(67 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Mobility Scooter, S8 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 text is a 510(k) summary for the HEARTWAY Power Mobility Scooter, S8. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a medical AI/software device submission would.
The document focuses on demonstrating substantial equivalence to an existing legally marketed device (HEARTWAY Power Mobility Scooter, PT7 (K073044)) rather than proving performance against predefined clinical or analytical acceptance criteria with a dedicated study.
Based on the provided text, I cannot complete most of your requested information as it is not present in this type of submission. The content provided is typical for a medical device (hardware) 510(k) submission, not a medical AI/software device.
Here's an analysis of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic device, or a specific functional outcome for a therapeutic device). Instead, it relies on demonstrating that the new device (S8) is similar enough to a predicate device (PT7) by having comparable characteristics and meeting certain general safety standards.
The performance testing section mentions:
- 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)
These are standards that the device meets, not acceptance criteria in the sense of a clinical benchmark. The "reported device performance" is essentially that it complies with these standards and is comparable to the predicate device in terms of:
- Intended use
- Mainframe materials (strength and fatigue)
- Maximum speed
- Suspension of cross brace
- Footplates
- Armrest type
- Overall dimensions
- Back upholstery material (passed resistance ignition test)
- Electronic systems (same suppliers, UL certificated - electronic controller, batteries, recharger, switches, switching power supplies), assuring the "same safety level."
Differences noted (weight capabilities, maximum slope, weights, cruising range, warranty) are deemed "not safety aspect" and do not prevent substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study involving a test set of data samples for an algorithm. It's a submission for a physical medical device.
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. There's no ground truth establishment in the context of an AI/software device.
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-assisted device.
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 consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary:
The provided document is a 510(k) submission for a physical power mobility scooter. Its purpose is to demonstrate that the new device, HEARTWAY Power Mobility Scooter, S8, is "substantially equivalent" to a legally marketed predicate device (HEARTWAY Power Mobility Scooter, PT7). This type of submission relies on comparing specifications, materials, and compliance with general safety and performance standards (like EMC and RESNA) rather than clinical studies with explicit acceptance criteria for algorithmic performance, ground truth, or human reader effectiveness, as would be expected for an AI/software as a medical device (SaMD).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a logo on the left and some text on the right. The logo is a stylized floral design with several petals. The text on the right includes the word "HEART" in large, bold letters, followed by an address "NO.6, ROAD", a telephone number "TEL:886-4-2", a website "Web: www.he", and an email address "E-mail: sales".
HEARTWAY MEDICAL PRODUCTS CO
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 40
TEL:886-4-23580357 (Sales)-23583232 (Rep) FAX:886-4-23590786
Web: www.heartway.com.tw
Image /page/0/Picture/4 description: The image is blurry and contains some text. The text is not clear enough to be read. The image is mostly white with some black text in the upper portion of the image.
ISO-9001
CERTIFICATED
K6921SS
દ દ 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:
July 5, 2009
Proprietary Name: Common or Usual Name: Classification Name:
HEARTWAY Power Mobility Scooter, S8 POWERED SCOOTER MOTORIZED 4-WHEELED VEHICLE, Class II, 21 CFR 890.3800 INI
Indications for Use:
Product Code:
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, S8 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 with a stylized floral design above the word "HEARTWAX". The floral design is composed of several rounded shapes arranged in a circular pattern, resembling petals or leaves. The word "HEARTWAX" is written in a bold, sans-serif font, with each letter clearly defined. The logo has a simple, yet distinctive appearance.
HEARTWAY MEDICAL PRODUCTS CO .. LTD.
10.6. ROAD 25. TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R.O.C. 408 -4-23580357 (Sales)- 23583232 (Ren) FAX · 886-4-23590788
Image /page/1/Picture/3 description: The image shows a logo with the letters "TUV" in a stylized font at the top. Below the logo, there is a box with the text "ISO-9001 CERTIFIED" inside. The text is in a smaller font size and is less clear than the logo.
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 maximum speed, the suspension of cross brace, footplates, armrest type, and even the overall dimensions for the two devices are similar. 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 scooter and the new device is four wheels scooter. Thus the main differences for the two devices are including weight capabilities, maximum slope, weights, cruising range, and the warranty. The safety levels of the two devices are the same and the differences of the overall weight and outer appearance are not safety aspect. They are substantially equivalent.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
SEP 2 1 2009 Heartway Medical Products Co., LTD % Chinese-European Industrial Research Society Dr. Ke-Min Jen No., 58, Fu-Chiun Street
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Re: K092155
Hsin-Chu City China (Taiwan) 408
Trade/Device Name: HEARTWAY Power Mobility Scooter, S8 Regulation Number: 21 CFR 890.3800 Regulation Name: Motorized three-wheeled vehicle Regulatory Class: II Product Code: INI Dated: July 5, 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 iddictions 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, Or ug, 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 misbaranding 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/cdrl/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 McMillan
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, S8
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) AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Surgical, Orthopedic, and Restorative Devices |
Page 1 of
K092155510(k) Number ـ
§ 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).