(25 days)
Not Found
No
The description focuses on remote control functionality and interfacing with existing wheelchair electronics, with no mention of AI or ML.
No
The device is a remote control module for an unoccupied powered wheelchair, designed only for motion control and not for any therapeutic intervention or treatment of a medical condition.
No
The device is described as a wireless remote control product for powered wheelchairs, allowing remote motion control when the wheelchair is unoccupied. It does not perform any diagnostic functions related to health conditions or disease.
No
The device description explicitly states it is a "wireless, remote control product" and interfaces with the wheelchair using a "host wheelchair attendant control interface on the motor controller." This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control a powered wheelchair remotely when it is unoccupied. This is a mechanical/electrical control function, not a diagnostic test performed on biological samples.
- Device Description: The device description reinforces its function as a remote control for a wheelchair, interfacing with the wheelchair's electronics.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing diagnostic information.
- Performance Studies: The performance studies mentioned relate to the mechanical and powered wheelchair guidance document, not to the performance metrics typically associated with IVDs (sensitivity, specificity, etc.).
In summary, the Freedom Sciences Version 1.5 Motion Control Module is a device for controlling a powered wheelchair, which falls under the category of medical devices but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Freedom Sciences Version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchair that uses the Invacare MK6 Electronics while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM Version 1.5 is compatible with powered wheelchairs that use Invacare MK6 Electronics.
Product codes
ITI
Device Description
The Freedom Sciences Version 1.5 Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs which use the Invacare MK6 Electronics . Its intended function and use is to allow for remote motion control of the powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM v1.5 allows for remote motion control using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MCM v1.5 was tested as required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles". The Freedom Sciences MCM v1.5 met the applicable required performance criteria and functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
| FreedomSciences |
|---|
| Special 510(k) Premarket Notification |
JUL - 6 2009
Version 1.5 Motion Control Module
1691723
510(k) SUMMARY
Freedom Sciences LLC Version 1.5 Motion Control Module
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Freedom Sciences, LLC The Navy Yard - Quarters M2 4601 South Broad Street Philadelphia, PA 19112
Contact Person: Edward A. Kroll Representative Consultant for Freedom Sciences, LLC
Date Prepared: June 8, 2009
Name of Device and Name/Address of Sponsor
Freedom Sciences Version Motion 1.5 Control Module (MCM)
Freedom Sciences, LLC The Navy Yard - Quarters M2 4601 South Broad Street Philadelphia, PA 19112
Common or Usual Name
Power Wheelchair
Classification Name
Wheelchair, Powered
Predicate Devices
Freedom Sciences LLC Motion Control Module for Powered Wheelchairs (K073330)
1
Image /page/1/Picture/0 description: The image shows a black and white drawing of a cluster of grapes. The grapes are tightly packed together and appear to be ripe. The stem of the grapes is visible at the top of the cluster. The drawing is simple and realistic.
FreedomScience
Special 510(k) Premarket Notification
Version 1.5 Motion Control Module
Intended Use
The intended use of the Freedom Sciences Version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchair that uses the Invacare MK6 Electronics while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Freedom Sciences Version 1.5 Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs which use the Invacare MK6 Electronics . Its intended function and use is to allow for remote motion control of the powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM v1.5 allows for remote motion control using high level motion control commands. It interfaces to the power wheelchair using the host wheelchair attendant control interface on the motor controller. This method of interfacing with the powered wheelchair retains all configured safety interlocks inherent to the host motor controller itself and is the standard means for integrating auxiliary input devices.
B. Substantial Equivalence
The Freedom Sciences MCM v1.5 Motion Control Module is substantially equivalent to the Freedom Sciences Motion Control Module (MCM) for powered wheelchairs (K073330).
Performance Data
The MCM v1.5 was tested as required by FDA's July 26, 1995, draft publication entitled "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three- Wheeled Vehicles". The Freedom Sciences MCM v1.5 met the applicable required performance criteria and functioned as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 6 2009
Freedom Sciences, LLC % Spectre Solutions, Incorporation Mr. Edward A. Kroll President 5905 Fawn Lane Cleveland, Ohio 44141
Re: K091723
Trade/Device Name: Freedom Sciences, LLC Version 1,5. Motion Control
Module (MCM)
Regulation Number: 21 CFR 890.3860 Regulation Name: Powered Wheelchair Regulatory Class: II Product Code: ITI Dated: June 8, 2009 Received: June 11, 2009
Dear Mr. Kroll:
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 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
3
Page 2-Mr. Edward A. Kroll
and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
for Dr. Doodr x/clor
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): TBD
Device Name: Freedom Sciences, LLC Version 1.5 Motion Control Module (MCM)
Indications for Use:
The intended use of the Freedom Sciences version 1.5 Motion Control Module is to allow for remote motion control of a powered wheelchairs while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM Version 1.5 is compatible with powered wheelchairs that use Invacare MK6 Electronics.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091723
Page 1 of 1