(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.
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510(k) Summary for The Hausted® POWERTRAN™ Series Stretcher
K041924 SEP - 9 2004 510(k) SUMMARY PERTAINING TO THE SAFETY AND EFFECTIVENESS OF The Hausted® POWERTRAN™ Series Stretcher
Submitter Information:
Robert H. McCall Senior Regulatory Affairs Specialist 2720 Gunter Park Drive East Montgomery, Alabama, 36109 334-277-6660 334-271-3579
Date Summary Prepared: July 14, 2004
| Name of the device: | The Hausted® POWERTRAN™ Series Stretcher |
|---|---|
| Common or usual name of the device: | Powered Patient Transport |
| Classification name of the device: | Powered Patient Transport |
Predicate Device: Stryker ZOOM® Motorized Stretchers
Device Description: 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.
Intended Use: 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.
Device Comparison: The Hausted® POWERTRAN™ Series Stretcher is substantially equivalent to the ZOOM® Motorized Stretchers and the Stryker Powered Wheeled Stretcher in function and intended use.
The Hausted® POWERTRAN™ Series Stretcher is substantially equivalent to the ZOOM® Motorized Stretchers and the Stryker Powered Wheeled Stretcher in function and intended use. The minor differences described in the submission between The Hausted® POWERTRAN™ Series Stretcher and that of the predicate devices does not raise any new issues of safety or effectiveness.
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The intended use, basic technology, and performance characteristics of the systems are the same. The device does not contact the patient, so biocompatibility is not a concern.
The subject stretcher is intended to be used in any clinical environment where atient care is I he subject streicher is michied to be about in any cass for patient treament, recovery and for administered. Health facintes ordinary ass bactered best painterspy, diagnostic radiography, etc.
The labels and labeling (Operator's and Maintenance Manuals) provide information for the safe I ne idoels and ideeming on and the intended operation features.
No performance standards or special controls have been promulgated for powered patient transport devices under sections 513 and 514 of the FD& C Act.
Safety Testing and performance characteristics have been conducted and successfully completed in 1 CER Safety Testing and performatic characteristions. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations.
An assessment of known and reasonable hazards has been conducted to ensure that any risk An assessment of known alle feasonable in product release is as low as reasonably possible. Design associated with the device as of the date of product results is a 3.30 and Sub-clause 4.4 of ISO 9001.
Design review has been conducted by a cross-functional team, including but not limited to Design forlow has engineering, technical writing and manufacturing.
The stretcher will comply with the following voluntary standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, Salety, 1988 (General), Amendment 1, 1991-11, Amendment 2, 1995-03
- IEC 60601-1-2, (First Edition, 1993-04), Medical Electrical Equipment Part 1: IEC 00001-1 2, (1 115 Builden) 1998-11-27 Electromagnetic Compatibility - Requirements and Tests (General)
- UL 2601-1 (2nd Ed.) Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- CAN/CSA C22.2 No. 601.1-M90 Standard for Medical Electrical Equipment
The subject stretcher and predicate stretcher included in this submission are substantially equivalent.
Prepared by:
Robert H. McCall Senior Regulatory Affairs Specialist STERIS-Montgomery Operations
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
Mr. Robert H. McCall, RAC Senior Regulatory Affairs Specialist STERIS Corporation 2720 Gunter Park Drive East Montgomery, Alabama 36109-0509
Re: K041924
Ro4124
Trade/Device Name: The Hausted® POWERTRAN™ Series Stretcher Regulation Number: 21 CFR 890.3690 Regulation Name: Powered Wheeled Stretcher Regulatory Class: II Product Code: INK Dated: August 10, 2004 Received: August 12, 2004
Dear Mr. McCall:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the endroom's to regists of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetter for (110) that to nevice, subject to the general controls provisions of the Act. The Tou may, diorelore, mains of the Act include requirements for annual registration, listing of general controlly provisions 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 If your device is elassified (800 a00 roy als. Existing major regulations affecting your device can may or backed to been as a 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 r loase of acrisou that I promination that your device complies with other requirements of the Act that I DIT has made a aoninistered by other Federal agencies. You must or any I oderal statutes and states and station of limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Orth 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 - Mr. Robert H. McCall, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to ogen mailioning of substantial equivalence of your device to a legally promatics notication: "The sification 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 If you desire specific acrite for your (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Come to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A. Milhem
Celia M. Witten, Ph.D., M.D. 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
510(k) Number (if known): _K041924
Device Name: _The Hausted® POWERTRAN™ Series Stretcher
Indications for Use: 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
な
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)
Mach N. Milken
Mivision Division of General, Restorative, and Neurological Devices
Page 1 of 1_
510 (k) Number_
§ 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.