(20 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, or related concepts, and the device description is not available to provide further clues.
Yes
The device is intended for TENS (Transcutaneous Electrical Nerve Stimulation) and Neuromuscular Stimulation, which are therapeutic applications used for pain relief and muscle rehabilitation.
No
The intended use statement specifies "For TENS and Neuromuscular Stimulation," which are therapeutic applications, not diagnostic ones. Diagnostic devices are used to identify or detect medical conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components for TENS and Neuromuscular Stimulation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For TENS and Neuromuscular Stimulation." This describes a device that applies electrical stimulation to the body for therapeutic purposes, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
IVD devices are specifically designed to perform tests on samples taken from the body. This device's intended use clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
For TENS and Neuromuscular Stimulation
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
Prescription Use
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 logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 9 2004
Ira Duesler Director, RA/QA ConMed Corporation 525 French Road Utica. New York 13502
Re: K041953
Ko+1755
Trade/Device Name: ConMed™ VersaStim Neuromuscular Stimulator/TENS Regulation Number: 21 CFR §882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: July 19, 2004 Received: July 20, 2004
Dear Mr. Duesler:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn o ready fee device is substantially equivalent (for the indications felerenced above and nave determined in the enclicate devices marketed in interstate 101 use stated in the encrosare) to regars) to regars and the Medical Device Amendments, or to commerce provision to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have occh recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rist 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 IT your device is elassified (500 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD may oc subject to back adderal 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 I lease be advisou that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I odolar states and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFN in the quality systems (DF OFF Part 820); and if applicable, the electronic form in the quarty by evens (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 – Ira Duesler
This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the Cases of a lot of a lot stick assisselesses of your device to a This letter will anow you to begin makemig your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, per premarket notification. The PDA midning of succement or 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
s and the may be and cases of the collection and any and on anython entitle If you desire specific advice for your de vice on on on on on any mease note the regulation entitled, would of the may obtain Comact the Office of Comphance at (301) vification" (21CFR Part 807.97). You may obtain " Misoranding by reletence to premarket to title active act from the Division of Small
other general information on your responsibilities under the Act from the (800) 638, 00 other general information on your responsion in the mander (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the last demansman broke Manufacturers, International and Consultier Provisions Pages/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark N. Milburn
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ConMed Corporation Special 510(k) Application Attachment 2 Page 1 of 1 Revised August 5, 2004
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
ConMed Neuromuscular Stimulation/TENS Electrodes _____________________________________________________________________________________________________________________________ Device Name:
Indications For Use:
For TENS and Neuromuscular Stimulation
Prescription Use __ × (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 N. Mellauso
Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K041953