(27 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor clectric 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 document (K080242) is a 510(k) premarket notification for a medical device, specifically the HEARTWAY Power Mobility Scooter, PF7. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with strict acceptance criteria and clinical endpoints for standalone device performance.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with performance studies for novel AI/medical imaging devices, is not present in this document.
Instead, the document details the comparison to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT6 - K073044) to establish substantial equivalence. The "performance testing" mentioned is related to safety standards (EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) rather than clinical efficacy or diagnostic accuracy.
Here's a breakdown of what is available in the document, framed against your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document implies that the "acceptance criteria" for substantial equivalence are met when the new device (PF7) demonstrates that its intended use, materials, safety aspects (like electronic systems meeting UL certification), and key physical/performance characteristics (e.g., maximum speed, range per charge) are equivalent to the predicate device (PT6), and that differences (like the number of wheels) do not raise new questions of safety or effectiveness.
- Reported Device Performance:
Aspect Predicate Device (PT6) New Device (PF7) Substantial Equivalence Claim Intended Use Same Same Same Mainframes materials Fixed, strength/fatigue tests met Fixed, strength/fatigue tests met Same Maximum Speed Same Same Same Suspension of cross brace Same Same Same Footplates Same Same Same Armrest type Same Same Same Warranty Same Same Same Overall dimensions Same Same Same Back upholstery material Same fabric, passed ignition test Same fabric, passed ignition test Same Electronic Controller Same supplier, UL certified Same supplier, UL certified Same Batteries Same supplier, UL certified Same supplier, UL certified Same Recharger Same supplier, UL certified Same supplier, UL certified Same Range per charge 32 miles 32 miles Same Number of Wheels Three Four Different, but not a safety aspect Overall Weight Not explicitly stated Different (due to wheels), but not a safety aspect Differences not safety-critical Performance Testing (Safety) (Implied) EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3 EMC Report, ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3 All passed
2. Sample size used for the test set and the data provenance
- Not applicable. This submission relies on comparisons of device specifications and adherence to safety standards, not a clinical "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in the context of clinical endpoints or diagnostic accuracy is not addressed. The "ground truth" here is adherence to engineering and safety standards, and equivalence to a legally marketed device.
4. Adjudication method for the test set
- Not applicable. There is no "test set" in the clinical or diagnostic sense described here. The evaluation relies on engineering tests and comparison by the manufacturer and subsequently reviewed by the FDA.
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 motorized scooter, not an AI-powered diagnostic or imaging device. There are no "human readers" or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical/electrical product, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this submission is regulatory compliance and engineering specifications. It includes:
- Predicate Device Specifications: The established characteristics and performance of the legally marketed HEARTWAY Power Mobility Scooter, PT6 (K073044).
- Industry Standards: Adherence to standards like 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).
- Component Certifications: For example, UL certification for electronic systems (controller, batteries, recharger).
- Material Testing: Strength and fatigue tests for mainframes, resistance ignition test for upholstery.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set. The "ground truth" for demonstrating substantial equivalence is based on established engineering and safety standards and the characteristics of the predicate device.
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January 25, 2008
Image /page/0/Picture/1 description: The image shows a logo with a stylized floral design above the word "HEARTWAY". The floral design consists of four rounded shapes arranged in a circular pattern, resembling petals or leaves. The word "HEARTWAY" is written in a bold, sans-serif font, with all letters capitalized. The logo appears to be a simple, yet recognizable design, possibly representing a company or organization with a focus on nature, health, or well-being.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
NO.6. ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408
TEL:886-4-23580357 (Sales)-23583232 (Rep) FAX:886-4-23590786
Web: www.heartway.com.tw
E-mail: sales@heartway.com.tw
510(k) SUMMARY "
Submitter's Name: HEARTWAY Medical Products Co., Ltd. No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC
Date summary prepared:
Device Name:
HEARTWAY Power Mobility Scooter. PF7 Proprietary Name: POWERED SCOOTER Common or Usual Name: MOTORIZED 3-WHEELED VEHICLE, Class II, Classification Name: 21 CFR 890.3800 Product Code: INI
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 HEARTWAY Power Mobility Scooter, PF7 is an indoor / outdoor clectric 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: HEARTWAY Power Mobility Scooter, PT6 (K073044)
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Image /page/1/Picture/0 description: The image shows a logo for "HEARTWAY". The logo consists of a stylized floral design above the word "HEARTWAY". The floral design is composed of four petal-like shapes arranged in a circular pattern. The word "HEARTWAY" is written in a bold, sans-serif font.
HEARTWAY MEDICAL PRODUCTS CO.,LTD. 0.6, Road 25, Taichung Industrial Park, Taichung, Taiwan R.O.C. EL : 886-4-23580357 (Sales) : 23583232 (Rep) : FAX : B86-4-23590786
ISC-9001:
CERTIFICATE
riiv
Summary for substantial equivalence comparison:
According to the above table that the intended use between the two devices is the same. Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects. Moreover, the maximum speed, the suspension of cross brace, footplates, armrest type, warranty, and even the overall dimensions for the two devices are all the same. The back upholstery material is also the same fabric and passed the resistance ignition test.
Especially the electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, recharger, passed by per charge for the two devices is same 32 miles. Thus the same safety level for the two devices is assured.
Owing to the predicate device is three wheels scooter and the new device is four wheels scooter. Thus the main differences for the two devices are including weight wheels beeter. the same and the overall weight differences are not safety aspect. They are substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized eagle or bird-like symbol, composed of several curved lines that form the shape of a bird's head and wings.
Public Health Service
FEB 27 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd. % Dr. Jen, Ke-Min No. 6, Road 25 Taichung Industrial Park Taichung, Taiwan R.O.C. 408
K080242 Re:
Trade/Device Name: Heartway Power Mobility Scooter, PF7 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: January 25, 2008 Received: January 31, 2008
Dear Dr. 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 – Dr. 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 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 Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please 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 vours.
Mark M. Milliman
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 ):___K
Device Name: HEARTWAY Power Mobility Scooter, PF7_
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use $\sqrt{}$
(Part 21 CFR 801 Subpart D)
(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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
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| 510(k) Number | K080242 |
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).