(63 days)
AXS-1 Basic Wheelchair is indicated for providing mobility to persons limited to a sitting position.
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.
This document is a 510(k) premarket notification for the AXS-1 Basic Wheelchair. It describes the device, its intended use, and compares it to a predicate device. The primary method used to demonstrate substantial equivalence is through compliance with recognized international standards for wheelchairs.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Wheelchair: Determination of static stability ISO 7171-1 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Determination of efficiency of brakes ISO 7176-3 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Requirements and test methods for static, impact and fatigue strengths ISO 7176-8 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Test dummies ISO 7176-11 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Requirements for information disclosure, documentation and labeling. ISO 7176-15 | Access Point Medical wheelchair production meets this standard |
| Wheelchair: Resistance of ignition of upholstered parts --Requirements and test methods ISO 7176-16 | Access Point Medical wheelchair production meets this standard |
| Furniture – Assessment of the Ignitability of Upholstered Furniture EN 1021-1 | Access Point Medical wheelchair production meets this standard |
| Applicable 21 CFR references | AXS-1 Basic Wheelchair conforms fully to applicable 21 CFR references |
| Pinhole FDA requirements | AXS-1 Basic Wheelchair meets pinhole FDA requirements |
| Biocompatibility requirements | AXS-1 Basic Wheelchair meets biocompatibility requirements |
| Labeling claims required by these standards | AXS-1 Basic Wheelchair meets labeling claims |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set in the traditional sense of a clinical or performance study with human subjects or a dataset. The demonstration of compliance is based on the design and manufacturing adherence to recognized international standards. This is typical for Class I medical devices like a basic wheelchair, where safety and effectiveness are primarily established through engineering design, material specifications, and testing to recognized standards, rather than large-scale clinical trials. The data provenance is implied to be from the manufacturer's internal testing and quality control processes to ensure compliance with the stated standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of device performance testing through standard compliance, refers to whether the device physically performs according to the standard's specifications. This is determined by engineering tests and measurements, not expert consensus on a dataset.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, the compliance is based on engineering tests against standards, not on expert adjudication of a test set.
5. 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 basic mechanical wheelchair and does not involve AI or human "readers" in its function or evaluation.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
Not applicable. This device is a basic mechanical wheelchair and does not involve algorithms or human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is compliance with recognized international performance and safety standards (ISO and EN standards listed in Section P). This means the device was designed and tested to meet the objective, measurable requirements set forth in those standards.
8. The sample size for the training set
Not applicable. The AXS-1 Basic Wheelchair is a mechanical device, and the submission does not involve machine learning or AI models that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this mechanical device.
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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.
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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.
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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.
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AXS-1 Basic Wheelchair PROPRIETARY (TRADE) NAMF: િ.
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Wheelchair ت . COMMON NAME:
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CLASSIFICATION NAME: Wheelchair, mechanical G.
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REGULATION NUMBER: 21 CFR 890.3850 H.
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PROPOSED REGULATORY CLASS: Class 1 l.
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DEVICE PRODUCT CODE: IOR .J.
... !!!!!!
10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet.
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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.
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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.
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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
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Indications for Use
Page 1 of I
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510(k) Number (if known): __ K050280 _________________________________________________________________________________________________________________________________________
Device Name: AXS-1 Basic Wheelchair
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- 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 |
§ 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).