (UL certified): electronic controller, batteries, motor, competent switches, and switching power supplies. Different rechargers, but both UL certified. |
| Safety | "Thus the same safety level for the two devices is assured." Overall appearance differences are "not safety aspect." |
| Performance Testing | EMC Report (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a physical device (powered wheelchair), not an AI/software as a medical device (SaMD) that typically involves a "test set" of data. The "testing" referred to is performance testing for a physical product (e.g., EMC, strength, fatigue). Therefore, the concepts of "sample size for the test set," "data provenance," "retrospective or prospective," are not applicable in the context of this document. The testing would have involved prototypes of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/diagnostic device where "experts" would establish "ground truth" for a test set of data. The "ground truth" for a physical product like a wheelchair is compliance with engineering standards and functional specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving expert adjudication of data.
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
Not applicable. This is a physical medical device, not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance would be:
- Compliance with recognized engineering standards: ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers -- requirements and test methods).
- Functional specifications: Meeting parameters like maximum speed, weight capabilities, and structural integrity (strength and fatigue tests).
- Safety certifications: UL certification for electronic components.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI model training data.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device and does not involve AI model training data.
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MAR 1 4 2007
February 1, 2007
Image /page/0/Picture/1 description: The image shows the logo for P & F BROTHER IND., CORP. The logo consists of a hexagon shape with three triangles inside. To the right of the logo is the text "P & F BROTHER IND., CORP."
NO. 12, 611 ROAD, INDUSTRIAI. PARK. TAICHUNG, TAIWAN. R.O.C. TEL : 886-4-2359-1000 FAX : 886-4-2359-0921
510(k) SUMMARY " દર્
Submitter's Name: P & F BROTHER IND., CORP.
No.12, 6TH Road, Industrial Park, Taichung, 40755, Taiwan, ROC
Date summary prepared:
Device Name:
P & F POWERED WHEELCHAIR, HC-510 Proprietary Name: Common or Usual Name: POWERED WHEELCHAIR Classification Name: POWERED WHEELCHAIR, Class II, 21 CFR 890.3860
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
Description of the device:
The P & F POWERED WHEELCHAIR, HC-510 is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.
Performance Testing:
EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers -- requirements and test methods)
Legally marketed device for substantial equivalence comparison: FORYOU POWERED WHEELCHAIR, FC-100 (K061693)
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Image /page/1/Picture/0 description: The image shows a logo and text. The logo is a hexagon containing three triangles. To the right of the logo, the text reads "P & F BROTHER IND., CORP."
NO. 12, 6" ROAD, INDUSTRIAL PARK. TAICHUNG, TAIWAN, R.O.C. TEL : 886-4-2359-1000 = FAX : 886-4-2359-0921
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes of two devices are fixed. Mainframes materials of the two devices all meet the strength and fatigue tests and they are similar for the material aspects. The overall dimensions are similar. The weight capabilities, maximum speed, suspension of cross brace, footplates, armrest, and the incline degree are all the same. Back upholstery material is also the same fabric. Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, motor and the competent switches and switching power supplies. Though the two devices use the different recharge and also passed the UL certificated. Thus the same safety level for the two devices is assured.
The major differences existing are the overall dimensions, and the subject device is heavier than the predicate device. The overall appearance differences are not safety Thus the new device is substantially equivalent to the predicate devices in this aspect. aspect.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
P & F Brother Ind., Corp. % Roc Chinese-Europe Industrial Research Society Jen Ke-Min No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan)
MAR 1 4 2007
Re: K070350
Trade/Device Name: P & F Powered Wheelchair, HC-510 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 1, 2007 Received: February 6, 2007
Dear Jen Ke-Min:
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.
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.
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Page 2 - Jen Ke-Min
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melke Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510 (K) Number ( If Known ):_ K
Device Name: P & F POWER WHEELCHAIR, HC-510
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
Prescription Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDI
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 10703 Page 1 of 1
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).