(71 days)
Not Found
No
The device description focuses solely on the physical components and materials of a disposable EMG needle, with no mention of software, algorithms, or data processing capabilities that would indicate the presence of AI or ML.
No
The device is used for recording muscle activity for Electromyograph (EMG) applications, which is a diagnostic procedure, not a therapeutic one. The description focuses on its design for signal acquisition.
Yes
The device is described as "Recording muscle activity for Electromyograph (EMG) applications," which is a diagnostic procedure used to assess the health of muscles and the nerves that control them.
No
The device description clearly details physical components like a needle, needle body, stainless steel, insulation, brass, and polyethylene, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Recording muscle activity for Electromyograph (EMG) applications." This describes a procedure performed on a living patient to measure electrical signals from muscles.
- Device Description: The description details a needle designed for insertion into muscle tissue to record electrical activity.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose, monitor, or screen for diseases or conditions. This device is used in vivo (within the body) for a diagnostic procedure.
N/A
Intended Use / Indications for Use
Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
Product codes
IKT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
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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
1256 First Street South Extension
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162
Owner Operator #: 9052354 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact Person: | James M. Mewborne
Director of Engineering and Regulatory Affairs
Rhythmlink International, LLC
1256 First Street South Extension
Columbia, SC 29209
Phone: 803-252-1222 ext. 12
Email: 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 Electrode
Regulatory Class:
Class II
Classification Name: 21 CFR §890.1385, Diagnostic Electromyograph Needle Electrode
This device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K973529 K071186
Manufacturer: Ambu®
Trade Name: Neuroline Concentric Needle |
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| Device Description: | 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. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
3
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
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