(318 days)
The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.
The Wardray Premise MR 4500 is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to person limited to a sitting position. It may be used as an attendant propelled transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 12inch rear wheels and 5-inch front casters and handles for the wheelchair to be pushed. It is folding or non-rigid type of wheelchair that is designed for use by a patient weighing up to 280 lbs. The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.
The provided text describes the MR4500 Wheelchair and its substantial equivalence to a predicate device, focusing on its physical characteristics and MRI compatibility. It does not contain information typically found in a study proving the device meets acceptance criteria related to software performance, AI algorithms, or clinical effectiveness as one might find in a submission for a diagnostic AI device.
Therefore, many of the requested fields cannot be filled based on the provided text.
Here's what can be extracted:
Acceptance Criteria and Reported Device Performance (as far as applicable):
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Mobility to persons limited to sitting position as a transport chair within a healthcare facility. | Intended function and use is to provide mobility to person limited to a sitting position. May be used as an attendant propelled transport device in a healthcare environment. |
| User Weight Capacity: Up to 280 lbs. | Designed for use by a patient weighing up to 280 lbs. |
| Radiological Safety (MRI Compatibility): Safe for use in an MRI environment up to and including 7 Tesla. Meets ASTM F2503-8. | The magnetic field strength and magnetic field spatial gradient data showed that no magnetically induced displacement force was produced in the MR4500 up to and including 7.0T MR system. The MR4500 meets the ASTM F2503-8 requirements to be labeled MR Conditional up to and including 7.0T. |
| Mechanical Strength (Overload Test): Passed a 24-hour sustained 100% overload test. | The MR4500 passed a 24 hour sustained 100% overload test, a determination of Strength. |
| Applicable Standard: ISO 7176 - Standard for manual Wheelchairs for its intended use. | The MR 4500 manual wheelchair is designed to meet the applicable requirements of ISO 7176 - Standard for manual Wheelchairs for this intended use. |
Information Not Available in the Provided Text:
- Sample size used for the test set and the data provenance: Not applicable to a mechanical device's performance tests described. The "test set" here refers to the physical wheelchair being tested. The text does not provide details on the number of individual wheelchairs tested for the overload or MRI compatibility, nor the provenance of data from such tests beyond stating they were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wheelchair's mechanical and MRI safety is established through engineering standards, physical testing, and measurements, not by expert consensus on interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for subjective interpretations/diagnoses, not for physical test results.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a mechanical wheelchair, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical strength and MRI compatibility, the "ground truth" would be the direct measurements and observations during testing against established engineering standards (ISO 7176, ASTM F2503-8).
- The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (as described for this device):
The MR4500 Wheelchair underwent specific physical performance tests to ensure safety and functionality, particularly for its intended use in an MRI environment.
- Mechanical Strength Test: The device was subjected to a 24-hour sustained 100% overload test, which it successfully passed. This test demonstrates its structural integrity under stress.
- MRI Compatibility Test: The MR4500 was tested in 1.5T, 3.0T, and 7.0T MRI systems. The magnetic field strength and spatial gradient data indicated that no magnetically induced displacement force was produced, thus meeting the ASTM F2503-8 requirements to be labeled "MR Conditional" up to and including 7.0T.
These tests were designed to demonstrate compliance with relevant performance standards and safety requirements for a mechanical wheelchair, particularly its unique feature of MRI compatibility. The study essentially involved physical engineering tests rather than clinical or AI performance studies.
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K12039)
510(k) Summary for MR 4500
1. SPONSOR
Warday Premise Limited Hampton Court Estate Summer Road Thames Ditton Surrey, KT7 0SP, UK
+44(0)20 8398 9911 Telephone:
Date Prepared: February 1, 2012
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name: Classification Number: Product Code:
MR 4500 Wheelchair Wheelchair, Mechanical 890.3850 IOR
PREDICATE DEVICES 3.
Invacare Corp, Tracer Series, K935398, March 1, 1994 Classification Name: Wheelchair, Mechanical 890.3850 Classification Number: Product Code: IOR
4. INTENDED USE
The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.
5. DEVICE DESCRIPTION
The Wardray Premise MR 4500 is a manually operated wheelchair that is propelled by human power. Its intended function and use is to provide mobility to person limited to a sitting position. It may be used as an attendant propelled
DEC 2 1 2012
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transport device in a healthcare environment such as a hospital, nursing home or extended care facility. The wheelchair consists primarily of an aluminum frame; 12inch rear wheels and 5-inch front casters and handles for the wheelchair to be pushed. It is folding or non-rigid type of wheelchair that is designed for use by a patient weighing up to 280 lbs.
The frame is constructed of one inch (1) outside diameter Aluminum tube that is welded that has a wall thickness of 1/8 inch. The rear urethane wheels are fixed and front are urethane casters.
6. TECHNOLOGICAL CHARACTERISTICS
The MR4500 is constructed from the following materials: Aluminum alloys, 6063 T6 and 6082 T4, Stainless Steel EN 100883/1.44044 and Brass CW614 N which allows the chair to be used safely in a MRI environment up to and including 7 Tesla.
7. SUBSTANTIAL EQUIVALENCE
The Wardray Premise MR 4500 is substantially equivalent to Invacare Corporation Tracer series manual wheelchairs (ALB19HBFR). The above device was granted marketing clearance by the FDA on March 18 1994, under 510K number K935398. When the MR4500 is compared to the predicate device their is no difference in safety and effectiveness.
8. PERFORMANCE STANDARDS
No performance standards applicable to this device have been adopted under Section 514 of the Act. The MR 4500 manual wheelchair is designed to meet the applicable requirements of ISO 7176 - Standard for manual Wheelchairs for this intended use.
The MR4500 passed a 24 hour sustained 100% overload test, a determination of Strength.
The MR4500 has been tested and data provided for 7.0, 3.0 and 1.5 T MR systems environments. The magnetic field strength and magnetic field spatial gradient data showed that no magnetically induced displacement force was produced in the MR4500 up to and including 7.0T MR system. The MR4500 meets the ASTM F2503-8 requirements to be labeled MR Conditional up to and including 7.0T.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Wardray Premise, Limited % Maelor Group, Incorporated James Wason Ph.D. 7 Village Woods Drive Amherst, New Hampshire 03031
December 21, 2012
Re: K120391
Trade/Device Name: MR4500 Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: IOR Dated: December 03, 2012 Received: December 10, 2012
Dear Dr. Wason:
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
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Page 2 - James Wason Ph.D.
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/ReportalProblem/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,
Victor Krauthamer -S
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K120391
.Device Name: MR4500 Wheelchair
Indications For Use:
The MR4500 is an adult Manual Mechanical Wheelchair intended to provide mobility to person limited to the sitting position as a transport chair within a healthcare facility.
Prescription Use __ (Part 21 CFR 801 subpart D) OR
Over-The-Counter Use X (Part 21 CFR 801 subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Brian D. Pullin -S
Division of Neurological and Physical Medicine Devices 510(k) Number: K120391
§ 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).