(10 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Lightweight Power Mobility Scooter, S33 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.
This document is a 510(k) premarket notification for the HEARTWAY Lightweight Power Mobility Scooter, S33. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for a new, standalone medical device.
Therefore, many of the requested categories (like specific numerical acceptance criteria, various types of studies, ground truth establishment, sample sizes for training/test sets for AI models, human-in-the-loop studies) are not applicable to this type of regulatory submission. This submission primarily relies on performance testing to established standards and comparison to a predicate device.
Here's an analysis based on the information provided, with "N/A" for categories that are not present or applicable to this document's scope:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance | Comments |
|---|---|---|---|
| Performance Testing | ANSI/RESNA WC/Vol.2-1998 | Conforms | Standard for electrically powered wheelchairs, scooters, and their chargers. |
| CISPR 11: 1990 | Conforms | Standard for industrial, scientific and medical (ISM) radio-frequency equipment - electromagnetic disturbance characteristics. | |
| EN61000-3-2: 1995 | Conforms | Standard for electromagnetic compatibility (EMC) - limits for harmonic current emissions. | |
| IEC61000-3-3: 1995 | Conforms | Standard for electromagnetic compatibility (EMC) - limitation of voltage changes, voltage fluctuations and flicker. | |
| Material Strength/Fatigue | N/A (Implied by comparison) | Mainframes fixed & meet strength/fatigue tests | Compared to predicate device. |
| Electrical Systems Safety | UL certificated | All electrical systems UL certificated | Same suppliers as predicate device; includes controller, batteries, switches. |
| Incline Capability | Driving angle up to 10° | Can drive under 10° slope | Improved over predicate device (8°), with user manual guidance. |
| Cruising Range | N/A (Comparison, not a specific pass/fail criteria) | 18 miles | Improved over predicate device (10 miles); noted that real range varies. |
| Resistance to Ignition | N/A (Implied by comparison) | Back upholstery passed resistance ignition test | Same fabric as predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. This document describes performance testing against standards and comparison to a predicate device, not a test set of data points in the way an AI/ML model would be evaluated. The testing is on the physical device itself.
- Data Provenance: N/A for a "test set" of data. The performance testing was carried out on the device by HEARTWAY Medical Products Co., Ltd. (Taiwan, ROC) to international and national standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. The "ground truth" here is compliance with established engineering and safety standards (e.g., ANSI/RESNA, CISPR, EN, IEC, UL) and manufacturing specifications, rather than expert consensus on medical image interpretations or diagnoses. Compliance is typically verified through laboratory testing and engineering analysis.
4. Adjudication method for the test set
- N/A. This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on ground truth labeling of data for AI/ML studies. Here, compliance is determined by test results against specifications.
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
- N/A. This is not an AI/ML device, nor is it a diagnostic device where human reader performance is a relevant metric. It is a power mobility scooter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Engineering and Safety Standards Compliance: The "ground truth" for this device's performance testing is its adherence to a series of recognized international and national standards for electric wheelchairs/scooters and electromagnetic compatibility (e.g., 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 is also established by direct comparison to a legally marketed predicate device (WU'S 3-WHEELED NEO SCOOTER, WT-T3D).
8. The sample size for the training set
- N/A. This document does not describe the development or evaluation of an AI/ML model; therefore, there is no "training set."
9. How the ground truth for the training set was established
- N/A. As there is no training set for an AI/ML model, this question is not applicable.
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Image /page/0/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, sans-serif font at the bottom. Above the text is a black square containing a stylized, abstract floral or butterfly-like design. The design consists of rounded shapes that intersect in the center, creating a symmetrical pattern.
HEARTWAY MEDICAL PRODUCTS CO.,LTD.
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408
mail : sales@heartway.com.tw
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April 4, 2007
PR 1 9
510(k) SUMMARY " 66
Submitter's Name: HEARTWAY Medical Products Co., Ltd. No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwan, ROC
Date summary prepared:
Device Name:
Proprietary Name: Common or Usual Name: Classification Name:
HEARTWAY Lightweight Power Mobility Scooter, S33 POWERED SCOOTER MOTORIZED 3-WHEELED VEHICLE, Class II, 21 CFR 890.3800
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 Lightweight Power Mobility Scooter, S33 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: WU'S 3-WHEELED NEO SCOOTER, WT-T3D (K032488)
DI
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HEARTWAY MEDICAL PRODUCTS CO.
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK. TAICHUNG TAIWAN I :886-4-23580357 (Sales) - 23583232 (Rep) FAX :886-4-2359078
Image /page/1/Picture/3 description: The image contains two logos. The top logo is the TUV logo, which is a circle with the letters "tuv" inside. The bottom logo is a rectangle with the text "ISO-9001 CERTIFICATED" inside. The logos are both black and white.
Summary for substantial equivalence comparison:
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. The weight capabilities, maximum speed, suspension of cross brace, footplates, 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.
The main difference for the two devices is overall appearance. Besides, the incline degree is 8° for the predicate device and the new device can drive under 10° slope. We provide the relevant specifications for ground clearance and curb climbing ability in the Owner's Manual. Thus, the user is not allowed to operate the device on the incline angle higher than the specified angle. The safety levels of the two devices are the same when operating the devices on the different inclines. They are substantially equivalent.
The cruising range per charge for the two devices is difference. This means the new device is 18 miles cruising range, the predicate device is 10 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd. % Chinese-European Industrian Research Society Dr. Ke-Min Jen No. 58, Fu-Chium Street Hsin-Chu City, Taiwan 408 Republic of China
APR 1 9 2007
Re: K071007
Trade/Device Name: Heartway Lightweight Power Mobility Scooter, S33 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: Class II Product Code: INI Dated: April 4, 2007 Received: April 9, 2007
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. Iisting 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. Ke-Min Jen
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,
for Rob
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 Lightweight Power Mobility Scooter, S33
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 NEEDE
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign- IT) Division of Get eral. Restorative, and Neurological Devices
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§ 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).