INVACARE 3G TARSYS

K033819 · Invacare Corp. · ITI · Jun 4, 2004 · Physical Medicine

Device Facts

• Record ID: K033819
• Device Name: INVACARE 3G TARSYS
• Applicant: Invacare Corp.
• Product Code: ITI · Physical Medicine
• Decision Date: Jun 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered clevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tiltonly and recline only versions are rated for a comhined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

Device Story

Battery-powered, motorized seating system for power wheelchairs; provides tilt, recline, and seat elevation functions. Input: user commands via joystick connected to Invacare MK V EX controller. Transformation: electrically operated linear actuators drive tilt/recline; linear ball screw actuator drives elevation. Output: physical repositioning of seat/user. Used in clinical or home settings; operated by patient or caregiver. Safety features: drive lock-out prevents driving when tilted beyond 20 degrees. Benefits: pressure relief, improved accessibility, and assistance with daily transfers.

Clinical Evidence

Bench testing only. Device tested for stability and safety of the power seating system additions. Flammability testing conducted per CAL 117. No clinical data provided.

Technological Characteristics

Battery-powered motorized seating system; linear actuator for tilt/recline; linear ball screw actuator for elevation. Max elevation 7" ± 0.25". Connectivity via accessory port to Invacare MK V EX controller. Tested to ANSI/RESNA standards and CAL 117 flammability standard.

Indications for Use

Indicated for individuals with injury or disability preventing independent repositioning or weight shifting for pressure relief; also indicated for users requiring powered seat elevation to assist with daily activities, transfers, and general accessibility. Rated for 300 lbs (full system) or 400 lbs (tilt/recline only).

Regulatory Classification

Identification

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Predicate Devices

• Invacare Model 2G Tilt/Recliner for Powered Wheelchairs (K991119)
• Invacare Elevating Seat Option ESS6 (K013516)
• Motion Concepts TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline and Power Elevating Seat (K021264)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the Invacare logo. The logo is in black and white and features the word "INVACARE" in bold, sans-serif font. The word is enclosed in a black oval shape with white outlines. The logo is simple and recognizable.

## 510(K) SUMMARY FOR INVACARE CORPORATION'S 3G TARSYS SEATING SYSTEM

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

033819 The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Date: November 20, 2003

Submitted by: Invacare Corporation One Invacare Way Elvria, Ohio 44035-4190

Telephone: [phone] Fax: [phone]

Contact Person: Carroll L. Martin, Regulatory Generalist

Trade Name: 3G Tarsys

Common Name: Power wheelchair

Classification Name: Wheelchair, powered

Legally Marketed Predicate Device(s): Invacare Model 2G Tilt/Recliner for Powered Wheelchairs Invacare Elevating Seat Option ESS6 Motion Concepts TRZ-CG Power Positioning System with Center-of-Gravity Shifting Power Tilt, Recline and Power Elevating Seat

Device Description: The Invacare 3G Tarsys is a battery powered, motorized seating system designed for use with power wheelchairs. The seating system is rated for 300 pounds. Tilt only and recline only versions are rated for 400 pounds

An electrically operated linear actuator drives the tilt and recline functions with weight balance maintained through the stability of the base. The recline function incorporates a mechanical sliding back mechanism to reduce back shear as well as optional power elevating leg rests. The elevate function is driven by an electrically operated lincar ball screw actuator mounted in a vertical fashion and allows the seat to be elevated to a maximum of 7" ± .25".

The tilting, reclining and elevating systems are separate modules and are independent of each other. As such, they will be offered as either a complete tilt/recline/elevate system, a combination of tilt/recline, tilt/elevate or as separate tilt only, elevate only systems depending on the user's needs.

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Image /page/1/Picture/0 description: The image shows the Invacare logo. The logo consists of the word "INVACARE" in white, bold, sans-serif font, set against a black oval background. The oval is slightly tilted, giving the logo a dynamic appearance.

The joystick in conjunction with the Titt Recline Elevate Control Mechanism (TRECM) and the The joystick in conjunction with the Tift it comic positioning modules. FDA granted the Invacare
Invacare MK V EX controller activates the power position in 2002 and and 1000 Invacare MK V EX controller activates in power 19, 2002 under 510(k) Accession Number MKV EX controller marketing creatance on November 17,2000's been in conjunction with the K0223589. The Titl Rechine Control McChanish Call only of ac
MKV controller. It connects to the MKV controller by way of an accessory port located on the MK V controller housing.

Safety features include a drive lock-out which prevents the user from driving the power chair while Safety teatures include a drive lock-out which previses was tested in our facility to ensure that tilled beyond a pre-set limit of 20 . The Stability of the SGTTLE Tables of the power seating system.
the safety of the power wheelchair was not compromised by the addition o

Intended Use: The intended function of the tilt/recline seating system is for repositioning and/or Intended Use: The Intended fulleton of the the cannot do this independently due to injury of the wheel weight shift for pressure refler ior incritualis who easing to cannot of the wheelchair
disability. The elevate function is intended primarily to provide powered ecoescibilit disability. The elevate fullchoil is incharty to provided fransfers and general accessibility.

Substantial Equivalence: Products that are substantially equivalent to the Invacare 3G Taxys are the Substantial Equivalence: Products uita ac 300stanting Seat Option ESSO (K013516.
Invacare 2G Tarsys (K991119, August 19, 1999), the Invactionity of System with Center-of-Invacare 26 Tarsys (K991119, August 17, 1977), the Concept Positioning System with Center-ofDecember 13, 2001) and the Motion Concepts TRZ-CG Power Positioning System with December 13, 2001) and the Motion Colleople TELEVAting Seat (K021264. July 30, 2002).

Each of these products are battery powered, motorized seating systems designed for use with powered Each of these products are battly powersupply and drive mechanisms are similar. The wheelenans. Then performance characters from Positioning System with Center-of-Invacare 30 Tarsys and the Motion Concepts TRE Co . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Gravity Smithing Power Thi, Rechne and Fower Erefoning to a power wheelchair by providing a
they are intended to aid in the pressure relief of persons confined to a possible they are intentied to all in the pressure refer of provide powered elevation of the method of thing the scal and rechling the basic and with daily activities, transfers and general wheelenair seal and user in ofter to assist the asse min an Tarsys have the same intended use in that accessibility. The intere 50 Talsys and the lief of persons confined to a power wheelchain by they are both intended to ald in the pressure renor of policial. The Invacare 3G Tarsys and the Invacare providing a method of thing the seat and recommig are e in that they both are intended to provide Elevating Seat Option 1:550 have the same meeneed assist the user with daily activities.
powered clevation of the wheelchair seat and user in order to assist the user with da transfers and general accessibility.

The Invacare 3G Tarsys offers an clevating seat option and a tilt/rectine option, which makes it is The Invacale 3G Tarsys offers an elevating Sout option FSS . respectively.

Performance Standards: Although there are no industry or ISO standards for power till and recline Performance Standards. Annough there are no hosen to test this product to ANSI/RESNA systems of power elevating systems, invasale has encount has also been tested to meet the CAL 117 flammability standard.

INVACARE CORPORATION

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Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized human profiles connected by flowing lines, suggesting interconnectedness and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, indicating the department's name and national affiliation.

Public Health Service

JUN 0 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carroll L. Martin Regulatory Affairs Invacare Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125

Re: K033819

.

Trade/Device Names: Invacare 3G Tarsys Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: II Product Code: ITI Dated: May 14, 2004 Received: May 17, 2004

Dear Mr. Martin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused in addevice 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 encreative) it the enactment date of the Medical Device Amendments, or to conimeres prior to they 20, 1978) in accordance with the provisions of the Federal Food, Drug, de necs that have been recuire approval of a premarket approval application (PMA). and Coometer Flov ( 100 ) 100 ) 100 ( 100 ) 200 the general controls provisions of the Act. The r ou may, merceive, manel as act include requirements for annual registration, listing of general controls pro resuring 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 to such additional controls. Existing major regulations affecting your device can may be subject to basil assisted 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 I lease oe arrisou that I Dr. Dr. device complies with other requirements of the Act that I Dr Has Intatutes and regulations administered by other Federal agencies. You must or any reach statutes and registements, 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 – Carroll L. Martin

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to organ mailing of substantial equivalence of your device to a legally premaired 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), please If you desire specific acrioliance at [phone]. Also, please note the regulation entitled, Coniact the Office of Compulars market notification" (21CFR Part 807.97). You may obtain Milsolanding of Icrorence to premaintens in the Act from the Division of Small other general information on your response Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Milken

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): K033819

Device Name: Invacare 3G Tarsys

Indications for Use:

The intended function of the tilt/recline seating system is for repositioning and/or weight shift for pressure relief for individuals who cannot do this independently due to injury or disability. The elevate function is intended primarily to provide powered clevation of the wheelchair seat and user in order to assist the user with daily activities, transfers and general accessibility. The Invacare 3G Tarsys is rated for a combined user and accessory weight of 300 pounds. The tiltonly and recline only versions are rated for a comhined user and accessory weight of up to 400 pounds. The seating system is intended to be used with power wheelchair bases for which it is found to be compatible.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (2) CFR 807 Subpart C)

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

Concurence of
Office of Device Evaluation (ODE)

**Division Sign-Off**

Division of General, Restorative, and Neurological Devices

510(k) Number K033819

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