The PDG Product Design Group, Inc. Elevation Manual Wheelchair (Elevation) is a manually operated, user propelled, manual, mechanical wheelchair. Its intended function and use is to provide mobility to persons ages 12 and up (adolescents and adults) limited to a seated position. It is an ultra-light, rigid (non-folding frame) type wheelchair.

The device consists primarily of a lower frame assembly, a seat sling, a back rest and back upholstery, large rear wheels with hand rims for self-propelling the chair and front swivel type pivoting casters for turning.

The Elevation also has seat height and back rest recline angle adjustment capability that allow the user to self-adjust either the seat to floor height or the back rest recline angle while seated in the wheelchair. The Elevation is capable of up to 5 inches of rear to front seat height difference.

AI/ML Overview

This document describes the premarket notification for the Elevation Manual Wheelchair (K140023). Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices, particularly those in Class I, the "acceptance criteria" often refer to meeting established safety standards (like ISO standards) and demonstrating substantial equivalence to a predicate device. The "reported device performance" indicates how the new device fulfills these standards and compares to the predicate.

Item/Specification	Acceptance Criteria (Predicate: ICON Adult Manual Wheelchair K110985)	Reported Device Performance (PDG Product Design Group Elevation)	Discussion (Meeting Criteria)
Indications for Use	Provide mobility to persons limited to a seated position	Same	No difference. Device meets the same intended use.
Front Seat to Floor Height	12"-21"	19 1/2"-20 1/2"	The Elevation's range is narrower but falls within the predicate's range, indicating acceptable adjustability for its target user population.
Caster Size	3"-6"	4"x1", 4"x 1.5" or 5"x 1.5"	The Elevation's caster sizes are within the range of the predicate, despite not offering the 3" or 6" options. This is considered acceptable.
Rear Wheel Diameters	24"-25"	24", 25" and 26"	The Elevation offers a 26" wheel, which the predicate does not. However, the existing common sizes (24", 25") are shared. The 26" wheel is noted as making the chair slightly easier to self-propel, which is considered a non-significant difference in terms of safety or effectiveness, thus meeting acceptance functionally.
Seat Width	12"-19"	14"-18"	The Elevation's seat widths are within the predicate's range.
Seat Depth	12"-20"	14"-18"	The Elevation's seat depths are within the predicate's range.
User Weight Limit	250 lbs.	Same	No difference. The device meets the same weight capacity.
Chair Weight	23 lbs.	25 lbs. (including wheels)	The Elevation is slightly heavier, attributed to gas springs. This 2-pound difference is considered "not significant and has no effect on safety or effectiveness," thus meeting acceptance for practical use.
Frame Material	Aluminum, Titanium and Composite	Aluminum	Both use aluminum, which is acceptable. The Elevation uses aluminum entirely while the predicate also offers Titanium and Composite; however, using aluminum is deemed equivalent given its presence in the predicate and its established safety.
Upholstery	Polyurethane Foam with Nylon Cover	Same	No difference. Device uses the same upholstery materials.
Hand Rims	Aluminum Tubing	Same	No difference. Device uses the same hand rim material.
Ultra-Light Frame	Yes	Yes	No difference. Both are ultra-light frames.
Back Angle Adjustment	Yes but must be done without user seated in the wheelchair	Yes but can be adjusted with the user in the wheelchair.	While the method differs, both have back angle adjustment. The ability to adjust with the user seated is a new feature. The discussion explicitly states this has "no effect on safety" due to slow gas spring movement and the non-compromise of safety even in case of failure. This demonstrates the new feature meets safety acceptance criteria.
Elevating Seat	No	Yes. Seat may be raised and lowered while the user is seated in the wheelchair.	This is a new feature not present in the predicate. Acceptance is based on passing the ISO 7176-1 Static Stability test with the seat in its highest position and the slow, safe operation of gas springs minimizing safety risk in case of failure.
Full Frame Design	Yes	No. Frame is in two pieces mounted with gas springs.	The two-piece frame is a design difference from the predicate's full frame. Acceptance is based on the statement that it "has no effect on device safety" and "frame strength is not compromised," implying it met structural integrity standards despite the design change.
Non-clinical Standards Testing	Adherence to ISO 7176-1, -3, -5, -7, -8, -13, -15, -16, -22	Conforms to all listed ISO standards.	Device successfully passed all required non-clinical tests based on recognized international standards for wheelchairs, demonstrating its mechanical safety and performance characteristics meet established criteria. Materials conform to ISO 7176-16.

The study that proves the device meets the acceptance criteria is a series of non-clinical tests conducted according to international ISO standards. The document explicitly states: "The Elevation Manual Wheelchair has been tested to the following standards."

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

Test Set Sample Size: Not explicitly stated as a numerical sample size of devices, but rather indicated by testing "The Elevation Manual Wheelchair" against the listed ISO standards. This implies at least one device was tested to each standard, which is typical for mechanical device performance and safety testing.
Data Provenance: The testing was non-clinical. The standards are international (ISO), making the origin of the testing methodology international. The manufacturer (PDG Product Design Group, Inc.) is based in Vancouver, British Columbia, Canada, suggesting the device and possibly the testing might have originated there, or at a contracted testing facility. The data is prospective in the sense that the testing was performed on this specific device to demonstrate its compliance.

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 is not applicable to this type of device. The "ground truth" for a mechanical wheelchair's performance and safety is established by its adherence to internationally recognized engineering and safety standards (ISO standards), rather than expert medical consensus or interpretation of images. The tests themselves are objective measurements against specified criteria within the ISO standards.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data or image interpretation where there's subjectivity. For objective mechanical testing against ISO standards, the results are derived directly from the test procedures.

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. An MRMC study is relevant for diagnostic imaging AI devices, not for a manual mechanical wheelchair.

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

Not applicable. This device is a mechanical wheelchair, not an algorithm or AI system.

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

The "ground truth" for this device's performance and safety is its conformance to established international safety and performance standards (ISO standards). These standards define the acceptable mechanical properties, stability, braking effectiveness, dimensions, material ignition resistance, etc. The results of non-clinical tests against these standards serve as the objective evidence of "ground truth."

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI or algorithm that requires a training set.

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

Not applicable. As noted above, there is no "training set" for this type of device.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a central emblem. The emblem consists of a stylized image of an eagle or bird with three human profiles nested within its wing or body.

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

October 16, 2014

PDG Product Design Group, Inc. c/o Edward Kroll, President Spectre Solutions, Inc. 5905 Fawn Lane Cleveland, OH 44141

Re: K140023

Trade/Device Name: Elevation Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 16, 2014 Received: September 19, 2014

Dear Mr. Kroll:

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

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

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 the following 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 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,

Felipe Aquel -S

for

Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140023

Device Name Elevation Manual Wheelchair

Indications for Use (Describe)

The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

te: 2014.10.16 :09:22 -04'00'

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

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/4/Picture/1 description: The image shows the logo for PDG Mobility. The logo is in two colors, orange and gray. The letters "PDG" are in orange, and the word "MOBILITY" is in gray and is located below the letters "PDG".

K140023 510(k) Premarket Notific

"510(k) SUMMARY"

AS REQUIRED BY SECTION 807.92(c)

(Modified October 06, 2014)

510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.

PDG Product Design Group, Inc. 103-318 East Kent Ave, South Vancouver, British Columbia Canada V5X4NC Phone: (604) 326-6644 Fax: (604) 323-9097 Email: tbrown@pdgmobility.com Web Site: www.pdgmobility.com

Contact Person:

Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant for PDG Product Design Group, Inc. 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9801 Fax: (440) 546-9124

Date Prepared: December 26, 2013

Name of Device

Trade Name: Elevation Manual Wheelchair
Common Name: Manual Wheelchair ●
Classification Name: Wheelchair, Mechanical Product Code IOR

Predicate Device

The Elevation Manual Wheelchair is substantially equivalent to the Icon Wheelchairs ICON Adult Manual Wheelchair (K110985)

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

K140023 510(k) Premarket Notific

Device Description:

Device Function

Device function is dependent solely upon the wheelchair user. It does not function on its'own in any manner. The wheelchair user controls motion, speed and direction by propelling themselves using the hand rims located on the rear wheels.

Scientific Concepts

There are no complex scientific concepts related to the Elevation manual wheelchair. The Elevation is a simple, basic, manually operated mobility device.

Significant Physical and Performance Characteristics

Design:

The Elevation allows the user to adjust the seat height and back rest angle while the wheelchair is occupied. Seat height and back rest angle adjustment are achieved using gas springs which are mounted to the upper and lower frame assemblies. A tilt activator lever located on the right side of the lower frame is used to open and close the gas springs, thus activating and de-activating the adjustment features. It is to be used by adults and adolescents ages 12 and up with a maximum weight limit of 250lbs (114kg).

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for PDG Mobility. The logo is orange and gray. The word "PDG" is in orange and the word "MOBILITY" is in gray and is located below the PDG letters.

K140023 510(k) Premarket Notific

Materials:

The Elevation frame is made from round, mechanical aluminum tubing that is welded together. The upholstery is made from foam polyurethane padding with nylon cover. These materials conform to FDA recognized standard ISO 7176-16:2012.

Physical Properties:

Intended Use/Indications for Use

The Elevation Manual Wheelchair is intended to provide mobility to persons limited to a seated position.

Predicate Device Comparison

The Elevation Manual Wheelchair is substantially equivalent to the Icon Wheelchairs ICON Adult Manual Wheelchair (K110985)

Performance Data: (Non-clinical Testing)

The Elevation Manual Wheelchair has been tested to the following standards;

ISO 7176-1:1999 Determination of Static Stability -
ISO 7176-3:2003 Determination of Effectiveness of Brakes -
ISO 7176-5:2008 Determination of Overall Dimensions, -Mass and Maneuvering Space
-ISO 7176-7:1998 Determination of Seating and Wheel Dimensions
-ISO-7176-8:1998 Requirements and Test Method for Static Impact and Fatigue Strength
-ISO 7176-13:1989 Determination of Coefficient of Friction of Test Surfaces
ISO 7176-15:1996 Requirements for Information -Disclosure, Documentation and Labeling
-ISO 7176-16:2012 Resistance to ignition of upholstered parts Requirements and test methods
-ISO 7176-22:2000 Set up Procedures

{7}------------------------------------------------

K140023 510(k) Premarket Notification

Conclusions of non-clinical tests

The results of the non-clinical tests confirm that Elevation Manual Wheelchair is substantially equivalent to the predicate device.

ITEM/SPECIFICATION	ICON Adult ManualWheelchair	PDG PRODUCT DESIGNGROUP ELEVATION	DISCUSSION
510(k) Accession Number	K110985	K140023	N/A
Clearance Date	May 3, 2011	TBD	N/A
Indications for Use	Provide mobility topersons limited to aseated position	Same	No difference
DIMENSIONS, WEIGHT AND WEIGHT LIMITATION
Front Seat to Floor Height	12"-21"	19 1/2"-20 1/2"	While the ICON has a wider range itincludes seat to floor heights which arethe same as the Elevation.
Caster Size	3"-6"	4"x1", 4"x 1.5" or 5"x 1.5"	The predicate offers 3" and 6" diametercasters and the Elevation does not.However, the Elevation caster sizes arewithin the range of the predicate
Rear Wheel Diameters	24"-25"	24", 25" and 26"	The Elevation offers a 26" diameterwheel and the ICON does not.However, the remaining rear wheelsizes are the same. This difference isnot significant in terms of safety oreffectiveness. The 26" rear wheelwould make the Elevation slightlyeasier to self-propel.
Seat Width	12"-19"	14"-18"	The predicate offers a wider range thanthe Elevation however, the Elevationseat widths are within the range of thepredicate.
Seat Depth	12"-20"	14"-18"	The predicate offers a wider range thanthe Elevation however, the Elevationseat depths are within the range of thepredicate.
User Weight Limit	250 lbs.	Same	No difference
ITEM/SPECIFICATION	ICON Adult ManualWheelchair	PDG PRODUCT DESIGNGROUP ELEVATION	DISCUSSION
Chair Weight	23 lbs.	25 lbs. including wheels	The Elevation is slightly heavier thanthe ICON. This is likely due to the gassprings which are used for the seat andback angle adjustment features of theElevation. The 2 pound difference isnot significant and has no effect onsafety or effectiveness.
MATERIALS
Frame Material	Aluminum,Titanium andComposite	Aluminum	No difference since both are made fromaluminum
Upholstery	Polyurethane Foamwith Nylon Cover	Same	No Difference
Hand Rims	Aluminum Tubing	Same	No Difference
Ultra-Light Frame	Yes	Yes	No Difference
Back Angle Adjustment	Yes but must be donewithout user seatedin the wheelchair.	Yes but can be adjustedwith the user in thewheelchair.	Both devices have back angleadjustment capability and the fixedangles for the predicate are within therange of the Elevation. Adjusting theback angle with the chair beingoccupied has no effect on safety. Thegas springs move the back rest angleslowly. A failure of the gas spring whilefully extended would only return theback rest to its' lower most position ina slow manner. A failure in the fullyretracted position would only result inthe back rest feature not functioning.In either case, patient safety is notcompromised.
Elevating Seat	No	Yes. Seat may be raisedand lowered while theuser is seated in thewheelchair.	Adjusting the seat height with the userin the chair has no effect on safety.The gas springs raise and lower theseat slowly. While a raised seat doesmake the chair more susceptible totipping, the Elevation passed the ISO7176- 1 Static Stability test with theelevated seat in its' highest position.Gas spring failure in the retractedposition would result only in theelevating seat feature becomingnonfunctional. Failure of one spring ina fully extended position has no effectas one spring has sufficient force toensure the seat is lowered in a slowand non-abrupt manner.
Full Frame Design	Yes	No. Frame is in two piecesmounted with gas springs	Two piece frame has no effect ondevice safety. Frame strength is notcompromised.

Elevation Manual Wheelchair Comparative Analysis

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for PDG Mobility. The logo is in two lines, with the top line showing the letters "pdg" in a stylized, connected font. The letters are orange. The bottom line shows the word "MOBILITY" in gray, block letters.

K140023 510(k) Premarket Notification

Response to RTA Decision

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).