(41 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The P & F POWERED WHEELCHAIR, HC-500SB is an indoor / outdoor wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the wheelchair 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.
Here is the information about the acceptance criteria and study for the P & F POWERED WHEELCHAIR, HC-500SB:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Predicate Device) | Reported Device Performance (P & F POWERED WHEELCHAIR, HC-500SB) |
|---|---|
| Mainframe strength and fatigue test compliance | Mainframes meet strength and fatigue tests, material aspects are similar. |
| Maximum speed | Same as predicate device. |
| Suspension of cross brace | Same as predicate device. |
| Footplates | Same as predicate device. |
| Armrest | Same as predicate device. |
| Wheel lock | Same as predicate device. |
| Seat and back upholstery material resistance ignition test compliance | Same fabric as predicate device, passed resistance ignition test by SGS. |
| Electronic systems (controller, batteries, motor, switches, power supplies) UL certification | Same suppliers, all passed UL certification. |
| Recharger UL certification | Different recharger than predicate, but also passed UL certification. |
| Safety level | Assured to be the same safety level as the predicate device. |
| Overall dimensions (comparable for intended use) | Different (lighter and more ingenious), but "overall appearance differences are not safety aspect" and considered substantially equivalent. |
| Weight capabilities (comparable for intended use) | Different, but considered substantially equivalent. |
| Incline degree (comparable for intended use) | Different, but considered substantially equivalent. |
| Cruising range (comparable for intended use) | Different, but considered substantially equivalent. |
| 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) | Device was tested against these standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of devices tested for each individual criterion. The testing appears to have been conducted on a single prototype or representative unit of the P & F POWERED WHEELCHAIR, HC-500SB.
- Data Provenance: Not applicable in the context of patient data for a diagnostic/AI device. The testing was conducted by the manufacturer (P & F BROTHER IND., CORP.) and potentially third-party labs (e.g., SGS for upholstery, UL for electronics) on the device itself, not on patient data. This is product performance testing, not clinical data testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI or diagnostic device that relies on expert interpretation of data to establish a ground truth for a test set. The "ground truth" here is compliance with established engineering and safety standards.
4. Adjudication method for the test set:
- Not applicable. There was no "test set" of patient data requiring adjudication. Compliance with engineering standards and comparison to a predicate device were the primary methods.
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, an MRMC comparative effectiveness study was not done. This device is a powered wheelchair, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm-based device. Performance testing focused on the physical and electrical safety and functionality of the wheelchair itself.
7. The type of ground truth used:
- The "ground truth" for this submission is based on:
- Compliance with established international and national standards: Specifically, EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and UL certification for electrical components.
- Substantial Equivalence to a legally marketed predicate device: The P & F POWER WHEELCHAIR, HC-510 (K070350). The performance characteristics of the predicate device serve as the benchmark for many of the "acceptance criteria."
8. The sample size for the training set:
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. There was no training set.
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OCT 2 8 2008
September 10, 2008
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P & F BROTHER IND., CORP.
´ ROAD. INDESTRIAL PARK, TAICHUNG, FAIWAN. R.O.C. NO. 12.6 11:1 886-4-2359-1000 - 1 AX : 886-4-2359-0921
510(k) SUMMARY "
Submitter's Name: P & F BROTHER IND., CORP.
No.12, 6TH Road, Industrial Park, Taichung, 40755, Taiwan, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
P & F POWERED WHEELCHAIR, HC-500SB POWERED WHEELCHAIR 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-500SB is an indoor / outdoor wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the wheelchair 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: P & F POWER WHEELCHAIR, HC-510 (K070350)
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P & F BROTHER IND., CORP.
ROAD, INDI STREAF PARK. TAICHUNG. FAIWAN. R.O.C. [ EL = 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 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 maximum speeds, suspension of cross brace, footplates, armrest, and the wheel lock are all the same. The seat and back upholstery materials are also the same fabric and passed the resistance ignition test by SGS.
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.
Owing to the subject device is lighter and ingenious than the predicate device, the major differences existing are the overall dimensions, weight capabilities, incline degree, and cruising range. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this 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. Corporation % ROC Chinese-European Industry Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) 30067
OCT 2 8 2008
Rc: K082722
Trade/Device Name: P & F Power Wheelchair, HC-500SB Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair. Regulatory Class: Class II Product Codc: ITI Dated: September 10, 2008 Received: September 17, 2008
Dear Dr. Jen:
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
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Page 2 - Dr. Ke-Min Jen
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Survcillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), plcase contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mulkeran
Mark N. Melkerson 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 ):
Device Name: P & F POWER WHEELCHAIR, HC-500SB
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use $\sqrt{ }$
彩
8
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDEL
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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| 510(k) Number | K082722 |
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§ 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).