STRYKER POWERED WHEELED STRETCHER

K022309 · Stryker Corp. · INK · Nov 8, 2002 · Physical Medicine

Device Facts

• Record ID: K022309
• Device Name: STRYKER POWERED WHEELED STRETCHER
• Applicant: Stryker Corp.
• Product Code: INK · Physical Medicine
• Decision Date: Nov 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3690
• Device Class: Class 2

Intended Use

The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications. The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force.

Device Story

Stryker Powered Wheeled Stretcher is an electromechanical patient transport device. It features a motorized 'Big Wheel' drive-assist system to reduce caregiver force during steering and transport. Unlike its predicate, this version lacks patient-operated controls for positioning (head/knee adjustment). Operated by healthcare caregivers in clinical environments (e.g., examination, surgery, recovery, therapy). The device provides a stable, height-adjustable surface for patient support and transport. Benefits include improved maneuverability and reduced physical strain on caregivers during patient movement.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation plans were developed to address identified risks and hazards, including compliance with IEC 601-1-1, IEC 601-1-2, UL 2601-1, and CAN/CSA-C22.2 No. 601.1-M90 standards.

Technological Characteristics

Electromechanical powered patient transport stretcher. Features motorized drive-assist fifth wheel. Height-adjustable lift system. Complies with IEC 601-1-1, IEC 601-1-2, UL 2601-1, and CAN/CSA-C22.2 No. 601.1-M90. Connectivity: None stated. Sterilization: Not applicable.

Indications for Use

Indicated for patients requiring transport within healthcare facilities for minor procedures and short-term stay.

Regulatory Classification

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).

Special Controls

(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.

Predicate Devices

• Stryker Powered Wheeled Stretcher (K942948)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 2002 NOV

Stryker Corporation c/o King and Spalding Lynette Gabriel 1730 Pennsylvania Avenue, N.W. Washington, D.C. 20006-4706

Re: K022309

Trade/Device Name: Stryker Powered Wheeled Stretcher Regulation Number: 890.5150 Regulation Name: Powered patient transport Regulatory Class: Class II Product Code: INK Dated: August 13, 2002 Received: August 13, 2002

Dear Ms. Gabriel:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Lynette Gabriel

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Mark A. Millman

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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Page_1_of _1_

| 510(k) Number: | K022309 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Stryker Powered Wheeled Stretcher |
| Indications For Use: | The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications.<br>The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force. |

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR Over-The- Counter Use | |
|----------------------|--------------------------|--|
| (Per 21 CFR 801.109) | | |

(Optional Format 1-2-96)

Mark A. Millerson

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K022309

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12:12 JUN-06-2003

P.02/03

K022309

**stryker**
Medical

6300 Sprinkle Road B300 Gpmmale Koopo1-8799 www.stylermedical.com Fhone [phone]

Fax [phone] RED A CAR

Device Name:

| Trade Name: | Stryker Powered Wheeled Stretcher |
|----------------------|------------------------------------------------------|
| Common Name: | Powered Wheeled Stretcher |
| Classification Name: | Powered Patient Transport, 21 CFR 890.5150, Class II |

### Device Sponsor:

Manufacturer.

Stryker Corporation Stryker Medical 6300 S. Sprinkle Road Kalamazoo, MI 49001 Registration No .: 1831750

Regulatory Class:

Class II

# ldentification Of The Marketird Device(s) To Which Equivalence is Claimed

Stryker Powered Wheel Stretcher (510k#. K942948)

#### Intended Use Statement:

The Styker Powered Wheeled Stretcher is a powered patient transport device with a motorized The Styker Powered Wheeled Streicher is a powered peach transporting patients within healthcare facilities.

Summary:
The new stretcher is a drive be in the former Stryier Powered Wheeled Stretcher.
The new stretcher is a drive in the he vest to transport nations areas within the The new stretcher is a drive-assited version of the romer onlying areas within the This stretcher is a motorized device to be used to transport patients with the many contract, and patient securement straps.

The predicate device has patient controls that allow the patient to adjust the street, the head and knee section The predicate device has patient controls that and the participal theat and knesseding comfort level. The stretcher helght can or increased on other to and the maneuverability of
can be raised or lowered. This stretcher doesn't have a fith wheel to and he man can be raised on lowered. This suelonel adoption and patient controls.

The stretcher, which is the subject of this submission, will have a motorized drive-assist fifth The stretcher, which is the subject of inis suchins. Only the caregiver, not the caregiver, not the wheel that will assist the caregive in manedver the Breaker. controls to adjust patient positioning.

As with the predicate device, the stretcher of this submission will be a moveble, caster mounted As with the predicate device, the strential of this stumes. In addition, as with the predicate stretcher, the lift system provides both support and height and life surface to the patient surface stretcher, the ill system provides bour appen and haghined to meet UL and IEC stablily requirements.

The subject stretcher and predicate stretcher are intended to be used in any clinical environment The subject streicher and predicate sired. Healthcare facilities typically use stretchers as

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treatment, recovering or transporting surfaces. Clinical activities to include, but not limited to
ries and the supportunes massyon, therasy, and transport. When fitted wit treatment, recovering or transporting surfaces. Cirical activities to normal
examination, surgery, therepy, and transport. When fitted with the optional radiolucent trackers, surgery, recovery, therapy, and transport. Which Roomin
examination, surgery, recovery, therapy, and tradiographic images.

eurface, the stretcher may our and provide information that describes the stretcher, its intended
The labels and operation for smanly operating the stretcher safely. The labels and Operations Manual provide information would be

Use, and and a loaders or special controls applicable to powered patient transport devices
No performance de ador sections 513 of the FD & C Act. No parformance standards or special controls appliable to por
have been established under sections 513 or 514 of the FD & C Act.

Significant safety and performance characteristics are tested to ensure compliance with Significant safety and performance characteristics are tested o ensure completed in
specifications. After testing is complete, the test resorts become part of the Device Mas specifications. After testing is complete, the test roperte out

Record of risks and hazards of the product was conducted. This included complaints, recalls,

A review of the trians annone annives Also, a review was also conducted to id A review of risks and hazards of the product was conducted to identify other
and medical device reports analyes. Also, a review was also conducted to included Alevice reports and performance hazards by a cross-functional caron with houded on House of the many of the many of the sense by a cross-libroomer of the many.
Potential structs form, but not limited to, Engineering, Quality, and Regulatory Africa. perfication and validation plan has been developed to ensure these hazards have been
verification and validation plan has been developed to ensure these have been
the been vermication and validation plan naturence minimized.

The stretcher will also comply with the following voluntary standards:

| IEC 601-1-1 | Medical Electrical Equipment - Part 1: General Requirements<br>For Safety 1: Safety Requirements For Medical Electrical<br>Systems. |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------|
| IEC 601-1-2 | M Medical Electrical Equipment - Part 1: General Requirements<br>For Safety 2: Electromagnetic Capability - Requirements and<br>Tests. |
| UL 2601-1 | Standard For Medical Electrical Equipment - Part 1: General<br>Requirements For Safety. |
| CAN/CSA-C22.2 | No. 601.1-M90, Medical Electrical Equipment Part 1: General<br>Requirements For Safety. |

The subject stretcher and predicate stretcher in this submission are substantially equivalent.

By: Catherine McBuday

Cathenne Friday Regulatory Affairs/Quality System Engineer

Dated: July 15, 2002

TOTAL P.03