The device is a product which changes people position not only from sitting to standing and standing to sitting but also reclines and lifts the seat and back position. The product provides indoor and outdoor mobility.

Device Description

The COMFORT Standing Wheelchair is an indoor / outdoor standup wheelchair that is manual wheelchair, not an electric power wheelchair, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.

AI/ML Overview

Here's an analysis of the provided text regarding the COMFORT Standing Wheelchair, HERO series, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Testing)	Reported Device Performance
Mechanical Conformity to Standards:
- ANSI / RESNA WC/Vol.2-1998 (Wheelchairs)	Not explicitly stated as "met," but implied by the statement: "The safety and performance functions of two systems [new and predicate device] are assured and validated. They are substantially equivalent."
Electromagnetic Compatibility (EMC) Standards:
- CISPR 11: 1990	"EMC Report" (indicating testing was performed). The statement "the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge" suggests conformity to electronic safety and performance standards, which would include EMC. The document explicitly lists CISPR 11: 1990 as a standard used for performance testing.
- EN61000-3-2: 1995	Same as above. The document explicitly lists EN61000-3-2: 1995 as a standard used for performance testing.
- IEC61000-3-3: 1995	Same as above. The document explicitly lists IEC61000-3-3: 1995 as a standard used for performance testing.
Ignition Resistance (Upholstery):
- Resistance ignition test (by SGS)	"the back upholstery is the same material, and also passed the resistance ignition test by SGS."
Other Functional Equivalence:
- Overall dimensions	"the overall dimensions and visional appearance are similar" to the predicate device.
- Electronic systems (UL certified)	"the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge."
- Suspension of cross brace, footplates, etc.	"the suspension of cross brace, footplates, incline degree 12°, armrest type, the size of tires, the weight limit, and warranty are all the same" as the predicate device.
- Intended use	The new device and predicate device "have the same intended use." This is crucial for substantial equivalence.
- Technological aspects	The new device and predicate device "have the same technological aspects."

Study Proving Acceptance Criteria Met:

The provided document describes a substantial equivalence comparison study rather than a traditional research study with statistically significant endpoints against specific acceptance criteria. The primary method used to demonstrate device performance and safety is by showing its equivalence to a legally marketed predicate device, the COMFORT Standing Wheelchair, HERO 2 (K031618).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable in the context of this submission. The comparison is made against the predicate device based on its established performance and adherence to standards. The document doesn't describe a separate "test set" of patients or devices for a new clinical trial. Instead, it relies on testing the subject device against relevant engineering and safety standards and comparing its features and performance to the predicate device.
Data Provenance: The device manufacturer, COMFORT ORTHOPEDIC CO., LTD., is located in Taiwan, R.O.C. The performance testing (EMC, ignition resistance) was conducted based on international standards (ANSI/RESNA, CISPR, EN, IEC) and by an accredited body (SGS for ignition resistance). This implies prospective testing of the new device against these standards. The comparison data for substantial equivalence is derived from the predicate device, K031618, which was previously cleared by the FDA.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission focuses on engineering and performance standards conformity and substantial equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth in a clinical sense. The "ground truth" here is adherence to recognized industry standards and the demonstrated safety and effectiveness of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is described as this is not a study involving human reader interpretations of data. The assessment is based on objective testing against technical standards and a direct comparison of specifications and features with the predicate device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of medical images or data. The COMFORT Standing Wheelchair is a physical medical device (wheelchair), not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical standing wheelchair, not an algorithm or AI system. Its performance is inherent to its physical and electronic design and functionality, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this submission is primarily:
- Adherence to recognized international and national engineering and safety standards: ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995, and general "UL certified" for electronic components.
- Demonstrated safety and effectiveness of the predicate device (K031618): The predicate device serves as the established benchmark for what constitutes an acceptable standing wheelchair. The new device's "sameness" in critical aspects to this predicate device forms the basis of its "ground truth" for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" described in the context of this device. This is not an AI/machine learning device that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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K102734

MFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No. 120,Nan Shiang Tsuen,Shoei Shang Shiang,Chia-yi, 60858, Taiwan, R.O.C. TEL : 886-5-2892093 FAX : 886-5-2890070

ર ૮ 510(k) SUMMARY "

DEC 1 4 2010

Submitter's Name: COMFORT ORTHOPEDIC CO., LTD.

N0. 120, NAN SHIANG TSUEN, SHOEI SHANG SHIANG, CHIA-YI, 60858, TAIWAN, ROC

Date summary prepared:

August 23, 2010

Device Name:

Proprietary Name: CQMFORT Standing Wheelchair, HERO series Common or Usual Name: Standup Wheelchair Classification Name: WHEELCHAIR, STANDUP, Class II, 21 CFR 890.3900

Product code:

COMFORT Standing Wheelchair, HERO series including:

IPL

LY-ESA120 (HERO 3), .
LY-ESA120-N (HERO 3-N).

All of the specifications are same as LY-ESA120 (HERO 3) just different headrest.

. LY-ESA140 (HERO 4)

All of the specifications are same as LY-ESA120 (HERO 3 ) but made by steel for the frame; and the HERO 3 and HERO 3-N are made by aluminum.

Indications for Use:

Description of the device:

{1}------------------------------------------------

OMFORT COMFORT ORTHOPEDIC CO., LTD. www.comfort.com.tw No.120,Nan Shiang Tsuen,Shoei Shang,Chia-yi, 60858, Taiwan, R.O.C. TEL:886-5-2892093 FAX : 886-5-2890070

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:

COMFORT Standing Wheelchair, HERO 2 (K031618)

Summary for substantial equivalence comparison:

Compare to the new device and predicate device, the overall dimensions and visional appearance are similar, and the electronic systems between the two devices are all passed by the UL certificated, for instance the electronic controller, batteries, and recharge. Besides, the back upholstery is the same material, and also passed the resistance ignition test by SGS. Moreover, the suspension of cross brace, footplates, incline degree 12°, armrest type, the size of tires, the weight limit, and warranty are all the same. The safety and performance functions of two systems are assured and validated. They are substantially equivalent.

Besides, we would like to emphasize that the new device and predicate device are also the Standing Wheelchairs which are the manual wheelchair, not the electric power wheelchairs, with an electric power standing wheelchair. The electric power is not used to move the wheelchair but to stand the patient.

Based on the above the information and the analysis, we know that the subject device and the predicate device have the same intended use, the same technological aspects and only minor differences exist. We believe that FDA can decide the subject device and the predicate device are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Comfort Orthopedic Co., LTD % Mr. Eric H. C. Lee No. 120. Nan Shiang Tsuen Shoei Shang Shiang Chia-Yi 60858, Taiwan, R.O.C.

DEC 1 4 2010

Re: K102734

Trade/Device Name: COMFORT Standing Wheelchair, HERO series Regulation Number: 21 CFR 890.3900 Regulation Name: Standup wheelchair Regulatory Class: Class II Product Code: IPL Dated: September 30, 2010 Received: Ocotber 6, 2010

Dear Mr. Lee:

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 (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.

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Page 2 - Mr. Eric H. C. Lee

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/ucm1138007.blog for 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Q: www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours.

AZ B. Rh
p.

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510 (K) Number ( If Known ):

DEC 1 4 2010

Device Name: COMFORT Standing Wheelchair, HERO series

Intended Use:

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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

__, and I am not sure what to do with it.

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page_ l of _l

510(k) Number K102734

Regulation Number and Section

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).