(44 days)
The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.
The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.
The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.
This is a submission for a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested categories for AI/algorithm performance studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards | Meets the requirements of UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards. |
| Flame Retardancy | Upholstery meets the requirements of CAL 117 for Flame Retardancy. |
| Substantial Equivalence | Found substantially equivalent to TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043). |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device submission for a physical product (a stretcher), not an AI/algorithm-based device. Performance was assessed against electrical safety and flame retardancy standards, not through clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device submission for a physical product. "Ground truth" in the context of AI/algorithm performance is not relevant here. Compliance with standards is typically verified by certified testing laboratories and regulatory bodies.
4. Adjudication Method for the Test Set
Not applicable. The evaluation was based on compliance with established safety and material standards, not on expert consensus or adjudication of a test set in the AI sense.
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 powered wheeled stretcher, not an AI or imaging diagnostic tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical product; there is no algorithm or standalone performance to evaluate in this context.
7. The Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of requirements outlined in recognized safety and material standards:
- UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards
- CAL 117 for Flame Retardancy
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this type of device submission.
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510(k) SUMMARY
Winco Mfg., LLC APR 2 2 2011 Stretchair Powered Wheeled Stretcher
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Winco, Inc. 5516 Southwest 1st Lane Ocala, Florida 34474
Contact Person: James Ankoviak President and CEO Winco Mfg., LLC 5516 Southwest 1st Lane Ocala, Florida 34474
Date Prepared: February 19, 2011
Name of Device and Name/Address of Sponsor
Winco Stretchair
Winco Mfg., LLC 5516 Southwest 1st Lane Ocala, Florida 34474
Common or Usual Name
Stretcher
Classification Name
Stretcher, Wheeled, Powered
Predicate Device
TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043)
Intended Use
The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.
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Technological Characteristics and Substantial Equivalence
A. Device Description
The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.
The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.
The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.
B. Substantial Equivalence
The Winco Stretchair is substantially equivalent to the TransMotion Medical, Inc. Power Drive Chair Model TMM6 (K091043)
Performance Data
The Winco Stretchair has been tested to and meets the requirements of UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards. The upholstery used meets the requirements of CAL 117 for Flame Retardancy.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Winco, Inc. % Mr. James Ankoviak President and CEO 5516 Southwest 15t Lane Ocala, Florida 34474
APR 2 2 2 2011
Re: K110671
Trade/Device Name: Winco Stretchair Regulation Number: 21 CFR 890.3690 Regulation Name: Powered wheeled stretcher Regulatory Class: Class II Product Code: INK Dated: February 25, 2011 Received: March 09, 2011
Dear Mr. Ankoviak:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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Page 2 - Mr. James Ankoviak
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807-97) .- For-questions-regarding-the-reporting-of-adverse-events-under the MDR-regulation(211 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm1
Sincerely vours.
Alin B. Dick
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): TBD
Device Name: Winco Stretchair
Indications for Use:
.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X AND/OR (21 CFR 801 Subpart C)
X(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
_**_, and the division sign-off) under it.
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110671
§ 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.