(154 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of a stimulating electrode, with no mention of AI or ML technologies.
No
The device itself is a stimulating electrode, which is an accessory to muscle stimulating devices. It's an interface, not the therapeutic device itself.
No.
The device is described as a "disposable, adhesive, conductive interface" between skin and muscle stimulating devices. Its function is to
transmit electrical signals for muscle stimulation, not to diagnose a condition. The "Summary of Performance Studies" focuses on skin irritation and effectiveness through impedance testing, not diagnostic accuracy.
No
The device description explicitly states it is a "disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface," which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices." It is applied to the patient's skin and interacts with external devices. It does not analyze samples taken from the body.
- Lack of Biological Sample Analysis: There is no mention of analyzing any biological samples (blood, urine, etc.) in the description or intended use.
This device is a medical device, specifically an electrode used for muscle stimulation, but it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.
Product codes (comma separated list FDA assigned to the subject device)
NUW, KZM
Device Description
A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.
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)
Safety & Effectiveness Information: There are no significant differences between the design and manufacture of the cited equivalent devices. Skin irritation was the only potential hazard identified by risk analysis. Patient contact materials have been tested by an independent testing laboratory and found to be "not an irritant" and to meet pertinent requirements of ISO 10993 (Test results on file.) Effectiveness was demonstrated through impedance testing.
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.
K010431, K961141, K921498, K842224/A, K842223, K031998
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 13 2005
Mr. Fray Adib President Myotronics-Noromed, Incorporated 15425 53rd Ave South Tukwila, Washington 98188
Re: K040400
Trade/Device Name: Myo-trode SG Disposable Electrodes Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NUW Dated: June 2,2004 Received: June 4,2004
Dear Mr. Adib:
This letter corrects our substantially equivalent letter of July 20, 2004, regarding the classification of your device which was incorrectly identified as "unclassified."
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 (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 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.
1
Page 2 - Mr. Fray Adib
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.
This letter will allow you to continue 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" (21 CFR 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 (301) 443-6597 or at its internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours.
iu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________ Myo-trode SG Electrodes
Indications for Use:
As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models 54, JS, and BNS-40.
Prescription Use XX (Per 21 CFR 801.109)
OR Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runor
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control. Dental Devices K6404CD
510(k) Number.
3
JUL 2 0 2004
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Myo-trode SG Electrodes,
510(k) # K-040400
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21CFR 807.92(c)
| Submitter: | Myotronics-Noromed, Inc.
15425 – 53rd Avenue South
Tukwila, WA 98188
Telephone (206) 243-4214
Contact: Mr. Fray Adib, President |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 10, 2004 (Revised July 6, 2004) |
| Device Name: | Myo-trode SG disposable, adhesive, electrodes |
| Common name: | Muscle monitoring devices, accessory |
| Classification: | Unclassified, Product code KZM |
| Predicate devices: | Lead-Lok neurostimulation electrodes, K010431,
Uni-Patch TENS Electrodes, K961141, Myotrodes II, K921498,
Model BNS-40, K842224/A, Model J-4, K842223, Model J-5,
K031998 |
Description of the Device: A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.
Intended Use: As a disposable, adhesive, conductive interface between a patient's skin and muscle stimulating devices manufactured by Myotronics-Noromed, Inc. including the Models J4, J5, and BNS-40.
Comparison with equivalent devices: The device is virtually identical to several devices that have previously been legally marketed. K010431 and K961141 (as above) are given as specific examples.
Safety & Effectiveness Information: There are no significant differences between the design and manufacture of the cited equivalent devices. Skin irritation was the only potential hazard identified by risk analysis. Patient contact materials have been tested by an independent testing laboratory and found to be "not an irritant" and to meet pertinent requirements of ISO 10993 (Test results on file.) Effectiveness was demonstrated through impedance testing.
Conclusion: The Myo-trode SG is substantially equivalent to the cited predicate devices, has been certified to meet current standards for irritation, cytotoxicity and allergic potential, and has been tested for effectiveness.