(274 days)
Not Found
No
The device description focuses on the physical design and electrical properties of a stimulating probe, with no mention of AI or ML for data analysis, interpretation, or control. The performance studies are standard bench and biocompatibility tests, not related to AI/ML model validation.
No
Explanation: The device is used for localized stimulation to identify and monitor nerves during surgery, not for treating a disease or condition. Its purpose is diagnostic/monitoring.
Yes
Explanation: The device is described as being used to "locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery" and to "provide a measurable response" to stimulation, which are all diagnostic activities. It is also used with "EMG/EP electroneurodiagnostic equipment."
No
The device description clearly details physical components like an inner stainless steel wire, outer cannula, heat shrink tubing, plastic handle, and leadwires, indicating it is a hardware device.
Based on the provided information, the Rhythmlink Disposable Concentric Stimulating Probe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "perform localized stimulation of neural tissue and to locate, identify and monitor cranial motor nerves, peripheral nerve and spinal nerve roots during surgery." This involves direct interaction with the patient's body (in vivo) during a surgical procedure.
- Device Description: The device is a probe designed to deliver electrical stimulation to nerves within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body. IVD devices are specifically designed for testing these types of samples in a laboratory or clinical setting.
Therefore, this device falls under the category of a surgical or neurological stimulating device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
ETN, PDQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neural tissue, cranial motor nerves, peripheral nerve, spinal nerve roots
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)
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).
Summary of Biocompatibility testing:
- ISO BET Get Clot 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
§ 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.
0
ﺮ
f
. .
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, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222
FDA Registration #: 1067162
Owner Operator #: 9052354 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Daniel McCoy
Director of Engineering and Regulatory Affairs
Rhythmlink International, LLC
1140 First Street South
Columbia, SC 29209
Phone: 803-252-1222 ext. 102
Email: 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/Locator
Regulatory Class:
Class II
Classification Name:
21 CFR §874.1820, Surgical Nerve Stimulator/Locator
Product 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 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. |
| 807.92(a)(5)
Intended Use(s) | 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. |
1
. -'
.
・・
.
2
. .
r
・・
| 807.92(a)(6)
Technological
| Characteristics | An evaluation of the technological characteristics of the Rhythmlink Disposable Concentric Stimulating Probe where compared to the predicate device, Cadwell Probes. | ||
|---|---|---|---|
| Rhythmlink | |||
| Concentric Probe | Predicate Device | ||
| Cadwell | |||
| 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-Clinical | |||
| Tests | 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 Get | |||
| Clot 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 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
5
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
6
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
1 --- 13:51:09 -04'00' 13:51:09 -04'00'
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."