(34 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter. S11 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 documents describe a 510(k) premarket notification for the HEARTWAY Power Mobility Scooter, S11. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics in the way a novel medical device might.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details for an AI-powered device is largely not applicable to this 510(k) submission.
However, I can extract the relevant performance testing and equivalence information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| EMC Report ANSI / RESNA WC/Vol.2-1998 | Device meets this standard |
| CISPR 11: 1990 | Device meets this standard |
| EN61000-3-2: 1995 | Device meets this standard |
| IEC61000-3-3: 1995 | Device meets this standard |
| UL certified electronic systems | Electronic systems (controller, batteries, switches, power supplies) are UL certified. |
| Strength and Fatigue tests | Mainframes meet strength and fatigue tests. |
| Resistance Ignition test | Back upholstery material passed the resistance ignition test. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not explicitly stated in terms of a "test set" for performance evaluation of a new algorithm. The performance testing refers to compliance with established international standards for wheelchairs, scooters, and their chargers. These are typically engineering and safety tests performed on representative units of the device.
- Data Provenance: The manufacturing company is HEARTWAY Medical Products Co., Ltd. in Taichung, Taiwan, R.O.C. The certifications are to international standards (ANSI / RESNA, CISPR, EN, IEC, UL).
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 submission does not involve expert-established ground truth for a diagnostic or AI-driven device. Compliance with engineering and safety standards is assessed through physical testing methods, not expert review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 (mobility scooter), not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the typical sense of "ground truth" for clinical data. The "ground truth" for this device's performance is adherence to established engineering, safety, and electrical standards as measured through predefined test protocols (e.g., strength tests, electrical compatibility tests, flammability tests).
8. The sample size for the training set
- Not applicable. This submission does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary of the Study (510(k) Submission for Substantial Equivalence):
The "study" described in these documents is essentially a demonstration of substantial equivalence for the HEARTWAY Power Mobility Scooter, S11, to a legally marketed predicate device, the HEARTWAY Power Mobility Scooter, PF6 (K072104).
The core of the submission focuses on demonstrating that all critical safety and performance aspects of the new device are either identical to the predicate device or meet relevant recognized consensus standards.
Key arguments for substantial equivalence include:
- Identical Intended Use: Both devices provide mobility to persons restricted to a seated position.
- Similar Materials: Mainframe materials are fixed and meet strength and fatigue tests; back upholstery uses the same fabric and passed ignition resistance.
- Similar Components/Design: Suspension, cross brace, footplates, incline degree, and armrest type are all the same.
- Identical & Certified Electronic Systems: The electronic systems (controller, batteries, switches, power supplies) are from the same suppliers and are UL certified, ensuring the same safety level.
- Compliance with Standards: The device underwent performance testing against EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, and IEC61000-3-3: 1995.
The differences noted (overall appearance, weight capabilities, maximum speed, and total weight) are argued not to affect the safety and effectiveness, and thus the devices are considered substantially equivalent. The new device also has an additional "free-wheel" manual feature, which is presented as an advantage rather than a safety concern.
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Image /page/0/Picture/0 description: The image shows the numbers 1143 written in black ink on a white background. The numbers are handwritten and slightly slanted. The number 1 is written twice, followed by the numbers 4 and 3.
Image /page/0/Picture/1 description: The image shows a logo for HEARTWAY. The logo consists of a stylized floral design above the word "HEARTWAY" in a bold, sans-serif font. The floral design is composed of several petal-like shapes arranged in a circular pattern, all contained within a square.
HEARTWAY MEDICAL
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
ISC-922
CERTIFIED
2 5 2010
510(k) SUMMARY "
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6. Road 25. Taichung Industrial Park. Taichung, 40850. Taiwan, ROC
Date summary prepared: Device Name:
April 15. 2010
Proprietary Name: HEARTWAY Power Mobility Scooter, S1 l Common or Usual Name: POWERED SCOOTER Classification Name: MOTORIZED 4-WHEELED VEHICLE, Class II, 21 CFR 890.3800 Product Code: 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. S11 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: HEARTWAY Power Mobility Scooter. PF6 (K072104)
DI
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Image /page/1/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 butterfly or a flower with rounded petals. The logo is in black and white, with the graphic appearing to be solid black against a white background.
HEARTWAY MEDICAL PRODUCTS CO.,LTD NO 6. ROAD 25 TAICHUNG INCUSTRIAL PARK, TAICHUNG, TAIWAN TEL. BBE-4-23580357 (Sales) - 23583232 (Rep) FAX: 886-4-23590796
Image /page/1/Picture/2 description: The image shows a certification logo. The text "ISO-9001 CERTIFICATED" is stacked on top of each other. The text is in a bold, sans-serif font. The logo is simple and straightforward.
TIV
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 suspension of cross brace. footplates. incline degree 10°. and armrest type 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.
Owing to the new device is more agile and easy for storage or transportation and the predicate device is more general use. Besides, the new device has a "free-wheel" manual feature that means the new device can be moved without turning it on. Free-wheeling is accomplished by adjusting the free-wheeling lever to the free-wheeling position. Thus the main difference for the two devices is overall appearance, weight capabilities. maximum speed. and the weight are differences 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/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing the department's focus on health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Heartway Medical Products Co., Ltd. % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen No. 58, Fu-Chiun Street Hsin-Chu City, 30067, Taiwan Republic of China
MAY 2 & 2010
Re: K101143
Trade/Device Name: HEARTWAY Power Mobility Scooter, S11 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: April 9, 2010 Received: April 22, 2010
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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or ve, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not machary.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm1117809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. J Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Preud 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/medicaldevices/ResourceforYou/Industry/default.htm.
Sincerely yours.
Sincerely yours,
For
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative 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, $11
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 Surgical, Orthopedic, and Restorative Devices
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510(k) Number K101143
F1
§ 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).