The Winco Model S550 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 Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position.

The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.

AI/ML Overview

The provided documents are a 510(k) premarket notification for a medical device (Winco Model S550 Stretchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than showcasing a new device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information regarding acceptance criteria and a study proving the device meets them:

A table of acceptance criteria and the reported device performance.
Sample sizes used for the test set and data provenance.
Number of experts used to establish ground truth and their qualifications.
Adjudication method for the test set.
MRMC comparative effectiveness study results or effect sizes.
Standalone performance study results for an algorithm.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

Instead, the document focuses on:

Device Description: Details the functionality and components of the Winco Model S550 Stretchair.
Predicate Device: Identifies the Winco Stretchair Model S999 (K110671) as the predicate.
Comparison of Technological Characteristics: Discusses similarities and differences between the new device and the predicate, emphasizing that differences (like weight capacity and width) do not affect safety, effectiveness, or substantial equivalence.
Performance Data (Standards Conformance): States that the Winco Model S550 Stretchair meets general safety and essential performance standards:
- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirement for Safety
- IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Conclusion: Asserts substantial equivalence based on identical technology, principle of operation, indications for use, and conformance to the same safety standards as the predicate device. The document explicitly states, "Performance testing and use of the same identical lift mechanism and linear actuator supports the safety of the Winco Model S550 Stretchair. Since the predicate was cleared in part on these data, conformance with the same requirements demonstrates that the Winco Model S550 Stretchair will perform as intended in the specified use conditions."

In summary, the provided text describes a mechanical device cleared via the 510(k) pathway, which primarily relies on demonstrating equivalence to an existing device and adherence to relevant industry standards, not on clinical performance studies with acceptance criteria in the way an AI/software device often would.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with the top profile being the most prominent. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2016

Winco Manufacturing LLC % Ronald M. Scott 5516 SW 1st Lane Ocala, FL 34474

Re: K152056

Trade/Device Name: Winco Model S550 Stretchair Regulation Number: 21 CFR 890.3690 Regulation Name: Powered Wheeled Stretcher Regulatory Class: Class II Product Code: INK Dated: July 22, 2015 Received: July 24, 2015

Dear Ronald M. Scott:

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 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -S/

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152056

Device Name Winco Model S550 Stretchair

Indications for Use (Describe)

The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Premarket Notification K152056 Winco Model S550 Stretchair

Response to Al Reguest

Winco, LLC Model S550 Stretchair 510(k) Summarv (Modified April 8, 2016)

l. SUBMITTER

Winco Mfg., LLC 5516 Southwest 1st Lane Ocala, Florida 34474 Phone: (800) 237-3377 (352) 854-9544 Fax:

II. DEVICE

Name of Device: Winco Model S550 Stretchair Common or Usual Name: Stretcher Classification Name: Powered. Wheeled Stretcher (890,3690) Regulatory Class: II Product Code: INK

011. PREDICATE DEVICE

Winco Stretchair Model S999 (K110671)

IV. DEVICE DESCRIPTION

The patient can be transported only when in the seated position. (See Figures 1 and 2 below). When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.

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Image /page/4/Picture/0 description: The image shows the logo for Winco. The logo is in silver and is set against a dark gray oval background. The word "Winco" is written in a stylized font, with the letters slightly overlapping each other.

Device Function:

The Winco Model S550 Stretchair has three basic functions. These are; the patient transport function, the patient surface adjustment function and the height adjustment function. The patient transport function is dependent solely upon the healthcare facility attendant to transport the patient by physically pushing on the device push handles. The attendant controls the motion and direction of the device.

The patient surface adjustment function allows the patient to be seated or supine (laying down) while on the device. This function is achieved using a DC motor with worm gear type linear actuator. The adjustment from seated to supine is initiated by the attendant using a hand held controller. When engaged, the linear actuator pivots the patient surface either up or down to change the position from seated to supine or supine to seated. Limit switches disable power to the motor when travel limits are reached.

The height adjustment function raises or lowers the patient surface. This is achieved using a DC Powered hydraulic pump and four hydraulic cylinders. The lift mechanism is activated by the attendant using the same hand held pendant control. When raised, hydraulic fluid is simultaneously pumped into the four cylinders, which then extend and raise the chair frame upward. When lowered, the flow of hydraulic fluid is reversed and returns the cylinders to their compressed state.

Scientific Concepts

There are no complex scientific concepts related to the Winco Model S550 Stretchair. The patient adjustment function uses a standard worm gear type linear actuator. The lift mechanism use standard hydraulic cylinders to achieve its function.

Significant Physical and Performance Characteristics:

Design:

The patient can be transported in the sitting position only
Powered Height Adjustment
Powered sitting/supine adjustment
Adiustable Armrests
Adjustable Footrests
Locking Casters
Hand Held Pendant Control

Materials:

Materials used are:

Steel frame and support members

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Image /page/5/Picture/0 description: The image shows the Winco logo. The logo is in silver and is set against a black oval background. The word "Winco" is written in a stylized font.

Plastic casters
Vinyl covered upholstery ﺬ

Physical Properties:

The Winco Model S550 Stretchair consists primarily of the following:

1. Stretcher Base and Chair Frame : Made from steel and with a powder coated finish. Base is used to support the stretcher and lift mechanism. Chair is used structure and user support.
1. Hydraulic Lift System Used to raise and lower entire chair in either the sitting or supine position.
1. Casters Made from plastic and steel. Used for transport (steering, prevent movement, etc...)
Actuator System 4. Transfers chair seat and back from upright sitting position to lay-flat position.

V. INDICATIONS FOR USE

The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technology and principle of operation for the Winco Model S550 Stretchair and Winco Model S999 Stretchair is identical. Both products are electromechanical devices with the intended function and use of providing a method of transporting patients within a health care facility. They have the same indications for use, have the same features and performance characteristics and are made from the same materials. They utilize the same technology and they all function in the same manner.

Both products include a frame assembly, a patient support surface, a power lift actuator for adjusting the height of the device and for adjusting the patient surface from a seated position to a supine position and both are battery powered. Additionally, both can be used to transport a patient in a seated position. They use the same identical lift mechanism, linear actuator, hand control pendent, upholstery, and casters.

Discussion of Similarities and Differences:

The primary difference between Winco Model S550 Stretchair and Winco Model S999 Stretchair is that the Winco Model S550 Stretchair has a patient weight limitation of 550 pounds whereas the Winco Model S999 Stretchair has a patient weight limitation of 1000 pounds. Also, the Winco Model S550 Stretchair is 6" narrower than the Winco Model S999 Stretchair. This narrower frame is designed to better accommodate the smaller, 550 pound patient.

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Image /page/6/Picture/0 description: The image shows a logo with the word "Winco" in a stylized font. The word is in silver or gray color, and it appears to be metallic or reflective. The background is a dark oval shape, providing a contrast to the text. The logo has a sleek and modern design.

This 6" narrower width does not affect safety, effectiveness or substantial equivalence. The smaller width is the result the lower weight limitation. It allows for a better patient fit than the wider predicate and like the predicate, the Winco Model S550 Stretchair is labeled with a maximum allowed patient weight. The difference only means that it is not to be used on a patient that exceeds 550 pounds.

This 6" narrower width does not affect safety, effectiveness or substantial equivalence. The smaller width is the result of the lower weight limitation. It allows for a better patient fit than the wider predicate and product is labeled with the maximum allowed patient weight.

Based on the above discussion, Winco Mfg., LLC believes that the Winco Model S550 Stretchair is substantially equivalent to the Winco Model S999 Stretchair (K110671). While there are some differences between the Winco Model S550 Stretchair and its predicate, these differences are minor and do not alter the intended function and use of the device, nor do they raise any new questions pertaining to safety or effectiveness.

PERFORMANCE DATA VII.

The Winco Model S550 Stretchair meets the following standards,

IEC 60601-1 Medical Electrical Equipment Part 1: General Requirement for Safety and:
IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

The upholstery used on the Winco Model S550 Stretchair is made from the same materials as the upholstery used on the Winco Model S999 Stretchair (K110671).

VIII. CONCLUSIONS:

Performance testing and use of the same identical lift mechanism and linear actuator supports the safety of the Winco Model S550 Stretchair. Since the predicate was cleared in part on these data. conformance with the same requirements demonstrates that the Winco Model S550 Stretchair will perform as intended in the specified use conditions. Further, technology, principle of operation and indications for use between Winco Model S550 Stretchair and its predicate are identical. This demonstrates that it performs comparably to the predicate device that is currently marketed for the same intended use. Therefore, the Winco Model S550 Stretchair is substantially equivalent to the Winco Model S999 Stretchair.

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Image /page/7/Picture/0 description: The image shows the word "Winco" in a stylized font. The word is in silver or gray color, and it appears to be embossed or raised. The background is a dark oval shape, possibly black or dark gray, which provides a contrast to the word. The overall design looks like a logo or emblem.

FEATURE/SPECIFICATION	WINCOMODEL $550STRETCHAIR	WINCOMODEL S999STRETCHAIR	EXPLANATION OF DIFFERENCES.
510(k) Accession Number	K152056	K110671	NA
Clearance Date	TBD	April 22, 2011	NA
Intended Use	To provide a methodof transportingpatients within ahealth care facility	Same	No difference
Transport Method	Manual Only	Same	No difference
Transport Mode	Seated	Same	No difference
Maximum Patient Weight	550 lbs.	1000 lbs.	This does not affect safety, effectiveness or substantialequivalence. Like the predicate, the Winco Model S550Stretchair is labeled with a maximum allowed patientweight. The difference only means that it is not to beused on a patient that exceeds 550 pounds.
Stretcher Length	72" (182.9 cm)	Same	No difference
Overall Width	34" (86.4 cm)	40" (101.6 cm)	This 6" narrower width does not affect safety,effectiveness or substantial equivalence. Thesmaller width is the result the lower weightlimitation. It allows for a better patient fit than thewider predicate and product is labeled with themaximum allowed patient weight.
Overall Height	54" (137.2 cm)	Same	No difference
Seat Width	25" (63 cm)	31" (78.7 cm)	This 6" narrower width does not affect safety,effectiveness or substantial equivalence. Thesmaller width is the result the lower weightlimitation. It allows for a better patient fit than thewider predicate and product is labeled with themaximum allowed patient weight.
Vertical Lift Range (TotalRange)	22" (55.9 cm) - 38"(96.5 cm)	Same	No difference
Travel Speed Height	Low to High = 25secondsHigh to Low = 28seconds	Same	No difference
Supine Travel Speed	Upright to Supine =25 secondsSupine to Upright =26 seconds	Same	No difference
Height Adjustment Method	Hydraulics	Same	No difference. The Winco Model S550 Stretchairuses the same lift mechanism as its' predicate
Seat/Supine DriveMechanism	Motor Driven Linearactuator	Same	No difference. The Winco Model S550 Stretchair usesthe same motor driven linear actuator as its' predicate
Battery Powered	Yes	Yes	No difference
Trendelenburg Position	No	No	No difference

Regulation Number and Section

§ 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.