(48 days)
Not Found
No
The description focuses on using a force platform and virtual reality stimuli to assess and train balance, without mentioning any AI or ML algorithms for analysis, diagnosis, or treatment planning. The "tailored rehabilitation program" is described as being designed based on identifying the patient's weakness using different stimuli, which doesn't necessarily imply AI/ML.
Yes
The device is clearly indicated for "Rehabilitation" of patients with balance disorders, vertigo, or instability and describes the process of designing a "tailored rehabilitation program."
Yes
The device performs a functional assessment of patients with balance disorders, identifying weaknesses and evaluating performance through posturographies. This assessment is used to design tailored rehabilitation programs, indicating its role in diagnosing or characterizing a patient's condition.
No
The device description explicitly lists multiple hardware components including a force platform, virtual reality goggles, head tracker, safety frame, harness, and a computer, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- BRU Function: The Balance Rehabilitation Unit (BRU) assesses and trains patients' balance by measuring their physical responses to various stimuli (visual, somatosensorial, vestibular) using a force platform and other components. It does not analyze biological samples.
- Intended Use: The intended use is for "Balance Evaluation and Rehabilitation," which is a functional assessment and training process, not an in vitro diagnostic test.
- Device Description: The components and how they are used (force platform, VR goggles, head tracker) are all focused on interacting with the patient's physical body and responses, not analyzing biological specimens.
Therefore, the BRU falls under the category of a medical device used for assessment and therapy, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Balance Evaluation and Rehabilitation
The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.
Product codes
LXV, KHX
Device Description
The Balance Rehabilitation Unit (BRUTM) is composed of a static force platform, virtual reality projection goggles, a head tracker for sensing head movements, a safety frame, a harness, an accessory kit for different exercises, and a computer to generate stimuli.
The system performs a sequence of posturographies while the patient is receiving different visual stimuli (images displayed on the projection goggles). By using the different stimuli to identify the patient's weakness a tailored rehabilitation program with specific perceptual cues can be designed for each patient.
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)
A clinical study has confirmed the clinical efficacy of the Balance Rehabilitation Unit (BRUTM).
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
N/A
0
WEIDMANN
Developments for a better life
FEB 2 6 2007
510(k) Summary
(per 21 CFR 807.92)
I. Applicant Medicaa (Uruguay) S.A. Miraflores 1476 11500, Montevideo Uruguay Phone: +(598) 2 601 3998 Fax: +(598) 2 601 3839
Contact Person: Rodolfo Oppenhemier, CEO roppenheimer@medicaa.com
December 21, 2006 Date Prepared:
II. Device Name
BRUTM - Balance Rehabilitation Unit Proprietary Name: Common/ Usual Name: Apparatus, vestibular analysis Platform, force-measuring Classification Name: Unclassified / Force-measuring platform Regulation Number: Unclassified / 890.1575 Product Codes: LXV / KHX Classification: Unclassified / 1、 Ear, Nose& Throat / Physical Medicine Classification Panel:
III. Predicate Device
The Balance Rehabilitation Unit (BRU™) is substantially equivalent to the Balance Manager from Neurocom International, Inc. The Balance Manager was cleared by the FDA on August 4, 1995 under 510(k) K946229.
IV. Intended Use of the Device
Balance Evaluation and Rehabilitation
The Balance Rehabilitation Unit (BRU™) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.
V. Description of the Device
The Balance Rehabilitation Unit (BRUTM) is composed of a static force platform, virtual reality projection goggles, a head tracker for sensing head movements, a safety frame, a harness, an accessory kit for different exercises, and a computer to generate stimuli.
1
REEDECK
Developments for a better life
The system performs a sequence of posturographies while the patient is receiving different visual stimuli (images displayed on the projection goggles). By using the different stimuli to identify the patient's weakness a tailored rehabilitation program with specific perceptual cues can be designed for each patient.
Summary of the Technical Characteristics VI.
The Balance Rehabilitation Unit (BRUTM) performs an assessment of the impaired postural skills of patients through a series of posturographies with different sensory stimuli. The posturographies are performed using a forcemeasuring platform, which helps the physician evaluate the patient's performance. The sensory stimuli used with the Balance Rehabilitation Unit (BRUTM) include visual stimuli, through virtual reality projection goggles, somatosensorial stimuli, and vestibular stimuli.
Testing VII.
A clinical study has confirmed the clinical efficacy of the Balance Rehabilitation Unit (BRUTM).
Safety & Effectiveness VIII.
There are no substantial differences between the Balance Rehabilitation Unit (BRUTM) and the predicate device. They have the same intended use and similar technological characteristics.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicaa (Uruguay) S.A. C/O Ian P. Gordon Vice President Emergo Group, Inc. 1101 South Capital Texas Hwy, Suite F254 Austin, TX 78746
FEB 2 6 2007
Re: K070085
Trade/Device Name: Balance Rehabilitation Unit (BRUTM) Regulation Number: Unclassified Regulation Name: Vestibular analysis apparatus Regulatory Class: Unclassified Product Code: LXV and KHX Dated: December 26, 2006 Received: January 10, 2007
Dear Mr. Gordon:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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.
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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4. Indication for Use Statement
510(k) Number (if known):
Device Name:
Balance Rehabilitation Unit (BRUTM)
Indications for Use:
Balance Evaluation and Rehabilitation
The Balance Rehabilitation Unit (BRUTM) is a system that enables the functional assessment and training/retraining of patients with balance disorders, vertigo or instability.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Millane
(Divi: n a Sign-Off) (Division of General, Restorative, and Neurological Devices
510(k) Number
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