(22 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, P16RT 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 describes a 510(k) premarket notification for a powered wheelchair, the HEARTWAY Power Tilt Seating System Power Chair, P16RT. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting de novo studies with specific acceptance criteria as you'd find for a novel device.
Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, as typically associated with performance evaluations of AI algorithms or diagnostics, is not applicable in this context. The 510(k) submission focuses on comparing the new device against an existing one to show it's equally safe and effective.
Here's how to interpret the provided information within the framework of a 510(k):
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for 510(k)s): The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. This means showing that the new device has the same intended use as the predicate and is as safe and effective, or has different technological characteristics but those differences do not raise different questions of safety and effectiveness.
- Reported Device Performance: The submission argues for substantial equivalence by stating:
- "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." (Implies the new device passed these tests, aligning with predicate performance.)
- "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 document also lists specific performance testing standards it met: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995. These standards themselves contain specific acceptance criteria for various aspects of powered wheelchairs (e.g., stability, braking, durability, electromagnetic compatibility). The implication is that the HEARTWAY device passed all relevant criteria within these standards.
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 for a 510(k) substantial equivalence submission. The "test set" here refers to the device itself being tested against established industry standards. There isn't an external "data set" in the sense of patient data or algorithm performance data. The device itself undergoes performance testing.
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. "Ground truth" in the context of device performance testing generally refers to the physical measurements and evaluations against predefined standards by qualified testing engineers and laboratories (e.g., UL certified labs).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 are used in clinical trials or studies assessing clinical endpoints or subjective interpretations (e.g., image reading). This submission focuses on 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. This relates to AI or diagnostic device performance, not a powered wheelchair.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI or diagnostic device performance, not a powered wheelchair.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the clinical sense. The "ground truth" for the performance testing mentioned (e.g., strength, fatigue, ignition resistance, EMC) would be the measured values of the device's performance against the specified limits in the referenced ANSI/RESNA, CISPR, EN, and IEC standards.
8. The sample size for the training set:
- Not applicable. "Training set" refers to data used to train AI algorithms. This is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable. Same reason as above.
In summary, for K070489:
This submission is a traditional 510(k) for a physical medical device (powered wheelchair). The "proof" that it meets acceptance criteria comes from demonstrating that its technological characteristics are substantially equivalent to a predicate device and that it complies with relevant industry performance and safety standards. The detailed questions about studies, experts, ground truth, and AI-related metrics do not apply to this type of regulatory submission.
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Image /page/0/Picture/1 description: The image shows a logo for HEARTWAY. The logo features a stylized floral design above the word HEARTWAY. The floral design is composed of four petal-like shapes arranged in a circular pattern, set against a square background.
HEARTWAY MEDICAL PRODUC
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MAR 1 4 2007
February 13, 2007
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:
HEARTWAY Power Tilt Seating System Power Chair, P16RT POWERED WHEELCHAIR POWERED WHEELCHAIR, Class II, 21 CFR 890.3860
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, P16RT 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: FORYOU POWERED WHEELCHAIR, FC-100 (K061693)
DI
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HEARTWAY MEDICAL PRODUCTS CO.,L BOAD 25 TAICHUNG INDUSTRIAL PARK. TAICHUNG TAIM
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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.
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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. % ROC Chinese-European Industrial Research Society Dr. Ke-Min Jen Official Correspondent No. 58, Fu-Chiun Street Hsin-Chu City, Taiwan Republic of China
MAR 1 4 2007
Re: K070489
Trade/Device Name: Heartway Power Tilt Seating System Power Chair, P16RT Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: February 5, 2007 Received: February 14, 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
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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 Pedro Nunez
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 Power Tilt Seating System Power Chair, P16RT
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted t 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative, | |
| and Neurological Devices | |
| 510(k) Number | K070489 |
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§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).