POWERED WHEELCHAIR, MODEL B-500

• K Number: K041208
• Device Name: POWERED WHEELCHAIR, MODEL B-500
• Manufacturer: OTTO BOCK HEALTH CARE, LP
• Date Cleared: 2004-10-01 ( 144 days)
• Product Code: ITI
• Regulation Number: 890.3860
• Type: Traditional
• Panel: Physical Medicine
• Reference & Predicate Devices: K924278
• Predicate For: N/A

Intended Use

The B-500 is rear wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.
Provide mobility to persons physically challenged and limited to sitting position.

Device Description

The B-500 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-500 has an "H" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.

AI/ML Overview

This document does not contain an acceptance criteria table or a study description as typically found for complex medical devices that rely on AI or extensive performance testing against defined metrics.

Instead, this document is a 510(k) summary for a powered wheelchair (B-500 Powered Wheelchair) seeking market clearance through the substantial equivalence pathway. The "study" mentioned for this type of device is usually compliance with recognized international and national standards, rather than a clinical trial or performance study against specific acceptance criteria in the way a diagnostic AI algorithm would be evaluated.

Here's a breakdown of the information that is present in the document, formatted to address your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standards Adhered To)	Reported Device Performance (Conclusion)
EN 12184	"the test sample fulfills the requirements."
ISO 7176 Series	"the test sample fulfills the requirements."
ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC	"the test sample fulfills the requirements."

Explanation: For a powered wheelchair, "acceptance criteria" are typically defined by compliance with established safety and performance standards. The document states that the B-500 was tested by TÜV Product Service to the listed standards, and the conclusion was that "the test sample fulfills the requirements." This indicates that the device met the requirements outlined in these standards, which serve as the de facto acceptance criteria for this type of medical device.

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

This document does not specify a "test set sample size" or "data provenance" in the context of clinical data or AI model evaluation. The "test sample" refers to the physical wheelchair(s) that underwent testing against the specified engineering standards. The typical number of units tested for such compliance would be a limited number of production or prototype units, not a large patient cohort.

• Sample Size: Not explicitly stated, but typically a small number of physical units for engineering standard compliance testing.
• Data Provenance: Not applicable in the context of clinical data. The tests were performed by TÜV Product Service. The manufacturing location is stated as Germany.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this document. The "ground truth" for a powered wheelchair's compliance is determined by its adherence to engineering standards and functional performance, not by expert consensus on clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable. The testing was against engineering and safety standards, not a clinical trial requiring adjudication of patient outcomes or interpretations.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images with and without AI assistance. This document describes a powered wheelchair, which is a therapeutic device, not a diagnostic one.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Standalone performance, in the context of an algorithm, is not applicable to this device. The B-500 is a physical device, and its performance is evaluated through physical testing against standards, not through an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is its compliance with established engineering and safety standards (EN 12184, ISO 7176 Series, and ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).

8. Sample Size for the Training Set

This information is not applicable. The device manufacturing process does not involve a "training set" in the context of AI or machine learning.

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

This information is not applicable as there is no "training set" for this device.

Summary

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

Otto Bock
HEALTH CARE

4/208

OCT 1 - 2004

QUALITY FOR LIFE

North American Headquarters Two Carlson Parkway N., Suite Minneapolis, MN 55447-4467 Phone [phone] Fax [phone]

Customer Support & Distribution Center 14630 28" Avenue North Minneapolis, MN 55447-4821 Phone [phone] Fax [phone]

Technical Center 14800 28th Avenue North, Suite Minneapolis, MN 55447-4873 Phone [phone] Fax [phone]

Florida Area Fabrication Center 755 Clay Street
Winter Park, FL 32789
Phone [phone] Fax [phone]

Ohio Area Fabrication Center 84 Westpark Road Centerville, OH 45459 Phone [phone] Fax [phone]

Utah Design & Manufacturing Center 3820 W. Great Lakes Drive Salt Lake City, UT 84120-720
Phone [phone]
Fax [phone]
Fax [phone]

Minnesota Design & Manufacturing Center 820 Sundial Drive Waite Park, MN 56387 Phone [phone] Fax [phone]

Customer Satisfaction Hotline 1.877.OBSOLVE 1.877.627.6583

www.ottobockus.com

510(k) SUMMARY 01 SAFETY and EFFECTIVENESS

A. General Information

1.	Submitter's Name:	OTTO BOCK HealthCare LP
2.	Address:	Two Carlson Parkway N., Suite 100Minneapolis, MN 55447-4467
3.	Telephone:	763-489-5105
4.	Contact Person:	Bob Clarke
5.	Date Prepared:	April 12, 2004
6.	Registration Number:	2182293
	B. Device
1.	Name:	B-500 Powered Wheelchair
2.	Trade Name:	B-500 Powered Wheelchair
3.	Common Name:	Powered wheelchair

4. Classification Name: Powered wheelchair

5. Product Code: ITI

6. Class: II

7. Regulation Number: 890.3860

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

Image /page/1/Picture/0 description: The image shows the logo for Otto Bock Health Care. The logo is in black and white and features the company name in a stylized font. The words "HEALTH CARE" are written in a smaller, sans-serif font below the company name.

C. Identification of Legally Marketed Devices

1. Name:	P200
2. K Number:	K924278
3. Date Cleared:	March 28.

D. Description of the Device

The B-500 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-500 has an "H" frame, controlled by a P&G Controller, electronic regenerative disc brakes and Micro Motor.

994

E. Intended Use Statement

The B-500 is rear wheel drive powered wheelchair for active users. These wheelchairs provide mobility to physically challenged persons. The wheelchair can be moved by the user operating the remote control. The wheelchair can also be pushed by an assistant grasping the handles attached to the back rest.

F. Technological Characteristics Summary

The B-500 Wheelchair is substantially equivalent to the Ouickie Designs P200 Wheelchair, cleared on March 28, 1994 as K924278.

Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics.

The B-500 was tested by TÜV Product Service to the following standards:

• . EN 12184
• ISO 7176 Series .
• ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC .

with the conclusion that "the test sample fulfills the requirements."

QUALITY FOR LIFE

North American Headquarters Two Carlson Parkway N., Suite Minneapolis, MN 55447-4467 Phone [phone] Fax [phone]

Customer Support & Distribution Center 14630 28th Avenue North Minneapolis, MN 55447-4821 Phone [phone] Fax [phone]

Technical Center 14800 28th Avenue North, Suite Minneapolis, MN 55447-4873 Phone [phone] Fax [phone]

Florida Area Fabrication Cente 55 Clay Street Winter Park, FL, 32789 Phone [phone] Fax [phone]

Dhio Area Fabrication Cente Westpark Road enterville, OH 45459 ?hone 1.937.432.0082 Fax [phone]

Utah Design & Manufacturing Center 3820 W. Great Lakes Drive Salt Lake City, UT 84120-720 Phone [phone] Fax 1,801.956,2401

Minnesota Design & Hanufacturing Center 820 Sundial Drive Waite Park, MN 56387 Phone [phone] Fax [phone]

Customer Satisfaction Hotline 1.877.OBSOLVE 1.877.627.6583

www.ottobockus.com

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol consisting of three stylized lines, which is the department's emblem.

OCT 1 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Otto Bock HealthCare, LP C/o William Jackson W.F. Jackson Associates, Limited 2247 Jennifer Lane St. Paul, Minnesota 55109-2851

Re: K041208

Trade/Device Name: B-500 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: September 18, 2004 Received: September 22, 2004

Dear Mr. Jackson:

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 such 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); 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.

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

Page 2 - Mr. Bill Jackson

This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will unow you to ough maning of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific at notialize at [phone]. Also, please note the regulation entitled, Contact the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark N Millham

Celia M. Witten, PhD. MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K041208

Device Name: B-500 Powered Wheelchair

Indications for Use:

• Provide mobility to persons physically challenged and limited to sitting . position.
  Prescription Use ___ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (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)

Mark N. Millerson

(Division Sign-Off) (Division Sign-On)
Division of General, Restorative, Division of Neurological Devices

Neurological De
510(k) Number K041208

Page 1 of 1

Regulation Number and Section

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).