The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies. This process is known as electromyography (EMG).

Device Description

The disposable monopolar needle electrode is designed for single use only. The stainless steel needle electrode is insulated with a special PTFE coating to ensure minimal friction between the needle and the tissue. The tip of the conically sharpened needle is uninsulated and serves as recording area. The sterile electrode is individually sealed and delivered in sets of 48 pcs. In a hygienic and practical package ready for use package. The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the K990375 device, addressing the requested information:

Device: 13 S Series Disposable Monopolar Needle Electrodes

Description of Device: The device is a disposable, single-use monopolar needle electrode used for electromyography (EMG). It consists of a PTFE-coated stainless steel needle with an uninsulated tip for recording, a larger hub for ergonomic grip, and a connector for electrical signal transfer.

Acceptance Criteria and Study Details

This 510(k) submission is for a Special 510(k) Notification, indicating modifications to a previously cleared predicate device (13 R Series Disposable Monopolar Electrodes, K915741). The primary goal of a Special 510(k) is to demonstrate that the changes do not adversely affect the safety or effectiveness of the device. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on demonstrating substantial equivalence to the predicate device, rather than establishing novel performance metrics.

The "acceptance criteria" are implied to be that the enhanced device performs at least as well as the predicate device in relevant non-clinical tests and that the changes do not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and the Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied: Substantially Equivalent to Predicate)	Reported Device Performance	Comments
Non-Clinical Performance	Enhanced device performs as the predicate device. This encompasses mechanical, electrical, and material properties relevant to its intended use (recording unit potentials in skeletal muscles, spontaneous activity, interference patterns, and conduction velocity studies).	"Verifications results shows that the enhanced device performs as its predicate device."	This is a general statement indicating the device passed all non-clinical tests designed to show equivalence. Specific numerical performance data is not provided in this summary.
Biocompatibility	Materials in contact with the patient (specifically the Whitford PTFE coat, Xylan 8400/3349) must be biocompatible per ISO 10993 standards and USP 23. No cytotoxicity, significant intracutaneous reaction, or delayed contact hypersensitivity.	"The results of these tests shows that the material Whitford PTFE coat, xylan 8400/3349 have passed all tests."	Tests performed: In Vitro Cytotoxicity Test (USP 23/ISO 10993-5 Elution Test), Intracutaneous Test (ISO 10993-10:1995), Guinea Pig Maximization Test.
Sterilization	Process consistently achieves predetermined specifications for sterility (EN 556). No compromise in sterility due to product changes.	"It is concluded that the process consistently with predetermined specifications. The specified requirements for sterility (EN 556) are met."	Sterilization method is Ethylene Oxide (ETO) at a vendor plant.
Safety/Efficacy Concerns	The changes (e.g., coating material, hub design, connector size, tip exposure process, enhanced assortment of sizes) must not introduce any new safety or efficacy concerns compared to the predicate.	"The changes in the new device doesn't effect any safety or efficacy concerns."	This is a declarative statement based on the overall assessment of the modifications and verification testing.
Mechanical Pull Strength	20 N (same as predicate)	20 N	Explicitly stated as unchanged.
Exposed Length	0.8 mm (same as predicate)	0.8 mm	Explicitly stated as unchanged.
Recording Area	0.3 mm sq (same as predicate)	0.3 mm sq	Explicitly stated as unchanged.

2. Sample Size Used for the Test Set and the Data Provenance:

Test Set Sample Size: The submission does not specify numerical sample sizes for non-clinical testing. It generally refers to "Verifications results" and "The results of these tests."
Data Provenance: The data is generated from laboratory testing (e.g., mechanical testing, biocompatibility studies, sterilization validation) performed by Medtronic Functional Diagnostics A/S and/or its vendors. This is prospective testing conducted specifically for this submission. The country of origin of the data is implicitly Denmark, where the manufacturer is located, and potentially the locations of the testing facilities (e.g., Maersk Medical A/S for sterilization).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This device is not an AI/ML diagnostic or image-based device. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation or diagnosis is not applicable.
The "ground truth" for the non-clinical tests (e.g., biocompatibility, mechanical strength) is established by the specifications and standards (e.g., ISO 10993, EN 556) themselves and the results of the validated test methods. The "experts" would be the qualified laboratory personnel conducting and interpreting these tests, whose qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This submission is for a medical device (needle electrode) used to facilitate a diagnostic procedure, not to perform the diagnosis itself or interpret complex data.
The submission explicitly states: "Clinical evaluation not performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is not an algorithm or AI system. It is a physical medical device.

7. The Type of Ground Truth Used:

For non-clinical performance (mechanical, electrical, material): Engineering specifications, standardized test methods, and compliance with recognized industry standards (e.g., for pull strength, exposed length, recording area).
For biocompatibility: Results from standardized in vitro and in vivo biological tests (e.g., cytotoxicity, intracutaneous, sensitization tests) as per ISO 10993 and USP 23, where biocompatibility is the 'ground truth'.
For sterility: Validation of the sterilization process demonstrating a Sterility Assurance Level (SAL) of 10^-6, compliant with EN 556.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set was used.

Summary

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K990375

510(k) SUMMARY

as required per 807.92(c)

1. Submitters Name, Address:

Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK - 2740 SKOVLUNDE DENMARK

Tel: (45 ) 44 57 95 02 Fax: (45) 44 57 90 10 Contact person for this submission: Ann-Christine Jönsson Date submission was prepared: 5th February, 1999

2. Trade Name, Common Name and Classification Name:

13 S Series Disposable Monopolar Needle Electrodes A. Trade Name:

B. Classification Name: Needle Electrode

C. Common name, Class and Regulation Number:

Common Name	Medtronic Code	Class	Regulation Number
Disposable Monopolar Needle Electrode, DMF25	9013S0611	II	21 CFR 882.1350
Disposable Monopolar Needle Electrode, DMN25	9013S0621	II	21 CFR 882.1350
Disposable Monopolar Needle Electrode, DMF37	9013S0631	II	21 CFR 882.1350
Disposable Monopolar Needle Electrode, DMN37	9013S0641	II	21 CFR 882.1350
Disposable Monopolar Needle Electrode, DMN50	9013S0651	II	21 CFR 882.1350
Disposable Monopolar Needle Electrode, DMN75	9013S0661	II	21 CFR 882.1350

3. Predicate Device Identification:

The new 13 S Series Disposable Monopolar Needle electrodes are substantially equivalent to previously marketed 13 R Series Disposable Monopolar Needles electrodes, which were previously determined by FDA to be substantially equivalent the 8th of December, 1992, K915741.

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COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

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4. Device Description:

The electrodes consists of a PTFE coated needle with an exposed area in the tip. The PTFE coating eases insertion into tissue and isolates the needle electrical. There are two diameters of the needles. In the non-invasive end of the device there is attached a connector, which enables the electrical signal to be transferred to the cable.

5. Intended Use:

6. Table of Device Similarities and differences to predicate device:

Manufacturer	Dantec Medical A/S	Medtronic FunctionalDiagnostics A/S	Comments todifferences
510(k) number	Predicate devices13 R Series DisposableMonopolar Electrodesand13P82 Disposable ElectrodeCable- K 915741	Modified Device13 S Series DisposableMonopolar Electrode- K number to be decided- K 990375	-

Intended Use /Indication of Use	Records unit potentials inskeletal muscles, spontaneousactivity, interference patternsand conduction velocity studies.	Same	--
IntendedPopulations	Pediatric to Adults	Same	--
Sterilization	Gamma irradiation (originally)but it was changed to EthyleneOxid via our change controlsystem and this was filedinternally.	Ethylene Oxid	Today it is the same, averification report ofthe sterilization isenclosed under flap PQ.

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COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

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Special 510(k) Notification 13 S Series of Disposable Monopolar Needle

SAL level	10-6	Same	--
Packaging	48 pieces individually blisterpacked electrodes in each box.	Same	--
Uses	Single Use	Same	--
Offered Sizes	0.35 x 20 mm0.35 x 30 mm0.45 x 30 mm0.45 x 40 mm0.45 x 50 mm0.45 x 60 mm0.45 x 80 mm	0.35 x 25 mm0.45 x 25 mm0.35 x 37 mm0.45 x 37 mm0.45 x 50 mm0.45 x 75 mm	Enhanced assortiment
Shelf-life(Expiring date)	4 years	Same	--
Electrode cable	13P82 Disposable ElectrodeCable	9013C0031 shielded 1m withDIN plug9013C0041 unshielded 80cmwith 1,5mm connector.	Class I device, thecable is adjusted to fitthe 13 S series needles.
Materials –Needle shaft	Stainless Steel ASTM 304	Same	--
Materials –Needle head(hub)	Polyethylen needle head	Same material, but the hub hasbeen enlarged.	Enhanced ergonomicdesign on grip
Materials –coating	Teflon coated with Dupont850.314 Teflon 2 Prog. PrimerGreen and finished with Dupont851-214 Teflon Topcoat Green.	Wthitford PTFE coat, Xylan8400/3349	Easier to use andimproves workenvironment whenproducing the needles.
Protection tube	Mounted on needle head,polyethylene, medical grade	Same	--
Connection	Snap mounted in needle head.Needle and connections arecrimped together. Brass	Same	--
Connector	2 mm	0.7 mm	Enhanced changeability
Exposed length	0.8 mm	Same	--
Mechanical pullstrength	20 N	Same	--
Recording area	0.3 mm sq	Same	--
Tip Exposureprocess	The needle point was leftuninsulated	Tip exposure process removesthe coat via an abrasive media	Enhanced tipperformance

Medtronic Functional Diagnostics has reviewed its own files and is unaware of any safety or efficacy concerns that have resulted from the use of the predicate device 13 R Series of Disposable Monopolar Needle Electrode.

The changes in the new device doesn't effect any safety or efficacy concerns.

7. Assessment of non-clinical performance data for equivalence:

Verifications results shows that the enhanced device performs as its predicate device.

3(4) COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

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8. Assessment of clinical performance data for equivalence:

Clinical evaluation not performed.

9. Biocompatability:

The following biocompatibility tests have been performed on the Whitford PTFE coat, Xylan 8400/3349:

In Vitro Cytotoxicity Test (USP 23/ISO 10993-5 Elution Test) -
Intracutaneous Test performed according to the method described in International Standard -ISO 10993-10:1995
Test for Delayed Contact Hypersensitivity using the Guinea Pig Maximization Test -

The results of these tests shows that the material Whitford PTFE coat, xylan 8400/3349 have passed all tests.

10. Sterilization:

The needles are sterilized with ETO at a vendor sterilization plant, Maersk Medical A/S.

It is concluded that the process consistently with predetermined specifications. The specified requirements for sterility (EN 556) are met.

11. Standards and Guidances:

All the performed biocompatibility tests have been performed according to the following standards:

EN45001 -
ISO 10993-1 Biological evaluation of medical devices part 1: Guidance on selection of tests.
ISO 10993-10:1995 Biological evaluation of medical devices -
USP 23 / ISO 10 993 -5 -

The needle itself have been developed according to

EN 46001 -- Quality systems- Medical devices- Particular requirements for the application of -EN ISO 9001.
. . ISO/DIS 14971-1 - Medical Devices - Risk Management

This 510(k) content follow the Guidance document for the preparation of premarket notification 510(k), application for electromyograph needle electrodes.

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COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, with three wavy lines forming the body and head.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1999

Ms. Anne-Christine Jönsson Regulatory Affairs Specialist Medtronic Functional Diagnostics A/S Tonsbakken 16-18 DK-2740 Skovlunde Denmark

Re: K990375

Trade Name: 13 S Series Disposable Monopolar Needle Electrodes Regulatory Class: II Product Code: IKT Dated: February 5, 1999 Received: February 8, 1999

Dear Ms. Jönsson:

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 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Ann-Christine Jönsson

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 regulation (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 regulation 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. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Notification 13 Sx series of Disposable Monopolar Needle

Indication for Use Statement

Page_1_of_1__

510(k) Number (if known): K 990375

Device Name: 13 S Series Disposable Monopolar Needles Electrodes

Indications for Use:

The Disposable Monopolar Needles Electrodes are used for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns and conduction velocity studies.

MRI Compatibility Statement:

Device is not claimed for use in MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
--	--------------------------------------------------------	--

Prescription Use_ X	OR	Over-The-Counter Use_
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number 1499035

COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

Regulation Number and Section

§ 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).