(30 days)
Not Found
No
The device description and performance studies focus on mechanical function and safety standards, with no mention of AI or ML.
No.
The device's primary function is mobility, and while it includes features for comfort and pressure relief ('therapeutic benefits'), it is not primarily for treating or diagnosing a medical condition.
No
This device is a manual wheelchair, designed to provide mobility and comfort to individuals. It does not perform any diagnostic functions, such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly states it is a "manually operated, self propelled mechanical wheelchair," which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To provide mobility to persons limited to a seated position." This is a mechanical function for physical support and movement, not for examining specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a manually operated wheelchair with a tilt mechanism. This is a physical assistive device, not a diagnostic tool.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in the body
- Providing information for diagnosis or treatment based on laboratory tests
The device is clearly a mobility aid, falling under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the PDG Models Fuze T20 and T50 manual wheelchairs is to provide mobility to persons that may be limited to a seated position.
To provide mobility to persons limited to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
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)
The Fuze T50 and Fuze T20 are designed to meet both the ISO 7176 -Determination of Static Stability as well as Static, Impact and Fatigue Strength; and the ANSI/RESNA WC - 19 Motor Vehicle Transportation Crash Test.
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.
Invacare Corporations' Action AT II Manual Wheelchair (K989447)
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
K063736
Page 1 of 2
510(k) Premarket Fuze T20 and T50 Wheelchairs
510(k) SUMMARY PDG PRODUCT DESIGN GROUP, INC. MODELS FUZE T20 AND T50 MANUAL WHEELCHAIRS
JAN 17 2007
Submitter
PDG Product Design Group, Inc. Unit 102-366 E. Kent Avenue South Vancouver, British Columbia Canada V5X 4N6
Contact Person
Edward A. Kroll President Spectre Solutions 5905 Fawn Lane Cleveland, Ohio 44141 Phone: (440) 546-9810 Fax: (440) 546-9124
Date Prepared: December 8, 2006
Name of Device
Fuze T20 and T50 Manual Wheelchairs
Common or Usual Name
Manuai Wheelchair
Classification Name
Wheelchair, Mechanical
Predicate Devices
Invacare Corporations' Action AT II Manual Wheelchair (K989447)
Intended Use
The intended use of the PDG Models Fuze T20 and T50 manual wheelchairs is to provide mobility to persons that may be limited to a seated position.
1
K063736
Page 2 of 2
510(k) Premarket Notification Fuze T20 and T50 Wheelchairs
Device Description
The PDG Models Fuze T20 and T50 wheelchairs are manually operated, self propelled mechanical wheelchairs. Their intended function and use is to provide mobility to persons that may be limited to a seated position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.
Both wheelchairs include a tilt mechanism which allows the upper frame of the wheelchair to be tilted. This feature is used to provide pressure relief as well as comfort to those users who may be confined to the wheelchair for extended periods of time. The tilt mechanism can also serve as an attendant aid in those situations where a patient needs to be tilted for attendant access.
Substantial Equivalence
The PDG Models Fuze T20 and T50 manual wheelchairs are substantially equivalent to Invacare Corporations' AT II Manual Wheelchair (K989447)
Performance Data
The Fuze T50 and Fuze T20 are designed to meet both the ISO 7176 -Determination of Static Stability as well as Static, Impact and Fatigue Strength; and the ANSI/RESNA WC - 19 Motor Vehicle Transportation Crash Test.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
PDG Product Design Group, Inc. % Mr. Edward A. Kroll President, Spectre Solutions, Inc. and Representative Consultant 5905 Fawn Lane Cleveland, Ohio 44141
JAN 1 7 2007
Re: K063736
Trade/Device Name: Fuze T20 and T50 Manual Wheelchairs Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: December 12, 2006 Received: December 22, 2006
Dear Mr. Kroll:
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. Edward A. Kroll
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 contact the Office of Compliance at (240) 276-0120 Also, please note the regulation entitled, "Misbranding 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
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):
Device Name: Fuze T20 and T50 Mechanical Wheelchairs
Indications for Use:
To provide mobility to persons limited to a seated 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
(Division Sign-On)
Division of General, Restorative, Page Page 1_of 1 Division
and Neurological Devices
510(k) N. K06372