(217 days)
Not Found
No
The summary describes electrodes and accessories for recording muscle activity, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as being used for "recording muscle activity for electromyography applications," which is a diagnostic purpose, not a therapeutic one.
Yes
The device is described as "intended for use in recording muscle activity for electromyography applications," which is a diagnostic procedure used to evaluate muscle and nerve function.
No
The device description explicitly states it consists of "needle electrodes and accessories," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "recording muscle activity for electromyography applications." This involves measuring electrical signals from the body, which is an in vivo (within the living body) process, not an in vitro (outside the living body) process.
- Device Description: The device consists of "needle electrodes and accessories to be used in eletromyographic applications." Electrodes are used to interface with the body to measure electrical signals.
- Lack of IVD Indicators: There is no mention of analyzing samples like blood, urine, tissue, or other bodily fluids, which are characteristic of IVD devices.
Therefore, the SLE EMG Electrodes and Accessories are intended for in vivo diagnostic use (specifically, electromyography), not in vitro diagnostic use.
N/A
Intended Use / Indications for Use
SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.
Product codes
IKT
Device Description
The SLE EMG Electrodes and Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K973529, K953887, K953886, K932059, K931966, K912282, K870795
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K 981004
SLE EMG Electrodes and Accessories
OCT 21 1998
510(K) SUMMARY
-
A. Manufacturer: Specialised Laboratory Equipment Limited Twin Bridges Business Park 232 Selsdon Road South Croydon Surrey CR2 6PL United Kingdom
Ferguson Medical Submitted By: Consultant to Specialised Laboratory Equipment Limited -
B. Contact Information: Phone : 44 181 681 1414 44 181 649 8570 FAX:
-
C. Classification Name: Electrode, needle, diagnostic electromyograph Common/Usual Name: Electrode, needle electrode, etc.
-
D. Classification Number: 89IKT
Proprietary Name:
- E. Substantial Equivalence: Neuroline Disposable Concentric Needle Electrode, Medicotest A/S (K973529), Re-usable Concentric Needle, Chalgren (K953887), Re-usable Monopolar Needle, Ent., Inc. Chalgren Ent., Inc. (K953886), Needle Electrodes and Disposable Scalp Electrode, Dantec Medical, Inc. (K932059), Dantec Disposable Concentric Needle, Dantec Medical, Inc. (K931966), Disposable Monopolar Needle Electrode, Var Models, Chalgren (K912282), and Ent., Inc. EMG Electrodes and
1
Extension Cords, Nihon Koden, Inc. (K870795), and others.
- EMG Electrodes and Device Description: The SLE F. Accessories device consists of a variety of needle electrodes and accessories to be used in eletromyographic applications.
- The SLE EMG Electrodes and Accessories G. Intended Use: device is intended to be used in recording muscle activity for electromyography applications.
- Technological Characteristics: The design, materials, H. composition, packaging, and other chemical technological characteristics of the subject device are considered to be the same as the technological characteristics of the predicate devices.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Specialized Laboratory Equipment Limited Mr. Frank Ferguson Official Correspondent c/o Ferguson Medical 2581 California Park Drive, Suite 269 Chico, California 95928
Re: K981004 SLE EMG Electrodes and Accessories Trade Name: Regulatory Class: II Product Code: IKT July 6, 1998 Dated: Received: July 24, 1998
Dear Mr. Ferguson:
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 Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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
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Page 2 - Mr. Frank Ferguson
Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4595. 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 requlation 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. Whitton, Ph. D.
Witten, Ph.D., M.D. Celia M. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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10(k) Number (If known): K 98/00 4 SLE EMG Electrodes and Accessories Pevice Name: Indications For Use:
SLE EMG Electrodes and Accessories are intended for use in recording muscle activity for electromyography applications.
(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 of General Restorative Devices
510(k) Number K981004
!
rescription Use (Per 21 CFR 801.109)