(25 days)
No
The summary describes a mechanical wheelchair and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a mechanical wheelchair offering mobility assistance, which is not classified as a therapeutic function for treating diseases or conditions.
No
Explanation: The device description clearly states it is a "mechanical wheelchair intended to provide mobility," which is a rehabilitative or assistive function, not a diagnostic one. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly states it is a "rigid manual wheelchair" with "frame components of the chair are aluminum," indicating it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons with disabilities restricted to a seated position. This is a physical function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mechanical wheelchair. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- No mention of biological samples: There is no mention of the device interacting with or analyzing biological samples.
- Performance Studies: The performance studies focus on mechanical properties like stability, strength, and resistance to ignition, which are relevant to a physical mobility device, not a diagnostic test.
An IVD would involve analyzing something from the patient's body to gain information about their health status. This wheelchair is a tool to assist with mobility, not to diagnose or monitor a medical condition through biological analysis.
N/A
Intended Use / Indications for Use
The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide mobility to persons with disabilities restricted to a seated position.
Product codes
IOR
Device Description
The Icon Adult Manual Wheelchair is a rigid manual wheelchair, with a centralized modular design. The frame components of the chair are aluminum.
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)
Performance Test Summary-New Device
- Characteristic: Static Stability; Standard/Test/FDA Guidance: ANSI/RESNA WC/Volume 1-1998, Section 1: Determination of Static Stability; Results Summary: There is no pass/fail criteria for this test - results were as expected.
- Characteristic: Overall dimensions, mass and manoeuvring space; Standard/Test/FDA Guidance: ANSI/RESNA WC/Volume 1-1998, Section 5: Determination of overall dimensions, mass and manoeuvring space; Results Summary: There is no pass/fail criteria for this test - results were as expected.
- Characteristic: Static, Impact & Fatigue Strength; Standard/Test/FDA Guidance: ANSI/RESNA WC/Volume 1-1998, Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths; Results Summary: There is no pass/fail criteria for this test - results were as expected.
- Characteristic: Resistance to Ignition; Standard/Test/FDA Guidance: ANSI/RESNA WC/Volume 1-1998, Section 16: Resistance to Ignition of Upholstered Parts; Results Summary: There is no pass/fail criteria for this test - results were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Marvel Wheelchair model K082970
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
lcon Adult Manual Wheelchair 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter Information | ||||
|---|---|---|---|---|
| Name | Icon Wheelchairs Inc. | |||
| Address | P.O. Box 418 | |||
| Northampton, MA 01060 | ||||
| Phone number | 413-584-4491 | |||
| Fax number | 413-380-0177 | |||
| Name of contact | ||||
| person | Tom Horton | |||
| Date prepared | April 1, 2011 | |||
| Name of device | ||||
| Trade or proprietary | ||||
| name | Icon Adult Manual Wheelchair | |||
| Common or usual | ||||
| name | Mechanical Wheelchair | |||
| Classification name | Wheelchair Mechanical | |||
| Classification panel | Physical Medicine | |||
| Regulation | 890.3850 | |||
| duct Code(s) | IOR | |||
| Legally marketed device(s) | ||||
| to which equivalence is | ||||
| claimed | Marvel Wheelchair model K082970 | |||
| Reason for 510(k) | ||||
| submission | The Icon Adult Manual Wheelchair is a new device. | |||
| Device description | The Icon Adult Manual Wheelchair is a rigid manual wheelchair, with a centralized | |||
| modular design. The frame components of the chair are aluminum. | ||||
| Intended use of the device | The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide | |||
| mobility to persons with disabilities restricted to a seated position. | ||||
| Indications for use | The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide | |||
| mobility to persons with disabilities restricted to a seated position. | ||||
| Summary of the technological characteristics of the device compared to the predicate device | ||||
| Element of | ||||
| Comparison | Icon Adult | |||
| Manual | ||||
| Wheelchair | Marvel | |||
| Wheelchair | ||||
| K082970 | Comparison to the predicate | |||
| device | ||||
| Product Weight | 23 lbs | 23lbs | No substantive differentiation | |
| Patient Capacity | 250 | 250 | No substantive differentiation | |
| Frame Material | Aluminum, | |||
| titanium, and | ||||
| composite | ||||
| materials | Aluminum | |||
| and | ||||
| composite | ||||
| materials | No substantive differentiation | |||
| Suspension | ||||
| Seat Width | Air Shock | |||
| 12-19" | Air Shock | |||
| 12-18" | No substantive differentiation | |||
| The predicate device adjusts in | ||||
| width using a system based on the | ||||
| side-guards, whereas the Icon Adult | ||||
| Manual Wheelchair seat width | ||||
| adjustment system relies on the | ||||
| backrest canes. The Icon system | ||||
| will add to the structure of the | ||||
| backrest, adding strength. | ||||
| Seat Depth | 12-20" | 12-20" | No substantive differentiation | |
| Rear Seat to Floor | ||||
| Height | 12-21" | 15-21" | The Icon Adult Manual Wheelchair | |
| system for adjusting the rear seat | ||||
| height is based on a threaded seat- | ||||
| tube system that does not require the | ||||
| use of a "shim-kit" or replacing | ||||
| hardware as is the case in the | ||||
| predicate device. | ||||
| Front Seat to Floor | ||||
| height | 12-21" | 16-21" | The Icon Adult Manual Wheelchair | |
| system for adjusting the rear seat | ||||
| height is based on a threaded seat- | ||||
| tube system that does not require the | ||||
| use of a "shim-kit" or replacing | ||||
| hardware as is the case in the | ||||
| predicate device. | ||||
| Seat panel | Carbon Fiber | |||
| or Composite | Carbon Fiber | No substantive differentiation | ||
| Backrest | ||||
| composition | Upholstery or | |||
| solid (carbon | ||||
| fiber, | ||||
| aluminum or | ||||
| composite) | Carbon Fiber | The Icon Adult Manual Wheelchair | ||
| will be different from the predicate | ||||
| device in offering a wider choice of | ||||
| materials for the backrest. | ||||
| Castors | Elastomer tire | |||
| on aluminum | ||||
| or composite | ||||
| hub, available | ||||
| in sizes from | ||||
| 3-6" | Elastomer tire | |||
| on aluminum | ||||
| or composite | ||||
| hub, available | ||||
| in sizes from | ||||
| 3-6" | No substantive differentiation - the | |||
| castors are provided by third party | ||||
| vendors and are common to the | ||||
| wheelchair industry. | ||||
| Backrest | ||||
| manipulation | Available in | |||
| fixed or | ||||
| folding. | Available in | |||
| fixed or | ||||
| folding. | The backrest adjustment system in | |||
| the Icon Adult Manual Wheelchair | ||||
| will widen the distance between the | ||||
| backrest canes - this will provide | ||||
| additional lateral structural integrity | ||||
| under torsion load. | ||||
| Rear wheel camber | ||||
| angles | Available | |||
| from 0-6 | ||||
| degrees | Available | |||
| from 0-6 | ||||
| degrees | No substantive differentiation | |||
| Handrims | Aluminum | Aluminum | No substantive differentiation | |
| Rear Wheels | 20, 22, 24, 25, 26 | 20, 22, 24, 25, 26 | No substantive differentiation | |
| Drive | Manual | Manual | No substantive differentiation | |
| Footrest adjustability | Footrest can be adjusted forward, backward, in height, and for angle. | Footrest can be adjusted in height. | The Icon Adult Manual Wheelchair will offer an angle adjustable footrest option, allowing the user to adjust the angle of the footrest, improving comfort and reducing strain on the ligaments of their lower legs - the predicate device does not provide a similar option. | |
| PERFORMANCE DATA | ||||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | ||||
| Performance Test Summary-New Device | ||||
| Characteristic | Standard/Test/FDA Guidance | Results Summary | ||
| Static Stability | ANSI/RESNA WC/Volume 1-1998, Section 1: Determination of Static Stability | There is no pass/fail criteria for this test - results were as expected | ||
| Overall dimensions, mass and manoeuvring space | ANSI/RESNA WC/Volume 1-1998, Section 5: Determination of overall dimensions, mass and manoeuvring space | There is no pass/fail criteria for this test - results were as expected | ||
| Static, Impact & Fatigue Strength | ANSI/RESNA WC/Volume 1-1998, Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | There is no pass/fail criteria for this test - results were as expected | ||
| Resistance to Ignition | ANSI/RESNA WC/Volume 1-1998, Section 16: Resistance to Ignition of Upholstered Parts | There is no pass/fail criteria for this test - results were as expected | ||
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
1
2
There are no pass/fail criteria for these test – results were as expected.
י
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the text is also in black.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Icon Wheelchair Inc. % Regulatory Technology Services, LLC. Mr. Mark Job 1394 25th Street, Northwest Buffalo, Minnesota 55313
MAY - 3 2011
Re: K110985
Trade/Device Name: Adult Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: Class I Product Code: IOR Dated: April 13, 2011 Received: April 18, 2011
Dear Mr. Job:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Mr. Mark Job
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 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.
K.J. vs. R.h.
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number:
Device Name: Icon Adult Manual Wheelchair
Indication for Use: The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide mobility to persons with disabilities restricted to a seated position.
Prescription Use______________________________________________________________________________________________________________________________________________________________
And/Or
Over the Counter Use__X_
(21 CFR Part 801 Subpart D)
. (21 CFR Part 801 Subpart C)
Please do not write below this line; CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
Division Sign-Off
Division of Surgical, Offhopedic, and Restorative Devices
Evaluation and Safety
Office of Device Evaluation
Division Sign-Off
510(k)_
510(k) Number .