RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R

K091055 · Rhythmlink International, LLC · IKT · Jun 23, 2009 · Physical Medicine

Device Facts

• Record ID: K091055
• Device Name: RHYTHMLINK DISPOSABLE CONCENTRIC EMG NEEDLE, MODEL D039032252R
• Applicant: Rhythmlink International, LLC
• Product Code: IKT · Physical Medicine
• Decision Date: Jun 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

Recording muscle activity for Electromyography (EMG) applications. For single patient use only.

Device Story

Disposable concentric needle electrode for electromyography (EMG). Device consists of stainless steel inner sensor and outer cannula separated by biocompatible insulation; sharpened at 15° angle. Needle body houses gold-plated brass inner sensor pin and outer ring; encased in polyethylene body for handling. Connects to reusable cable for interface with EMG recording equipment. Used by clinicians in clinical settings to record muscle electrical activity. Provides signal input to EMG equipment to assist in diagnostic decision-making regarding muscle/nerve pathology. Single-patient use design.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing and design comparison to legally marketed predicate devices.

Technological Characteristics

Stainless steel inner sensor and outer cannula; biocompatible insulation; gold-plated brass sensor pin and outer ring; polyethylene body. 15° needle tip angle. Recording surface area 0.07mm² or 0.12mm². Unidirectional connection to reusable cable. Passive electrode device.

Indications for Use

Indicated for recording muscle activity during electromyography (EMG) procedures in patients requiring diagnostic evaluation of muscle or nerve function.

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

• Neuroline Concentric Needle (K973529)
• Neuroline Concentric Needle (K071186)

Submission Summary (Full Text)

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# KO91055

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## 5. 510(k) Summary

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### 510(k) Summary of Safety and Effectiveness

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| Company Name: | Rhythmlink International, LLC<br>1256 First Street South Extension<br>Columbia, SC 29209<br>Phone: [phone]<br>FDA Registration #: 1067162<br>Owner Operator #: 9052354 |
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| Official Contact Person: | James M. Mewborne<br>Director of Engineering and Regulatory Affairs<br>Rhythmlink International, LLC<br>1256 First Street South Extension<br>Columbia, SC 29209<br>Phone: [phone] ext. 12<br>Email: [e-mail] |
| Summary Date: | April 8, 2009 |
| Device Identification: | Proprietary Device Name:<br>Rhythmlink Disposable Concentric EMG Needle (Trade name has not been finalized at this time)<br>Generic Device Name:<br>Diagnostic Electromyograph Needle Electrode<br>Regulatory Class:<br>Class II<br>Classification Name: 21 CFR §890.1385, Diagnostic Electromyograph Needle Electrode<br>This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K973529 K071186<br>Manufacturer: Ambu®<br>Trade Name: Neuroline Concentric Needle |

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| Device Description: | The design of the Rhythmlink Disposable Concentric EMG<br>Needle is similar to existing stainless steel needles used to record<br>muscle activity during electromyograph procedures. The device<br>consists of a needle and a needle body. The inner sensor of the<br>needle is made of stainless steel and is separated from the<br>stainless steel outer cannula by a layer of biocompatible<br>insulation. The needle is sharpened at a 15° angle, creating a<br>recording surface area of 0.07mm² or 0.12mm², depending upon<br>needle diameter. The needle body houses the component that<br>connects the needle to the leadwire. Inside this body, a gold-<br>plated brass inner sensor pin is crimped onto the end of the inner<br>sensor of the needle and is isolated from the outer cannula of the<br>needle. The needle and pin assembly is then cased in a gold-<br>plated brass outer ring, which is crimped onto the outer cannula.<br>Finally, the entire end of the needle assembly is covered with a<br>polyethylene body that protects the needle and allows the<br>clinician to accurately secure the needle into place. The assembly<br>connects creates a unidirectional connection to the reusable cable,<br>which connects the needle to electromyography recording<br>equipment. |
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| Indications for Use: | Recording muscle activity for Electromyography (EMG)<br>applications. For single patient use only. |

This concludes the 510(k) summary.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 its wings spread and head facing to the right. The bird is composed of three curved lines that create the impression of feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the bird symbol.

## JUN 23 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rhythmlink@ International, LLC c/o James M. Mewborne Director of Engineering and Regulatory Affairs 1256 First Street South Extension Columbia, SC 29209

Re: K091055

Trade/Device Name: Rhythmlink Disposable Concentric EMG Needle Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic Electromyograph Needle Electrode Regulatory Class: II Product Code: IKT Dated: April 9, 2009 Received: April 13, 2009

Dear Mr. Mewborne:

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 application (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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological. and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 4. Indications for Use Statement

#### Indications for Use

KAI0ES

510(k) Number (if known): Pend ing

Device Name Rhythmlink Disposable Concentric EMG Needle

Indications For Use: Recording muscle activity for Electromyograph (RMG) applications. For single patient use only.

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices

510(k) Number K091055

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