(266 days)
Not Found
No
The summary describes a device that measures vibration perception threshold and does not mention any AI or ML components.
No
The device measures vibration perception threshold to quantify the loss of sensation and monitor pathology progression, but it does not treat or cure any condition.
Yes
Explanation: The device is designed to measure the threshold of vibration perception to identify patients with sensory neuropathy and quantify the loss of sensation and monitor the progression of pathology, which are all diagnostic activities.
No
The device description explicitly states it is an "instrument" and a "digital device" designed to provide a "quantitative measurement of vibration perception threshold (VPT)". This strongly implies the presence of hardware components to generate and measure vibration, not just software for analysis or display. The predicate device is also described as a "Vibrameter," further suggesting a hardware-based device.
Based on the provided information, the VPT Meter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the VPT Meter clearly states it is an "instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects." It directly interacts with the patient's body to measure a physiological response (vibration perception).
- The device description focuses on measuring a physical sensation. It quantifies the loss of sensation and monitors the progression of pathology based on this measurement. This is a direct physiological assessment, not an analysis of a biological sample.
Therefore, the VPT Meter falls under the category of a medical device used for physiological measurement and assessment, not an IVD.
N/A
Intended Use / Indications for Use
The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.
Product codes
LLN
Device Description
The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.
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)
Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious.
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 and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Ruben G. Zamorano President Xilas Medical, Inc. 12665 Silicon Drive San Antonio, Texas 78249
11 2017 MAY
Re: K030829
Trade/Device Name: Vibration threshold measurement device Regulation Number: 21 CFR 882.1200 Regulation Name: Two-point discriminator Regulatory Class: Class I Product Code: LLN Dated: September 30, 2003 Received: October 2, 2003
Dear Mr. Zamorano:
This letter corrects our substantially equivalent letter of December 5, 2003.
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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
1
Page 2 - Mr. Ruben G. Zamorano
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.
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/ResourcesforYou/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
Indications for Use
510(k) Number (if known): K030829
Device Name: _VPT Meter
Indications For Use:
The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.
Presctiption Use XX (Part 2) CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| K(k) Number | 1030829 |
| Page | 1 of 1 |
3
Image /page/3/Picture/0 description: The image shows the logo for Xilas Medical, Inc. along with the date DEC - 5 2003. The logo features a tree on the left side and the company name in a stylized font. The company name is underlined.
1/2
September 30, 2003
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K030829.
-
- Submitter:
Xilas Medical Inc. (formerly Salix Medical, Inc.) 12665 Silicon Drive San Antonio, Texas 78249
- Submitter:
Name of Device: 2.
Vibration Perception Threshold (VPT) Meter
3. Predicate Device Information:
The VPT Meter is similar to the following predicate device: 1) Vibrameter, Somedic AB, Stockholm, Sweden (510(k) number K843486).
4. Device Description:
The Xilas Medical VPT Meter is designed to identify patients with sensory neuropathy. These patients have lost sensation and the "gift of pain" from their extremities or elsewhere. The instrument provides a quantitative measurement of vibration perception threshold (VPT). The digital device allows the clinician to quantify the loss of sensation, initially to establish a baseline loss of sensation and subsequently monitor the progression of established pathology.
5. Intended Use:
The VPT Meter is an instrument designed to measure simply and accurately the threshold of appreciation of vibration in human subjects.
4
K030829 2/2
Substantial Equivalence: 6.
The Xilas Medical VPT Meter is substantially equivalent to the Vibrameter, a product produced by Somedic AB, Stockholm, Sweden.
- Both devices consist of a control box and a handheld vibration apparatus. The ● handheld apparatus on both devices is similar in size, shape and weight and both use a tip to transfer vibrations to the patients skin.
- Both devices have a digital display and easy access to the control mechanism on ● the face of the box.
- Both devices are free standing and independent and do not require a computer ● interface to achieve the desired output.
- Both devices vibrate at a similar frequency and vibration displacement. ●
- Both devices ramp up power to the handheld vibration apparatus, which changes ● the amplitude of the vibration displacement at the tip.
- Both devices are dependent on patient acknowledgement of the level where ● vibration is being felt.
- The Vibrameter measures in microns and the VPT Meter measures in volts, . however in the VPT Meter User's Manual a conversion graph is provided that represents the relationship between microns and volts.
- Both devices are easy-to-use and non-invasive. .
- Both devices are designed to be used as a clinical assessment tool by health care . professionals to evaluate peripheral sensory neuropathy on the upper and lower extremities.
7. Conclusions:
The Xilas Medical VPT Meter has the same intended use and similar characteristics to the Somedic AB Vibrameter. Testing of the device (included with this submission) demonstrates the VPT Meter to be both safe and efficacious. Therefore, the VPT Meter is substantially equivalent to the predicate product, the Vibrameter.