(70 days)
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.
Disposable Hypodermic Needle Electrode
The provided text is a 510(k) premarket notification letter from the FDA to TECA Corporation regarding their disposable monopolar needle electrodes and MyoJect disposable needle electrodes. This type of document is a regulatory approval, not a description of a scientific study that proves a device meets acceptance criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. It does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used.
- Sample size for a training set.
- How ground truth for the training set was established.
The letter simply states that the FDA has reviewed the 510(k) and found the devices to be substantially equivalent to devices marketed prior to May 28, 1976. This is a regulatory determination, not a scientific study report.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The bird is positioned within a circular border. 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
Mr. James P. Hurlman Manager, Regulatory Affairs TECA Corporation 3 Campus Drive Pleasantville, New York 10570
NOV 20 1997
K973442 Re : TECA Disposable Monopolar Needle Electrodes K973444 K97544
TECA MyoJect Disposable Needle Electrodes Regulatory Class: II Product Code: IKE Dated: September 11, 1997 Received: September 11, 1997
Dear Mr. Hurlman:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to devices marketed in interstate commerce prior to May 28, 1976, the markment 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. James P. Hurlman
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 requlations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Additionally, for questions on Compliance at (301) 594-4659. the promotion and advertising of your devices, please contact Also, please note the Office of Compliance at (301) 594-4639. the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). 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,
Jolly Da
elia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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510(k) Number (if known):
Device Name: Disposable Hypodermic Needle Electrode
Indications For Use:
The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that musche. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug, delivery. Once the physician is satisfied with the location, he/she injects a very. therein via the lumen of the needle.
Note: TECA Corp. does not supply any drugs with needle electrodes nor does TECA Corp. offer for sale any form of drugs.
(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 Sign-Off)
Division of General Restorative Devices
510(k) Number K973442
Prescription Use (Per 21 CFR 801.009)
OR
Over-The-Counter Use___
(Optional Format 1-2-96)
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§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).