(15 days)
Not Found
No
The summary describes standard signal processing and analysis of eye movements based on established parameters, without mentioning AI or ML.
No
The device is described as supporting the identification of balance disorders by recording, viewing, and analyzing eye movements; it does not provide therapy or treatment.
No
Explanation: The device description explicitly states, "This device provides no diagnoses nor does it provide diagnostic recommendations." While it aids in identifying balance disorders by recording, viewing, and analyzing eye movements, the final diagnostic determination is made by the clinician using this information along with other clinical data.
No
The device description explicitly mentions hardware components like IR light sources, IR cameras, and a projector, which are integral to the device's function of capturing eye movements and providing visual stimuli. While software is used for processing and analysis, the device is not solely software.
Based on the provided information, this device is likely an IVD (In Vitro Diagnostic), although it doesn't fit the most common definition of an IVD which involves testing samples taken from the body (like blood or urine).
Here's why:
- Intended Use: The device is intended for "recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects." This analysis of physiological data (eye movements) is used to provide information about a patient's health status (balance disorders).
- Device Description: It describes a system that captures data (eye movements via IR cameras), processes that data (signal processing software), and presents reports of parameters associated with eye movement tests. This aligns with the function of many diagnostic devices.
- Comparison to Predicate Device: The predicate device, K042529 balanceback™ Intuitive VNG System, is a VNG system. VNG systems are generally considered diagnostic tools used to assess vestibular function, which is directly related to balance. While the predicate's IVD status isn't explicitly stated here, the nature of the device and its intended use strongly suggest it falls under the diagnostic category.
- Regulatory Context: While the term "In Vitro Diagnostic" specifically refers to tests performed outside the body, regulatory bodies often categorize devices that provide diagnostic information based on physiological measurements as diagnostic devices. VNG systems are typically regulated as medical devices used for diagnosis.
However, it's important to note the nuance:
- "In Vitro" vs. "In Vivo": The term "In Vitro" means "in glass" or "outside the body." This device is clearly performing measurements on the body (eye movements), which is an in vivo measurement.
- Lack of Traditional IVD Components: It doesn't involve reagents, test strips, or analysis of biological samples in the typical sense of an IVD.
Conclusion:
While the device doesn't fit the strict definition of an In Vitro Diagnostic in the sense of analyzing samples outside the body, its intended use and function as a tool to gather and analyze physiological data to support the identification of a medical condition (balance disorders) places it firmly in the realm of diagnostic medical devices. Regulatory bodies would likely classify it as a diagnostic device, even if it's not a traditional IVD.
Therefore, based on the provided text and the context of VNG systems, it is highly probable that this device is considered a diagnostic medical device, and in a broader regulatory sense, could be grouped under the umbrella of devices used for diagnosis, which often includes IVDs.
N/A
Intended Use / Indications for Use
The balanceback " Mobile iVNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
Product codes (comma separated list FDA assigned to the subject device)
GWN
Device Description
Eye movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system.
Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed.
The patient under examination wears the iVNG goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations.
The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eve movements for the attending clinician. The Mobile iVNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test.
Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and Mobile iVNG software record the patient's eve movements while he/she follows the stimulus.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video (Infrared)
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physicians or clinicians in an appropriate doctor's office or health care facility.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1460 Nystagmograph.
(a)
Identification. A nystagmograph is a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.(b)
Classification. Class II (performance standards).
0
balanceback™ Mobile VNG 510 (k) Submission BBQMS M00100 ISO13485 4.2, 5.0, 7.3
Doc ID: MAR 3 0 2007
510(k) Summary E
070729
| Submitter's Name: | Fall Prevention Technologies, LLC | ||||
|---|---|---|---|---|---|
| Submitter's Address: | 4601 Gateway Circle | ||||
| Kettering, OH 45440 | |||||
| Submitter's Telephone: | 937-434-5455 | ||||
| Contact Name: | Frank Scarpino, PhD | ||||
| Date Summary was | |||||
| Prepared: | December 10, 2006 | ||||
| Trade or Proprietary Name: | balanceback™ Mobile Intuitive VNG System | ||||
| Common or Usual Name: | Mobile VNG | ||||
| Classification Name: | Nystagmograph (21 CFR 882.1460), product code GWN, | ||||
| Class II | |||||
| Predicate Devices: | Device Name510(k) Numberbalanceback™ Intuitive VNG SystemK042529 | Device Name | 510(k) Number | balanceback™ Intuitive VNG System | K042529 |
| Device Name | 510(k) Number | ||||
| balanceback™ Intuitive VNG System | K042529 |
Indications for Use:
The balanceback " Mobile iVNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
Description of the Device and Summary of the Technological Characteristics:
Eye movements have long been known to provide important clues to the identification and location of balance disorders. Physicians and other clinicians employ the VNG system to conduct a set of established, well-known and well-documented eye movement tests. The results of the VNG eye movement tests are combined with other clinical information so that the attending clinicians may render findings on the health of the patient's primary balance sensors and related balance processing system.
Using the Mobile VNG, clinicians guide patients through a series of eye movement tests. A testing battery (i.e., an examination) typically consists of all eight tests supported by the VNG: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, optokinetic, and highfrequency head shake. The attending physician may select one, several, or all tests, and has full flexibility in determining the sequence of the tests to be performed.
The patient under examination wears the iVNG goggles contain one IR light source and one IR camera for each eye. The IR video cameras sense the infrared signal reflected from the eyes and create a continuous monochromatic (grayscale) video motion
Fall Prevention Technologies, LLC
Page E-1
p. 1 of 2
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balanceback™ Mobile VNG 510 (k) Submission
Doc ID: BBQMS_M00100 ISO13485 4.2, 5.0,
picture stream of the eyes. The infrared signal is used because the human eye cannot detect the presence of the infrared signal and therefore this illumination does not create perturbations in measurements of eye movement. Measurements may therefore be made both in the presence and in the absence of visible light, thus providing clinicians with maximum flexibility for making measurements in a wide variety of situations.
The video stream from the IR cameras is digitized and transferred into the memory of the digital computer where signal processing software tracks, records, analyzes and displays eve movements for the attending clinician. The Mobile iVNG system makes appropriate calculations and presents reports of well-known and well-documented parameters associated with each eye movement test.
Some eye tests require the patient to follow a visual stimulus. A projector, controlled by the iVNG hardware, displays stimuli on any light-colored surface, such as a wall or projection screen. The goggles and Mobile iVNG software record the patient's eve movements while he/she follows the stimulus.
Substantial Equivalence:
The balanceback "10 Mobile iVNG device is substantially equivalent to the balanceback TM iVNG Workstation System (Desktop Configuration). This device supports the recording. viewing, and analyzing of horizontal and vertical eve movements to assist in the identification of balance disorders in human subjects. This device uses near identical technology, including the same goggles mounted with video cameras and software handling all the same tests (such as: caloric, positional, Hallpike, gaze, saccades, smooth pursuit, and optokinetic examinations). These devices use the same sampling rate and similar illumination wavelengths. The primary differences are the configuration (from desktop to laptop) and the controls of the control box (additional video management hardware).
Testing:
Various tests of the hardware and software are being performed to verify system specifications. Verification procedures with pass/fail criteria were developed to ensure that the product met all the specified requirements. As part of this verification, a certified body shall conduct tests to determine the conformance of the device to the recognized standards shown below. The device will not be marketed or sold until it has been certified to pass these tests.
- · ANSI Z-136.1 (2000)
- IEC 60601-1 (1988) +A1 (1991) +A2 (1995)
- · IEC 60601-1-1 (2000)
- · IEC 60601-1-2 (2001)
- · UL 60601-1 (2003)
7.3
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Fall Prevention Technologies, LLC % Intertek Testing Services Mr. Neil E. Devine, Jr. 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
MAR 3 0 2007
Re: K070729
Trade/Device Name: balanceback™ Mobile Intuitive VNG System Regulation Number: 21 CFR 882.1460 Regulation Name: Nystagmograph Regulatory Class: II Product Code: GWN Dated: February 14, 2007 Received: March 15, 2007
Dear Mr. Devine:
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
Page 2 -- Mr. Neil E. Devine, Jr.
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 A. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
D Indications for Use Statement
Indications for Use
Ko 70729
510(k) Number (if known):
Device Name:
balanceback TM Mobile Intuitive VNG System
Indications for Use:
The balanceback ™ Mobile Intuitive VNG device is intended for recording, viewing, and analyzing eye movements in support of identifying balance disorders in human subjects. The Mobile iVNG is intended for use only by trained physicians or clinicians in an appropriate doctor's office or health care facility. This device provides no diagnoses nor does it provide diagnostic recommendations.
Prescription Use Yes AND/OR Over-The-Counter-Use No (Part 21 CFR 801 Subpart (Part 21 CFR 801 Subpart D) C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence o Evaluation (ODE) sion Sign-(Division Sign-on)
Division of General, Restorative, and Neurological Dev Fall Prevention Technologies, LLC 510(k) Number Page D-1