DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75

K990375 · Medtronic Functional Diagnostics A/S · IKT · Mar 9, 1999 · Physical Medicine

Device Facts

• Record ID: K990375
• Device Name: DISPOSABLE MONOPOLAR NEEDLE ELECTRODE, DMF 25; DMN 25; DMF 37; DMN 37; DMN 50; DMN 75
• Applicant: Medtronic Functional Diagnostics A/S
• Product Code: IKT · Physical Medicine
• Decision Date: Mar 9, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.1385
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Disposable monopolar needle electrode for electromyography (EMG); used by clinicians to record electrical unit potentials in skeletal muscles. Device consists of stainless steel needle (ASTM 304) with PTFE coating (Xylan 8400/3349) to reduce friction and provide electrical insulation; conically sharpened tip remains uninsulated for signal recording. Connector at non-invasive end transfers electrical signals to external EMG recording equipment via shielded or unshielded cables. Single-use device; provided sterile. Clinician inserts needle into patient muscle tissue; output signals are processed by external EMG system to assist in diagnosing neuromuscular conditions or assessing muscle/nerve function. Benefits include improved ergonomic grip and enhanced tip performance via abrasive coating removal process.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed on PTFE coating (Cytotoxicity, Intracutaneous, Guinea Pig Maximization) per ISO 10993 standards; all tests passed.

Technological Characteristics

Stainless steel (ASTM 304) needle; PTFE (Xylan 8400/3349) coating; polyethylene hub; brass connector. Sensing principle: monopolar needle electrode for EMG signal acquisition. Dimensions: 0.35-0.45mm diameter; 25-75mm length. Connectivity: wired to EMG system via 0.7mm connector. Sterilization: Ethylene Oxide (EN 556).

Indications for Use

Indicated for pediatric to adult patients requiring electromyography (EMG) for recording unit potentials in skeletal muscles, spontaneous activity, interference patterns, and conduction velocity studies.

Regulatory Classification

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).

Predicate Devices

• 13 R Series Disposable Monopolar Needle Electrodes (K915741)
• 13P82 Disposable Electrode Cable (K915741)

Submission Summary (Full Text)

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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: [phone] 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.

## 1(4)

#### COMPANY CONFIDENTIAL

Medtronic Functional Diagnostics A/S

Tonsbakken 16-18 DK-2740 SKOVLUNDE DENMARK

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## 4. 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.

## 5. Intended Use:

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).

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

| Manufacturer | Dantec Medical A/S | Medtronic Functional<br>Diagnostics A/S | Comments to<br>differences |
|---------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) number | Predicate devices<br>13 R Series Disposable<br>Monopolar Electrodes<br>and<br>13P82 Disposable Electrode<br>Cable<br>- K 915741 | Modified Device<br>13 S Series Disposable<br>Monopolar Electrode<br>- K number to be decided<br>- K 990375 | - |

| Intended Use /<br>Indication of Use | Records unit potentials in<br>skeletal muscles, spontaneous<br>activity, interference patterns<br>and conduction velocity studies. | Same | -- |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------|------------------------------------------------------------------------------------------------------|
| Intended<br>Populations | Pediatric to Adults | Same | -- |
| Sterilization | Gamma irradiation (originally)<br>but it was changed to Ethylene<br>Oxid via our change control<br>system and this was filed<br>internally. | Ethylene Oxid | Today it is the same, a<br>verification report of<br>the sterilization is<br>enclosed 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 blister<br>packed electrodes in each box. | Same | -- |
| Uses | Single Use | Same | -- |
| Offered Sizes | 0.35 x 20 mm<br>0.35 x 30 mm<br>0.45 x 30 mm<br>0.45 x 40 mm<br>0.45 x 50 mm<br>0.45 x 60 mm<br>0.45 x 80 mm | 0.35 x 25 mm<br>0.45 x 25 mm<br>0.35 x 37 mm<br>0.45 x 37 mm<br>0.45 x 50 mm<br>0.45 x 75 mm | Enhanced assortiment |
| Shelf-life<br>(Expiring date) | 4 years | Same | -- |
| Electrode cable | 13P82 Disposable Electrode<br>Cable | 9013C0031 shielded 1m with<br>DIN plug<br>9013C0041 unshielded 80cm<br>with 1,5mm connector. | Class I device, the<br>cable is adjusted to fit<br>the 13 S series needles. |
| Materials –<br>Needle shaft | Stainless Steel ASTM 304 | Same | -- |
| Materials –<br>Needle head<br>(hub) | Polyethylen needle head | Same material, but the hub has<br>been enlarged. | Enhanced ergonomic<br>design on grip |
| Materials –<br>coating | Teflon coated with Dupont<br>850.314 Teflon 2 Prog. Primer<br>Green and finished with Dupont<br>851-214 Teflon Topcoat Green. | Wthitford PTFE coat, Xylan<br>8400/3349 | Easier to use and<br>improves work<br>environment when<br>producing the needles. |
| Protection tube | Mounted on needle head,<br>polyethylene, medical grade | Same | -- |
| Connection | Snap mounted in needle head.<br>Needle and connections are<br>crimped together. Brass | Same | -- |
| Connector | 2 mm | 0.7 mm | Enhanced changeability |
| Exposed length | 0.8 mm | Same | -- |
| Mechanical pull<br>strength | 20 N | Same | -- |
| Recording area | 0.3 mm sq | Same | -- |
| Tip Exposure<br>process | The needle point was left<br>uninsulated | Tip exposure process removes<br>the coat via an abrasive media | Enhanced tip<br>performance |

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.

## 4(4)

#### 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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_ <b>X</b> | 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