(71 days)
Not Found
No
The device description focuses solely on the physical components of a disposable EMG needle and its intended use for recording muscle activity. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
Explanation: The device is intended for recording muscle activity (Electromyograph applications) as a diagnostic tool, not for treating any condition.
Yes
The device is intended for "recording muscle activity for Electromyograph (RMG) applications" and during "EMG procedures." Electromyography (EMG) is a diagnostic procedure used to assess the health of muscles and the nerve cells that control them (motor neurons). The device records muscle activity, which is then used by clinicians for diagnosis.
No
The device description clearly outlines physical components such as a needle, needle hub, connector, and plastic needle cover, all made of physical materials like stainless steel, Teflon, brass, and polyethylene. This indicates it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Rhythmlink Disposable Monopolar EMG Needle is used to record muscle activity directly from within the body during an EMG procedure. This is an in vivo (within the living body) measurement, not an in vitro test of a specimen.
- Intended Use: The intended use clearly states "Recording muscle activity for Electromyograph (RMG) applications." This describes a procedure performed on a living patient, not a laboratory test on a sample.
Therefore, based on the provided information, the device falls under the category of a medical device used for physiological measurement in vivo, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Recording muscle activity for Electromyograph (RMG) applications . For single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
IKT
Device Description
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
5. 510(k) Summary
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一
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510(k) Summary of Safety and Effectiveness
JUN 23 2009
·
1091056
| 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 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 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: K071185
Manufacturer: Ambu®
Trade Name: Neuroline Disposable Monopolar Needle Electrode
Product Code: IKT |
1
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.
2
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.
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/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
4
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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