(126 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The Home Health Power Wheelchair, HC-200 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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 Home Health Power Wheelchair, HC-200. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data for the HC-200 itself.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not present in this document. The document primarily discusses the comparison of design features and a general statement about meeting certain performance standards.
Here's a breakdown of what can and cannot be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not explicitly provided in the format requested. The document states that the device underwent "Performance Testing" according to certain standards, but it does not detail specific acceptance criteria values or the quantitative performance results (e.g., maximum speed, range, turning radius, battery life).
However, it does implicitly state that the device meets the functional requirements by citing adherence to these standards and by asserting substantial equivalence.
Implicit Acceptance of Performance Standards:
| Acceptance Criteria (Standard Adherence) | Reported Device Performance (Adherence Indicated) |
|---|---|
| Adherence to ANSI/RESNA WC/Vol.2-1998 | Meets ANSI/RESNA WC/Vol.2-1998 standards for Electrically Powered Wheelchairs |
| Adherence to CISPR 11: 1990 | Meets CISPR 11: 1990 standards for Electrically Powered Wheelchairs |
| Adherence to EN61000-3-2: 1995 | Meets EN61000-3-2: 1995 standards for Electrically Powered Wheelchairs |
| Adherence to IEC61000-3-3: 1995 | Meets IEC61000-3-3: 1995 standards for Electrically Powered Wheelchairs |
| Electronic systems passed UL certification | Electronic systems (controller, batteries, charger) are from UL-certified suppliers and passed UL certification. |
| Overall substantial equivalence to predicate device (SINON Power Wheelchair, SN-P401) | Determined to be substantially equivalent to K040320 based on design and safety aspects. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document refers to "Performance Testing" but doesn't mention the number of units or specific test cases.
- Data provenance: The performance testing was done in relation to international and national standards (ANSI/RESNA, CISPR, EN, IEC). The location of the testing facility is not explicitly stated, but the company is based in Taiwan. It's likely prospective testing conducted by the manufacturer or a contracted lab to demonstrate compliance with these standards for the specific device model (HC-200). It's not a clinical study on a patient population.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable/not specified. The "ground truth" here is compliance with established engineering and safety standards, not a diagnostic or clinical outcome requiring expert consensus.
- Qualifications of experts: Not applicable. Compliance with standards is typically assessed by engineers and technicians.
4. Adjudication method for the test set:
- Adjudication method: Not applicable. This document describes performance testing against engineering standards, not a study where human judgment or adjudication of outcomes would be used. The testing would follow the methodologies outlined in the cited 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:
- MRMC study: No, this is not an MRMC study. The device is a power wheelchair, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone algorithm performance: Not applicable. The device is a physical product (power wheelchair), not an algorithm. The "performance testing" described refers to the functional and safety performance of the wheelchair itself.
7. The type of ground truth used:
- Ground truth type: The "ground truth" for this submission is adherence to recognized engineering and safety standards (ANSI/RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995) and the UL certification of its electronic components. The comparison to the predicate device (SINON Power Wheelchair, SN-P401) also serves as a "ground truth" for substantial equivalence.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This document is not describing an AI/machine learning model, so there is no training set in that context.
9. How the ground truth for the training set was established:
- Ground truth for training set established: Not applicable, as there is no training set in this context.
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FEB - 3 2005
દર 510(k) SUMMARY "
Submitter's Name: Home Health Technology Co., Ltd.
NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C.
| Date summary prepared: | September 27, 2004 |
|---|---|
| Device Name: | |
| Proprietary Name: | Home Health Power Wheelchair, HC-200 |
| Common or Usual Name: | Powered Wheelchair |
| Classification Name: | 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 Home Health Power Wheelchair, HC-200 is an indoor / outdoor Powered Wheelchair that is battery operated. It has a base with four-wheeled with a seat. The movement of the Wheelchair 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, controller, and their chargers - requirements and test methods)
Legally marketed device for substantial equivalence comparison:
SINON Power Wheelchair, SN-P401 (K040320)
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HOME HEALTH TECHNOLOGY CO., LTD. NO. 77. Gongye Rd. Dalli city Taichung county 412, Taiwan, R.O.C. Fax: 886-4-24914401 Tel: 886-4-24914315 http://www.homehealth.com.tw E-mail: info@homehealth.com.tw
Summary for substantial equivalence comparison:
.
ﺩﻏﻪ ﺩ ﺩﻏﻪ ۱۰ ﺩ
The electronic systems between two devices are the same suppliers and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured. The major differences existing of the two Powered Wheelchairs are the different batteries, and the overall dimension, the size of tires, and the weight limit 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
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. There is a number "0" at the bottom of the image.
Public Health Service
FEB - 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Home Health Technology Co., LTD. C/o Dr. Ke-Min Jen C/o Dr. RC-Mini John Industrial Research Society No.58, Fu-Chun ST. HSIN-CHU CITY, Taiwan, ROC
Re: K042719
K042719
Trade/Device Name: HOME HEALTH Power Wheelchair, HC – 200 Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: January 20, 2005 Received: January 27, 2005
Dear Dr. Ke-Min:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(K) premarket is substantially equivalent (for the indications for referenced above and have determined the devices marketed in interstate comments.
use stated in the enclosure) to legally market of Malice Mexicos Americas that use stated in the enclosure) to legally inate collect Device Amendments, or to devices that prior to May 28, 1976, the enactlient with the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features in have been reclassified in accordance will the provisions of wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval applications of t Act (Act) that to not require apploval of a prematics apple moreisions of the Act. The general
therefore, market the device, subject to the general courses proxistions of dev therefore, market the device, subject to me generation, listing of devices, good
controls provisions of the Act include requirements for annial registration, listing of devic controls provisions of the Act melude requirements for and adulteration.
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 If your device to such additional controls. Existing major regulations affecting your device can be
may be subject to such additional controls. Title All Redditions FDA may may be subject to such additions, "İxle 21, Parts 800 to 89% In addition, FDA may publish
found in the Code of Federal Regulations, "Title 21, Parts 800 to 89% In additi found in the Code of I caeral migg your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that HDA s Issualice of a subscription with other requirements of the Act or any
FDA has made a determination that your device complex . You must comply wit FDA has made a determination that your device only researces. You must comply with all
Federal statutes and regulations administerial by other condition (1) CFR Part 807): Federal statutes and regulations administered by other registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration as as a the Act's requirements, including but not unnited to requirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing proctice requirements as set fort labeling (21 CFR Part 801); good manufacturing (nactive station in and control
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation systenis (QB) rogalaton (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Dr.Jen Ke-Min
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Celia M. Witten, Ph.D., M.D. 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 ):
Device Name: HOME HEALTH Power Wheelchair, HC-200
Indications for Use:
The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.
Prescription Use Over-The-Counter Use AND/OR
(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 1
510(k) Number K042719
F
§ 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).