(39 days)
Not Found
No
The device description and performance studies focus on the mechanical and structural aspects of a manual wheelchair, with no mention of AI or ML technologies.
No
The device is a wheelchair, which provides mobility assistance rather than therapy for a medical condition.
No
The device description clearly states its purpose is to provide mobility for individuals who cannot walk, and it describes a manual wheelchair with its components and features. There is no mention of diagnostic functions or capabilities.
No
The device description clearly outlines a physical, manually operated wheelchair with various hardware components (backrest, seat frame, wheels, etc.). There is no mention of software as the primary or sole component.
Based on the provided information, the Aquilla Modular Wheelchair is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mobility for individuals with walking difficulties. This is a physical aid, not a diagnostic test performed on samples from the human body.
- Device Description: The description details a mechanical device with components like a backrest, seat frame, wheels, etc. It does not mention any reagents, assays, or procedures for analyzing biological samples.
- Lack of IVD-related information: There is no mention of sample types, analytical methods, diagnostic markers, or any other elements typically associated with IVD devices.
IVD devices are used to examine specimens from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Aquilla Modular Wheelchair does not perform any such function.
N/A
Intended Use / Indications for Use
The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.
Product codes
IOR
Device Description
The Aquilla Modular Wheelchair is manually operated, and can be configured for propulsion by an attendant or an occupant. The range of sizes and build configurations are suitable for male or female sizes from junior to adult.
The Aquilla Modular Wheelchair consists of typical components found on most manual wheelchairs. The chairs feature a backrest, folding seat frame, footrest, rear wheels and front castors. Accessories include occupant-positioning belts, and optional features which allow a chair to be changed simply to meet the changing environmental and health requirements of the occupant.
Aquilla is suitable for use both indoors and outdoors on surfaces that are intended typically for public access. This type of wheelchair is not suitable for soft and undulating terrain or for climbing obstacles. Aquilla can be easily folded for compact storage, and armrests and footrests can be removed to reduce the weight for lifting.
Aquilla is labeled to indicate important aspects of use, including warnings and cautions.
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
from junior to adult
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 Aquilla wheelchair has been tested to and met the following ISO requirements: ISO 7176-1, -3, -5, -7, -8, -15, -16, -19.
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
510(k) SUMMARY 9.
09/04/02
9.1 Submitter's Name and Contact Information
Submitter Company: Bell, Boyd & Lloyd, LLC 70 W. Madison St. Suite 3300 Address: City, State, Zip Chicago, IL 60602
OCT 1 8 2002
| Contact Person: | Name: | Richard O. Wood |
|---|---|---|
| Phone/Fax: | (312) 807-4364 | |
| (312) 827-8189 (Fax) | ||
| Email: | rowood@bellboyd.com | |
| Date Prepared: | Date: | September 5, 2002 |
9.2 Name of Device and Name/Address of Applicant
Aquilla Model Wheelchair
Haywood Vocational Opportunities, Inc. 56 Scates St., Waynesville, N.C. 28786,
9.3 Name and Address of Manufacturer
Remploy Mobility Jubilee Industrial Estate, Ashington, Northumberland, United Kingdom NE63 8UE 01670 813718 01670 851990 (Fax)
9.4 Common or Usual Name
Mechanical wheelchair
9.5 Classification Name
Wheelchair, mechanical
1
09/04/02
KOD 300
2002
9.6 Predicate Device
The Aquilla wheelchair is substantially equivalent to the Breezy® 510 model wheelchairs manufactured by Sunrise Medical (K974820, 1/27/1998).
9.7 Intended Use
The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.
9.8 Technological Characteristics and Substantial Equivalence
9.8.1 Device Description
The Aquilla Modular Wheelchair is manually operated, and can be configured for propulsion by an attendant or an occupant. The range of sizes and build configurations are suitable for male or female sizes from junior to adult.
The Aquilla Modular Wheelchair consists of typical components found on most manual wheelchairs. The chairs feature a backrest, folding seat frame, footrest, rear wheels and front castors. Accessories include occupant-positioning belts, and optional features which allow a chair to be changed simply to meet the changing environmental and health requirements of the occupant.
Aquilla is suitable for use both indoors and outdoors on surfaces that are intended typically for public access. This type of wheelchair is not suitable for soft and undulating terrain or for climbing obstacles. Aquilla can be easily folded for compact storage, and armrests and footrests can be removed to reduce the weight for lifting.
Aquilla is labeled to indicate important aspects of use, including warnings and cautions.
9.8.2 Substantial Equivalence
The Aquilla Modular Wheelchair is substantially equivalent to the Breezy® 510 wheelchair manufactured by Sunrise Medical (K974820, 1/27/98). They are both lightweight wheelchairs with the intended use of providing mobility to occupants unable to walk or have difficulty in walking without assistance.
9.9 Performance Data
The Aquilla wheelchair has been tested to and met the following ISO requirements: ISO 7176-1, -3, -5, -7, -8, -15, -16, -19.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest wings and a head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 8 2002
Haywood Vocational Opportunities Bell, Boyd & Lloyd, LCD c/o Richard O. Wood 70 W. Madison Street, Suite 3300 Chicago, Illinois 60670
Re: K023005
Trade/Device Name: Aquilla Modular Wheelchair Regulation Number: 890.3850 Regulation Name: Wheelchair, mechanical Regulatory Class: Class I Product Code: IOR Dated: September 4, 2002 Received: September 9, 2002
Dear Mr. Wood:
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. Richard O. Wood ·
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
O Mark N Millenn
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Aquilla Modular Wheelchair
1. INDICATIONS FOR USE:
Aquilla Modular Wheelchair:
The Aquilla Modular Wheelchair is intended to provide mobility for occupants who are unable to walk or have difficulty in walking without assistance.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark n Milkerso
(Division Sign-Off) Di ision of General : storative and Neurological Deloces 510(k) Number _
Prescription Use
OR
Over-The-Counter Use X
(Optional Format 1-2-96)