Profhand pedal wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.

Device Description

Profhand pedal wheelchair is manually driven, lightweight, performance type of wheelchairs that have been designed and developed to be used in both indoor and outdoor environments, and to transport one (1) person at a time. The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion and back are made from flame retardant Nylon and/or Polyester fabric. The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device): Put a suitable seat cushion on the wheelchair seat. Put your foot into the pedal and attach the foot strap to stabilize foot. When riding use both legs to pedal for forward movement. To stop use the brake mounted in the control lever. For parking or getting on/off the wheelchair lock the brakes. In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.

AI/ML Overview

The provided document is a 510(k) summary for the Profhand Pedal Wheelchair Model HM-10. It describes the device's technical specifications, intended use, and claims substantial equivalence to a predicate device. However, it does not include acceptance criteria or a study that evaluates the device's performance against specific clinical metrics as typically seen for AI/ML-driven devices.

Instead, the document focuses on compliance with established international standards and FDA guidance documents for mechanical wheelchairs. This type of submission relies on demonstrating adherence to safety and performance benchmarks already defined for similar mechanical devices, rather than novel clinical performance metrics.

Therefore, many of the typical AI/ML-related questions cannot be answered from this document. I will answer what is available and clarify what information is not present.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard Compliance)	Reported Device Performance
ISO 7176-1: 1999 Determination of static stability	Profhand pedal wheelchair passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motonzed Three-Wheeled Vehicles. The document states: "Profhand pedal wheelchair/Model HM-10 have been designed, manufactured and tested for conformance to the relevant FDA recognized ISO standards for mechanical wheelchair as referenced in this submission." Specifically, it states compliance with ISO 7176-1: 1999.
ISO 7176-3: 2003 Determination of effectiveness of brake	Compliant
ISO 7176-5: 2008 Determination of overall dimensions, mass, and maneuvering space	Compliant
ISO 7176-11: 1992 Test dummies	Compliant
ISO 7176-13: 1989 Determination of coefficient of friction of test surface	Compliant
ISO 7176-15: 1996 Requirement for information disclosure, documentation and labeling	Compliant
ISO 7176-16: 1997 Resistance to ignition of upholstered parts	Compliant
ISO 10993-1: 2009- Guidance on selection of biocompatibility tests	Compliant
ISO 10993-5: 2009- Biocompatibility tests for cytotoxicity in vitro method	Compliant
ISO 10993-10: 2009 Biological tests for irritation and delayed-type hypersensitivity	Compliant

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described refers to compliance with ISO standards for mechanical wheelchairs, which typically involves physical testing of the device itself and its components, rather than a clinical "test set" of patient data as might be relevant for AI/ML devices.

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)

This information is not applicable and therefore not provided. The ground truth for this type of mechanical device is compliance with engineering and safety standards, which is determined through laboratory testing and verification against the specific requirements outlined in the ISO standards, not by expert medical review of patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. Adjudication methods are relevant for subjective interpretations of data (e.g., medical image reads) to establish ground truth. For mechanical device testing against ISO standards, the results are typically objective measurements and observations, not requiring adjudication in the clinical sense.

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

This information is not applicable and therefore not provided. MRMC studies are designed to evaluate the performance of AI/ML systems in a clinical context, often with human readers. The Profhand Pedal Wheelchair is a mechanical device, not an AI/ML system, and therefore such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's safety and effectiveness is established through its conformance to recognized international standards (ISO standards) and FDA guidance documents for mechanical wheelchairs. This involves objective testing against predefined parameters for stability, braking, dimensions, material properties (e.g., flammability, biocompatibility), etc. It is not based on expert consensus, pathology, or outcomes data related to disease diagnosis or patient treatment in a clinical sense.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a mechanical wheelchair and does not involve an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided. As there is no AI/ML model or training set, there is no ground truth to establish for such a set.

Summary

{0}------------------------------------------------

Harmony Hill International Co., Ltd.

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K123076 .

AUG 0 9 2013

Date of Summary prepared: July 22, 2013

Harmony Hill International Co., Ltd. 1. Submission Correspondent:
Address:

Rm. 1068, 10F, H bldg. of NKSP, No. 3-2,

Park St., Nangang Dist., Taipei, Taiwan

Phone:

Fax:

Contact:

Mrs Tina Lai

+886-2-2655-7717

+886-2-2655-7715

Harmony Hill International Co., Ltd. Rm. Submission Sponsor: 1068, 10F, H bldg. of NKSP, No. 3-2, Park St., Nangang Dist., Taipei, Taiwan Tel +886-2-2655-7717 Fax +886-2-2655-7715 E-mail tina@hhic.com.tw

Date Prepared:

Trade Name(s): 4.

Common/Usual Name: Classification Name: Classification Number: Classification Panel: CDRH Product Code: Requlatory Class:

May 25, 2013

Profhand Pedal Wheelchair Models HM-10 Mechanical Wheelchair Wheelchair, Mechanical 890.3850 Physical Medicine Devices IOR ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Description

For the main construction of HM-10 wheelchair, please see the following detailed description: The Chassis and pedaling mechanism are made form a aluminum alloy. Wheels are of a spoke and hub design using metal components and rubber tires, while the casters are of a semi-solid polymer base design. The seat cushion

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

Harmony Hill International Co., Ltd.

and back are made from flame retardant Nylon and/or Polyester fabric.

The main operation of Profhand pedal wheelchair is as the following description (Note: This main operation can only be done under the instruction and permission of physician, so it is classified as a prescription device):

· Put a suitable seat cushion on the wheelchair seat.
· Put your foot into the pedal and attach the foot strap to stabilize foot.
· When riding use both legs to pedal for forward movement.
· To stop use the brake mounted in the control lever.
· For parking or getting on/off the wheelchair lock the brakes

In addition to the main operation as above mentioned, the Profhand pedal wheelchair also provide the handle bars in rear side of the chair to let healthcare person help moving the person who is seated on the wheelchair as the other general mechanical wheelchair.

6. Intended Use

Profhand pedal mechanical wheelchair is manually operated multifunctional wheelchairs designed for indoor/outdoor use and intended to provide mobility to persons that have the capability of operating a mechanical wheelchair.

7. Predicate Devices

Panthera Mechanical wheelchairs / Model S2 (K083231)

8. Safety and Effectiveness

By definition. the HM-10 device is substantially equivalent to a predicate device because the device has the same intended use and different technological characteristics. The main technology difference is that for our HM-10 wheelchair, the device provide mobility to person restricted to a sitting position either by attendant via using rear handle bar or by himself via using leg-pedalinq mechanism, but for the predicate Panthera wheelchair, the device provide mobility to person restricted to a sitting position either by attendant via using rear handle bar or by himself via using hand-pedaling mechanism.

Through the rationale justification, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

As such, it has been shown in this 510(K) submission, that the differences between the Profhand pedal wheelchair/Model HM-10 and the predicate devices, the Panthera Mechanical wheelchair (ref K083231), do not raise any questions regarding their safety and effectiveness.

{2}------------------------------------------------

9. Performance Date

Profhand pedal wheelchair/Model HM-10 have been designed, manufactured and tested for conformance to the relevant FDA recognized ISO standards for mechanical wheelchair as referenced in this submission. In addition, Profhand pedal wheelchairs passed all required consensus standards testing for conformance to the FDA's Guidance Document for the Preparation of Premarket Notification [510(K)] Applications for Mechanical and Powered Wheelchairs, and Motonzed Three-Wheeled Vehicles.

Compliance testing to FDA recognized standards includes the following list:

1. ISO 7176-1: 1999 Determination of static stability.
1. ISO 7176-3; 2003 Determination of effectiveness of brake.
1. ISO 7176-5; 2008 Determination of overall dimensions, mass, and maneuvering space.
1. ISO 7176-11: 1992 Test dummies.
1. ISO 7176-13; 1989 Determination of coefficient of friction of test surface.
1. ISO 7176-15; 1996 Requirement for information disclosure, documentation and labeling.
1. ISO 7176-16: 1997 Resistance to ignition of upholstered parts.
1. ISO 10993-1; 2009- Guidance on selection of biocompatibility tests.
1. ISO 10993-5; 2009- Biocompatibility tests for cytotoxicity in vitro method.
1. ISO 10993-10: 2009 Biological tests for irritation and delayed-type hypersencitivity.

10. Conclusion

Profhand pedal wheelchair/Model HM-10 as designed and manufactured is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the predicate devices, the Panthera Mechanical wheelchair (ref K083231).

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract shapes, possibly representing human figures or abstract forms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

August 9, 2013

Harmony Hill International c/o Ms.Tina Lai Room 1068, 10F, H Bldg. of NKSP, NO.3-2 Park Street, Nangang Dist Taipei China (Taiwan) 11503

Re: K123076

Trade/Device Name: Profhand Pedal Wheelchair Model HM-10 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: June 2, 2013 Received: June 5, 2013

Dear Ms. Tina Lai:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

{4}------------------------------------------------

Page 2 - Ms. Tina Lai

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

for

Sincerely yours.

Joyce M. Whang -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): _K123076

Device Name: Profhand Pedal Wheelchair Model HM-10

Indications For Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang -S

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number_K123076

Page 1 of 1

Regulation Number and Section

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).