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

AI/ML Overview

This K091055 submission describes the Rhythmlink Disposable Concentric EMG Needle. The provided document does not contain explicit acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of clinical accuracy or a comparative effectiveness study with human readers.

The submission focuses on establishing substantial equivalence to predicate devices (Ambu Neuroline Concentric Needle K973529 and K071186) based on similar design, indications for use, and materials. The testing mentioned in such submissions typically relates to biocompatibility, sterility, electrical safety, and performance characteristics like impedance and signal quality, rather than clinical efficacy studies.

Therefore, the specific information requested cannot be fully extracted from the provided text for items 1-6 and 8-9.

Here's what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., signal-to-noise ratio requirements, impedance ranges) within the provided text. Substantial equivalence is the primary acceptance criterion for 510(k) devices.
Reported Device Performance: The document states the device "is similar to existing stainless steel needles used to record muscle activity during electromyograph procedures." This implies that its performance is expected to be comparable to the predicate devices. The listed physical specifications (e.g., 0.07mm² or 0.12mm² recording surface area, 15° sharpening angle) are design specifications, not performance outcomes from an efficacy study.

2. Sample sized used for the test set and the data provenance

Not specified in the provided text. The submission is a 510(k) for substantial equivalence, which primarily relies on technological comparison and bench testing rather than large-scale clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is an EMG needle, a measurement tool. Ground truth in the context of clinical interpretation by experts is not directly relevant to this type of device's 510(k) submission for substantial equivalence.

4. Adjudication method for the test set

Not applicable for a device of this nature in a 510(k) submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an EMG needle and does not involve AI or "human readers" in the context of diagnostic interpretation that would warrant an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a physical medical instrument, not an algorithm, so a standalone performance study in this context is not applicable.

7. The type of ground truth used

As a diagnostic EMG needle, its "ground truth" performance would typically be assessed by its ability to accurately detect and transmit electrical signals from muscle activity, verified against established physiologcal principles and comparison to predicate devices, rather than an expert consensus on a diagnosis. The submission focuses on substantial equivalence to legally marketed predicate devices, meaning its performance characteristics (e.g., electrical properties, biocompatibility) are expected to be similar enough that it can be used for the same intended purpose.

8. The sample size for the training set

Not applicable. This is a physical device, and the concept of a "training set" is not relevant in the context of its 510(k) submission.

9. How the ground truth for the training set was established

Not applicable.

Summary

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KO91055

5. 510(k) Summary

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510(k) Summary of Safety and Effectiveness

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 8, 2009
Device Identification:	Proprietary Device Name:Rhythmlink Disposable Concentric EMG Needle (Trade name has 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: K973529 K071186Manufacturer: Ambu®Trade Name: Neuroline Concentric Needle

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Device Description:	The design of the Rhythmlink Disposable Concentric EMGNeedle is similar to existing stainless steel needles used to recordmuscle activity during electromyograph procedures. The deviceconsists of a needle and a needle body. The inner sensor of theneedle is made of stainless steel and is separated from thestainless steel outer cannula by a layer of biocompatibleinsulation. The needle is sharpened at a 15° angle, creating arecording surface area of 0.07mm² or 0.12mm², depending uponneedle diameter. The needle body houses the component thatconnects the needle to the leadwire. Inside this body, a gold-plated brass inner sensor pin is crimped onto the end of the innersensor of the needle and is isolated from the outer cannula of theneedle. The needle and pin assembly is then cased in a gold-plated brass outer ring, which is crimped onto the outer cannula.Finally, the entire end of the needle assembly is covered with apolyethylene body that protects the needle and allows theclinician to accurately secure the needle into place. The assemblyconnects creates a unidirectional connection to the reusable cable,which connects the needle to electromyography recordingequipment.
Indications for Use:	Recording muscle activity for Electromyography (EMG)applications. For single patient use only.

Device Description:

The design of the Rhythmlink Disposable Concentric EMGNeedle is similar to existing stainless steel needles used to recordmuscle activity during electromyograph procedures. The deviceconsists of a needle and a needle body. The inner sensor of theneedle is made of stainless steel and is separated from thestainless steel outer cannula by a layer of biocompatibleinsulation. The needle is sharpened at a 15° angle, creating arecording surface area of 0.07mm² or 0.12mm², depending uponneedle diameter. The needle body houses the component thatconnects the needle to the leadwire. Inside this body, a gold-plated brass inner sensor pin is crimped onto the end of the innersensor of the needle and is isolated from the outer cannula of theneedle. The needle and pin assembly is then cased in a gold-plated brass outer ring, which is crimped onto the outer cannula.Finally, the entire end of the needle assembly is covered with apolyethylene body that protects the needle and allows theclinician to accurately secure the needle into place. The assemblyconnects creates a unidirectional connection to the reusable cable,which connects the needle to electromyography recordingequipment.

Indications for Use:

Recording muscle activity for Electromyography (EMG)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 (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

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

Page 1 of ਜ

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).