(63 days)
Not Found
No
The device description and intended use clearly describe a basic, mechanical wheelchair with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
A therapeutic device is used to treat or alleviate a medical condition. A wheelchair provides mobility assistance and does not directly treat a medical condition.
No
The device description clearly states it is a wheelchair intended for mobility, not for diagnosing any medical conditions.
No
The device description clearly states it consists of a rigid, mechanical, steel frame and upholstery, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide mobility to persons limited to a sitting position. This is a mechanical function related to physical support and movement, not the diagnosis of disease or other conditions through the examination of specimens derived from the human body.
- Device Description: The description details a mechanical wheelchair with a frame, wheels, and upholstery. There is no mention of reagents, calibrators, controls, or any components used for testing biological samples.
- Lack of IVD-related information: The document does not contain any information typically associated with IVDs, such as:
- Mentions of biological samples (blood, urine, tissue, etc.)
- Assays or tests
- Measurement of analytes
- Diagnostic claims
Therefore, the AXS-1 Basic Wheelchair is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
Product codes (comma separated list FDA assigned to the subject device)
IOR
Device Description
The Access Point Medical AXS-1 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and leatherette or nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
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)
Access Point Medical AXS-1 Basic Wheelchairs conform fully to the standards which are mentioned in Section P as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims required by these standards. There are no safety/efficiency issues or claims that differ from the predicate devices cited.
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.
Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-N. 4000 Series (K002669)
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
Image /page/0/Picture/0 description: The image shows the logo for Access Point Medical. The logo consists of the words "ACCESS POINT" stacked on top of the word "MEDICAL". Above the words is a symbol that looks like a circle with a triangle inside of it. The logo is black and white.
1/2
APR 1 1 2005
SUMMARY OF SAFETY AND EFFECTIVENESS 3.
- SPONSOR IDENTIFICATION A. Mr. Patrick Richey Access Point Medical, L.L.C. 10 Glenville Street Greenwich, CT 06831
ESTABLISHMENT REGISTRATION NUMBER: Pending B.
-
C. OFFICIAL CONTACT PERSON Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, MD 20854 estrin@yourFDAconsultant.com
Tel: (301) 279 -2899 Fax: (301) 294-0126 -
DATE OF PREPARATION OF THIS SUMMARY: February 4, 2005 D.
-
AXS-1 Basic Wheelchair PROPRIETARY (TRADE) NAMF: િ.
-
Wheelchair ت . COMMON NAME:
-
CLASSIFICATION NAME: Wheelchair, mechanical G.
-
REGULATION NUMBER: 21 CFR 890.3850 H.
-
PROPOSED REGULATORY CLASS: Class 1 l.
-
DEVICE PRODUCT CODE: IOR .J.
... !!!!!!
10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet.
1
MEDICAL SPECIALTY: Physical Medicine K.
DESCRIPTION OF DEVICE L.
The Access Point Medical AXS-1 Basic Wheelchair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of rigid, mechanical, steel frame and leatherette or nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 24" rear wheels and two 8" front casters for turning and maneuverability. The Access Point Medical Transport Series Transport Chair is intended for use indoors and outdoors, over smooth surfaces (all standard indoor flooring surfaces, concrete, asphalt and packed dirt) that are free of large obstacles and inclines greater that 9 degrees.
INDICATIONS FOR USE: The AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position
- PREDICATE DEVICE: Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-N. 4000 Series (K002669).
- COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
The AXS-1 Basic Wheelchair and the Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-Light 4000 series (K002669) are substantially equivalent products in all areas impacting safety and effectiveness.
TECHNOLOGICAL CHARACTERISTICS SUMMARY: P.
Access Point Medical wheelchair production meets the following standards:
Wheelchair: Determination of static stability ISO 7171-1 Wheelchair: Determination of efficiency of brakes ISO 7176-3 Wheelchair: Requirements and test methods for static, impact and ISO 7176-8 fatigue strengths ISO 7176-11 Wheelchair: Test dummies ISO 7176-15 Wheelchair: Requirements for information disclosure, documentation and labeling. ISO 7176-16 Wheelchair: Resistance of ignition of upholstered parts --Requirements and test methods Furniture – Assessment of the Ignitability of Upholstered Furniture EN 1021-1
Q. CONCLUSION
Access Point Medical AXS-1 Basic Wheelchairs conform fully to the standards which are mentioned in Section P as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims required by these standards. There are no safety/efficiency issues or claims that differ from the predicate devices cited.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
APR 1 1 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Norman F. Estrin Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K050280
Trade/Device Name: AXS-1 Basic Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical wheelchair Regulatory Class: I Product Code: IOR Dated: March 24, 2005 Received: March 24, 2005
Dear Dr. Estrin:
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 - Dr. Norman F. Estrin Ph.D., RAC
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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Miria
Acting
Sincerely yours,
Stupt Rurdia
Mirian C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of I
:
V
510(k) Number (if known): __ K050280 _________________________________________________________________________________________________________________________________________
Device Name: AXS-1 Basic Wheelchair
-
- Indications for Use: AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
| Prescription Use
(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ✓
(21 CFR 801 Subpart C) |
| ------------------------------------------------- | -------- | -------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative, | |
| and Neurological Devices | 0010 |
| 510(k) Number | K050280 |