(212 days)
Not Found
No
The document describes a manual wheelchair and does not mention any AI or ML components or functionalities.
No
The device is a manual wheelchair, which provides mobility, but does not treat a medical condition or restore health, which are characteristics of a therapeutic device.
No
Explanation: The described device is a manual wheelchair, whose intended use is to provide mobility. It does not perform any diagnostic functions.
No
The device description clearly states it is a manual wheelchair with aluminum and steel components, indicating it is a physical hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to children with physical disabilities. This is a mechanical function related to movement and support, not the examination of specimens from the human body.
- Device Description: The description details a manual wheelchair with components like a frame, seating module, and transport anchors. These are all physical components for mobility.
- No mention of biological samples: There is no mention of collecting, analyzing, or testing any biological samples (blood, urine, tissue, etc.).
- No mention of diagnostic purposes: The device is for mobility, not for diagnosing a disease or condition.
IVD devices are used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Convaid’s Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its’ intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently nonambulatory and limited to a sitting position.
In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vehicle when used in conjunction with an approved fourpoint, strap-type tiedown system per ANSI-RESNA WC-19:2000.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Champ CH10 and CH10T are lightweight folding aluminum and steel framed wheelchairs with a seating module that can be used with an optional activity base. It contains the same typical components found on most manual wheelchairs. Champ CH10T transit model is the CH10 model with the addition of transport anchors. The CH10T model has been crash tested to WC- Vol 1 section 19:2000 and approved for use as seating in a motor vehicle.
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
children
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)
Convaid’s Champ manual wheelchair met the applicable performance requirements as specified below; RESNA WC 1:2009-1 RESNA WC 2:2009-3 RESNA WC 1:2009-5 RESNA WC 1:2009-7 RESNA WC 1:2009-8 RESNA WC 1:2009-15 RESNA WC 1:2009-16 ANSI-RESNA WC Vol 1 section 19:2000, CH10T only ISO 10993-5 ISO 10993-10
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.
Not Found
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
Convaid
PO Box 4209 • Palos Verdes, CA 90274 • USA B88-CONVAID • 310/ 618-0111 www.convaid.com
Convaid Product Inc. Model: CHAMP Manual Wheelchair K120501 510(k) Summary of Safety and Efficacy
A. General Information
-
- Submitter Name: 2. Address:
-
- Telephone: Fax:
-
- Contact Person:
Date Prepared:
Registration Number:
Torrance CA, 90503 310-618-0111 310-618-2172 Donald Griggs Quality Assurance Manager 2022883 07/02/2012
Convaid Products Inc.
2830 California St.
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SEP 2 0 2012
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PAGE 1 OF 3
B. Device
ನ
- Device Trade Name: Champ 1. Wheelchair-Manual 2. Common/Generic Name: Mechanical Wheelchair Device Classification Name: 3. 222022883 Registration Number: 4. IOR న. Product Code: Device Classification Class 1 Q: 890.3850 Regulatory Number: 7.
C. Identification of Legally Marketed Devices
- Manufacture Name: Otto Bock 1.
- Bravo Racer 2. Name: K082314 3. K Number:
- 10/28/2008 Date Cleared: 4.
1
PO Box 4209 · Palos Verdes, CA 90274 · USA 888-CONVAID • 310/ 618-0111 www.convaid.com
D. Description of the device
The Champ CH10 and CH10T are lightweight folding aluminum and steel framed wheelchairs with a seating module that can be used with an optional activity base. It contains the same typical components found on most manual wheelchairs. Champ CH10T transit model is the CH10 model with the addition of transport anchors. The CH10T model has been crash tested to WC- Vol 1 section 19:2000 and approved for use as seating in a motor vehicle.
See section 11 device description for a more detailed description.
E. Intended Use
Convaid's Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its' intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently non-ambulatory and limited to a sitting position.
In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vchicle per ANSI WC -vol-1 section19:2000.
F. Technological Characteristics Summary
The Convaid Champ is substantially equivalent to Otto Bock's Bravo Racer cleared on 10/28/2008 on K082314. The wheelchairs are self or attendant propelled manual wheelchairs, the Champ is a non- ridge folding frame with ten inch seat width were as the Bravo Racer has a ridged frame and has the availability of multiple seat widths ranging from eight to fourteen inches. They both have removable seating modules for easy storage or transport and the Champ's seating module can be used with an optional indoor activity base. The frames are made of tubular coated aluminum and or steel and have small caster in the front for steering and maneuverability and large wheels in the back to allow for self propulsion. Both can be used as seating in a motor vehicle per ANSI-RESNA WC Vol1-19:2000
G: Comparison of device characteristics to predicate
This device (Convaid Champ) has similar characteristics, construction and technology as the predicate device Bravo Racer manufactured by Otto Bock. The Bravo Racer has a ridge frame and removable seating for easy storage and transport, the Champ has a non-ridge frame and removable seating module for easy storage and transport. They use similar materials in the frame and components and both use powder coated frames. The operating characteristics and maneuverability are equivalent and recommended for indoor or outdoor use on flat firm terrain.
2
PO Box 4209 • Palos Verdes, CA 90274 • USA 888-CONVAID • 310/ 618-0111 www.convaid.com
H: Non-Clinical Testing
Convaid's Champ manual wheelchair met the applicable performance requirements as specified below; RESNA WC 1:2009-1 RESNA WC 2:2009-3 RESNA WC 1:2009-5 RESNA WC 1:2009-7 RESNA WC 1:2009-8 RESNA WC 1:2009-15 RESNA WC 1:2009-16 ANSI-RESNA WC Vol 1 section 19:2000, CH10T only ISO 10993-5 ISO 10993-10
I: Safety:
The Convaid Champ Wheelchair Series is substantially equivalent to the predicated device listed in the 510(k). The technology and construction of the Champ Wheelchair series does not raise any new issues of safety and effectiveness.
: Conclusion:
The Champ Wheelchair series shares performance features and technology with the predicate device as well as a number of similar devices already legally marketed within the United States. The use of additional predicate devices and historical data was used in the determination of compliance to specific requirements; see the device description section 11 of this document for detailed information. Therefore the Champ Series wheelchairs are substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. · Silver Spring, MD 20993-0002
SEP 20 2012
Comvaid Products, Incorporated % Mr. Donald Griggs Quality Assurance Manager 2830 California Street Torrance, California 90503
Re: K120501
Trade/Device Name: Convaid Products Champ Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: August 28, 2012 Received: August 30, 2012
Dear Mr. Griggs:
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
4
Page 2 - Mr. Donald Griggs
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 forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
510(k) Number: K 120501
Convaid Products Champ Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Convaid's Champ model CH10 is a lightweight non-ridge high strength aluminum and steel manual wheelchair with a tilt and recline mobility system for everyday indoor and outdoor use on flat firm terrain. The Convaid Champ is a self or attendant propelled device, its' intended function and use is to provide mobility to children with physical disabilities who are frequently or permanently nonambulatory and limited to a sitting position.
In addition the Champ CH10T transit model has been tested and approved for use as seating in a motor vehicle when used in conjunction with an approved fourpoint, strap-type tiedown system per ANSI-RESNA WC-19:2000.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR × (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)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120501