(67 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, S9 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.
This appears to be a 510(k) premarket notification for a medical device, specifically a power mobility scooter. The document describes a comparison to a predicate device to establish substantial equivalence, rather than a study with a defined set of acceptance criteria for a novel device's performance.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details are not applicable in the context of this 510(k) submission.
This document focuses on demonstrating that the new device (HEARTWAY Power Mobility Scooter, S9) is substantially equivalent to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PF6 (K072104)).
Here's an breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and reported device performance in the way a clinical trial or performance study report for a novel medical algorithm might. Instead, it compares the new device to a predicate device on various design and performance aspects to establish substantial equivalence.
The document states:
- "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 weight limit, maximum speed, cruising range, 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, battery charge, and the competent switches and switching power supplies."
- "The maximum slope for the two devices is difference. This means the new device is 12°, the predicate device is 10°." (This is a difference, not an 'acceptance criterion' being met, but the document argues it's still substantially equivalent, stating "For the real life use, the two devices are substantially equivalent.")
- "The main differences for the two devices are overall appearance, wheels size, weights, and the warranty 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."
Summary Table (based on substantial equivalence comparison, not specific acceptance criteria):
| Feature/Performance Aspect | New Device (S9) Performance | Predicate Device (PF6) Performance | Substantial Equivalence Claim |
|---|---|---|---|
| Intended Use | To provide mobility | To provide mobility | Same |
| Mainframe Materials | Meet strength/fatigue tests | Meet strength/fatigue tests | Same |
| Weight Limit | Not explicitly stated | Not explicitly stated | Same |
| Maximum Speed | Not explicitly stated | Not explicitly stated | Same |
| Cruising Range | Not explicitly stated | Not explicitly stated | Same |
| Suspension of Cross Brace | Not explicitly stated | Not explicitly stated | Same |
| Footplates | Not explicitly stated | Not explicitly stated | Same |
| Armrest Type | Not explicitly stated | Not explicitly stated | Same |
| Back Upholstery Material | Same fabric | Same fabric | Same (passed resistance ignition) |
| Electronic Systems (Suppliers) | Same as predicate | UL certificated | Same (UL certificated) |
| Maximum Slope | 12° | 10° | Argument for substantial equivalence despite difference |
| Overall Appearance | Different | Different | Not a safety aspect, still equivalent |
| Wheels Size | Different | Different | Not a safety aspect, still equivalent |
| Weights | Different | Different | Not a safety aspect, still equivalent |
| Warranty | Different | Different | Not a safety aspect, still equivalent |
| Performance Testing (Standards) | EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 | Implied similar standards due to substantial equivalence claim | Same |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This is not a study involving a test set of data like an AI/ML algorithm. It's a comparison of device specifications.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for a test set is not relevant here as this is a device specification comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 not an AI/ML device requiring an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the context of "ground truth" for a dataset. The "truth" here is the documented specifications and performance of the predicate device (K072104) and the measured specifications and performance of the new device (S9), which are then compared.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: This document is a 510(k) submission focused on demonstrating substantial equivalence between a new power mobility scooter and a previously cleared predicate device based on design, materials, components, and performance specifications. It is not a performance study for an AI/ML device that would include acceptance criteria, test/training sets, or expert ground truth as typically defined for such a submission.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains a handwritten word, "Kogaisy". The word is written in a cursive style with varying stroke thicknesses. The letters are connected, and the overall appearance suggests a signature or informal writing.
Image /page/0/Picture/1 description: The image shows the text "SEP 21 2009" in a simple, sans-serif font. The text is likely part of a date stamp or label. To the right of the text is a stylized graphic that appears to be a four-leaf clover or a similar botanical design. The clover is rendered in black and white, with the leaves appearing solid black against a white background.
HEARTWAY MEDICAL PRODUCTS CO
NO.6, ROAD 25. TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 4
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/4 description: The image shows the text "ISO-9001 CERTIFICATED". The text is in a simple, sans-serif font and is arranged in two lines. The word "CERTIFICATED" is underlined with a thin, horizontal line.
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:
Proprietary Name: Common or Usual Name: Classification Name:
July 1, 2009
HEARTWAY Power Mobility Scooter, S9 POWERED SCOOTER MOTORIZED 4-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, S9 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
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo with the word "HEARTWAY" in bold, block letters at the bottom. Above the text 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 against a square background.
HEARTWAY MEDICAL PRODUCTS CO.,L 6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN 886-4-23580357 (Sales) 23588282 (Rep) FAX:886
Image /page/1/Picture/2 description: The image contains two logos. The top logo is the TUV logo, which is a circle with the letters "TUV" in the center. The bottom logo is a rectangle with the text "ISO-9001 CERTIFICATED" inside. The text is in a sans-serif font and is black in color.
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 weight limit, maximum speed, cruising range, 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, battery charge, and the competent switches and switching power supplies. Thus the same safety level for the two devices is assured.
The maximum slope for the two devices is difference. This means the new device is 12°, the predicate device is 10°. Certainly the real incline depends on the practical environments, i.e., weight, surface, and temperature. For the real life use, the two devices are substantially equivalent.
The main differences for the two devices are overall appearance, wheels size, weights, and the warranty 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.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. In the center of the seal is an image of an eagle with its wings spread.
SEP 2 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Heartway Medical Products Co., LTD % Chinese-European Industrial Research Society Ke-Min Jen No., 58, Fu-Chiun Street Hsin-Chu City China (Taiwan) 408
Re: K092154
Trade/Device Name: HEARTWAY Power Mobility Scooter, S9 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 1, 2009 Received: July 16, 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 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N Millenson
Mark N. Melkerson 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, S9
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number .
AND/OR
Over-The-Counter Use
V
(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
Page 1 of
§ 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).