(55 days)
The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified powered patient transports as a Class II device.
The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified the device as a Class II device. The FDA has classified powered patient transports as a Class II device.
The Hausted® POWERTRAN™ Series Stretcher is designed to assure compliance with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). The device will also carry the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings. Electrical testing will be certified by the accredited testing facility shown at the end of this certification. Software testing is being certified by STERIS as the manufacturer.
The provided text is a 510(k) summary for a medical device called "The Hausted® POWERTRAN™ Series Stretcher." This document describes a submission for regulatory clearance, not a study that proves the device meets acceptance criteria in the way clinical studies for AI/diagnostic devices do.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this submission.
However, I can extract the relevant information regarding the acceptance criteria and how "proof" is presented in this context, which is primarily through safety and performance testing against recognized standards and comparison to predicate devices.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Standard/Requirement) | Reported Device Performance/Compliance |
|---|---|---|
| Electrical Safety | IEC 60601-1 (Electrical Safety), Amendment 1, 1991-11, Amendment 2, 1995-03 | The device is designed to assure compliance with IEC 60601-1. Electrical testing will be certified by an accredited testing facility, and the device will carry ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings. Safety Testing and performance characteristics have been conducted and successfully completed. |
| EMC | IEC 60601-1-2 (Electromagnetic Compatibility - Requirements and Tests), 1993-04 | The device is designed to assure compliance with IEC 60601-1-2. Safety Testing and performance characteristics have been conducted and successfully completed. |
| General Safety (US) | UL 2601-1 (2nd Ed.) Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety | The device will carry ETL (to UL 2601-1) marking. Safety Testing and performance characteristics have been conducted and successfully completed. |
| General Safety (Canada) | CAN/CSA C22.2 No. 601.1-M90 Standard for Medical Electrical Equipment | The device will carry cETL (to CAN/CSA C22.2 No. 601.1-M90) marking. Safety Testing and performance characteristics have been conducted and successfully completed. |
| Risk Management | ISO 9001, Design Control 4.4 and (implied) assessment of known and reasonable hazards | An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible. Design review has been conducted by a cross-functional team. |
| Software Quality | (Not explicitly-stated standard, but mentioned as distinct testing) | Software testing is being certified by STERIS as the manufacturer. |
| Substantial Equivalence | Comparison to Predicate Devices: Stryker ZOOM® Motorized Stretchers and Stryker Powered Wheeled Stretcher | The Hausted® POWERTRAN™ Series Stretcher is substantially equivalent to the predicate devices in function and intended use. Minor differences do not raise new issues of safety or effectiveness. The intended use, basic technology, and performance characteristics are the same. |
Non-Applicable / Not Provided Information for AI/Diagnostic Device Studies:
- Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/diagnostic software. Testing involves physical device evaluations against engineering standards, not data sets for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's safety and performance is established by compliance with engineering and safety standards, and by comparison to predicate devices, not by expert consensus on data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device like a stretcher, "ground truth" relates to engineering specifications and compliance with recognized safety standards (like IEC, UL, CSA). It means the device physically meets the requirements set forth in those standards and performs its intended function safely, as demonstrated through testing and design reviews.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of "Study" (in this context):
The "study" or rather, the evidence presented for this 510(k) submission, is a comprehensive set of safety and performance characteristic tests conducted by the manufacturer (STERIS) and certified by accredited testing facilities. These tests ensure compliance with various national and international electrical, electromagnetic compatibility (EMC), and general safety standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1, CAN/CSA C22.2 No. 601.1-M90). Additionally, a risk assessment and design review process (following ISO 9001 principles) were conducted by a cross-functional team. The core of the 510(k) argument is the demonstration of substantial equivalence to already legally marketed predicate devices (Stryker ZOOM® Motorized Stretchers and Stryker Powered Wheeled Stretcher) in terms of intended use, basic technology, and performance characteristics. The minor differences were deemed not to raise any new issues of safety or effectiveness.
§ 890.3690 Powered wheeled stretcher.
(a)
Identification. A powered wheeled stretcher is a battery-powered table with wheels that is intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions).(b)
Classification. Class II (performance standards). The powered wheeled stretcher is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9, and the following conditions for exemption:(1) Appropriate analysis and nonclinical testing must demonstrate that the safety controls are adequate to ensure safe use of the device and prevent user falls from the device in the event of a device failure;
(2) Appropriate analysis and nonclinical testing must demonstrate the ability of the device to withstand the rated user weight load with an appropriate factor of safety;
(3) Appropriate analysis and nonclinical testing must demonstrate the longevity of the device to withstand external forces applied to the device and provide the user with an expected service life of the device;
(4) Appropriate analysis and nonclinical testing must demonstrate proper environments of use and storage of the device to maximize the longevity of the device;
(5) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate electromagnetic compatibility and electrical safety;
(6) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the skin-contacting components of the device are biocompatible;
(7) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate the software life cycle and that all processes, activities, and tasks are implemented and documented;
(8) Appropriate analysis and nonclinical testing must validate that the device components are found to be nonflammable;
(9) Appropriate analysis and nonclinical testing (such as outlined in appropriate FDA-recognized consensus standards) must validate that the battery in the device performs as intended over the anticipated service life of the device;
(10) Adequate labeling is provided to the user to document proper use and maintenance of the device to ensure safe use of the device in the intended use environment; and
(11) Appropriate risk assessment including, but not limited to, evaluating the dimensional limits of the gaps in hospital beds, and mitigation strategy to reduce entrapment.