(39 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 electric scooter that is battery operated. It has a base with three-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) submission for the HEARTWAY Power Mobility Scooter, PF7. This is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with detailed acceptance criteria and performance metrics in the way a novel AI/software medical device would.
Therefore, many of the requested elements (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable to this type of device and submission. The document primarily details performance testing related to safety and engineering standards, and comparison to an existing device to establish equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like power mobility scooters, acceptance criteria are typically met through compliance with recognized standards for safety, performance, and electrical compatibility. The "reported device performance" is framed as meeting these standards and demonstrating equivalence to a predicate device in key functional areas.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance | Comments |
|---|---|---|---|
| Electromagnetic Compatibility (EMC) | ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 | Passed | These standards govern electrical safety and electromagnetic interference for electrically powered wheelchairs and scooters. |
| Material Strength and Fatigue | Not explicitly stated (implied by "meet the strength and fatigue tests") | Mainframes materials are fixed and meet strength and fatigue tests. | The device's structural integrity meets defined standards. |
| Resistance Ignition Test | Not explicitly stated (implied for back upholstery) | Back upholstery material passed the resistance ignition test. | Ensures safety against flammability. |
| Electronic Systems Certification | UL certificated | Electronic controller, batteries, and competent switches and switching power supplies are UL certificated. | Verification of electrical component safety. |
| Cruising Range (Comparison Point) | 18 miles (predicate device) | 32 miles (new device) | The new device exceeds the predicate device's range, which is noted as a difference but not a failure criterion, as "the real range depends on the practical environments." |
| Overall Safety Level | Substantially equivalent to predicate device | Same safety level as the predicate device (HEARTWAY Power Mobility Scooter, PF6). | Established through comparison of components and testing. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical or AI performance. The "test set" here refers to the physical device undergoing engineering and safety tests. It's typically one device or a representative sample for these types of compliance tests.
- Data Provenance: The testing was conducted by or for HEARTWAY Medical Products Co., Ltd. in Taiwan, R.O.C. The reports (e.g., EMC Report) would be generated from this physical testing. This is a design validation/verification process, not a clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The "ground truth" for a power mobility scooter's performance is objective measurements against established engineering and safety standards, not expert consensus on medical images or clinical outcomes. Certification bodies (like UL, those associated with ISO/IEC/EN standards) provide the "ground truth" by defining the tests and acceptable limits.
4. Adjudication Method for the Test Set
- Not applicable. Performance against engineering standards is typically binary (pass/fail) based on objective measurements, not a consensus or adjudication process.
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 device is a power mobility scooter, not an AI or diagnostic imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is electro-mechanical, not an algorithm.
7. The Type of Ground Truth Used
- Engineering and Safety Standards: The "ground truth" is defined by internationally recognized engineering and safety standards (e.g., ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, UL certifications). Compliance with these standards serves as the ground truth for safety and basic performance.
8. The Sample Size for the Training Set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there's no training set, there's no ground truth to be established for it.
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Image /page/0/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, block letters. Above the word is a stylized graphic that resembles a four-leaf clover or a stylized heart shape. The graphic is solid black and appears to be set against a square background, also in black.
ARTWAY MEDICAL PRODUCTS C
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
Image /page/0/Picture/3 description: The image contains the text "ISO-9001 CERTIFICATED". The text is written in a simple, sans-serif font. The word "ISO-9001" is placed above the word "CERTIFICATED". The text is likely part of a logo or certification mark.
" 510(k) SUMMARY "
DEC 07 2007
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC
Date summary prepared:
Device Name:
October 20, 2007
Proprietary Name: Common or Usual Name: Classification Name:
HEARTWAY Power Mobility Scooter, PF7 POWERED SCOOTER MOTORIZED 3-WHEELED VEHICLE, Class II, 21 CFR 890.3800 INI
Product Code:
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 electric scooter that is battery operated. It has a base with three-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, PF6 (K072104)
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Image /page/1/Picture/0 description: The image shows a logo for HEARTWAY. The logo consists of a black square with a white abstract floral design inside. Below the square, the word "HEARTWAY" is written in a bold, sans-serif font.
HEARTWAY MEDICAL PRODUCTS CO.,LTD. NO.6, ROAD 25. TAICHUNG INDUSTRIAL PARK. TAICHUNG, TAIWAN R.O.C. 408 886-4-23580357 (Sales) - 23583232 (Rep) FAX : 886-4-23590786
Image /page/1/Picture/2 description: The image shows a logo with the letters "TUV" stacked on top of each other. Below the logo, the text "ISO-9001 CERTIFICATE" is visible. The image appears to be a certification mark or emblem, possibly indicating compliance with ISO 9001 standards.
Summary for substantial equivalence comparison:
According to the above table that the intended use between the two devices is the Mainframes materials of the two devices are fixed, and all meet the strength and same. fatigue tests and they use the same material aspects. Moreover, the maximum speed, the suspension of cross brace, footplates, incline degree 10°, armrest type, and warranty 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, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
The cruising range per charge for the two devices is difference. This means the new device is 32 miles cruising range, the predicate device is 18 miles. Certainly the real range depends on the practical environments, i.e., weight, surface, incline, and temperature. For the real life use, the two devices are substantially equivalent.
Owing to the predicate device is four wheels scooter and the new device is three wheels scooter. Thus the main difference for the two devices is overall appearance, weight capabilities, and the weights are difference between the two devices. The safety levels of the two devices are the same and the overall appearance differences are not safety aspect. They are substantially equivalent.
D2
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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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other, creating a sense of depth and unity.
JAN 2 2 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Heartway Medical Products Co., LTD. % Dr. Jen. Ke-Min No. 6. Road 25 Taichung Industrial Park Taichung, Taiwan R.O.C. 408
Re: K073044
Trade Device Name: HEARTWAY Power Mobility Scooter, PT7 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: October 20, 2007 Received: October 29, 2007
Dear Dr. Jen, Ke-Min:
This letter corrects the substantially equivalent letter dated December 7, 2007.
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 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 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 vours.
Mark N. Millman
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 √
(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)
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Division of General, Restorative and Neurological Devices
510(k) Number.
EI
§ 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).