(141 days)
The indication for use of the Invacare® TDX® SP2 Power Wheelchair is to provide mobility and positioning to persons limited to a sitting position.
The subject device is an update to the existing previously cleared Invacare® TDX® SP2 Power Wheelchair (K141783) with the MK6i™ control system and Formula™ CG Seating System. The updated subject version of the Invacare® TDX® SP2 Power Wheelchair has the following changes:
- . The LiNX® control system, which incorporates updated software, wireless technology and a touch user interface,
- The Ultra-Low Maxx™ Seating System, and ●
- Minor changes to mechanical components such as rim inserts and new colours. .
The TDX® SP2 Power Wheelchair is a battery-powered, motor-driven powered wheelchair, controlled by the LiNX® control system with enhanced suspension and additional back, arm and leg rest types. The subject device is a rigid or "non-folding" type power wheelchair base with centre-wheel drive capability, two casters in the rear and two casters in the front. It is powered by two 12-volt DC batteries and two 4-pole single stage drive motors.
This document describes acceptance criteria and testing for the Invacare® TDX® SP2 Power Wheelchair.
1. Table of Acceptance Criteria and Reported Device Performance:
The document highlights conformity to various ISO, IEC, ANSI, CAL, and EN standards for different aspects of the wheelchair's hardware, software, and materials. Due to the nature of the device (a configurable power wheelchair) and the submission type (510(k) for substantial equivalence), the acceptance criteria are primarily described as meeting the requirements and passing the tests of these recognized standards. The reported device performance is generally stated as meeting these requirements and demonstrating substantial equivalence.
Here's a summary derived from the document, focusing on categories rather than specific numerical values where not explicitly provided for the subject device in comparison tables:
| Test Category | Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|---|
| Hardware Performance (Physical Characteristics) | Conformity to relevant ISO 7176 standards (e.g., static/dynamic stability, braking, energy consumption, dimensions, speed, impact/fatigue strengths, climatic tests, obstacle climbing, power/control systems) | Met all acceptance criteria for each section of ISO 7176 |
| Material Performance | Conformity to flammability standards (CAL117, EN 1021-1, EN 1021-2) | Met relevant flammability standards |
| Electromagnetic Compatibility (EMC) | Conformity to ISO 7176-21, ANSI/RESNA WC-2:2009 Section 21 EMC requirements | Met relevant EMC requirements |
| Wireless Coexistence | Conformity to ANSIC63.27 Wireless Coexistence standard | Met relevant wireless coexistence standard requirements |
| Software Life Cycle | Conformity to IEC 62304:2006 for medical device software life cycle | Evaluated against IEC 62304:2006, passed verification |
| Software Functionality | Functionality as designed, demonstrating safety and effectiveness | Software verification testing confirmed functionality |
| Biocompatibility | Conformity to ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation) | Passed cytotoxicity and skin irritation tests |
| Information Disclosure/Labeling | Conformity to ISO 7176-15 requirements | Met requirements for information disclosure/labeling |
| Risk Management | Conducted in accordance with ISO 14971:2012 | Risk management conducted per ISO 14971:2012 |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Because the subject Invacare® TDX® SP2 Power Wheelchair is highly configurable Power Wheelchair (PWC), intended to serve a diverse population with unique individual needs, a wide variety of options and accessories have been designed. However, due to the highly customizable nature of the subject device, testing to every possible combination would not be practical. However, every design feature of the subject device was verified. This was accomplished by identifying the specific wheelchair configurations that represent the full range of product permutations."
- Sample Size: The exact numerical sample size for "test sets" (e.g., number of individual wheelchairs or components tested) is not explicitly provided. Instead, it indicates that "specific wheelchair configurations that represent the full range of product permutations" were identified and tested for each design feature. This implies a comprehensive, representative testing approach rather than a fixed "sample size" in the sense of clinical trials.
- Data Provenance: The testing was "Non-clinical Test" and "Software Verification Testing" performed on the "subject Invacare® TDX® SP2 Power Wheelchair." This indicates that the data was generated through laboratory testing by the manufacturer (Invacare Corporation) as part of their design verification process. There is no mention of country of origin for the data or whether it was retrospective or prospective in the clinical sense, as it was non-clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to this submission. The device is a physical product (power wheelchair) and the testing performed is non-clinical laboratory testing against established engineering and safety standards (ISO, IEC, etc.). The "ground truth" is defined by the technical specifications and performance limits set by these international standards, not by expert consensus on clinical diagnoses or interpretations.
4. Adjudication Method for the Test Set:
This information is not applicable. As the testing is non-clinical laboratory testing against defined standards, there is no ambiguity or subjective interpretation requiring adjudication by multiple parties or a specific method like 2+1 or 3+1. The tests yield objective results (e.g., pass/fail for a specified load, speed, or range).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human interpretation (e.g., radiologists reading images) is involved, and the AI's assistance to human readers is being evaluated. This submission is for a physical medical device (power wheelchair) and involves non-clinical performance and safety testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
While not an "algorithm only" in the sense of an AI diagnostic tool, the non-clinical tests performed on the physical wheelchair and its software are effectively "standalone" tests in that they evaluate the device's performance against defined criteria without active human intervention in the loop of the specific test itself (beyond setting up and observing the test). For example, stability tests, braking tests, and energy consumption tests are direct measurements of the device's inherent capabilities. The "Software Verification Testing" also falls into this category, assessing the software's functionality independently.
7. The Type of Ground Truth Used:
The ground truth used for these tests is objective performance specifications and safety requirements defined by internationally recognized standards (e.g., ISO 7176 series for wheelchairs, IEC 62304 for software, ISO 10993 for biocompatibility, flammability standards). The device's performance characteristics are measured and compared against the limits and criteria set forth in these standards.
8. The Sample Size for the Training Set:
This information is not applicable. This is a 510(k) submission for a physical medical device based on engineering and safety testing, not a machine learning or AI-driven diagnostic device that would typically involve a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as point 8.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).