POWERED WHEELCHAIR, MODEL B-600

• K Number: K041210
• Device Name: POWERED WHEELCHAIR, MODEL B-600
• 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-600 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.

Device Description

The B-600 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-600 has an "H" frame, controlled by Curtis Instruments Controller, electronic regenerative disc brakes, and Micro Motor.

AI/ML Overview

This document is a 510(k) summary for the Otto Bock B-600 Powered Wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the context of diagnostic accuracy or performance like an AI/ML medical device.

Therefore, many of the requested categories for AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance) are not applicable or extractable from this document.

However, I can extract information related to the demonstration of technological characteristics and standards used.

Device: B-600 Powered Wheelchair

Predicate Device: Quickie Designs (Sunrise Medical) P200 (P220) Wheelchair (K924278)

Here's the information that can be extracted, adapting to the nature of this submission:

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1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category (Standards Complied With)	Reported Device Performance (Conclusion)
EN 12184 (Electric wheelchairs, scooters and their chargers - Requirements and test methods)	"the test sample fulfills the requirements."
ISO 7176 - Series (Wheelchairs - Test methods)	"the test sample fulfills the requirements."
ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Wheelchair standards for electromagnetic compatibility)	"the test sample fulfills the requirements."

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated as a numerical count of wheelchairs tested, but it refers to "the test sample" which implies at least one B-600 Powered Wheelchair was subjected to the listed standards.
• Data Provenance: The standards testing was conducted by TÜV Product Service and Montena EMC SA. The device is manufactured in Germany.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a clearance for a powered wheelchair based on performance against established standards and substantial equivalence to a predicate device, not a diagnostic device requiring expert interpretation of results. The "ground truth" here is compliance with engineering and safety standards, determined by testing facilities.

4. Adjudication method for the test set:

• Not Applicable. See point 3.

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. This is not an AI/ML diagnostic device.

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

• Not Applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used:

• Compliance with established international and national standards for electric wheelchairs and electromagnetic compatibility (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML diagnostic device. There is no concept of a "training set" in this context.

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

• Not Applicable. See point 8.

Summary

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Image /page/0/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.

K 041210

OCT 1 - 2004

510(k) SUMMARY of 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-600 Powered Wheelchair
2. Trade Name:	B-600 Powered Wheelchair
3. Common Name:	Powered wheelchair
4. Classification Name:	Powered wheelchair
5. Product Code:	ITI
6. Class:	II
7. Regulation Number:	890.3860

QUALITY FOR LIFE

North American Headquarters Torth Parlson, Morkwoon Portoners
Two Carlson, Mit

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

Ohio Area Fabrication Center 84 Westpark Road
Centerville, OH 45459 Sone 1.937.432.0082
Fax [phone]

Utah Design & Manufacturing Center 3820 W. Great Lakes Drive Salt Lake City, UT 84120-7205 Phone [phone] Fax [phone]

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

Customer Satisfaction Hotline 1.877.OBSOLVE 1.877.627.6583

www.ottobockus.com

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Image /page/1/Picture/0 description: The image shows the logo for Otto Bock Health Care. The logo is in black and white, with the words "Otto Bock" in a stylized font on the top line. Below that is a horizontal line, and below that is the text "HEALTH CARE" in a sans-serif font. The logo is simple and clean, and it conveys a sense of professionalism and trustworthiness.

C. Identification of Legally Marketed Devices

1. Name:	P220
2. K Number:	K924278
3. Date Cleared:	March 28, 1994

D. Description of the Device

The B-600 Powered Wheelchair is a rear wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The B-600 has an "H" frame, controlled by Curtis Instruments Controller, electronic regenerative disc brakes, and Micro Motor.

E. Intended Use Statement

The B-600 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-600 Wheelchair is substantially equivalent to the Quickie Designs (Sunrise Medical) P200 (P220) 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-600 was tested by TÜV Product Service and Montena EMC SA 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 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 55 Clay Street Winter Park, FL 32789 Phone [phone] F2x 1.407.599.7999

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

tah Design & Manufacturing Center 820 W. Great Lakes Drive alt Lake City, UT 84120-720' Phone [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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three wavy lines below the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 - 2004

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

Re: K041210

Trade/Device Name: B-600 Powered Wheelchair Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: 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 we nave reviewed your becamed in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered proct to May 20, 1978, are cance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Ocometie : for ( roy ( roy ( roy ) recent al controls provisions of the Act. The r ou may, dierelere, mains 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 If your abilier 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.

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Page 2 - Mr. William Jackson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter wift and w your to ough finding of substantial equivalence of your device to a legally prematics notification. The stassification 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 active of Compliance at [phone]. Also, please note the regulation entitled, Contider the Office or 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 s. International 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 A. Milken

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

Enclosure

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Indications for Use

510(k) Number (if known): K041210

Device Name: B-600 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 A. Millere

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

510(k) Number K041210

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).