(63 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available.
No
The input "Stimus latio OV INTERFERENTIAL" refers to interferential stimulation, which is a therapeutic modality. However, the question asks if this device is a therapeutic device, and the "Device Description" is explicitly stated as "Not Found". Without a device description, it is impossible to confirm if a device actually exists or what its purpose is. Therefore, based solely on the provided information, we cannot definitively say this device is therapeutic.
No
The provided text only contains "Stimus latio OV INTERFERENTIAL" under "Intended Use / Indications for Use," which does not indicate a diagnostic purpose. Interferential current therapy is typically used for pain relief and muscle stimulation, not diagnosis.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that the "Stimus latio OV INTERFERENTIAL" device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use "Stimus latio OV INTERFERENTIAL" strongly suggests a device that applies electrical stimulation. This is characteristic of physical therapy or pain management devices, not devices used to examine specimens from the human body.
- Lack of IVD Indicators: The provided information is completely devoid of any terms or descriptions typically associated with IVDs, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Diagnosing diseases or conditions based on sample analysis
- Laboratory use
- Device Description (Not Found): While the description is missing, the intended use points away from IVD functionality.
- Other Missing Information: The absence of details about image processing, AI/ML, imaging modality, anatomical site, patient age, user/setting, training/test sets, performance studies, and key metrics further supports the idea that this is not an IVD. These details are often relevant for medical devices, but the type of device suggested by the intended use doesn't align with IVD characteristics.
In summary, the intended use "Stimus latio OV INTERFERENTIAL" points towards a device that provides electrical stimulation, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Stimus latio OV INTERFERENTIAL
Product codes
GXY
Device Description
Not Found
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): 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.
Not Found
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
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 1999
Mr. Peter D. Marks Quality Manager MSB Limited Ramsbury Marlborough, Wiltshire SN8 2RB, United Kingdom
K990370 Re: MSB (Electrical Stimulation) Electrodes Trade Name: (Disposable) (TENS/FES/NMES) Regulatory Class: II Product Code: GXY December 22, 1998 Dated: February 8, 1999 Received:
Dear Mr. Marks:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Peter D. Marks
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten Ph.D. M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Allachinent I b
Page 2 of 2
l Jevice Name:
Indications For Usc:
510(k) Number (if known):
Stimus latio OV INTERFERENTIAL ﻠ
(PLEASE DO NOT WRITE BELOW THIS I.INE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of (DRH, Office of Device Evaluation (C
luation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990370
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter I Ise
(Optional Format 1-2-96)