(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.
§ 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).