(274 days)
The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery.
The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.
target nerves and to locally stimulate them in order to provide a measurable response. The stimulus will have a very small current spread to reduce the innervation of the surrounding nerves.
The concentric design has two main parts, an inner stainless steel wire and an outer cannula also insulated from reading un-intended signals.
The Inner wire is isolated from the outer stainless steel cannula using a biocompatible heat shrink tubing. This Inner Wire acts as the stimulator and is surrounded by the outer cannula. The Outer Cannula is isolated with a biocompatible heat shrink which isolates the outer cannula allowing contact in a localized area of the intended nerves of interest.
The inner wire, the cathode, is stimulated using EMG/EP electroneurodiagnostic equipment cleared for the stimulation of nerve tissue and recording muscle activity during surgical procedures (not part of this 510(k) submission) The outer cannula acts as the anode or reference.
The Inner wire and outer cannula are isolated from each other using a dielectric heat shrink and are connected to a color coded pair of leadwires which are terminated by two DIN 42 802 touch proof connectors. The concentric stimulators are terminated on the distal end inside of a plastic handle and are independently connected to the leadwires.
This document describes a 510(k) submission for the Rhythmlink Disposable Concentric Stimulation Probe. It outlines the safety and effectiveness testing to demonstrate substantial equivalence to a predicate device, not the performance of an AI model. Therefore, many of the requested fields related to AI model acceptance criteria and study design are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Dimensional | Probe diameter and lengths within specified ranges (comparable to predicate) | Conducted (specific ranges not explicitly stated, but implied to be acceptable based on comparison to predicate in "Technological Characteristics" table) |
| Performance - Continuity | 0.5 Ohms | Achieved 0.5 Ohms |
| Performance - Hi Pot | No insulator breakdown | Passed (testing of insulator breakdown conducted and analyzed) |
| Performance - Stimulation Delivery | Effective stimulation delivery (comparable to predicate) | Conducted and analyzed (implied to be effective for intended use) |
| Performance - Pull-off Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Performance - Leadwire Strength | Adequate strength (specific value not stated, but implied to be acceptable) | Conducted and analyzed |
| Sterilization | Current, validated EO Sterilization Cycle 93007 met; acceptable residual EtO and ECH levels | Sterilized under Cycle 93007; residuals at "lowest possible limits" |
| Biocompatibility - ISO BET Get Clot Testing | No interference with lysate reaction; no inhibition or enhancement; no clotting at neat concentration; geometric mean endpoint concentration < 0.06 EU/mL and < 0.9 EU/Device of bacterial endotoxin. | The system did not interfere with the lysate reaction, and no inhibition or enhancement was present. The test articles did not clot at the neat concentration. The geometric mean endpoint concentration of each test article was <0.06 EU/mL and each contained <0.9 EU/Device of bacterial endotoxin. Results acceptable. |
| Biocompatibility - USP Inhibition and Enhancement Testing, Gel Clot Method | No inhibition or enhancement of Bacterial Endotoxin Test according to USP guidelines. | The test Concentric Stimulation Probe does not inhibit or enhance the Bacterial Endotoxin Test according to the USP guidelines. |
| Biocompatibility - ISO MEM Elution Test | No biological reactivity (Grade 0) of cells exposed to test article extract. Positive and negative controls confirm suitability. | There was no biological reactivity (Grade 0) of the cells exposed to the test article extract. The response obtained from the positive and negative control article extracts confirmed the suitability of the test system. |
| Biocompatibility - ISO Intracutaneous Reactivity Test | Test article sites do not show significantly greater biological reaction than control article sites. | The test article sites did not show a significantly greater biological reaction than the sites injected with the control article. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each non-clinical test conducted. It states "Non-clinical bench testing was comprised of dimensional measurements and performance tests." and "biocompatibility tests on the device". The data provenance is internal to the manufacturer (Rhythmlink International, LLC) and likely collected in a laboratory setting as part of product development and regulatory submission. This is not patient data; it's device performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm. Ground truth, in the context of an AI model, refers to the verified correct output for a given input. For this device, "ground truth" is established through engineering specifications, validated test methods, and compliance with industry standards (e.g., ISO, USP). There are no "experts" establishing ground truth in the sense of clinical annotations for AI.
4. Adjudication method for the test set
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm. Adjudication methods are relevant for resolving discrepancies in expert opinions used to create labels for AI training/test sets.
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 is a submission for a medical device (stimulating probe), not an AI algorithm. An MRMC study pertains to the evaluation of diagnostic performance involving multiple human readers and an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a medical device (stimulating probe), not an AI algorithm.
7. The type of ground truth used
For the non-clinical tests:
- Dimensional: Engineering specifications and comparisons to the predicate device.
- Performance Tests (Continuity, Hi Pot, Stimulation Delivery, Pull-off, Leadwire Strength): Engineering specifications and functional requirements based on the intended use and predicate device's performance.
- Sterilization: Regulatory standards for ethylene oxide sterilization and validated processes.
- Biocompatibility: Established international (ISO) and national (USP) standards for biological evaluation of medical devices, with pass/fail criteria defined by these standards.
8. The sample size for the training set
Not applicable. This is a submission for a medical device (stimulating probe). There is no "training set" in the context of artificial intelligence. The device design and manufacturing processes are validated through engineering and biocompatibility tests.
9. How the ground truth for the training set was established
Not applicable. As there is no AI training set, this question is not relevant.
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APR | 1 2014
5.0 Traditional 510(k) Summary Disposable Concentric Stimulation Probe
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR § 807.92(a).
| 807.92(a)(1)Submitter Information: | Rhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162Owner Operator #: 9052354 |
|---|---|
| Official Correspondent: | Daniel McCoyDirector of Engineering and Regulatory AffairsRhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222 ext. 102Email: dmccoy@rhythmlink.com |
| Summary Date: | March 6, 2014 |
| 807.92(a)(2)Device Identification: | Proprietary Device Name:Disposable Concentric Stimulating Probe (Trade name has not been finalized at this time)Generic Device Name:Surgical Nerve Stimulator/LocatorRegulatory Class:Class IIClassification Name:21 CFR §874.1820, Surgical Nerve Stimulator/LocatorProduct Code: ETN |
| 807.92(a)(3)Predicate Device(s): | K103128 Cadwell Disposable Stimulator Probes |
| Device Description | target nerves and to locally stimulate them in order to provide a measurableresponse. The stimulus will have a very small current spread to reduce theinnervation of the surrounding nerves. |
| The concentric design has two main parts, an inner stainless steel wire andan outer cannula also insulated from reading un-intended signals. | |
| The Inner wire is isolated from the outer stainless steel cannula using abiocompatible heat shrink tubing. This Inner Wire acts as the stimulator andis surrounded by the outer cannula. The Outer Cannula is isolated with abiocompatible heat shrink which isolates the outer cannula allowing contactin a localized area of the intended nerves of interest. | |
| The inner wire, the cathode, is stimulated using EMG/EPelectroneurodiagnostic equipment cleared for the stimulation of nervetissue and recording muscle activity during surgical procedures (not part ofthis 510(k) submission) The outer cannula acts as the anode or reference. | |
| The Inner wire and outer cannula are isolated from each other using adielectric heat shrink and are connected to a color coded pair of leadwireswhich are terminated by two DIN 42 802 touch proof connectors. Theconcentric stimulators are terminated on the distal end inside of a plastichandle and are independently connected to the leadwires. | |
| 807.92(a)(5)Intended Use(s) | The Rhythmlink Disposable Concentric Stimulating Probe is used to performlocalized stimulation of neural tissue and to locate, identify and monitorcranial motor nerves, peripheral nerve and spinal nerve roots duringsurgery. |
| The Rhythmlink Disposable Concentric Stimulating Probe is a single patientuse device. |
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| 807.92(a)(6)TechnologicalCharacteristics | An evaluation of the technological characteristics of the Rhythmlink Disposable Concentric Stimulating Probe where compared to the predicate device, Cadwell Probes. | ||
|---|---|---|---|
| RhythmlinkConcentric Probe | Predicate DeviceCadwell | ||
| 510(k) Number | K132138 | K103128 | |
| Shaft Length | 80 – 330mm | 80 - 340mm | |
| Handle Length | 100mm | 110mm | |
| Leadwire Length | 1.0m – 3.0m | 2.0m | |
| Tip Diameter/Exposure | $Ø$ 1.6mm x 0.0 – 0.3mm | $Ø$ 1.3mm x 0-0.3mm | |
| Shaft Material | SST 316 and SST 304 | SST 316 | |
| Shaft Insulation | PET | PTFE | |
| Handle Material | Medical Grade ABS | Medical Grade ABS | |
| Lead Wire Material | Tin Plated Copper | Tin Plated Copper | |
| Lead Wire Insulation | Medical Grade PVC | Medical Grade PVC | |
| 807.92(b)(1)Summary of Non-ClinicalTests | Non-clinical bench testing was comprised of dimensional measurements and performance tests. Dimensional testing was conducted of the Probe diameter and Probe lengths. Performance testing was conducted and analyzed for a continuity of .5 Ohms, Hi Pot testing of insulator breakdown, stimulation delivery, Pull-off strength and leadwire (patient cables) strength. The device was sterilized under the current, validated EO Sterilization Cycle 93007, and testing for residual EtO and ECH levels determined that the residuals are at the lowest possible limits. | ||
| Biocompatibility per ISO-10993-1: 1997, Part I "Biological Evaluation of Medical Devices, Evaluation and Testing" was confirmed by analyzing biocompatibility tests on the device (exclusive of the handle and lead wire). The biocompatibility testing is summarized in the table below: | |||
| Test | Results | Conclusion | |
| ISO BET GetClot Testing | The system did not interfere with the lysate reaction, and no inhibition or enhancement or enhancement was present. The test articles did not clot at the neat concentration. The geometric mean endpoint concentration of each test article was <0.06 EU/mL and each contained <0.9 EU/Device of bacterial endotoxin. The results are acceptable. | The device is non-pyrogenic. | |
| USP InhibitionandEnhancementTesting, GelClot Method | The test ConcentricStimulation Probe does notinhibit or enhance theBacterial Endotoxin Testaccording to the USPguidelines. | The device is non-pyrogenic. | |
| ISO MEMElution Test | There was no biologicalreactivity (Grade 0) of thecells exposed to the testarticle extract. The responseobtained from the positiveand negative control articleextracts confirmed thesuitability of the test system. | The device is non-cytotoxic. | |
| ISOIntracutaneousReactivity Test | The test article sites did notshow a significantly greaterbiological reaction than thesites injected with thecontrol article. | The device is non-irritant. | |
| Once the verification testing was completed it was confirmed that theproposed Rhythmlink Concentric Stimulation Probes are as safe andeffective as the predicate device. | |||
| 807.92(b)(2)Clinical Tests | There was no clinical testing performed on the proposed device. | ||
| 807.92(b)(3)Clinical Summary |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center . We 166 Silver Spring, MD 2005-0002
Image /page/4/Picture/12 description: The image shows a logo with a stylized bird in the center. The bird is composed of three curved lines that suggest movement or flight. Encircling the bird is text that appears to be part of the logo, though the specific words are not clear due to the image quality. The overall design is simple and symbolic, likely representing an organization or entity associated with aviation, freedom, or a similar concept.
April 11, 2014
Rhythmlink International. L.C. Mr. Daniel E. McCoy Director of Engineering and Regulatory Affairs 1140 First Sireet South Columbia. South Carolina 29209
Re: K132138
Trade/Device Name: Rhythmlink disposable concentric stimulating probe Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class H Product Code: PDQ. ETN Dated: March 1. 2014 Received: March 14, 2014
Dear Mr. McCoy:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent ffor 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. Ifsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in
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Page 2 - Mr. Daniel E. McCoy
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K132138
Device Name
Disposable Concentric Stimulating Probe
Indications for Use (Describe)
The Rhythmlink Disposable Concentric Stimulating Probe is used to perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery.
The Rhythmlink Disposable Concentric Stimulating Probe is a single patient use device.
Type of Use (Select one or both, as applicable)
🇿 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 A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
11 - - - Date: 2014.04.11
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FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.