(206 days)
The intended use of the Freedom Sciences Motion Control Module is to allow for remote motion control of a powered wheelchair while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The Freedom Sciences Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs. Its intended function and use is to allow for remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM allows for remote motion control of a differential drive power wheelchair 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.
The provided 510(k) Premarket Notification for the Freedom Sciences LLC Motion Control Module (K073330) indicates that the device's performance was evaluated against a specific FDA guidance document. However, it does not provide specific quantitative acceptance criteria or reported device performance metrics in a table format. Instead, it states that the device "met the applicable required performance criteria and functioned as intended."
Based on the provided document, here's an analysis of the study and the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Overall Performance | "Met the applicable required performance criteria" as outlined in FDA's July 26, 1995, draft publication: "Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three-Wheeled Vehicles." | "Functioned as intended" and "met the applicable required performance criteria." |
Note: The document only provides a high-level statement that the criteria were met, without detailing the specific criteria or quantitative results.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that the MCM "was tested as required" by the FDA guidance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide information on the number of experts, their qualifications, or how ground truth was established for any test set. Given the nature of the device (a remote control for an unoccupied wheelchair), it is unlikely that "expert ground truth" in the clinical imaging sense would be applicable. The testing would likely involve engineering and functional performance evaluations.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This type of method (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or subjective assessments, which do not appear to be central to the performance testing of this device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported. This type of study is relevant for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance, which is not applicable to this device.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device itself is designed for standalone operation (remote control of an unoccupied wheelchair by a human operator, but the device itself is "standalone" in automating the control signals) without human-in-the-loop performance in the sense of an AI assisting human decision-making. The performance data section refers to general compliance with a guidance document for wheelchairs, implying a standalone functional assessment of the device's ability to control the wheelchair remotely. However, the document does not explicitly describe a "standalone" algorithmic performance study in the context of typical AI/software device submissions.
7. Type of Ground Truth Used
The document does not explicitly state the "type of ground truth" used. For this type of device, "ground truth" would likely be defined by the successful execution of remote control commands, adherence to safety protocols (e.g., not allowing control while occupied), and compliance with electrical and mechanical safety standards specified in the referenced FDA guidance. This would be functional verification rather than clinical "ground truth" like pathology or outcomes data.
8. Sample Size for the Training Set
The document does not provide any information about a training set. This is not an AI/machine learning device, so the concept of a "training set" is not applicable in the typical sense.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/machine learning device, there is no training set mentioned, and therefore, no ground truth establishment for a training set.
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JUN 2 0 2008
510(k) Premarket Notification
Freedom. In Motion Control Module
510(k) SUMMARY
Freedom Sciences LLC 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: November 15, 2007
Name of Device and Name/Address of Sponsor
Freedom Sciences Motion Control Module (MCM)
Freedom Sciences, LLC The Navy Yard - Quarters M2 . 4601 South Broad Street Philadelphia, PA 19112
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Common or Usual Name
Power Wheelchair
Classification Name
Wheelchair, Powered
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510(k) Premarket Notification
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Freedom ... Motion Control Module
Predicate Devices
Dynamic Systems, Inc. PHC-2 Peachtree Proportional Head Control Unit (K972147) and the Sunrise Medical Breath Control (K983520).
Intended Use
The intended use of the Freedom Sciences MCM is to enable the remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use while the person is seated in the wheelchair.
Technological Characteristics and Substantial Equivalence
A. Device Description
The Freedom Sciences Motion Control Module for powered wheelchairs is a wireless, remote control product designed for use with powered wheelchairs. Its intended function and use is to allow for remote motion control of a powered wheelchair only while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
The MCM allows for remote motion control of a differential drive power wheelchair 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
Products which are substantially equivalent to the MCM are the Dynamic Systems, Inc. PHC-2, Peachtree Proportional Head Control Unit (K972147) and the Sunrise Medical Breath Control (K983520).
Performance Data
The MCM 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
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FreedomObian 18: Motion Control Module
510(k) Premarket Notification
Motorized Three- Wheeled Vehicles". The Freedom Sciences MCM met the applicable required performance criteria and functioned as intended.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Freedom Sciences, LLC % Spectre Solutions, Inc. Mr. Edward A. Kroll Representative Consultant 5905 Fawn Lane Cleveland, Ohio 44141
JUN 2 0 2008
Re: K073330 Trade/Device Name: Freedom Sciences, LLC Motion Control Module (MCM)
Regulation Number: 21 CFR 890.3860 Regulation Name: Powered wheelchair Regulatory Class: Class II Product Code: ITI Dated: June 2, 2008 Received: June 4, 2008
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 such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Edward A. Kroll
This letter will allow you to begin marketing your device as described in your Section 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson 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): 彌爾 (073330
Device Name: Freedom Sciences, LLC Motion Control Module (MCM)
Indications for Use:
The intended use of the Freedom Sciences Motion Control Module is to allow for remote motion control of a powered wheelchair while the wheelchair is unoccupied. It is not intended for use when a person is seated in the wheelchair.
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)
Nilfeah for mxs
(Division of General, Restorative, and Neurological Devices
510(k) Number K073330
Page 1 of 1
§ 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).