(98 days)
Not Found
No
The summary describes a computerized device for measuring vibratory thresholds, but there is no mention of AI, ML, or related concepts in the device description, intended use, or other sections. The predicate devices are also older, non-AI technologies.
No
The device is used for measurement and assessment of nerve function, not for treatment or therapy.
Yes
Explanation: The device is used to measure vibratory thresholds in clinical situations where neuropathies may exist, indicating its use in identifying or characterizing a medical condition.
No
The device description explicitly states it is a "computerized device" and measures the sensory threshold for vibration, implying the use of hardware components to generate and measure vibrations. The predicate devices are also hardware-based vibration testing devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure vibratory thresholds in clinical situations where neuropathies may exist. This is a measurement of a physiological response (sensory perception) in a living patient.
- Device Description: The device measures the sensory threshold for vibration. This is a direct assessment of nerve function in a living patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not process or analyze such specimens.
The device is designed for in vivo measurement of nerve function, not in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.
Product codes
LLN
Device Description
The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration. These thresholds deviate from the normal range in:
Metabolic neuropathies
Neurological disease associated with the workplace Neuropathies due to drug toxicity
Pain assessment
Lesions of the central nervous system
Vibratory testing is also a useful tool in tracking the progression of disease or response to treatment.
The VSA 3000 can also be used in the early detection and clinical evaluation of peripheral nerve dysfunction as well as being a useful tool in tracking the progression of disease or response to treatment.
The various devices used in Vibration Threshold Measurement all operate by means of applying varying amounts of vibration to the skin by the use a controller which allows the operator to vary the amount of vibration delivered.
The patient then indicates awareness of the vibrations either verbally or, in the VSA 3000, by pressing a patient response button. There are various protocols available for testing sensitivity such as Forced choice. Limits, Levels and Staircase, from which the tester may choose.
The VSA 3000 and Case IV both have data processing features while the Bio-Thesiometer and the Vibraton II do not.
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)
Not Found
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
§ 882.1200 Two-point discriminator.
(a)
Identification. A two-point discriminator is a device with points used for testing a patient's touch discrimination.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/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 is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to identify the U.S. Department of Health & Human Services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
MAY 1 1 2017
Mr. Emanuel A. Rosen, M.S., R.Ph. EARE Consulting Service P.O. Box 13009 88112 Eilat ISRAEL
Re: K970180
Trade/Device Name: VSA 3000 Vibratory Sensory Analyzer Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: January 8, 1997 Received: January 17, 1997
Dear Mr. Rosen:
This letter corrects our substantially equivalent letter of April 25, 1997.
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. Ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
Page 2 - Mr. Emanuel A. Rosen
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 Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page 1 of 1
510(k) Number (if known): K970180
Device Name:
VSA-3000 Vibratory Sensory Analyzer
Indications For Use:
For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various neuropathies may exist.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number _ K970/80
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
3
K970180
APR 25 1997
510(K) SUMMARY [as per 21 CFR 807.92]
8 January, 1997
Product: VSA 3000 - Vibratory Sensory Analyzer
Submitted by:
Emanuel A. Rosen - official correspondent for MEDOC LTD., Ramat Yishai, Israel P.O. Box 1309
Eilat, ISRAEL
Tel: International + 972 7 637-9645 Fax: International + 972 7 633-1069
Other commercially available devices:
Bio-thesiometer - Bio-Medical Instruments Co. - available for over 50 years. Vibraton II, Vibration Sensitivity Tester - Sensortek - K863607 approved 1986 Case IV - WR Medical Electronics Co. - K910624 approved in 1993
The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large nerve fiber dysfunction, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration. These thresholds deviate from the normal range in:
Metabolic neuropathies Neurological disease associated with the workplace Neuropathies due to drug toxicity Pain assessment Lesions of the central nervous system
Vibratory testing is also a useful tool in tracking the progression of disease or response to treatment.
Page 1 of 2
0004
4
510(K) SUMMARY [as per 21 CFR 807.92]
Page 2 of 2 8 January, 1997
The VSA 3000 can also be used in the early detection and clinical evaluation of peripheral nerve dysfunction as well as being a useful tool in tracking the progression of disease or response to treatment.
The various devices used in Vibration Threshold Measurement all operate by means of applying varying amounts of vibration to the skin by the use a controller which allows the operator to vary the amount of vibration delivered.
The patient then indicates awareness of the vibrations either verbally or, in the VSA 3000, by pressing a patient response button. There are various protocols available for testing sensitivity such as Forced choice. Limits, Levels and Staircase, from which the tester may choose.
The VSA 3000 and Case IV both have data processing features while the Bio-Thesiometer and the Vibraton II do not.
All the devices are similar in their energy source and design as well as meeting the various standards for clinical safety.
The VSA 3000 is designed and manufactured to meet various domestic and international standards such as:
UL 544; UL 2601-1/1994; EN 60601-1-2.
0005