(43 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), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.
Guardian Needle™ Electrodes are a sterile, single-use device. The electrodes are applied during the study of biopotentials such as electromyography (EMG), electroencephalography (EEG), nerve conduction and stimulation/response. The electrodes are invasive as they are placed subcutaneously or in contact with nerve or muscle tissue. The needle is housed inside a sheath until application and secured to the patient during use with adhesive tape.
The Rhythmlink International Guardian Needle™ Electrode (subject device) is compared to the predicate device, Subdermal Needle Electrodes (K022914), to demonstrate substantial equivalence. The document primarily focuses on non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Subject Device (Guardian Needle™ Electrode) Performance |
|---|---|---|
| Sterilization & Residuals | - Compliance with TIR 28:2009 guidance. | Subject device determined to fall under previously validated EtO sterilization cycle. |
| - EtO and Ethylene Chlorohydrin (ECH) levels after 24-hour aeration below maximum limits described in ANSI/AAMI/ISO 10993-7:2008/(R) 2012. | Reevaluation confirmed low levels of EtO and ECH. | |
| Biocompatibility | - Biological safety for intact skin contact (≤24 hours) as per ISO 10993 standards and risk management framework. | Biocompatibility evaluation establishes biological safety for intact skin contact for ≤24 hours. |
| Functional Performance | - Electrical Continuity | Passed predetermined acceptance criteria. |
| - Adhesion Testing (for adhesive tape) | Passed predetermined acceptance criteria. | |
| Technological Equivalence to Predicate | - Intended Use | Identical to predicate. |
| - Anatomical Site(s) | Identical to predicate. | |
| - Environment Usage | Identical to predicate. | |
| - Electrode Material | Identical to predicate. | |
| - Electrode Length | Identical to predicate. | |
| - Electrode Diameter | Identical to predicate. | |
| - Leadwire Material | Identical to predicate. | |
| - Leadwire Length | Identical to predicate. | |
| - Connector | Identical to predicate. | |
| - Operation of Applying the Device | Identical to predicate. | |
| - Prescription Use | Identical to predicate. | |
| - Targeted Procedures | Identical to predicate. | |
| - Compatibility with other devices | Identical to predicate. | |
| - Packaging | Identical to predicate. | |
| - Sterilization Method | Identical to predicate. | |
| - Single Patient Use | Identical to predicate. | |
| - Electrical Safety | Identical to predicate (Connectors comply with IEC 60601-1 (1988) sub clause 56.3(c) per CFR 898.12). | |
| - Mechanical Safety | Identical to predicate (Leadwires soldered to electrode using Tin/Silver solder and covered with heat shrink). | |
| - Duration of use | Identical to predicate (≤24 hours). | |
| - Standards | Identical to predicate (IEC 60601-1-1: 1988/a1: 1991/A2 :1995 § 56.3(c) per CFR 898.12, DIN 42802, ISO 14971, ISO 15223-1). |
Note on Differences: The subject device includes a needle sheath (thermoplastic polyester elastomer sheath) and adhesive tape, which differ from the predicate device (PVC tube for sheath, no adhesive tape). These differences were assessed through testing and determined not to adversely impact safety or effectiveness.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the functional performance benchtop tests (Electrical Continuity and Adhesion Testing). However, it states that "The test methods were identical to those used to assess the predicate device."
For sterilization, reevaluation of EtO residuals was performed, but the sample size is not explicitly stated.
The data provenance is from non-clinical benchtop testing conducted by Rhythmlink International, LLC. The document does not indicate any country of origin for the data that would suggest external sources. All testing appears to be retrospective relative to the submission date, as it's part of a 510(k) premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The document describes non-clinical benchtop tests and compliance with recognized standards. There isn't an explicit "test set" in the context of expert review for establishing ground truth, as the criteria are based on engineering and biocompatibility standards.
4. Adjudication method for the test set
This information is not applicable as the document does not describe a test set requiring expert adjudication for ground truth (e.g., image interpretation). The evaluation relies on established engineering and biocompatibility testing methodologies.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2)" and "No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3)."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical invasive medical electrode, not a software algorithm or AI system.
7. The type of ground truth used
The "ground truth" for demonstrating the device meets acceptance criteria is primarily based on:
- Compliance with recognized industry standards: ANSI/AAMI/ISO 10993-7:2008/(R) 2012 for EtO residuals, ISO 10993 for biocompatibility, IEC 60601-1-1: 1988/a1: 1991/A2 :1995 § 56.3(c) per CFR 898.12, DIN 42802, ISO 14971, ISO 15223-1, and TIR 28:2009 Guidance for sterilization.
- Predicate device characteristics: Substantial equivalence is established by demonstrating the subject device has identical technological characteristics, intended use, and performance to a legally marketed predicate device, with differences (needle sheath, adhesive tape) assessed not to adversely impact safety or effectiveness.
- Benchtop test results: Electrical continuity and adhesion testing against predetermined acceptance criteria.
8. The sample size for the training set
This question is not applicable as the device is not an AI/ML product that undergoes training.
9. How the ground truth for the training set was established
This question is not applicable as the device is not an AI/ML product that undergoes training.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 27, 2020
Rhythmlink International, LLC Gabriel Orsinger Vice President of Engineering and R&D 1140 First Street South Columbia, South Carolina 29209
Re: K200984
Trade/Device Name: Guardian Needle Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: April 9, 2020 Received: April 14, 2020
Dear Gabriel Orsinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Guardian Needle™ Electrode
Indications for Use (Describe)
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), Electroencephalography (EEG), and Nerve potential signals. The electrodes are sterile and for single patient use.
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) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------- |
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Guardian Needle™ Electrode Rhythmlink International, LLC
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510(k) Summary – K200984
| 807.92(a)(1)SubmitterInformation | Rhythmlink International, LLC1140 First Street SouthColumbia, SC 29209Phone: 803-252-1222FDA Registration #: 1067162 | |
|---|---|---|
| OfficialCorrespondent | Gabriel Orsinger, PhDVice President of Engineering and R&DEmail: gorsinger@rhythmlink.comPhone: 803-365-9664 | |
| Summary Date | May 27, 2020 | |
| 807.92(a)(2)DeviceIdentification | Device Trade Name:Classification Name:Product Code:Classification:Classification Panel: | Guardian Needle™ ElectrodeNeedle ElectrodeGXZ21 CFR 882.1350 Class IINeurology |
| 807.92(a)(3)Predicate Device | Device Trade Name:Classification Name:510(k) Number:Product Code:Classification:Classification Panel:Manufacturer: | Subdermal Needle ElectrodesNeedle ElectrodeK022914GXZ21 CFR 882.1350 Class IINeurologyRhythmlink International, LLC1140 First Street SouthColumbia, SC 29209 |
| 807.92(a)(4)Device Description | Guardian Needle™ Electrodes are a sterile, single-use device. Theelectrodes are applied during the study of biopotentials such aselectromyography (EMG), electroencephalography (EEG), nerve conductionand stimulation/response. The electrodes are invasive as they are placedsubcutaneously or in contact with nerve or muscle tissue. The needle ishoused inside a sheath until application and secured to the patient during usewith adhesive tape. | |
| 807.92(a)(5)Intended Use | Rhythmlink International Guardian Needle™ Electrodes are intendedfor use with recording, monitoring and stimulation equipment for thepurpose of recording of biopotential signals. Examples include:Electromyography (EMG), Electroencephalography (EEG) and Nervepotential signals. The electrodes are sterile and for single patient useonly | |
| 807.92(a)(6)TechnologicalCharacteristics | The technological characteristics of Guardian Needle™ Electrodes areidentical to the predicate device (K022914), with the addition of a needlesheath and adhesive tape, both of which have been assessed to not change thefundamental scientific technology, intended use, performance, or safety andeffectiveness of the predicate device (reference Substantial Equivalence of |
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| Technological Characteristics table, below). The test methods were identicalto those used to assess the predicate device. |
|---|
| 807.92(b)(1)Summary of Non-Clinical Tests |
| Guardian Needle™ Electrodes are substantially equivalent in technology,safety, and effectiveness as the predicate device (K022914), as demonstratedby the test results. |
| The Guardian Needle™ Electrode was assessed by applying the TIR 28:2009Guidance, from which it was determined that the subject device does notchallenge the Submitter's Master Challenge Device and can thus fall underthe previously validated EtO sterilization cycle. Reevaluation of the EtOresiduals was performed to confirm low levels of EtO and EthyleneChlorohydrin (ECH) after a 24-hour aeration time below the maximum limitsdescribed in ANSI/AAMI/ISO 10993-7:2008/(R) 2012. |
| The biocompatibility evaluation was conducted within the risk managementframework and in compliance with ISO 10993 standards. Thisbiocompatibility evaluation establishes the biological safety for the GuardianNeedle™ Electrode with intact skin contact for a limited (≤24 hours)duration |
| Functional performance equivalency was determined by electrical andadhesive benchtop testing, as follows: |
| Electrical Continuity Adhesion Testing |
| Benchtop performance testing passed predetermined acceptance criteria,demonstrating Guardian Needle™ Electrodes are equivalent to the predicatedevice in functionality, safety, and effectiveness. |
| 807.92(b)(2)Clinical Tests |
| No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(2). |
| 807.92(b)(3)Clinical Summary |
| No Clinical Tests were conducted as referenced in 21 CFR 807.92(b)(3). |
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Substantial Equivalence Table
| Characteristic | Subject Device:Guardian Needle™Electrodes | Predicate Device:Subdermal NeedleElectrodes | SubstantialEquivalence(SE)1 |
|---|---|---|---|
| 510(k)Number | K200984 | K022914 Subdermal NeedleElectrodes | |
| Manufacturer | Rhythmlink International,LLC | Rhythmlink International,LLC | SE |
| Device Class | Class II | Class II | SE |
| Product Code | GXZ | GXZ | SE |
| RegulatoryName | Subdermal Needle | Subdermal Needle | SE |
| Device Type | Subdermal Needle Electrodes | Subdermal Needle Electrodes | SE |
| Regulation # | 21 CFR 882.1350 | 21 CFR 882.1350 | SE |
| Intended Use | Rhythmlink InternationalSubdermal Needle Electrodesare intended for use withrecording, monitoring andstimulation equipment for thepurpose of recording ofbiopotential signals.Examples include:Electromyography (EMG),Electroencephalography(EEG), and Nerve potentialsignals. The electrodes aresterile and for single patientuse. | Rhythmlink InternationalSubdermal Needle Electrodesare intended for use withrecording, monitoring andstimulation equipment for thepurpose of recording ofbiopotential signals.Examples include:Electromyography (EMG),Electroencephalography(EEG), and Nerve potentialsignals. The electrodes aresterile and for single patientuse. | SE |
| AnatomicalSite(s) | Subdermal muscle or nervetissue | Subdermal muscle or nervetissue | SE |
| Environmentusage | Hospital | Hospital | SE |
| ElectrodeMaterial | Medical Grade 304VM(vacuum melt) Stainless Steel | Medical Grade 304VM(vacuum melt) Stainless Steel | SE |
| ElectrodeLength | 7mm to 22 mm | 7mm to 22 mm | SE |
| ElectrodeDiameter | 0.4mm | 0.4mm | SE |
| LeadwireMaterial | PVC-coated Electrical Wire | PVC-coated Electrical Wire | SE |
| LeadwireLength | 1.0m to 3.0m | 1.0m to 3.0m | SE |
| Connector | 1.5mm DIN 42 802 pin touchproof connector | 1.5mm DIN 42 802 pin touchproof connector | SE |
| Characteristic | Subject Device:Guardian Needle™Electrodes | Predicate Device:Subdermal NeedleElectrodes | SubstantialEquivalence |
| 510(k)Number | K200984 | K022914 Subdermal NeedleElectrodes | (SE)1 |
| Use ofAdhesive Tape | YES | NO | SE; Materialchange hasbeen validatedby testing anddoes notadverselyimpact safetyOreffectiveness |
| Needle Cover | Thermoplastic polyesterelastomer sheath | PVC tube | SE; Materialanddimensionalchange hasbeen validatedby testing anddoes notadverselyimpact safetyOreffectiveness |
| Operation ofApplying theDevice | Applied subcutaneously to theskin | Applied subcutaneously to theskin | SE |
| PrescriptionUse | YES - Inserted by a licensedphysician or practitioner | YES - Inserted by a licensedphysician or practitioner | SE |
| TargetedProcedures | IONM, EMG, EP, EEG | IONM, EMG, EP, EEG | SE |
| Compatibilitywith otherdevices | Neurophysiology Monitorswith a 1.5mm DIN 42 802 pintouch proof connector | Neurophysiology Monitorswith a 1.5mm DIN 42 802 pintouch proof connector | SE |
| Packaging | 24 electrodes sealed in aTyvek pouch and placedinside a sealed, labeled box | 24 electrodes sealed in aTyvek pouch and placedinside a sealed, labeled box | SE |
| SterilizationMethod | Supplied EtO Sterile | Supplied EtO Sterile | SE |
| Single PatientUse | YES - disposable | YES - disposable | SE |
| ElectricalSafety | Connectors comply with IEC60601-1 (1988) sub clause56.3(c) per CFR 898.12 | Connectors comply with IEC60601-1 (1988) sub clause56.3(c) per CFR 898.12 | SE |
| Characteristic | Subject Device:Guardian Needle™Electrodes | Predicate Device:Subdermal NeedleElectrodes | SubstantialEquivalence(SE)1 |
| 510(k)Number | K200984 | K022914 Subdermal NeedleElectrodes | |
| MechanicalSafety | Leadwires are soldered toelectrode using Tin/Silversolder and covered with heatshrink | Leadwires are soldered toelectrode using Tin/Silversolder and covered with heatshrink | SE |
| Duration ofuse | ≤24 hours | ≤24 hours | SE |
| Standards | • IEC 60601-1-1: 1988/a1:1991/A2 :1995 § 56.3(c)per CFR 898.12• DIN 42802• ISO 14971• ISO 15223-1 | • IEC 60601-1-1: 1988/a1:1991/A2 : 1995 § 56.3(c)per CFR 898.12• DIN 42802• ISO 14971• ISO 15223-1 | SE |
| Biocompatible | Yes | Yes | SE |
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¹Only differences are indicated in this column.
§ 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).