(63 days)
AXS Transport Chairs are indicated for providing mobility to persons limited to a sitting position
The Access Point Medical AXS Transport Chair is a wheelchair that provides mobility to persons limited to a sitting position. It consists of a rigid mechanical Aluminum Alloy or steel frame and nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 8x1" solid rubber rear wheels and two 8x1" 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 describes a 510(k) premarket notification for the "AXS Transport Chair" (K050281). This is a submission for a mechanical wheelchair, which is a Class I device. Class I devices are generally considered low risk and often establish substantial equivalence through a comparison to a predicate device, rather than extensive clinical studies with acceptance criteria for device performance.
Therefore, the typical structure for reporting acceptance criteria and a study proving device performance as seen in submissions for higher-risk devices with new technology or significant performance claims, is not applicable here. This submission relies on demonstrating the AXS Transport Chair is substantially equivalent to a legally marketed predicate device by showing identical technological characteristics and adherence to relevant consensus standards.
Here's how the information requested maps to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance (Claimed Conformance) |
|---|---|
| ISO 7176-1 Wheelchair: Determination of static stability | Conforms fully to standards listed, including ISO 7176-1 |
| ISO 7176-3 Wheelchair: Determination of efficiency of brakes | Conforms fully to standards listed, including ISO 7176-3 |
| ISO 7176-8 Wheelchair: Requirements and test methods for static, impact and fatigue strengths | Conforms fully to standards listed, including ISO 7176-8 |
| ISO 7176-11 Wheelchair: Test dummies | Conforms fully to standards listed, including ISO 7176-11 |
| ISO 7176-15 Wheelchair: Requirements for information disclosure, documentation and labeling | Conforms fully to standards listed, including ISO 7176-15 |
| ISO 7176-16 Wheelchair: Resistance of ignition of upholstered parts - Requirements and test methods | Conforms fully to standards listed, including ISO 7176-16 |
| EN 1021-1 Furniture - Assessment of the Ignitability of Upholstered Furniture | Conforms fully to EN 1021-1 (nylon upholstery meets this standard) |
| Applicable 21 CFR references (e.g., 21 CFR 890.3850) | Conforms fully to applicable 21 CFR references |
| Pinhole FDA requirements | Meets pinhole FDA requirements |
| Biocompatibility requirements | Meets biocompatibility requirements |
| Labeling claims required by standards | Conforms to labeling claims required by standards |
| No safety/efficiency issues or claims that differ from the predicate device (Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-Comfort Transporter 2000 series, K002673) | AXS Transport Chair and predicate are identical products made by the same manufacturer to the same specifications, implying no differences in safety/efficiency. |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a test set in the sense of a clinical trial or performance study involving human subjects or specific data samples. The "test" in this context refers to the manufacturer's internal verification and validation processes to ensure the product meets the cited consensus standards. These tests would involve physical testing of the wheelchair's components and assembled unit according to the methodologies outlined in each ISO and EN standard.
- Sample Size: Not explicitly stated as it's not a dataset-driven study. The sample size would be determined by the requirements of each specific ISO/EN standard for verifying compliance (e.g., number of units tested for static stability, brake efficiency, impact/fatigue strength).
- Data Provenance: The data would be from the manufacturer's own internal testing and quality control processes. The country of origin of the data would be where the manufacturing and testing occur, which is implied to be by the same manufacturer as the predicate device (Jiangsu Intco Medical Equipment & Supply Co., Ltd. - China). The testing is prospective in the sense that it's performed on the manufactured product to verify compliance.
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 a clinical or diagnostic study, refers to a definitive diagnosis or outcome. For a Class I mechanical device like a wheelchair, "ground truth" is defined by adherence to established engineering and safety standards (e.g., ISO, EN). The "experts" involved are the engineers, quality control personnel, and certification bodies responsible for conducting and verifying these tests. Their qualifications would be in engineering, product testing, and quality assurance relevant to medical devices and assistive technology.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" in the sense of resolving discrepancies in expert interpretations, as there are no expert interpretations of clinical data in this submission. Compliance with standards is typically binary (pass/fail) based on objective measurements and test procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. Such studies are relevant for diagnostic devices or those requiring human interpretation of results, where the impact of AI assistance on human performance (e.g., radiologists, pathologists) is assessed. This device is a mechanical wheelchair.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is objective compliance with established international and national consensus standards (ISO 7176 series, EN 1021-1, and 21 CFR regulations) for mechanical wheelchairs. This is verified through physical and material testing according to the specified methodologies within those standards.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this device does not involve machine learning or AI that would require data for training an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image shows the logo for Access Point Medical. The logo consists of a stylized image of a circle with a triangle inside of it, and the words "ACCESS POINT" in large letters, with the word "MEDICAL" in smaller letters underneath. The image also contains the date "APR 1 1 2005" in the upper right corner.
K050281
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3. SUMMARY OF SAFETY AND EFFECTIVENESS
SPONSOR IDENTIFICATION A. Mr. Patrick Richey Access Point Medical, L.L.C. 10 Glenville Street Greenwich, CT 06831
B. ESTABLISHMENT REGISTRATION NUMBER: Pending
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
D. DATE OF PREPARATION OF THIS SUMMARY: February 4, 2005
- PROPRIETARY (TRADE) NAME: AXS Transport Chair E.
- COMMON NAME: F. Wheelchair
- CLASSIFICATION NAME: Wheelchair, mechanical G.
- H. REGULATION NUMBER: 21 CFR 890.3850
- I. PROPOSED REGULATORY CLASS: Class 1
- DEVICE PRODUCT CODE: IOR J.
- MEDICAL SPECIALTY: K. Physical Medicine
- L. DESCRIPTION OF DEVICE The Access Point Medical AXS Transport Chair is a wheelchair that
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10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet.
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provides mobility to persons limited to a sitting position. It consists of a rigid mechanical Aluminum Alloy or steel frame and nylon upholstery that meets EN102-1: Assessment of the Ignitability of Upholstered Furniture. It has two 8x1" solid rubber rear wheels and two 8x1" 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.
M. INDICATIONS FOR USE:
The AXS Transport Chair is indicated for providing mobility to persons limited to a sitting position
N. PREDICATE DEVICE
Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ-Comfort Transporter 2000 series (K002673).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
The AXS Transport Chair and the Jiangsu Intco Medical Equipment & Supply Co., Ltd. EZ- Comfort Transporter 2000 series (K002673) are identical products made by the same manufacturer to the same specifications.
TECHNOLOGICAL CHARACTERISTICS SUMMARY: P.
The standards used for Access Point Medical wheelchair production meet the following standards:
ISO 7171-1 Wheelchair: Determination of static stability 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 Transport Chair conforms 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/2 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 eagle-like symbol, with three curved lines forming the body and wings.
APR 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: K050281
Trade/Device Name: AXS Transport Chair 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. Iisting 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.
Sincerely yours.
Hupt Clurds
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
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510(k) Number (if known): K050281_________________________________________________________________________________________________________________________________________
Device Name: AXS Transport Chair______________________________________________________________________________________________________________________________________________
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- Indications for Use: AXS Transport Chairs are 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 X(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
| 510(k) Number | K050281 |
|---|---|
| --------------- | --------- |
0009
§ 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).