(32 days)
Not Found
No
The description clearly states the device is "manually operated" and functions like a "standard mechanical wheelchair." There is no mention of any computational or intelligent features.
No.
The device functions as a standard mechanical wheelchair to provide mobility, which is assistive rather than therapeutic in nature.
No
The device description clearly states its purpose is to provide mobility to physically challenged persons, functioning like a standard mechanical wheelchair. There is no mention of it being used to diagnose conditions.
No
The device description clearly indicates it is a manually operated device with wheels constructed from steel tubing, describing physical components like a frame, wheels, and a cushion. There is no mention of software as the primary or sole component.
Based on the provided information, the Dignity 100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide mobility to physically challenged persons." This is a mechanical function related to physical assistance, not a diagnostic test performed on biological samples.
- Device Description: The description details a "manually operated device with wheels" that functions like a "standard mechanical wheelchair." It also mentions a custom cushion for toileting. These are all physical components and functions, not related to in vitro testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls
The Dignity 100 is clearly described as a mobility aid, specifically a wheelchair.
N/A
Intended Use / Indications for Use
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
To provide mobility for the disabled.
Product codes
IOR
Device Description
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical purposes and is an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replaced by the patient when he or she wishes to use the toilet.
The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.
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 Dignity 100 wheelchair passed all technical requirements identified in ANSV/RESNA parts 1, 3, 5, 7, 8 and 93.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K08 aa46
Dignity Medical Devices, Inc. Dignity 100
510(k) Premarket Notification
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1889 and 21 CFR 807.92.
510(k) Number ________________________________________________________________________________________________________________________________________________________________ Date Prepared: July 30, 2008
Submitter's Name, Address and Contact Person Dignity Medical Devices, Inc. 17500 29th Ave. North Minneapolis, Minnesota 55447
Contact Person: Charmaine Sutton
Trade Name: Dignity 100
Common Name: Manual Wheelchair
Classification Name: Wheelchair, mechanical
Predicate Device
The Dignity 100 wheelchair is substantially equivalent to the Sunrise Medical Quickie QX (K072153).
Intended Use
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
Device Description
The Dignity 100 is a manually operated device with wheels that is intended for medical purposes to provide mobility to physically challenged persons. The Dignity 100 is intended for indoor and outdoor use on firm surfaces free of climbing obstacles.
The Dignity 100 functions like a standard mechanical wheelchair with the addition of a custom cushion. This 21 CFR Sec. 890.3920 wheelchair component is intended for medical o rurgoses and surface an integral part of the wheelchair, but will also be sold separately as a replacement part. The custom cushion is designed with a keyhole shaped drop down panel which is replacement by the patient when he or she wishes to use the toilet.
The Dignity 100 is constructed from 7/8 inch outside diameter (OD) round, mechanical steel tubing. The chair is of welded construction. The sewn components are secured to the frame using screws and bolts. This device is a rigid wheelchair that incorporates a seating surface. The Dignity 10 has removable footrests.
Substantial Equivalence Comparison
The Dignity 100 is substantially equivalent to the Sunrise Medical/Quickie Design Model "Quickie QX Manual Folding Wheelchair" (K072153).
Performance Data
The Dignity 100 wheelchair passed all technical requirements identified in ANSV/RESNA parts 1, 3, 5, 7, 8 and 93.
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.
SEP 0 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dignity Medical Devices, Inc. %The Tamarack Group, Inc Ms. Charmaine Sutton 16917 73td Place North Maple Grove, Minnesota 55311
K082246 Trade/Device Name: Dignity 100 Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair. Regulatory Class: Class I Product Code: IOR Dated: July 31, 2008 Received: August 08, 2008
Dear Ms. Sutton:
Re:
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 adultcration.
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.
2
Page 2 – Ms. Charmaine Sutton
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image contains a handwritten word that appears to be "Koraayu". The text is written in a cursive style, with some letters having accents or diacritical marks above them. The writing is dark and stands out against the white background.
Dignity Medical Devices, Inc. Dignity 100
510(k) Premarket Notification
· 510{k) Number (if known): __________________________________________________________________________________________________________________________________________________
Device Name: Dignity 100
Indications for Use:
.
To provide mobility for the disabled.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use × (21 CFR 801 Subpart C)
25
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrent of CDRH, Office Of Device Evaluation (ODE)
(Posted November 13, 2003)
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