Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with a design element above them that resembles a stylized wing or feather. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2017 Invacare Corporation Elijah Wreh Regulatory Affairs Manager (pre-market) One Invacare Way Elyria, Ohio 44035 Re: K162621 Trade/Device Name: Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair Regulation Number: 21 CFR 890.3850 Regulation Name: Mechanical Wheelchair Regulatory Class: Class I Product Code: IOR Dated: October 5, 2016 Received: October 6, 2016 Dear Elijah Wreh: 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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements {1}------------------------------------------------ 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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, Image /page/1/Picture/8 description: The image shows the name "Michael J. Hoffmann -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are evenly spaced, and the overall impression is clean and professional. for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K162621 #### Device Name Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, Invacare Tracer IV Heavy Duty/extra Wide Manual Wheelchair #### Indications for Use (Describe) The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | SUBMITTER: | Invacare Corporation<br>One Invacare Way<br>Elyria, OH 44035 | |-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | | Phone: (440) 329-6840<br>Email: ewreh@invacare.com | | CONTACT PERSON: | Elijah N. Wreh<br>Regulatory Affairs Manager (Pre-Market) | | MANUFACTURER: | INVAMEX S.DE R.L. DE C.V.<br>Avenida El Puente S/N<br>Parque Industrial El Puente Manimex<br>Reynosa Tamaulipas, Mexico C.P. 88783 | | Date Prepared: | April 17, 2017 | | DEVICE<br>Name of Devices: | Invacare Tracer SX5 Manual Wheelchair<br>Invacare Tracer SX5 Recline Manual Wheelchair<br>Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair | | Common or Usual Name:<br>Classification Name: | Wheelchair, Mechanical<br>Mechanical Wheelchair 21 CFR §890.3850 | | Regulatory Class: | I | | Product Code: | IOR: Wheelchair, Mechanical | | Regulation Description: | Mechanical Wheelchair | | PREDICATE DEVICE: | Tracer Series Mechanical Wheelchairs (K935398) | | REFERENCE DEVICE: | Ride Lite 9000 Series Wheelchair (K881951) | {4}------------------------------------------------ ### DEVICE DESCRIPTION The Invacare® Tracer® SX5 Manual Wheelchair is intended to provide mobility to persons who may be restricted to a sitting position. The manual wheelchair is intended for ongoing daily use. The models offer a wide range of customization which allows for a better fit for the end user resulting in comfort, lightweight, easier propelling, transferring, and smooth ride. The manual wheelchair is intended for indoor and outdoor use on firm surfaces free of climbing obstacles. The Invacare® Tracer® SX5 Recliner Manual Wheelchair is a Tracer SX5 model with the addition of a recline feature. This recliner model incorporates a mechanism that allows the backrest to recline in angles from 90° to 180°. Both models of the chair have a weight capacity of 250 to 300 lbs. depending on the seat width. Both models also come with an anti-tipper device to ensure the chair remains stable while in use. The Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair has the same intended use as the Invacare® Tracer® SX5 Manual Wheelchair. However, the Tracer IV does not come with a recliner model and has a higher weight capacity of 350 lbs. depending on the configuration. Both models of Tracer IV chairs come with a push-to-lock or pull-to-lock feature to engage and disengage the wheel locks. Both models also come with anti-tippers that allow clearance of 1.5 to 2 inches. There is no prior submission for the subject devices. The associated model and accessories include: - . Invacare Tracer SX5 Manual Wheelchair - o Seat Width 14" to 18" 250 lbs. (114 Kg) - o Seat width 20" to 22" 300 lbs. (136 Kg) - Invacare Tracer SX5 Recline Manual Wheelchair . - o Seat Width 14" to 18" 250 lbs. (114 Kg) - o Seat width 20" to 22" 300 lbs. (136 Kg) - Invacare Tracer IV & Heavy Duty Manual Wheelchair . o Weight capacity at 350 lbs. and 450 lbs. - Tipper aid ● - Cane holder - Anti-theft device - Non-folding device - O2 holder ● - Wheel lock extension ● - IV rod telescopic fixed back . {5}------------------------------------------------ ### INDICATIONS FOR USE The Invacare® Tracer Manual Wheelchair, Invacare® Tracer® SX5 Manual Wheelchair, Invacare Tracer SX5 Recliner Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are intended to provide mobility to persons limited to a sitting position. # COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE and REFERENCE DEVICES The device comparison showed that the subject devices are substantially equivalent in intended use, design, materials, and operational principles to the previously cleared Tracer Series Mechanical Wheelchairs (K935398) to provide mobility to persons limited to a sitting position. # BASIS OF SUBSTANTIAL EQUIVALENCE The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" and the technological characteristics which include materials, design, energy source, and other device features, as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A). The subject device components are as safe and effective as the predicate and reference devices and do not raise different questions of safety and effectiveness. The major frame components for the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair and the previously cleared Tracer Series Manual Wheelchairs (K935398) are the same. The data generated from the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair test report supports a finding of substantial equivalence in regards to the device comparison, dimensional analysis, device specifications, design characteristics and to provide mobility to persons limited to a sitting position. The difference in weight capacity between the subject Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair and the previously cleared Tracer Series Manual Wheelchairs (K935398) do not raise no new issues of safety or effectiveness. {6}------------------------------------------------ In conclusion, the performance testing, device comparison, and dimensional analysis demonstrates that the subject device components are substantially equivalent to the predicate and reference devices in regards to static stability, effectiveness of brakes, dimensions, mass and maneuvering space, measurement of seating and wheel dimensions, static impact and fatigue strength, coefficient of friction, information disclosures, documentation and labeling. {7}------------------------------------------------ # Design Characteristics Comparison – Invacare® Tracer® SX5 Manual Wheelchair | Device | Invacare® Tracer® SX5 Manual Wheelchair | Tracer Series Manual Wheelchairs | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | 510(k) Number | Subject Devices<br>Pending Submission (K162621) | Predicate Device<br>(K935398) | | Intended Use | The Invacare® Tracer® Manual Wheelchair is intended to provide mobility to persons limited to a sitting position. | To provide mobility to persons who may be restricted to a sitting position. | | Indications for Use | The Invacare® Tracer® SX5 Manual Wheelchair and Invacare®<br>Tracer® SX5 Recliner Manual Wheelchair are intended to provide<br>mobility to persons limited to a sitting position. | Persons who may be restricted to a sitting position. | | Design | Tracer SX5<br>(Subject Device) | Tracer Series Manual Wheelchairs<br>(K935398) | | Weight Limit | 250 lbs.<br>300 lbs. | 250 lbs. | | Seat Width 14" to 18"<br>Seat Width 20" to 22" | X-design | X-design | | Cross-brace Configuration | 14", 16", 18", 20" or 22 " | 16.5 ", 18 " | | Seat Width | 14" to 18" with the weight limitation is 250 lbs.<br><br>20" to 22" with the weight limitation is 300 lbs. | 14" to 18" | | Seat Depth | 16" to 18" | 13", 14", 15", 16", 17", 18", 19", 20", 21" or 22" | | Back Style | Fixed | Fixed | | Arm Types | Fixed or adjustable height; desk or full length; removable | Permanent and/or Removable | | Anti-Tippers | Optional | Optional | | Wheel Locks | Push-to-lock and pull-to-lock | Push to lock | | Rear Wheel Sizes | 20", 22", 24 " | 20", 22", 24 " composite | | Caster Sizes | 6 " – 8" | 6 " – 8" | | Front riggings | Swing away | Swing away | {8}------------------------------------------------ | Device | Invacare Tracer SX5 Recliner Manual Wheelchair | Ride Lite 9000 Series Wheelchair | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Subject Device<br>(K162621) | Reference Device<br>(K881951) | | Intended Use | The Invacare® Tracer Manual Wheelchair is intended to provide<br>mobility to persons limited to a sitting position. | The Ride Lite 9000 Series Wheelchair is intended to provide mobility to persons limited<br>to a sitting position. | | Indications for Use | The Invacare® Tracer® SX5 Manual Wheelchair and Invacare®<br>Tracer® SX5 Recliner Manual Wheelchair are intended to<br>provide mobility to persons limited to a sitting position | The Ride Lite 9000 Series Wheelchair is indicated to provide mobility to person ages 12<br>and up (adolescents and adults) with a weight capacity of 350 lb. depending on the seat<br>width. | | Design | | | | Weight Limit | 250 lbs.<br>300 lbs. | 350 lb. | | Seat Width | 16" and 18" | 14" and 18" | | Recline Feature | Reclining | Reclining | | Cross-brace Configuration | X-design | X-design | | Seat Depth | 16" and 18" | 16", 17" and 18" | | Back Style | Reclining (5° – 78° vertical measurement) | Reclining (5° – 78° vertical measurement) | | Arm Types | Fixed or adjustable height; desk or full length; removable | Fixed or adjustable height; desk or full length; removable | | Anti-Tippers | Required | Required | | Wheel Locks | Push-to-lock and pull-to-lock | Push-to-lock and pull-to-lock | | Rear Wheel Sizes | 20", 22", 24" | 20", 22", 24" | | Caster Sizes | 6" – 8" | 6" – 8" | | Front riggings | Swing away | Swing away | # Design Characteristics Comparison – Invacare Tracer SX5 Recliner Manual Wheelchair Note: The reference device is used for the recline feature and technical characteristics comparison. {9}------------------------------------------------ | Device | Invacare® Tracer IV® Heavy Duty/Extra Wide Manual<br>Wheelchair | Tracer Series Manual Wheelchairs | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | 510(k) Number | Subject Device<br>Pending Submission (K162621) | Primary Predicate Device<br>(K935398) | | Intended Use | The Invacare® Tracer® Manual Wheelchair is intended to provide<br>mobility to persons limited to a sitting position. | To provide mobility to persons who may be restricted to a sitting position. | | Indications for Use | The Invacare® Tracer® IV Manual Wheelchair and Invacare®<br>Tracer® IV Heavy Duty/Extra Wide Manual Wheelchair are intended<br>to provide mobility to persons limited to a sitting position. | Persons who may be restricted to a sitting position. | | Design | | | | Weight Limit | 350lbs.<br>450 lbs. | 250 lbs. | | Cross-brace Configuration | X-design | X-design | | Seat Width | 18", 20", 22" or 24" | 16.5", 18" | | Seat Depth | 18" and 20" | 16", 16" | | Back Style | Fixed | Fixed | | Arm Types | Fixed or adjustable height; desk or full length; removable | Permanent and/or Removable | | Anti-Tippers | Optional | Optional | | Wheel Locks | Push to Lock (Adult), Pull to Lock (Hemi) | Push to lock | | Rear Wheel Sizes | 24" Composite; 24" pneumatic flat free insert | 20", 22", 24" composite | | Caster Sizes | 8 x 1 $1/4$ "Urethane<br>8 x 1 $3/4$ "Semi Pneumatic | 6"- 8" * | | Front riggings | Swing away | Swing away | # Design Characteristics Comparison – Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair {10}------------------------------------------------ ## PERFORMANCE DATA ## Non-Clinical Test Non-clinical laboratory testing was performed on the subject Invacare® Tracer Manual Wheelchairs to determine substantial equivalence. The following testing was performed: - ANSI / RESNA WC/Volume 1 2009, Section 1: Determination of Static Stability . - ANSI / RESNA WC/Volume 1 2009, Section 3: Determination of Effectiveness of . Brakes - ANSI / RESNA WC/Volume 1 2009, Section 5: Determination of Dimensions, Mass . and Maneuvering Space - . ANSI / RESNA WC/Volume 1 - 2009, Section 7: Measurement of Seating and Wheel Dimensions - ANSI / RESNA WC/Volume 1 2009, Section 8: Static, Impact and Fatigue Strengths . Tests - RESNA WC-1:2009 Section 11: Test Dummies . - RESNA WC-1:2009 Section 13: Determination of Coefficient of Friction of Test . Surfaces - ANSI / RESNA WC/Volume 1 2009, Section 15: Requirements for Information . Disclosure, Documentation and Labeling - CAL117:2013, Section 1: Flammability Testing . - ISO 8191-1:1987 & 8191-2:1988: Flammability Testing . Verification Testing demonstrated that the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual are substantially equivalent to the marketed predicate and reference devices. ## Biocompatibility Testing The biocompatibility evaluation for the subject Invacare® Tracer® SX5 Manual and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual were conducted in accordance with the FDA Blue Book Memorandum #G95 – 1 "Use of International Standard ISO – 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"' May 1, 1995, and International Standard ISO 10993 - 1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: - AAMI / ANSI / ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro Cytotoxicity {11}------------------------------------------------ - AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests for Skin Irritation ### Animal Study Animal testing was not required for this submission. ## Clinical Testing Clinical testing was not required for this submission. ## CONCLUSIONS The subject devices have the same intended use and similar technological characteristics as the predicate and reference devices. Design Verification Testing support the safety and performance of the subject devices and demonstrate that the subject devices should perform as intended in the specified use conditions. Therefore, the subject Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer SX5 Recline Manual Wheelchair, and Invacare® Tracer IV® Heavy Duty/Extra Wide Manual Wheelchair are substantially equivalent to the predicate and reference devices identified throughout this submission.