(108 days)
Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
Rhythmlink International Subdermal Needle Electrodes are single patient use, disposable, sterile devices. Electrodes are applied in the study of biopotentials such as electroencephalograph (EEG), electromyograph (EMG), nerve conduction and stimulation/response. Electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue.
The electrodes consist of a stainless steel needle with a lead wire attached. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet.
The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.
This submission is for a Class II medical device, Subdermal Needle Electrodes, and as such, the provided text does not contain the level of detail regarding device performance studies, acceptance criteria, or ground truth establishment that would be present for a complex AI/ML-based diagnostic device. The documentation primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
Therefore, many of the requested categories cannot be filled as they are not applicable to this type of device clearance given the provided information.
Here's an analysis based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission for a Subdermal Needle Electrode. Regulatory clearance for this type of device relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than meeting specific performance metrics from a clinical study with acceptance criteria as one would find for an AI/ML diagnostic or a novel therapeutic. The "performance" here relates to the device's technological characteristics being similar enough to the predicates that no new questions of safety or effectiveness are raised.
If we were to infer "acceptance criteria" for a physical device like this, it might involve:
- Material Compatibility: Biocompatibility of materials (stainless steel, lead wires).
- Sterility: Ability to maintain sterility.
- Electrical Conductivity/Impedance: Ability to reliably transmit biopotential signals.
- Mechanical Integrity: Strength of the needle and lead wire attachment.
- Safety Connector: Proper function of the safety connector to prevent connection to AC power.
However, the provided document does not include explicit test results or acceptance criteria for these aspects. The statement "The characteristics of Rhythmlink International Subdermal Needle Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." is the overarching "performance" claim.
2. Sample size used for the test set and the data provenance
Not applicable. There is no "test set" in the context of a clinical performance study as described for AI devices. The submission relies on a comparison of the device's design and materials to predicate devices. There wouldn't be a "data provenance" as it's not a data-driven device; it's a physical medical instrument.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no test set or ground truth in the context of a clinical performance study using expert consensus. The "ground truth" for this type of device is established through engineering and materiological standards, and the safety track record of similar predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication of findings is mentioned.
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
Not applicable. This device is a physical electrode, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical electrode, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, the "ground truth" is typically understood through:
- Engineering Standards: Electrical, mechanical, and material properties confirmed through bench testing (not detailed in this summary).
- Biocompatibility Standards: Ensuring the materials are safe for human contact.
- Predicate Device History: The long-standing safe and effective use of the identified predicate devices provides the basis for substantial equivalence.
The document does not detail specific "ground truth" establishment as would be done for diagnostic accuracy claims.
8. The sample size for the training set
Not applicable. This device is a physical electrode and does not involve AI/ML training.
9. How the ground truth for the training set was established
Not applicable. This device is a physical electrode and does not involve AI/ML training or a training set.
Summary of what the document does convey:
- Device: Rhythmlink International Subdermal Needle Electrodes
- Intended Use: For use with recording, monitoring and stimulation equipment for the purpose of recording biopotential signals (e.g., EMG, EEG, Nerve potential signals). Sterile, single-patient use.
- Technological Characteristics: Stainless steel needle with a lead wire, terminating in a safety connector that prevents connection to AC power. Invasive (subcutaneous or in contact with nerve/muscle).
- Predicate Devices:
- Basis for Clearance: Substantial equivalence to predicate devices, asserting that no new questions of safety or effectiveness are raised. This is the "study" and the "acceptance criteria" presented in the context of this 510(k).
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K022914 1/2
Rhythmlink International, LLC
| 9. 510(k) Summary | DEC 2 0 2002 |
|---|---|
| 510(k) Summary of Safety and Effectiveness | |
| Company Name: | Rhythmlink International, LLC2013 Windsor DriveCayce, SC 29033Phone: 803-926-8080FDA Registration #: PEND80891 |
| Official Contact Person: | Brett L Netherton, President |
| Summary Date: | August 29, 2002 |
| Device Identification: | Proprietary Device Name:Rhythmlink International Subdermal Needle ElectrodesGeneric Device Name:Subdermal Needle ElectrodesRegulatory Class:Class IIClassification Name:21 CFR 882.1350, Needle ElectrodeThis device has not been previously submitted to the FDA. |
| Predicate Device(s): | 510(k) Number: K990015Manufacturer: Technomed EuropeTrade Name: Various Needle ElectrodeProduct Code: 89IKT510(k) Number: K010019Manufacturer: Nicolet BiomedicalTrade Name: Sterile Subdermal Needle ElectrodesProduct Code: 84GXZ |
| Device Description: | Rhythmlink International Subdermal Needle Electrodes are singlepatient use, disposable, sterile devices. Electrodes are applied in thestudy of biopotentials such as electroencephalograph (EEG),electromyograph (EMG), nerve conduction and stimulation/response.Electrodes are invasive as they are placed subcutaneously or in contactwith nerve or muscle tissue.The electrodes consist of a stainless steel needle with a lead wireattached. The lead wires terminate in a safety connector that cannot beconnected to an AC power outlet.The electrodes provide the patient contact device. The electrodesconnect to the user's recording, monitoring and stimulation/responseequipment. The electrodes are used under the supervision of a physician. |
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- Rhythmlink International Subdermal Needle Electrodes are intended Intended Use: for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only. Technological Characteristics: The electrodes consist of a formed stainless steel needle with a lead wire attached. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The characteristics of Rhythmlink International Subdermal Needle Electrodes are
safety or effectiveness are raised.
substantially equivalent to the predicate devices. No new questions of
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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, arranged in a stacked formation.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2002
Rhythmlink International, LLC Brett L. Netherton President 2013 Windsor Drive Cayce, South Carolina 29033
Re: K022914
Trade/Device Name: Rhythmlink International Subdermal Needle Electrodes Regulation Number: 882.1350 Regulation Name: Needle electrode Regulatory Class: Class II Product Code: GXZ Dated: December 4, 2002 Received: December 11, 2002
Dear Mr. Netherton:
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 such 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); good manufacturing practice requirements as set forth in
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Page 2 - Mr. Brett L. Netherton
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provat
foCelia M. Witten, Ph.D., M.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page _ of _
| 510(k) Number (if known): | SEE BELOW |
|---|---|
| Device Name: | SEE BELOW |
| Indications For Use: |
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510(k) Number: K022914
Device Name: Rhythmlink International Subdermal Needle Electrodes
Indications for Use:
Rhythmlink International Subdermal Needle Electrodes are intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals. Examples include: Electromyography (EMG), Electroencephagraph (EEG) and Nerve potential signals. The electrodes are sterile and for single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Miriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
712(g) Number K022914
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).