(178 days)
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 elevation 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 tilt only and recline only versions are rated for a combined 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.
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 linear 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. The joystick in conjunction with the Tilt Recline Elevate Control Mechanism (TRECM) and the Invacare MK V EX controller activates the power positioning modules.
This response is based on the provided text, which is a 510(k) summary for the Invacare 3G Tarsys seating system. The document focuses on regulatory approval based on substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria. As such, much of the requested information, particularly regarding specific performance metrics, sample sizes, expert ground truth, and comparative effectiveness studies, is not present in the provided text.
Here's an analysis of what can be extracted and what is missing:
Invacare 3G Tarsys Seating System: Acceptance Criteria and Study Details
The provided 510(k) summary describes the Invacare 3G Tarsys seating system, a battery-powered, motorized seating system for power wheelchairs, and seeks to establish its substantial equivalence to legally marketed predicate devices. The document does not contain a detailed study proving the device meets specific quantitative acceptance criteria in the format typically seen for algorithm performance. Instead, it relies on demonstrating that the device's design, intended use, and performance characteristics are similar to existing approved devices.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a table of quantitative acceptance criteria with corresponding performance data in the typical sense of a clinical study or algorithm validation. The "performance" discussed is primarily related to safety, operational features, and design equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety - Drive Lock-out | Prevents driving when tilted beyond a pre-set limit of 20 degrees. |
| Safety - Stability | Stability of the power wheelchair is not compromised by the addition of the seating system (tested in Invacare facility). |
| Weight Capacity (Tilt/Recline/Elevate) | Rated for a combined user and accessory weight of 300 pounds. |
| Weight Capacity (Tilt-only/Recline-only) | Rated for a combined user and accessory weight of up to 400 pounds. |
| Elevate Function - Max Elevation | Allows the seat to be elevated to a maximum of 7" ± .25". |
| Flammability Standard | Tested to meet the CAL 117 flammability standard. |
| Industry Standards | Tested to ANSI/RESNA Section 7 (although no industry or ISO standards for power tilt/recline/elevating systems are explicitly mentioned as acceptance criteria, this serves as a general performance standard). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an algorithm or device performance study involving human subjects or collected data specific to the 3G Tarsys. The testing mentioned appears to be internal engineering verification and validation.
- Sample Size for Test Set: Not applicable/Not mentioned for performance claims. The "testing" referred to appears to be internal engineering verification on the device itself.
- Data Provenance: Not applicable. No external data or clinical data is cited for performance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not present. The 510(k) summary does not describe a study that used expert consensus to establish ground truth for performance metrics.
4. Adjudication Method for the Test Set
Not applicable. No expert adjudication method is described as there is no mention of a clinical or performance "test set" requiring expert review for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or is mentioned. The submission focuses on device design and functional equivalence to predicate devices, not on comparing reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical power wheelchair seating system, not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for the claims appears to be derived from:
- Engineering specifications and measurements: E.g., 7" ± .25" elevation.
- Internal safety testing: E.g., drive lock-out functionality, stability testing.
- Compliance with recognized standards: E.g., CAL 117 flammability, ANSI/RESNA Section 7.
- Substantial equivalence to predicate devices: The primary basis for regulatory clearance, implying that if predicate devices are safe and effective, a substantially equivalent new device will also be.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set exists for this type of device submission.
In summary: The provided text is a regulatory submission (510(k) summary) focused on demonstrating "substantial equivalence" of a physical medical device (a power wheelchair seating system) to pre-existing, legally marketed predicate devices. It outlines the device's features, intended use, and general safety considerations, along with basic performance specifications (like weight capacity and elevation range) determined through internal testing and adherence to relevant industry standards. It does not contain information about clinical studies with specific acceptance criteria, sample sizes, expert ground truth, or AI-related performance metrics, as these are typically not required for this type of 510(k) submission for a mechanical device.
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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: 440-329-6356 Fax: 440-326-3607
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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 890.3860 Powered wheelchair.
(a)
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.(b)
Classification. Class II (performance standards).