The Discovery Tmax is a manually operated, self/attendant propelled, mechanical wheelchair. It is intended exclusively for the adaptation of orthopedic seating systems (e.g. seating shells) for people who are unable to walk or have walking impediments. The Discovery Tmax can be used indoors and outdoors. In order to provide an optimized, individual fitting, the product is adjustable and/or adaptable.
The Discovery Tmax consists of a non-folding frame of aluminum, large wheels with hand rims, and small front pivoting casters. The width, depth, and height of seat are adjustable in 1 inch increments. The armrest is made of Polyurethane soft integral foam and is adjustable. It also has an adjustable backrest and removable footrest.
The Discovery Tmax includes a "Tilt in space" feature which allows the seat to be tilted. The seat angle can be adjusted from -5° to +50° in increments of 2.5°. The desired seat angle is achieved by moving the push handles/ push bar. The angle can be read from the angle indicator on the hole channel.

AI/ML Overview

This 510(k) summary describes a manual wheelchair, not a software or AI-powered device. Therefore, many of the requested categories related to AI/software performance, such as MRMC studies, standalone algorithm performance, and training/test set details, are not applicable.

Here's the information that can be extracted relevant to the performance of this medical device (a manual wheelchair):

Acceptance Criteria and Device Performance

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
DIN EN 12182:1999 (Technical aids for disabled persons)	Tested by TUV SUD, compliance implied by submission.
DIN EN 12183:1999 (Manually propelled wheelchairs requirements & test methods)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-1:1999 (Wheelchairs Part 1: Determination of static stability)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-3:2003 (Wheelchairs Part 3: Determination of efficiency of brake)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-5:2008 (Wheelchairs -- Part 5: Determination of overall dimensions, mass and maneuvering space)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-7:1998 (Wheelchairs part 7: Measurement of seating & wheel dimensions)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-8:1998 (Wheelchairs Part 8: Requirements, static impact/fatigue strengths)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-11:1992 (Wheelchairs Part 11: Test dummies)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-13:1989 (Wheelchair Part 13: Determination of coefficient of friction of test surfaces)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-15:1996 (Wheelchairs Part 15: Requirement for labeling)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-16:1997 (Wheelchairs Part 16: Resistance to ignition of upholstered parts - Requirements and test methods)	Tested by TUV SUD, compliance implied by submission.
ISO 7176-19:2008 (Wheelchairs Part 19: Wheeled mobility devices for use in motor vehicles)	Tested by TUV SUD, compliance implied by submission.

Study Details:

Sample size used for the test set and the data provenance: Not applicable in the context of a physical device. The testing was conducted on the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance against standards is typically established by certified testing laboratories using specified protocols, not expert consensus on medical images or data.
Adjudication method for the test set: Not applicable. Testing against performance standards for a physical device does not involve adjudication in the sense of expert review of data points.
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. This is a physical non-AI device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical non-AI device.
The type of ground truth used: Compliance with international and European ISO and DIN EN standards for wheelchairs. This is a form of objective engineering and safety ground truth, verified through physical testing.
The sample size for the training set: Not applicable. This is a finished physical device, not an AI/software model.
How the ground truth for the training set was established: Not applicable.

Summary based on provided text:

The Discovery Tmax Manual Wheelchair was tested by TUV SUD, Institute for Testing and Certification of Medical Devices, against a series of international and European standards (DIN EN 12182, DIN EN 12183, and various parts of ISO 7176). The compliance with these standards serves as the "acceptance criteria" and "device performance" proof for this physical medical device. The specific details of the testing (e.g., number of units tested, exact test results against each clause of the standards) are not provided in this 510(k) summary but are typically part of the full submission.

Summary

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K113164

510(k) SUMMARY of SAFETY and EFFECTIVENESS

MAR 1 1 2013

A. General Information

1. Submitter's Name.:	OTTO BOCK Health Care, LP
2. Address:	Two Carlson Parkway North, Suite 100Minneapolis, Minnesota USA 55447-4467
3. Telephone:	763-253-5614
4. Contact Person:	Angie Zhang, Regulatory Affairs Specialist
5. Date Prepared:	November 13, 2012
6. Registration Number:	2182293

B. Device

1. Name:	Discovery Tmax Manual Wheelchair
2. Trade Name:	Discovery Tmax Manual Wheelchair
3.Common Name:	Manual Wheelchair
4. Classification Name:	Wheelchair, Manual
5. Product Code:	IOR
6. Class:	I
7. Regulation Number:	890.3850

C. Identification of Legally Marketed Predicate Device

1. Name:	FUZE MECHANICAL WHEELCHAIR, MODEL T50
2. Manufacture:	PDG PRODUCT DESIGN GROUP, INC.
3. K Number:	K063736
4. Date Cleared:	01/17/2007

D. Description of the Device

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The Discovery Tmax consists of a non-folding frame of aluminum, large wheels with hand rims, and small front pivoting casters. The width, depth, and height of seat are adjustable in 1 inch increments. The armrest is made of Polyurethane soft integral foam and is adjustable. It also has an adjustable backrest and removable footrest.

The Discovery Tmax includes a "Tilt in space" feature which allows the seat to be tilted. The seat angle can be adjusted from -5° to +50° in increments of 2.5°. The desired seat angle is achieved by moving the push handles/ push bar. The angle can be read from the angle indicator on the hole channel.

Features

Available in a version for children and in three adult sizes .
. Suitable for use indoors and outdoors
Pneumatic or flat-free front and rear wheels available �
. Width, depth and height of seat adjustable in 1 inch increments
. Cable-free, maintenance-friendly seat angle release with foot pedal and release lock
Smooth seat angle adjustment without pneumatic spring thanks to adjustable . centre of gravity
Can be combined with various seating units: . -OBSS® custom contoured cushions -NUTEC custom seating systems -Standard wheelchair back systems
- -Standard wheelchair cushions
50° Tilt in Space .
Aluminum Frame .
Transit Tie Down .
Seat Pan .
Armrest ●
. Armpad
t Anti-tipper
Wheel lock ●
Push handles .
Front Rigging ●
Footrests .
Calf Strap .
Heel Strap .
casters
Rear Wheels

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E. Intended Use Statement

The wheelchair is intended exclusively for the adaptation of seating shells and other orthopaedic seating systems for people who are unable to walk or have walking impediments. It can be operated either by the user or by an attendant.

F. Indications

The Tmax wheelchair are suitable for patients with walking impediments/inability due to, but not limited to:

Palsies/Paralyses .
Loss of limbs .
. Defective and/or deformed limbs
Joint contractures ●
. Joint defects
. Other diseases

G. Substantial Equivalence

The Discovery Tmax Wheelchair is substantially equivalent to PDG's FUZE Mechanical Wheelchair, Model T50 (K063736)

H. Performance Data

The Discovery Tmax manual wheelchair was tested by TUV SUD, Institute for Testing and Certification of Medical Devices to the following standards:

DIN EN 12182:1999 -- Technical aids for disabled persons .
· DIN EN 12183:1999 manually propelled wheelchairs requirements & test methods
ISO 7176-1:1999 Wheelchairs Part 3: Determination of static stability
ISO 7176-3:2003 Wheelchairs Part 3: Determination of efficiency of brake �
ISO 7176-5: 2008-Wheelchairs -- Part 5: Determination of overall dimensions, mass and . maneuvering space
ISO 7176-7:1998 Wheelchairs part 7: Measurement of seating & wheel dimensions .
ISO 7176-8:1998 Wheelchairs Part 8: Requirements, static impact/fatigue strengths
ISO 7176-11: 1992- Wheelchairs Part 11: Test dummies ●
ISO 7176-13: 1989 Wheelchair Part 13: Determination of coefficient of friction of test . surfaces
ISO 7176-15:1996 Wheelchairs Part 15: Requirement for labeling .
ISO 7176-16: 1997 Wheelchairs Part 16: Resistance to ignition of upholstered parts-● Requirements and test methods
ISO 7176-19:2008 Wheelchairs Part 19: Wheeled mobility devices for use in motor . vehicles

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

March 11,2013

Public Health Service

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

Otto Bock Healthcare % Mr. William Kabitz 2 Carlson Parkway N., Suite 100 Minneapolis, Minnesota 55447

Re: K113164

Trade/Device Name: Discovery Tmax Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: February 21, 2013 Received: March 5, 2013

Dear Mr. Kabitz

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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Page 2 - Mr. William Kabitz

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Joyce M. Whang

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

Enclosure

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Otto Bock®

UALITY FOR LIFE

APPENDIX F

Indications For Use Form

510(k) Number (if known): To be determined

Device Name: Discovery Tmax Manual Wheelchair

Indications for Use:

The Tmax wheelchair are suitable for patients with walking impediments/inability due to, but not limited to:

Palsies/Paralyses .
Loss of limbs .
Defective and/or deformed limbs .
Joint contractures .
Joint defects .
Other diseases .

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)

Brian ወገን Bullin -S

Division of Neurological and Physical Medicine Devices 510(k) Number: K113164

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).