(144 days)
The C-1000 is front 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.
The C-1000 Powered Wheelchair is a front wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The C-1000 has an "H" frame, controlled by a Curtis Instruments MC-2, electronic regenerative disc brakes and Micro Motor.
The provided text describes a 510(k) submission for the Otto Bock C-1000 Powered Wheelchair, seeking clearance for marketing. The nature of this submission and the device itself (a powered wheelchair) means that the "acceptance criteria" and "device performance" are primarily related to safety, functionality, and equivalence to a predicate device, rather than diagnostic accuracy or predictive power as would be seen in a medical imaging AI product.
Therefore, many of the typical acceptance criteria points for an AI/ML device, such as sensitivity, specificity, AUC, and aspects related to human reader studies, are not applicable in this context. The study described focuses on compliance with established engineering and safety standards for wheelchairs.
Here's a breakdown of the requested information based on the provided text, acknowledging the differences due to the device type:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| Safety & Performance Standards Compliance: | |
| EN 12184 (Electrically-powered wheelchairs) | "the test sample fulfills the requirements." |
| ISO 7176 Series (Wheelchairs) | "the test sample fulfills the requirements." |
| ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Electromagnetic Compatibility) | "the test sample fulfills the requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states "the test sample" was used, implying one or a small number of C-1000 Powered Wheelchair units were subjected to testing. A specific numerical sample size is not provided.
- Data Provenance: The device was manufactured in Germany at OTTO BOCK HealthCare production facilities. The testing was conducted by TÜV Product Service, an organization based in Europe, which suggests the tests were likely performed in Europe. This was a prospective study, as the tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This concept is not directly applicable here. The "ground truth" for the performance of a powered wheelchair is its adherence to established engineering and safety standards. The "experts" would be the engineers and technicians at TÜV Product Service who conducted the tests and assessed compliance with the specified standards. Their qualifications would be expertise in mechanical, electrical, and medical device safety testing, and specifically in the standards listed (EN 12184, ISO 7176 Series, ANSI/RESNA WA Vol. 2 Section 21). The number of such individuals is not specified.
4. Adjudication Method for the Test Set
- Not applicable in the context of compliance testing against engineering standards. The results are typically objective measurements against predefined limits or pass/fail criteria within the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for assessing the impact of a diagnostic aid (often AI-based) on human reader performance, which is not the purpose of this device or its clearance pathway.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The C-1000 Powered Wheelchair is a physical medical device, not an algorithm. Its performance is inherent to the device itself.
7. The Type of Ground Truth Used
- The "ground truth" used for assessing the device's performance was the requirements outlined in the recognized international and national engineering and safety standards:
- EN 12184 (Electrically-powered wheelchairs)
- ISO 7176 Series (Wheelchairs)
- ANSI/RESNA WA Vol. 2 Section 21 Amendments 1998 for EMC (Electromagnetic Compatibility)
8. The Sample Size for the Training Set
- Not applicable. The C-1000 Powered Wheelchair is a physical product designed and manufactured according to established engineering principles, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device. The design and manufacturing processes are guided by established engineering specifications and quality control measures, which ensure the device's intended characteristics.
{0}------------------------------------------------
Otto Bock
HEALTH CARE
OCT 1 - 2004
510(k) Summary
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 |
| Device |
B. 1. Name: C-1000 Powered Wheelchair 2. Trade Name: C-1000 Powered Wheelchair 3. Common Name: Powered wheelchair 4. Classification Name: Powered wheelchair 5. Product Code: ITI 6. Class: I I 7. Regulation Number: 890.3860
QUALITY FOR LIFE
North American Headquarters Two Carlson Parkway N., Suite Minneapolis, MN 55447-4467 Phone 1.800.328.4058 Fax 1.800.655.4963
Customer Support & Distribution Center 14630 28t Avenue North Minneapolis, MN 55447-4821 Phone 1.800.328.4058 Fax 1.800.962.2549
Technical Center 14800 28th Avenue North, Suite Minneapolis, MN 55447-4873 Phone 1.800.795.8846 Fax 1.800.810.7994
Florida Area Fabrication Center 755 Clay Street Winter Park, FL 32789 Phone 1.800.354.5418 Fax 1.407.599.7999
Ohio Area Fabrication Center 84 Westpark Road Centerville, OH 45459 Phone 1.937.432.0082 Fax 1.937.432.0087
Utah Design & Manufacturing Center 3820 W. Great Lakes Drive Salt Lake City, UT 84120-7205 Phone 1.801.956.2400 Fax 1.801.956.2401
Minnesota Design & Manufacturing Center 820 Sundial Drive Waite Park, MN 56387 Phone 1.800.688.4832 Fax 1.320.251.0110
Customer Satisfaction Hotline 1.877.OBSOLVE 1.877.627.6583
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Otto Bock Health Care. The words "Otto Bock" are written in a cursive font, with a line underneath. Below the line, the words "HEALTH CARE" are written in a sans-serif font.
C. Identification of Legally Marketed Devices
| 1. Name: | Chairman |
|---|---|
| 2. K Number: | K960951 |
| 3. Date Cleared: | April 30, 1997 |
D. Description of the Device
The C-1000 Powered Wheelchair is a front wheel drive powered wheelchair, manufactured in Germany at production facilities of OTTO BOCK HealthCare. The C-1000 has an "H" frame, controlled by a Curtis Instruments MC-2, clectronic regenerative disc brakes and Micro Motor.
E. Intended Use Statement
The C-1000 is front 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 C-1000 Wheelchair is substantially equivalent to the Permobil AB Chairman Wheelchair, cleared on April 30, 1997 as K960951.
Each wheelchair is a powered wheelchair for the active user, with a rigid frame and similar characteristics.
The C-1000 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 1.800.328.4058 Fax 1.800.655.4963
Customer Support & Distribution Center 14630 28th Avenue North Minneapolis, MN 55447-482 Phone 1.800.328.4058 Fax 1.800.962.2549
Technical Center 14800 28th Avenue North, Suite Minneapolis, MN 55447-487 Phone 1,800,795,8846 Fax 1.800.810.7994
Florida Area Fabrication Cente 55 Clay Street Vinter Park, FL 32789 Phone 1.800.354.5418 Fax 1-407.599.7999
Ohio Area Fabrication Cente Westpark Road enterville, OH 45459 Phone 1.937.432.0082 x 1.937.432.0087
Itah Design & anufacturing Center 820 W. Great Lakes Drive alt Lake City, UT 84120-72 Phone 1.801.956.2400 ax 1.801.956.2401
innesota Design & anufacturing Center 20 Sundial Drive Vaite Park, MN 56387 hone 1.800.688.4832 ax 1.320.251.0110
Customer Satisfaction Hotline 1.877.OBSOLVE 1.877.627.6583
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is made up of three intertwined snakes and a staff.
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: K041211
Trade/Device Name: C-1000 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 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 for associated in 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. William Jackson
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icher will anow you to began mailing of substantial equivalence of your device to a legally premaince notification. " 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 dosire of Compliance at (240) 276-0120. Also, please note the regulation entitled, eonading by reference 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 international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Mellem
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): K041211
Device Name: C-1000 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 Melbern
al. Restorative, Division of Gener Divisions of Occal Devices
510(k) Number-
Page 1 of 1
1041211
§ 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).