This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to Market the P.R.O. CG® Manual Wheelchair. The P.R.O. CG® Manual Wheelchair is a rigid, non-folding, manually operated, center of gravity shifting (CG) tilt-in-space wheelchair. The design incorporates a fixed width base frame that is connected to a width and depth adjustable seat frame with struts connected to tilt arcs. This design allows the seat frame to change its position using a CG shifting tilt motion. The shift moves to reposition the seat frame angle from 0° to 50° in a smooth, downward, forward, and backward motion with little change in the overall center of gravity of the frame and the occupant. The device is not marketed with upholstery in the standard or optional configurations. The subject device intended use is to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.

AI/ML Overview

This document is a 510(k) premarket notification for the P.R.O. CG® Manual Wheelchair. The primary purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to determine the performance against specific acceptance criteria for a novel AI/medical device.

Therefore, the requested information regarding acceptance criteria, study details for proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information cannot be extracted from the provided text.

The document discusses the substantial equivalence of the P.R.O. CG® Manual Wheelchair to a predicate device (Manual Rigid Mobility Wheelchair K080270). The performance data presented refers to non-clinical laboratory testing to ensure the new device meets established safety and performance standards for manual wheelchairs, which are different from acceptance criteria for AI-powered devices.

Here's an overview of what the document does provide regarding "performance," which is related to substantial equivalence for a medical device:

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

This document does not present "acceptance criteria" in the way one would for an AI-enabled device (e.g., minimum sensitivity/specificity/AUC). Instead, it lists the ISO and ANSI/RESNA standards against which the device was tested to demonstrate safety and performance for a manual wheelchair. The reported device performance is that the testing "demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device." This implies that the wheelchair met the requirements of each standard.

Acceptance Criteria (Standards Tested)	Reported Device Performance
ISO International Standard 7176-1: Determination of Static Stability	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-3: Determination of Effectiveness of Brakes	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-5: Determination of Dimensions, Mass and Maneuvering Space	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-7: Measurement of Seating and Wheel Dimensions	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-8: Requirements and Test Methods for Static, Impact and Fatigue Strengths	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-11: Test dummies	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-13: Determination of Coefficient of Friction of Test Surfaces	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-15: Requirements for Information Disclosure, Documentation and Labeling	Demonstrated substantial equivalence to predicate device
ISO International Standard 7176-19: Wheeled Mobility Device for Use in Motor Vehicles Annex A. C and D	Demonstrated substantial equivalence to predicate device
ANSI/RESNA WC-4: 2012, Section 19: Wheelchairs Used as Seats in Motor Vehicles Annex A, B, C and E	Demonstrated substantial equivalence to predicate device
CAL117:2013, Section 1: Flammability Testing	Demonstrated substantial equivalence to predicate device

Missing Information (Not Applicable to this Document Type):

Sample size used for the test set and the data provenance: Not applicable. This refers to physical wheelchair testing, not a dataset of patient information.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device.
Adjudication method: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable. The "ground truth" for a manual wheelchair is whether it meets engineering standards for safety and structural integrity.
The sample size for the training set: Not applicable. There is no AI model or training set involved.
How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional medical device (manual wheelchair) submission, not an AI or diagnostic device that would have the requested acceptance criteria and study details.

Summary

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

October 22, 2015

Freedom Designs, Inc. Nancy F. Schmidt Manager, Customer Relations 2241 Madera Road Simi Valley, CA 93065

Re: K151893

Trade/Device Name: P.R.O. CG Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 24, 2015 Received: September 25, 2015

Dear Ms. Schmidt:

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 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

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151893

Device Name P.R.O. CG Manual Wheelchair

Indications for Use (Describe)

The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 2501bs.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

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	510(k) Summary K151893
SUBMITTER:	Freedom Designs, Inc.2241 Madera RoadSimi Valley, CA 93065
	Phone: (805) 915-1133
CONTACT PERSON:	Nancy F. SchmidtManager - Customer Relations/Quality ManagementRepresentative
Date Prepared:	October 22, 2015
DEVICEName of Device:	P.R.O. CG® Manual Wheelchair
Common or Usual Name:	Wheelchair, mechanical
Classification Name:	Mechanical wheelchair 21 CFR §890.3850
Regulatory Class:	I
Product Code:	IOR: Wheelchair, mechanical
PREDICATE DEVICE:	Manual Rigid Mobility Wheelchair (K080270)No reference devices were used in this submission.

DEVICE DESCRIPTION

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INDICATIONS FOR USE

The P.R.O. CG® Manual Wheelchair is intended to provide mobility to persons ages 12 and up (adolescents and adults) with a weight capacity of 250lbs.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The device comparison showed that the subject device is substantially equivalent in intended use, design and operational principles to the previously cleared Manual Rigid Mobility Wheelchair (K080270). The subject device is substantially equivalent to the predicate device in regards to intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.

PERFORMANCE DATA

Non-Clinical Test

Non-clinical laboratory testing was performed on the subject P.R.O. CG® Manual Wheelchair to determine substantial equivalence. The following testing was performed:

ISO International Standard 7176-1: Determination of Static Stability .
ISO International Standard 7176-3 : Determination of Effectiveness of Brakes .
ISO International Standard 7176-5: Determination of Dimensions, Mass and ● Maneuvering Space
ISO International Standard 7176-7: Measurement of Seating and Wheel Dimensions .
. ISO International Standard 7176-8: Requirements and Test Methods for Static, Impact and Fatigue Strengths
ISO International Standard 7176-11: Test dummies .
ISO International Standard 7176-13: Determination of Coefficient of Friction of Test . Surfaces
ISO International Standard 7176-15: Requirements for Information Disclosure, . Documentation and Labeling
ISO International Standard 7176-19: Wheeled Mobility Device for Use in Motor . Vehicles Annex A. C and D
ANSI/RESNA WC-4: 2012, Section 19: Wheelchairs Used as Seats in Motor Vehicles . Annex A, B, C and E
CAL117:2013, Section 1: Flammability Testing .

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Testing demonstrated that the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the marketed predicate device.

Animal Study

Animal testing was not required for this submission.

Clinical Testing

Clinical testing was not required for this submission.

CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the safety of the subject P.R.O. CG® Manual Wheelchair and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the subject P.R.O. CG® Manual Wheelchair is substantially equivalent to the predicate device identified throughout this submission.

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).