(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.
§ 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).