(123 days)
Not Found
No
The device description details a purely mechanical wheelchair with adjustable features and an optional lever drive system. There is no mention of any software, algorithms, or data processing that would indicate the presence of AI or ML.
No.
A therapeutic device is typically one that actively treats or prevents a medical condition, or restores a bodily function beyond simply providing mobility or support. While the wheelchair provides mobility and thus improves the user's quality of life, it does not actively treat a disease or restore a lost function in the way a physical therapy device might.
No
The device description indicates that the Stryker Sorano Wheelchair is a mechanical device designed to provide mobility, not to diagnose medical conditions.
No
The device description clearly outlines a physical, mechanical wheelchair with a frame, wheels, suspension, and optional lever drive. It is not solely software.
No, the Stryker Sorano Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Stryker Sorano Wheelchair is a mechanical device used for mobility. Its purpose is to help individuals who are restricted to a seated position move around. It does not interact with or analyze biological specimens.
The provided information clearly describes a physical mobility aid, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position.
The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
The Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature.
The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system.
The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.
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 Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Sociey of North American (RESNA) Standard ANSI/ RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs."
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
SEP 26 2005
struker
K05/369
Canada
510K Summary: Stryker Sorano Wheelchair
Trade Name: Stryker Sorano
Common Name: Manual Wheelchair
Classification Name: Wheelchair, Mechanical 8911OR
Device Sponsor:
Stryker Canada 45 Innovation Drive Hamilton, ON, Canada L9H 7L8
Regulatory Class: Class I 21 CFR 890.3850 Mechanical Wheelchair
Contact Person:
Kathryn Ronalds, Senior Regulatory Affairs Representative
Predicate Device:
The Stryker Sorano Wheelchair is substantially equivalent to the Invacare Top End Terminator Titanium Manual Wheelchair (K012167, Aug 1/01).
Intended Use:
The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position.
Device Description:
The Stryker Sorano Wheelchair is a manually operated, user propelled mechanical wheelchair. It is intended to provide mobility to persons restricted to a seated position.
The product consists of a titanium frame (also available in chrome-moly steel), large rear wheels with handrims for propelling the chair, and smaller front pivoting casters for stability. The wheelchair is a lightweight manual chair designed for everyday use, both indoors and outdoors. The wheelchair is a rigid, non-folding type wheelchair.
1
The Stryker Sorano offers a suspension system made of a fibre glass composite. The two suspension elements are part of the frame construction as they connect the main frame to the rear wheel axle. As it is part of the frame, the suspension is a standard feature.
The Stryker Sorano offers an additional propulsion method to conventional handrims. A lever drive option may be added that provides two forward gear ratios an incorporates a disc braking system. Handrim use is still possible as handrims are standard on all units. The key benefits to the drive system are that it eliminates the need to grip the handrim, provides mechanical advantage and provides an enhanced braking system.
The Stryker Sorano also offers modularity and adjustability features. The seat height, angle, rear seat-to-floor height, and front seat-to-floor height may be adjusted by the end user. The footrest module with caster wheels may be adjusted forward and backward, and the footrest height may be adjusted. The backrest angle and height may also be adjusted. In addition, the footrest module is removable and may be replaced with optional sports or other special purpose footrests. The seat/backrest module and the footrest module may be removed by the user, allowing the entire wheelchair to be packed in a compact space for travel. The optional folding backrest enhances this feature.
Performance Data:
The Stryker Sorano Wheelchair will meet the applicable performance standards specified in Rehabilitation Engineering Sociey of North American (RESNA) Standard ANSI/ RESNA WC/Vol. 1-1998 "Requirements and Test Methods for Wheelchairs."
Substantial Equivalence (SE) Rational:
The Stryker Sorano Wheelchair is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Invacare.
Safety and Effectiveness:
The Stryker Sorano Wheelchair does not raise any new safety and efficacy concerns when compared to a similar device already legally marketed. Therefore, the Stryker Sorano Wheelchair is substantially equivalent to this existing device.
Signed: Kathryn Ronalds Dated: May, 20 2005
Kathryn Ronalds Senior Regulatory Affairs Representative
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 6 2005
Ms. Sheryl Bagalio Regulatory and Quality Affairs Supervisor Stryker Canada 45 Innovation Drive Hamilton, ON, Canada L9H 7L8
Re: K051369
Trade/Device Name: Stryker Sorano Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: August 18, 2005 Received: August 19, 2005
Dear Ms. Bagalio:
We have reviewed your Section 510(k) premarket notification of intent to market the device WC nave rowed your be received the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of the May 20, 2017 11:11 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). and Cosmetic For (10) has the device, subject to the general controls provisions of the Act. The r ou may, diere, eroyisions 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 If your de rise to such additional controls. Existing major regulations affecting your device can may or sations 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 or any I 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 - Ms. Sheryl Bagalio
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin manketing your antial equivalence of your device to a legally premarket nother 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 If you desire specific advice for your as 11-07-20120. Also, please note the regulation entitled, Contact the Office of Compuners and (21 CFR Part 807.97). You may obtain Misolanding by reference to premail.org/w/index.php?title=Pivision of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
2
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
| 510K Number: | TBD |
|---|---|
| Device Number: | Stryker Sorano Wheelchair |
| Indications for Use: | The Stryker Sorano Wheelchair is a mechanical wheelchair intended to provide mobility to persons restricted to a seated position. |
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _ (Part 21 CFR 801.109)
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KOS 1369 369