(43 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, S12 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 document is a 510(k) premarket notification for a medical device: the HEARTWAY Power Mobility Scooter, S12. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study in the way typically associated with AI/ML-based medical devices or novel therapies.
Therefore, many of the requested categories (e.g., sample size for test sets, number of experts for ground truth, MRMC study, training set details) are not applicable to this document as it pertains to a mechanical mobility device and its comparison to an existing scooter.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
The document doesn't explicitly list "acceptance criteria" in a quantitative table format with corresponding performance results. Instead, it describes performance testing and then justifies "substantial equivalence" based on various device characteristics and safety standards. The "performance" in this context relates to meeting safety and functional standards, rather than clinical efficacy metrics.
| Acceptance Criteria Category (Derived from document) | Reported Device Performance / Justification |
|---|---|
| Intended Use | Met: "The intended use between the two devices is the same." (Predicate: HEARTWAY Power Mobility Scooter, PT7) |
| Mainframe Materials | Met: "Mainframes materials of the two devices are fixed, and all meet the strength and fatigue tests and they use the same material aspects." |
| Weight Capabilities | Met: "The weight capabilities... for the two devices are all the same." |
| Maximum Speed | Met: "The maximum speed... for the two devices are all the same." |
| Suspension (Cross Brace) | Met: "The suspension of cross brace,... for the two devices are all the same." |
| Footplates, Armrest Type | Met: "Footplates, armrest type... for the two devices are all the same." |
| Back Upholstery Material | Met: "The back upholstery material is also the same fabric and passed the resistance ignition test." |
| Electronic Systems (Suppliers, Certifications) | Met: "The electronic systems between two devices are the same suppliers, and all passed by the UL certificated, for instance the electronic controller, batteries, recharger, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured." |
| Incline Capability | Met (with user guidance): Predicate: 10°. New device: up to 12° slope. "We provide the relevant specifications for ground clearance in the User'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." |
| Cruising Range per Charge | Met (with practical consideration): New device: 25 miles; Predicate: 32 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." (Note: This is a recognized difference but deemed equivalent in practical use). |
| Performance Testing Standards | Met: "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)" (Implied that the device passed these tests, although specific results are not provided in this summary). |
The study proving the device meets the acceptance criteria is detailed in the "Performance Testing" and "Summary for substantial equivalence comparison" sections. The key aspects are:
- Nature of the "Study": This is not a clinical study but rather an engineering and regulatory comparison against a predicate device and relevant industry standards.
- Comparison to Predicate Device: The HEARTWAY Power Mobility Scooter, S12 (new device) was compared to the HEARTWAY Power Mobility Scooter, PT7 (K073044) (predicate device).
Specific Information Requests:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This is a physical device, and the "testing" refers to meeting engineering standards and direct comparison of specifications and components between the new device and the predicate device. There is no "test set" of clinical data. Data provenance would refer to the location of manufacturing and testing, which is Taichung, Taiwan, ROC.
-
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):
- N/A. "Ground truth" in the context of clinical expert consensus is not relevant here. The "ground truth" is established by adherence to recognized engineering standards (e.g., ANSI/RESNA, CISPR, EN, IEC) and the specifications of the predicate device. Expertise would be in engineering and regulatory compliance.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method for clinical data is described or applicable. The "adjudication" is essentially the manufacturer demonstrating compliance to FDA regulators.
-
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 device is a power mobility scooter, not an AI/ML diagnostic or assistive device for human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. This is a mechanical device, not an algorithm. Considerations of human-in-the-loop performance are related to the user operating the scooter safely and effectively, which is addressed by design and user manual instructions, not algorithmic performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Predicate Device Specifications: The "ground truth" used for demonstrating safety and effectiveness relies on established engineering and safety standards (e.g., EMC, strength, fatigue, ignition resistance, UL certifications) and the proven safety and performance characteristics of the legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7).
-
The sample size for the training set:
- N/A. This is not an AI/ML device with a training set. The "training" for the device would be its design and manufacturing process, optimized through engineering iterations, but not in the sense of an algorithmic training set.
-
How the ground truth for the training set was established:
- N/A. As above, no algorithmic training set is involved.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo and contact information for HEARTWAY MEDICAL PRODUCTS CO., LTD. The logo includes a stylized graphic to the left of the company name. The contact information includes the address, phone numbers, website, and email address. There is also a handwritten number "16092650" at the bottom right.
510(k) SUMMARY "
~ 9 2009
Submitter's Name: HEARTWAY Medical Products Co., Ltd.
No.6, Road 25, Taichung Industrial Park, Taichung, 408, Taiwań, ROC
Date summary prepared:
Device Name:
August 20, 2009
| Proprietary Name: | HEARTWAY Power Mobility Scooter, S12 |
|---|---|
| Common or Usual Name: | POWERED SCOOTER |
| Classification Name: | MOTORIZED 4-WHEELED VEHICLE, Class II |
| 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, S12 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, PT7 (K073044)
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for "HEARTWAX". The logo features a stylized graphic above the text. The graphic appears to be an abstract floral or butterfly-like design, composed of several rounded shapes arranged in a circular pattern. The word "HEARTWAX" is written in bold, sans-serif capital letters below the graphic.
HEARTWAY MEDICAL PRODUCTS CO.,LTD ROAD 25, TAICHUNG INDUSTRIAL PARK. TAICHUNG. TAIWAN R.A. 80357 (Sales) 23583232 (Rep) FAX: 886-4-23590786
Image /page/1/Picture/2 description: The image shows a logo for TUV. The logo consists of the letters "TUV" stacked on top of each other, with a small cross above the letters. Below the letters, there is some text that is too small to read. The logo is black and white and appears to be of low resolution.
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. Moreover, the weight capabilities, maximum speed, the suspension of cross brace, footplates, armrest type, and warranty 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, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
Owing to the predicate device is three wheels larger scooter and the new device is four wheels smaller scooter. Thus the main differences for the two devices are including overall dimensions, weight, and sizes of tires. Besides, the incline degree is 10° for the predicate device and the new device can drive under 12° slope. We provide the relevant specifications for ground clearance in the User'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 25 miles cruising range and the predicate device is 32 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.
D2
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (USA). The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing segments and a tail.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - 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 China (Taiwan) 30067
OCT - 9 2009
Re: K092650
Trade/Device Name: HEARTWAY Power Mobility Scooter, S12 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: August 20. 2009 Received: August 27, 2009
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 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 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.
{3}------------------------------------------------
Page 2 – Dr. Ke-Min Jen
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/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/defaqtt.htm
Sincerely yours,
Mark N. Melkerson
Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510 (K) Number ( If Known ): K
Device Name: HEARTWAY Power Mobility Scooter, S12
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)
Shuyler C.A. Gray FOR M.MELKERSON
(Dislon Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number
§ 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).