(31 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The HEARTWAY Power Tilt Seating System Power Chair, P17RT 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.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting studies:
This 510(k) summary focuses on demonstrating substantial equivalence rather than defining and meeting specific, quantitative acceptance criteria for device performance as might be seen for novel technologies or for specific diagnostic accuracy. The performance testing cited is primarily related to safety and general electrical/mechanical standards, not clinical efficacy or diagnostic performance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit from Document) | Reported Device Performance (from Document) |
|---|---|---|
| Safety and Standards Compliance | Meet EMC standards (ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) | Device passed: "EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995" |
| Structural Integrity | Mainframes materials meet strength and fatigue tests. | "Mainframes materials of the two devices all meet the strength and fatigue tests" |
| Material Safety (Upholstery) | Back upholstery fabric passed resistance ignition test. | "The back upholstery material is also the same fabric and passed the resistance ignition test." |
| Electrical System Safety | Electrical systems (controller, batteries, switches, power supplies) are UL certified. | "the electronic systems... are the same suppliers, and all passed by the UL certificated" |
| Intended Use | Provide mobility to persons restricted to a seated position. | Identical to predicate device: "The intended use between the two devices is the same." |
| Substantial Equivalence to Predicate | Overall performance and safety comparable to WU'S Powered Wheelchair MAMBO 36X (K050010), despite differences in dimensions, max speed, cruising range, incline, and power tilt system. | Demonstrated as substantially equivalent by the FDA letter: "...determined the device is substantially equivalent... to legally marketed predicate devices..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense for diagnostic or clinical performance. The "test set" here refers to the device itself undergoing engineering and safety evaluations. No human subject testing data is presented in this summary for performance.
- Data Provenance: The device manufacturer, HEARTWAY Medical Products Co., Ltd., is located in Taichung, Taiwan, ROC. The testing would have been conducted by them or by certified labs. The standards referenced are international (CISPR, EN, IEC) and American (ANSI/RESNA).
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 device is not a diagnostic tool requiring expert ground truth for interpretation. The "ground truth" for the engineering and safety tests are the specifications of the standards themselves (e.g., whether a material passes a fatigue test).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies, typically involving multiple human readers reviewing medical images or patient records. This summary details compliance with established engineering and safety standards.
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. MRMC studies are used for evaluating the performance of diagnostic devices or AI algorithms often with human readers. This device is a powered wheelchair and does not involve AI assistance for human diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a powered wheelchair. It does not employ an algorithm that would have standalone performance evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance testing cited is adherence to published engineering, safety, and electrical standards (e.g., ANSI/RESNA WC/Vol.2-1998, CISPR 11, EN61000-3-2, IEC61000-3-3, UL certification, resistance ignition tests). This can be considered a form of objective technical standard compliance.
8. The sample size for the training set
- Not applicable. There is no mention of a training set for an AI algorithm or model. This is a medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a logo with the word "HEARTWAY" in bold, black letters at the bottom. Above the word is a black square with a stylized, abstract floral or butterfly-like design in white. To the left of the square, there is a small circle connected to the word "HEARTWAY" by a thin, dotted line.
RTWAY MEDICA
Image /page/0/Picture/3 description: The image shows a blurry, low-resolution line. The line appears to be slightly curved and is positioned horizontally across the bottom portion of the image. Due to the image quality, it is difficult to discern any further details about the line's texture or composition.
CERTIFIED
66 510(k) SUMMARY "
MAR 2 3 2007
February 14, 2007
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:
HEARTWAY Power Tilt Seating System Power Chair. P17RT POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860
Classification Name:
Common or Usual Name:
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 Tilt Seating System Power Chair, P17RT 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:
WU'S Powered Wheelchair MAMBO 36X (K050010)
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows a logo for an organization called HEARTWAY. The logo features a stylized floral design above the word HEARTWAY. The floral design is composed of four rounded petals arranged in a circular pattern, and it is set against a square background. The word HEARTWAY is written in a bold, sans-serif font.
HEARTWAY MEDICAL PRODUCTS CO.,LTI
NO.6, ROAD 25, TAICHUNG INDUSTRIAL PARK, TAICHUNG, TAIWAN R. TEL: 886-4-23580357 (Sales) 23583232 (Rep) FAX: B86-4-23590786
Image /page/1/Picture/3 description: The image contains two logos. The first logo is the TÜV SÜD logo, which is a black oval with the letters "TÜV" in bold black letters at the top. Below the letters are smaller words that are difficult to read. The second logo is a black rectangle with rounded corners that says "ISO 9001 CERTIFICATED" in black letters.
Summary for substantial equivalence comparison:
The intended use between the two devices is the same. Mainframes materials of the two devices all meet the strength and fatigue tests and they use the same material aspects. The suspension of cross brace, footplates, armrest type, and the warranty 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 major differences existing are the overall dimensions, maximum speed, cruising range, the incline degrees, and special designed for the power tilt seating system are differences between the two devices. The overall appearance differences are not safety aspect. So the new device is substantially equivalent to the predicate devices in this aspect.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three swooping lines that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Heartway Medical Products Co., Ltd. % Republic of China Chinese-European Industrial Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan Republic of China
MAR 2 3 2007
Re: K070493
Trade/Device Name: Heartway Power Tilt Seating System Power Chair, P17RT Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: INI Dated: February 14, 2007 Received: February 20, 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, 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 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
{3}------------------------------------------------
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 1000-1050. 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,
Mark N. Melkerson
Mai Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K 510 (K) Number ( If Known ):
Device Name: HEARTWAY Power Tilt Seating System Power Chair, P 1 7 R T
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number /670453
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)
Page of 1
§ 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).