(92 days)
No reference devices were used in this submission
No
The device description and performance studies focus on the mechanical aspects and safety standards of a manual wheelchair, with no mention of AI or ML.
No
The device is a manual wheelchair, which provides mobility rather than direct therapeutic treatment for a medical condition.
No
Explanation: The device is a manual wheelchair designed for mobility, not to diagnose any medical condition. Its intended use and description focus on providing support for sitting and movement, not on detecting, monitoring, or predicting diseases or health conditions.
No
The device description clearly outlines a physical, mechanical wheelchair with various hardware components (wheels, castors, footrest, backrest, etc.). There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly describes a manual wheelchair designed to provide mobility to individuals with limited sitting ability. It is a mechanical device for physical support and movement.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
The device is a mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The device is indicated to provide mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Küschall Champion Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject Küschall Champion Manual Wheelchair is available in a number of seat width, depth and height options. The standard components of the subject device include a complete rear wheels (hand rims and tires), front castors, flip-up footrest, carbon cloth guards, fold down backrest, wheel locks and quick release axles. The seat upholstery has a central Velcro band that is used for fixation. There is no prior submission for the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test: The Küschall Champion Manual Wheelchair has been evaluated through non-clinical performance testing and is in compliance with the following test standards: RESNA WC-1:2009 Section 1: Determination of Static Stability; RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes; RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass and Maneuvering Space; RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel Dimensions; RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths; RESNA WC-1:2009 Section 11: Test Dummies; RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test Surfaces; RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, Documentation and Labeling; RESNA WC-1:2009 Section 16: Resistance to Ignition of Upholstered Parts; CAL 117:2013 Section 1: Flammability testing. Testing demonstrated that the subject Küschall Champion Manual Wheelchair is substantially equivalent to the marketed predicate device identified throughout this 510(k) submission.
Biocompatibility Testing: The biocompatibility evaluation for the subject Küschall Champion Manual Wheelchair was conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO - 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,'" May 1, 1995, and International Standard ISO 10993 - 1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity; AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Skin Irritation.
Animal Study: Animal testing was not required for this submission.
Clinical Testing: Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 28, 2016
Invacare Corporation Elijah Wreh Regulatory Affairs Manager (pre-market) One Invacare Way Elyria, Ohio 44035
Re: K162686
Trade/Device Name: Kuschall Champion Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: September 26, 2016 Received: September 27, 2016
Dear Elijah Wreh:
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
1
related adverse events) (21 CFR 803); 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.
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 its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162686
Device Name Küschall Champion Manual Wheelchair
Indications for Use (Describe) The device is indicated to provide mobility to persons limited to a sitting position.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| SUBMITTER: | Invacare Corporation
One Invacare Way
Elyria, OH 44035
Phone: (440) 329-6840
Email: ewreh@invacare.com |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Elijah N. Wreh
Regulatory Affairs Manager (Pre-Market) |
| MANUFACTURER: | KÜSCHALL AG
Benkenstrasse 260
Witterswil Solothurn
SWITZERLAND 4108 |
| Date Prepared: | December 19, 2016 |
| DEVICE
Name of Device: | Küschall Champion Manual Wheelchair |
| Common or Usual Name: | Wheelchair, Mechanical |
| Classification Name: | Mechanical Wheelchair 21 CFR §890.3850 |
| Regulatory Class: | I |
| Product Code: | IOR |
| PREDICATE DEVICE: | Küschall Champion Manual Wheelchair (K041072)
No reference devices were used in this submission |
DEVICE DESCRIPTION
The Küschall Champion Manual Wheelchair is a manual or attendant operated wheelchair that is designed to provide mobility to persons limited to a sitting position with a weight capacity of 265 lbs. The subject Küschall Champion Manual Wheelchair is available in a number of seat width, depth and height options. The standard components of the subject device include a complete rear wheels (hand rims and tires), front castors, flip-up footrest, carbon cloth guards, fold down backrest, wheel locks and quick release axles. The seat upholstery has a central Velcro band that is used for fixation. There is no prior submission for the subject device.
4
INDICATIONS FOR USE
The device is indicated to provide mobility to persons limited to a sitting position.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The device comparison showed that the subject device is substantially equivalent to the previously cleared Küschall Champion Manual Wheelchair (K041072) in regards to intended use, design, materials, and operational principles to provide mobility to persons limited to a sitting position.
| Device | Küschall Champion Manual Wheelchair | Küschall Champion Manual Wheelchair |
|---|---|---|
| 510(k) Number | Subject Device | |
| Pending Submission | ||
| (K162686) | Predicate Device | |
| (K041072) | ||
| Indications for Use | The device is indicated to provide mobility to | |
| persons limited to a sitting position. | The Kuschall Champion, Compact and Ultra-light are mechanical wheelchairs intended to provide mobility to persons restricted to a sitting position. | |
| Design | ||
| Weight Limit | 265 lbs. | 267 lbs. |
| Seat Width | 14"-19" | 13.5"-17.5" |
| Seat Depth | 13.5"-19" | 13.5"-18.5" |
| Back Height | 12"- 18.5" | 20" or 24" |
| Backrest Angle | 76° to 94°, 4.5° increments | 74° to 92° |
| Rear Wheel Sizes | 22"-26" | 22"-26" |
| Frame Style/Type | Folding | Folding |
Design Comparison - Küschall Champion Manual Wheelchair
PERFORMANCE DATA
Non-Clinical Test
The Küschall Champion Manual Wheelchair has been evaluated through non-clinical
performance testing and is in compliance with the following test standards:
- RESNA WC-1:2009 Section 1: Determination of Static Stability ●
- RESNA WC-1:2009 Section 3: Determination of Effectiveness of Brakes ●
- . RESNA WC-1:2009 Section 5: Determination of Dimensions, Mass and Maneuvering Space
- RESNA WC-1:2009 Section 7: Method of Measurement of Seating and Wheel ● Dimensions
- RESNA WC-1:2009 Section 8: Requirements and Test Methods for Static, Impact and ● Fatigue Strengths
5
- RESNA WC-1:2009 Section 11: Test Dummies
- . RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test Surfaces
- RESNA WC-1:2009 Section 15: Requirements for Information Disclosure, . Documentation and Labeling
- RESNA WC-1:2009 Section 16: Resistance to Ignition of Upholstered Parts ●
- CAL 117:2013 Section 1: Flammability testing ●
Testing demonstrated that the subject Küschall Champion Manual Wheelchair is substantially equivalent to the marketed predicate device identified throughout this 510(k) submission.
Biocompatibility Testing
The biocompatibility evaluation for the subject Küschall Champion Manual Wheelchair was conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO - 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993 - 1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
- . AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity
- AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: . Tests for Skin Irritation
Animal Study
Animal testing was not required for this submission.
Clinical Testing
Clinical testing was not required to demonstrate substantial equivalence to the predicate device.
CONCLUSIONS
The subject device has the same intended use and similar technological characteristics as the predicate device. The non-clinical laboratory data support the substantial equivalence of the subject Küschall Champion Manual Wheelchair and demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the Küschall Champion Manual Wheelchair is substantially equivalent to the predicate device identified throughout this submission.