(55 days)
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No
The device description details a conventional electric scooter with standard components and no mention of AI/ML capabilities.
No
The device is described as a transportation vehicle to provide mobility, not as something that treats or diagnoses a medical condition.
No
The device is described as a mobility aid (scooter) for transportation, not for diagnosing medical conditions. Its intended use is to provide mobility.
No
The device description clearly outlines a physical, motor-driven vehicle with a steel frame, transaxle motor drive system, braking system, electronic motor controller, and batteries, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The provided description clearly states that the Invacare Models Lynx and Panther scooters are "motor driven indoor and outdoor transportation vehicles" designed "To provide mobility to persons limited to a seated position."
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids or tissues, or any diagnostic purpose. It is purely a mobility aid.
Therefore, based on the provided information, this device falls under the category of a mobility device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Lynx and Panther scooters is to is provide mobility to persons limited to a seated position.
Product codes
INI
Device Description
The Invacare Models Lynx and Panther scooters are motor driven indoor and outdoor transportation vehicles. The Lynx series of scooters are three-wheeled vehicles while the Panther Series of scooters are four-wheeled vehicles.
All of the scooters products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They all consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. Like most scooters, they include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions. They are all powered by two (2) 12 volt DC batteries, and they all include a variety of options and accessories in order to meet the needs and preferences of various users.
LYNX SERIES SCOOTERS
Lynx SX-3 and SX-3P
As stated above the Lynx series of scooters are three-wheeled vehicles as opposed to the Panther series which are four wheeled. The Lynx series includes three different models These are the Lynx SX-3, Lynx SX-3P and the Lynx LX-3. The models are basically same with a few subtle differences.
The SX 3 and SX 3P differ only in that the SX - 3 includes an "on board" battery charger, which is fixed to the scooter, while the SX - 3P requires a remote and separate battery charger. There are also certain cosmetic differences such as shroud color availability, bumper trim, wood grain decorative decals and the like, which are included on the SX-3 version, but, not on the SX 3P version.
Lynx LX-3
The Lynx LX-3 scooter is similar to the Lynx SX-3 and SX-3P, but, is stightly larger. Like the SX-3 and SX3P, it is a three-wheel vehicle. However, it is designed to be a more heavy duty version scooter, with higher maximum weight capacity than the others in the Lynx series. Where the SX versions are rated for a maximum user weight of 200 lbs., the LX-3 version is rated for a maximum user weight of 250lbs.
PANTHER SERIES
The Invacare Models Panther scooters are motor driven indoor and outdoor four wheeled transportation vehicles. Like the Lynx series of scooters these products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They also consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions, and are powered by two (2) 12 volt DC batteries.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).
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AUG 12 -
510(k) SUMMARY INVACARE CORPORATION'S 510(k) PREMARKET NOTIFICATION MODELS LYNX AND PANTHER MOTORIZED SCOOTERS
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person: Edward A. Kroll Director, TQM and Regulatory Affairs Date Prepared: June 11, 1999
Name of Device and Name/Address of Sponsor: Models Lynx and Panther Motorized Scooters.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 366-9724
Common or Usual Name Scooter
Classification Name Motorized Three Wheel Vehicle
Predicate Devices
Products which are substantially equivalent to the Model Lynx and Panther Scooters are; Invacare Action Cat three wheeled scooter (K962583, 12/18/96) the Mega Motions Inc. Mega 4 scooter (K982144, 4/14/99), and the Pride Mobility Inc. Celebrity (K944939, 11/7/94).
Intended Use
The intended use of the Lynx and Panther scooters is to is provide mobility to persons limited to a seated position.
1
There are two models of Scooters in the Panther series. These are the Panther LX - 4 and the Panther MX - 4. A brief description of each is as follows.
Panther LX - 4
The Panther LX - 4 scooter is basically the same as the Lynx LX - 3 scooter except that the Panther LX -4 is a four wheeled vehicle whereas the Lynx LX - 3 is a three wheeled vehicle. It includes the same transaxle motor drive system, braking system, adjustable seat, upholstery, covers, tiller handle and throttle control as the Lynx LX - 3. Additionally, it incorporates the same Penny & Giles "Solo 60" motor controller and the Lynx version and it has an on board battery charger.
Because the Panther LX - 4 is a four wheel vehicle, the welded steel frame is slightly different than the Lynx version. While the rear section of the frame is basically the same, the front portion differs such that it can accept two front wheels as opposed to one wheel on the Lynx. With these exceptions, the Panther LX - 4 is basically the same as the Lynx LX - 3.
Panther MX - 4
The Panther MX - 4 is the largest scooter in the Invacare Lynx/Panther. Like the Panther LX -4 , the Panther MX - 4 is a four wheeled vehicle. It has the same intended function and use as the others, and consists of the same technology and construction. Like the others, it basically consists of a welded steel frame, transaxle drive mechanism. braking system and seat assembly. Also, it includes a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions.
The Panther MX - 4 differs from the others in the Lynx/Panther series in that it is designed as a heavy duty, more durable scooter with a recommended weight limitation of 400 lbs. maximum. It is larger and heavier than the others, and includes more options and features. As such the frame, transaxle drive and braking system are different from the others and , the Panther MX - 4 scooter is powered using a Penny & Giles model "Solo 110" motor controller.
Substantial Equivalence
Products which are substantially equivalent to the Invacare Action Cat three wheeled scooter (K962583, 12/18/96) the Mega Motions Inc. Mega 4 scooter (K982144, 4/14/99), and the Pride Mobility Inc. Celebrity (K944939, 11/7/94). Each of these products are motorized, three and four wheeled scooters with the same intended function and use of providing mobility to persons limited to a seated position. All are all constructed from the same basic materials and components, all have the same basic operational principles and all use DC batteries as their source of power. Drive mechanisms and braking systems are also similar as are performance specifications for speed, acceleration, deceleration, turning radius and braking.
2
Technological Characteristics and Substantial Equivalence
Device Description
The Invacare Models Lynx and Panther scooters are motor driven indoor and outdoor transportation vehicles. The Lynx series of scooters are three-wheeled vehicles while the Panther Series of scooters are four-wheeled vehicles.
All of the scooters products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They all consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. Like most scooters, they include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions. They are all powered by two (2) 12 volt DC batteries, and they all include a variety of options and accessories in order to meet the needs and preferences of various users.
LYNX SERIES SCOOTERS
Lynx SX-3 and SX-3P
As stated above the Lynx series of scooters are three-wheeled vehicles as opposed to the Panther series which are four wheeled. The Lynx series includes three different models These are the Lynx SX-3, Lynx SX-3P and the Lynx LX-3. The models are basically same with a few subtle differences.
The SX 3 and SX 3P differ only in that the SX - 3 includes an "on board" battery charger, which is fixed to the scooter, while the SX - 3P requires a remote and separate battery charger. There are also certain cosmetic differences such as shroud color availability, bumper trim, wood grain decorative decals and the like, which are included on the SX-3 version, but, not on the SX 3P version.
Lynx LX-3
The Lynx LX-3 scooter is similar to the Lynx SX-3 and SX-3P, but, is stightly larger. Like the SX-3 and SX3P, it is a three-wheel vehicle. However, it is designed to be a more heavy duty version scooter, with higher maximum weight capacity than the others in the Lynx series. Where the SX versions are rated for a maximum user weight of 200 lbs., the LX-3 version is rated for a maximum user weight of 250lbs.
PANTHER SERIES
The Invacare Models Panther scooters are motor driven indoor and outdoor four wheeled transportation vehicles. Like the Lynx series of scooters these products are basic conventional rear wheel drive, rigid frame vehicles that are battery powered, and include various options and accessories depending upon user needs and preferences. They also consist primarily of a welded steel frame, transaxle motor drive system, braking system, electronic motor controller and an adjustable seat. They include a tiller handle for steering, and a throttle control to engage and disengage scooter motion in both the forward and reverse directions, and are powered by two (2) 12 volt DC batteries.
3
PERFORMANCE DATA
The Invacare Models Lynx and Panther scooters meet the applicable requirements specified in the Rehabilitation Engineering Society of North America (RESNA) Standard ANSI/RESNA WC/14 (1991) and ISO Standard ISO 7176: 1993 (E) "ISO Standard, Wheelchairs - Requirements and Test Methods for the Power and Control Systems of Electric Wheelchairs
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines curving upwards and to the right, resembling a bird in flight. The caduceus is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1:2 1999
Mr. Edward A Kroll Director, TOM and Regulatory Affairs Invacare® Corporation One Invacare Way P.O. Box 4028 Elyria, Ohio 44036-2125
Re: K992052
Trade Name: Models "Lynx" and "Panther" metorized scooters Regulatory Class: II Product Code: INI Dated: June 17, 1999 Received: June 18, 1999
Dear Mr. Kroll:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subiect to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -- Mr. Edward A. Kroll
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally. for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
510(k) Number (if known): TBD
Device Name: Invacare Models Lynx and Panther Motorized Scooters
Indications For Use: To provide mobility to persons limited to a seated position..
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) (Division of General Restorative Devices 510(k) Number .