(63 days)
AXS-1 Lite Wheelchairs are indicated for providing mobility to persons limited to a sitting position
The Access Point Medical Explorer 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 FN102-1: 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, over smooth Transport Series. Transport Chair is and China C 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 Lite Wheelchair (originally submitted as Explorer Wheelchair). It primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and results.
Therefore, much of the requested information cannot be extracted directly from this document. However, I can provide what is available and indicate when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from this document) | Reported Device Performance (from this document) |
|---|---|
| Compliance with ISO 7171-1: Wheelchair: Determination of static stability | Access Point Medical wheelchair production meets ISO 7171-1. |
| Compliance with ISO 7176-3: Wheelchair: Determination of efficiency of brakes | Access Point Medical wheelchair production meets ISO 7176-3. |
| Compliance with ISO 7176-8: Wheelchair: Requirements and test methods for static, impact, and fatigue strengths | Access Point Medical wheelchair production meets ISO 7176-8. |
| Compliance with ISO 7176-11: Wheelchair: Test dummies | Access Point Medical wheelchair production meets ISO 7176-11. |
| Compliance with ISO 7176-15: Wheelchair: Requirements for information disclosure, documentation and labeling. | Access Point Medical wheelchair production meets ISO 7176-15. |
| Compliance with ISO 7176-16: Wheelchair: Resistance of ignition of upholstered parts – Requirements and test methods | Access Point Medical wheelchair production meets ISO 7176-16. |
| Compliance with EN 1021-1: Furniture – Assessment of the Ignitability of Upholstered Furniture | Access Point Medical wheelchair production meets EN 1021-1 (specifically, leatherette or nylon upholstery meets this standard). |
| Conformance to applicable 21 CFR references | Access Point Medical Explorer Wheelchair conforms fully to applicable 21 CFR references. |
| Meets pinhole FDA requirements | Access Point Medical Explorer Wheelchair meets pinhole FDA requirements. |
| Meets biocompatibility requirements | Access Point Medical Explorer Wheelchair meets biocompatibility requirements. |
| Meets labeling claims required by standards | Access Point Medical Explorer Wheelchair meets labeling claims required by these standards. |
| No safety/efficiency issues or claims that differ from the predicate device | "There are no safety/efficiency issues or claims that differ from the predicate device cited." |
2. Sample size used for the test set and the data provenance
This document does not describe a clinical study or a specific test set with a sample size for evaluating device performance in humans. The device's substantial equivalence is established through conformance to recognized standards, which typically involve laboratory testing, not human subject testing in the context of this 510(k). The "data provenance" in terms of country of origin or retrospective/prospective is not applicable here as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document does not describe a study involving expert assessment or ground truth establishment in a clinical context.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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 mechanical wheelchair, not an AI-powered diagnostic or assistive technology that would involve human readers or AI assistance in a clinical read.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used
For the safety and performance claims, the "ground truth" is defined by the compliance with the listed international and national standards (ISO, EN, and 21 CFR regulations). These standards outline specific test methods and criteria that, when met, are considered evidence of safety and effectiveness for a device of this class.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set for this mechanical device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 1 2005
ﺒﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K050279
Trade/Device Name: AXS-1 Lite 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:
This letter corrects our substantially equivalent letter of April 11, 2005 regarding the incorrect trade name listed as Explorer Wheelchair. The correct trade name is listed above.
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.
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Page 2 - Norman F. Estrin Ph.D., RAC
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.
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/cdrb/industry/support/index.html.
Sincerely yours,
Stypt Rhodes
Miriam 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
ﻴ
Page 1 of 1
| 51 Ojk) Number (if known): | K050279 |
|---|---|
| ---------------------------- | --------- |
Device Name: AXS-1 Lite Wheelchairs
- Indications for Use: AXS-1 Lite Wheelchairs are indicated for providing I. 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)
ion Sign-Of Division of General, Restorative, and Neurological Devices
0010
510(k) Number K050279
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Image /page/3/Picture/0 description: The image shows the date APR 1 2005, followed by a logo with a circle and a black arrow pointing upwards. Below the logo, the words ACCESS POINT are written in large, bold letters. Underneath ACCESS POINT, the word MEDICAL is written in smaller letters. There is also a letter K on the right side of the image.
SUMMARY OF SAFETY AND EFFECTIVENESS 3.
A. SPONSOR IDENTIFICATION
Mr. Patrick Richey Access Point Medical, L.L.C. 10 Glenville Street Greenwich. CT 06831
B. ESTABLISHMENT REGISTRATION NUMBER: Pending
OFFICIAL CONTACT PERSON C. 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.
- Explorer Wheelchair PROPRIETARY (TRADE) NAME: E.
- Wheelchair COMMON NAME: F.
- CLASSIFICATION NAME: Wheelchair, mechanical G.
- REGULATION NUMBER: 21 CFR 890.3850 H.
- PROPOSED REGULATORY CLASS: Class 1 l.
- DEVICE PRODUCT CODE: IOR .).
- K. MEDICAL SPECIALTY: Physical Medicine
10 Glenville Street, Greenwich, Ct 06831 USA Where well-being and accessibility meet.
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KO50279 2/2
し. DESCRIPTION OF DEVICE
The Access Point Medical Explorer 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 FN102-1: 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, over smooth Transport Series.
Transport Chair is and China C 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 Explorer Wheelchair is indicated for providing mobility to persons limited to a
sitting position sitting position.
N. PREDICATE DEVICE
Jiangsu Inco Medical Equipment Supply Co, EZ-Traveler 3000 Series Wheelchair (K002670).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 0.
The Explorer Wheelchair and Jee Jiangsu Inco Medical Equipment Supply Co, EZ-Traveler 3000 Series Wheelchair (K002670) are substantially equivalent products in all areas impacting safety and effectiveness.
P. TECHNOLOGICAL CHARACTERISTICS SUMMARY
Access Point Medical wheelchair production meets the following standards:
Wheelchair: Determination of static stability ISO 7171-1
ISO 7176-3 Wheelchair: Determination of efficiency of brakes
Wheelchair: Requirements and test methods for statics impact and ISO 7176-8 fatiguc 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
EN 1021-1 Furniture – Assessment of the Ignitability of Upholstered Furniture
Q. CONCLUSION
Access Point Medical Explorer Wheelchair conforms fully to the standards which are noted 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 prodicate device cited.
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§ 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).