Rhythmlink Disposable Monopolar EMG Needle is a device intended for recording muscle activity during electromyography (EMG) procedures. The device consists of an insulated monopolar needle, needle hub, connector (solderless crimped connection), and plastic needle cover. The monopolar needle is made of medical grade stainless steel and is available in three lengths. The entire needle is coated with Teflon (PTFE), except for the recording tip, to insulate the needle and reduce friction upon insertion. The solderless crimped connection consists of a gold-plated brass tube 1mm in thickness, crimped onto the isolated needle. The connection is covered with a needle hub made of black polyethylene molding. The plastic needle cover is made of polyethylene. The device is available in seven different needle sizes. The needles are available in 0.32 to 0.57mm in diameter and are available in 15 to 75mm lengths. The needle is intended to record muscle activity during EMG procedures, and the needle hub is designed to be held by the user to secure the needle in the recording site. The solderless crimped connection secures the needle to the end of the leadwire. With the exception of the needle length, needle diameter, and leadwire length, the components and their dimensions are consistent throughout the product line, and these material and dimensional specifications are outlined in the product drawing under Device Description.

AI/ML Overview

The provided text is for a 510(k) summary for the "Rhythmlink Disposable Monopolar EMG Needle". This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information on acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

This type of 510(k) submission, particularly for Class II devices like this EMG needle, relies primarily on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, material compatibility, and performance characteristics (e.g., electrical impedance, mechanical strength, biocompatibility). It typically does not involve the kind of clinical performance studies with detailed acceptance criteria, expert ground truth, or MRMC analysis that would be expected for more complex diagnostic or AI-driven devices.

Therefore, I cannot extract the requested information from the provided text because it is not present in the document. The text mainly focuses on device description, indications for use, and a comparison to a predicate device to establish substantial equivalence.

Summary

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5. 510(k) Summary

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一

510(k) Summary of Safety and Effectiveness

JUN 23 2009

1091056

Company Name:	Rhythmlink International, LLC1256 First Street South ExtensionColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162Owner Operator #: 9052354
Official Contact Person:	James M. MewborneDirector of Engineering and Regulatory AffairsRhythmlink International, LLC1256 First Street South ExtensionColumbia, SC 29209Phone: 803-252-1222 ext. 12Email: jmewborne@rhythmlink.com
Summary Date:	April 9, 2009
Device Identification:	Proprietary Device Name:Rhythmlink Disposable Monopolar EMG Needle (Trade names have not been finalized at this time)Generic Device Name:Diagnostic Electromyograph Needle ElectrodeRegulatory Class:Class IIClassification Name: 21 CFR §890.1385, Diagnostic Electromyograph Needle ElectrodeThis device has not been previously submitted to the FDA.
Predicate Device(s):	510(k) Number: K071185Manufacturer: Ambu®Trade Name: Neuroline Disposable Monopolar Needle ElectrodeProduct Code: IKT

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Rhythmlink Disposable Monopolar EMG Needle is a device Device Description: intended for recording muscle activity during electromyography (EMG) procedures. The device consists of an insulated monopolar needle, needle hub, connector (solderless crimped connection), and plastic needle cover. The monopolar needle is made of medical grade stainless steel and is available in three lengths. The entire needle is coated with Teflon (PTFE), except for the recording tip, to insulate the needle and reduce friction upon insertion. The solderless crimped connection consists of a gold-plated brass tube 1mm in thickness, crimped onto the isolated needle. The connection is covered with a needle hub made of black polyethylene molding. The plastic needle cover is made of polyethylene. The device is available in seven different needle sizes. The needles are available in 0.32 to 0.57mm in diameter and are available in 15 to 75mm lengths. The needle is intended to record muscle activity during EMG procedures, and the needle hub is designed to be held by the user to secure the needle in the recording site. The solderless crimped connection secures the needle to the end of the leadwire. With the exception of the needle length, needle diameter, and leadwire length, the components and their dimensions are consistent throughout the product line, and these material and dimensional specifications are outlined in the product drawing under Device Description. Recording muscle activity for Electromyography (EMG) Indications for Use: 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure with three stylized wing segments.

Public Health Service

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: K091056

Trade/Device Name: Rhythmlink Disposable Monopolar 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/cdrl/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 (800) 638-2041 or (240) 276-3150 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

510(k) Number (if known): Pending

K091056 Device Name Rhythmlink Disposable Monopolar EMG Needle

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

scription Use

AND/OR

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

LEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

JOE HUTTER

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

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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).