(154 days)
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.
A disposable cutaneous TENS stimulating electrode consisting of a metal snap connector, adhesive foam and hydrogel (solid gel) conductive surface.
The provided text describes the Myo-trode SG disposable electrodes and its FDA 510(k) submission. It includes information about safety and effectiveness, but it does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices and addressing potential hazards like skin irritation.
However, I can extract the information that is present and indicate where requested information is not available in the given text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Not an irritant | Patient contact materials tested by an independent testing laboratory and found to be "not an irritant." |
| Biocompatibility: Cytotoxicity | Certified to meet current standards for cytotoxicity (implied passing). |
| Biocompatibility: Allergic Potential | Certified to meet current standards for allergic potential (implied passing). |
| Effectiveness: Conductive Interface | Effectiveness demonstrated through impedance testing. (Specific thresholds or quantitative results for impedance are not provided) |
| Substantial Equivalence: Design and Manufacture Similarity | "No significant differences between the design and manufacture of the cited equivalent devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). The document mentions "an independent testing laboratory" for biocompatibility testing, but no further details.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable/Not specified. The assessment primarily relied on laboratory testing (biocompatibility, impedance) rather than expert-established ground truth for a test set in the traditional sense of clinical or diagnostic studies.
4. Adjudication Method for the Test Set
- Not applicable/Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study (MRMC) is generally relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. The Myo-trode SG is a disposable electrode for muscle stimulation, not a diagnostic device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Not applicable. This device is a physical electrode, not software or an algorithm with standalone performance.
7. The Type of Ground Truth Used
- Laboratory test results: Biocompatibility testing (irritation, cytotoxicity, allergic potential) was performed against established standards (ISO 10993).
- Impedance testing: Used to demonstrate effectiveness as a conductive interface.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This device is a physical product and does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8)
{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
{2}------------------------------------------------
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 SouthTukwila, WA 98188Telephone (206) 243-4214Contact: 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.
§ 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).