(238 days)
Disposable Concentric Needle electrodes are sterile electrodes indicated for recording muscle activity for Electromyography (EMG) applications. The electrodes are for single patient use only.
Disposable Monopolar Needle electrodes / EP Needle electrodes indicated for recording muscle activity for Electromyography (EMG) and/or Electroencephalography (EEG) applications. The electrodes are for single patient use only.
Disposable Hypodermic Needle electrodes indicated for injection of Botulium Toxin while recording muscle activity with Electromyography (EMG) applications. The electrodes are for single patient use only.
The Bio Protech Disposable Concentric Needle Electrode is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. Bio Protech Disposable Concentric Needle Electrode consists of a stainless steel cannula and an inner conductor of silver. Between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction lubricant.
The Bio Protech Disposable Monopolar / EP Needle Electrode is intended to be inserted in the subdermal, muscle or nerve tissue for use with recording equipment for the recording of biopotentials signals, EEG or EMG, and proximally connected to electromyography / Electroencephalogram recording equipment. The electrodes consist of a formed stainless steel needle with a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
The Bio Protech Disposable Hypodermic Needle Electrode is intended to be inserted in the muscle while recording electromyography activity, and proximally connected to electromyography recording equipment. The electrodes consist of an hypodermic stainless steel needle with an open lumen and a lead wire attached. The wire can be directly connected or removable and terminates in a safety connector that cannot be connected to an AC power outlet or and cannot get in touch with possible hazardous voltage.
This document describes the premarket notification for Bio Protech, Inc.'s Disposable Concentric Needle Electrodes, Disposable Monopolar Needle Electrodes, Disposable EP Needle Electrodes, and Disposable Hypodermic Needle Electrodes. The submission seeks to demonstrate substantial equivalence to legally marketed predicate devices.
Acceptance Criteria and Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating similar performance characteristics to predicate devices and adherence to relevant standards. The "Substantial Equivalence Chart" (Pages 5-7) directly compares the new device with predicate devices across various characteristics.
For "Performance", the report states:
- Acceptance Criteria (Implied): Equivalent penetration and friction force to predicate devices, and electrical properties conforming to DIN 13097. Assurance of functionality during the shelf life through aging tests. Optimal bevel and burr for sharpening, and electrical continuity and isolation of all poles.
- Reported Device Performance:
- Disposable Concentric Needle electrodes: "Tested for penetration and friction force and electrical properties (according to DIN 13097). Ageing tests are performed to verify and ensure the functionality during the shelf life of the product."
- Disposable Hypodermic Needle electrodes (under the "Performance" row for Concentric, but appears to relate to Hypodermic based on context within the table): "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
- Disposable Monopolar Needle electrodes / EP Needle electrodes: "Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles;"
The overall conclusion states: "The result of testing shows that the electrodes are as safe, effective and perform at least as the legally marketed device."
Summary of Studies and Information:
- Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria (Implied/Predicate Match) | Reported Device Performance (Bio Protech Needle Electrodes) |
|---|---|---|
| Penetration and Friction Force | Equivalent to predicate devices (according to DIN 13097 for Concentric/Hypodermic, unknown for Monopolar/EP as predicate performance is "Unknown") | Tested for penetration and friction force according to DIN 13097. Results show the electrodes are "as safe, effective and perform at least as the legally marketed device." |
| Electrical Properties | Conforms to DIN 13097 (for Concentric). Electrical continuity and isolation of all poles (for Hypodermic/Monopolar/EP). | Tested for electrical properties (according to DIN 13097) for Concentric. Sharpening; Camera visual examination with special attention to bevel and burrs; Electrical continuity and isolation of all poles for Hypodermic/Monopolar/EP. |
| Shelf-Life | Functionality during shelf life (implied by predicate's aging tests). Specific duration for predicates: 60 months (BIONEN Concentric), Unknown (Technomed, Axon). | Accelerated aging testing conducted according to ASTM F 1980. Test results indicate a shelf-life of 3 years. |
| Sterility | EO sterilization or Gamma irradiation (predicate dependent). | EO sterilization. Passed EO residual testing per ISO 10993-7: 2008. |
| Biocompatibility | Appropriate levels of biocompatibility (based on ISO 10993-1). | Evaluations performed for cytotoxicity (ISO MEM elution), intracutaneous reactivity, Guinea pig maximization sensitization, acute systemic toxicity, material-mediated pyrogenicity (rabbit), and hemolysis (based on ISO 10993-1). |
| Electrical Safety | "Touch-proof" safety connector, not pluggable into AC power outlet, cannot contact hazardous voltage. | The "touch-proof" safety connector is specifically designed so that it cannot be plugged into an AC power outlet and cannot get in touch with possible hazardous voltage. |
| Mechanical Safety | Packaged needle covered with a needle cover. | Packaged needle covered with a needle cover. |
| Materials | (Matches predicate materials: Stainless Steel, Silver/Platinum/Stainless Steel sensor, ABS/PE Hub, Epoxy Insulator, PELD Plastic protector, etc.) | Stainless Steel cannula, silver, ABS Hub, Epoxy Insulator, PELD Plastic protector, Stainless steel / gold plated connection (Concentric). Stainless steel cannula, ABS Hub, PELD Plastic protector, stainless steel/gold plated connection, lead wire (Hypodermic). Stainless Steel (Monopolar/EP). |
| Dimensions | (Similar to predicate dimensions) | Concentric: Diameter 0.30/0.45/0.36/0.65mm, L=25-30-38-50-75mm. Hypodermic: Diameter 0.30/0.40/0.45/0.65mm, L=25-37-40-50-75mm. Monopolar/EP: Diameter 0.36/0.45mm, L=25-37-50-75mm; Diameter 0.40mm, L=12mm. |
| Indications for Use / Anatomical Sites / Where Used | Functionally equivalent to predicates. | Demonstrated to be equivalent to BIONEN s.a.s. (K092973), Technomed Europe (K130136), and Axon System, Inc. (K050194) for their respective types of needle electrodes. |
-
Sample size used for the test set and the data provenance:
- The document does not specify the sample sizes used for the bench testing (penetration, friction force, electrical properties, aging, EO residual, biocompatibility).
- Data Provenance: The accelerated aging testing was conducted by KTR (Korea Testing and Research Institute). Biocompatibility evaluations were performed for manufactured and sterilized Bio Protech electrodes. The provenance of the specific test samples (e.g., country of manufacture) is not detailed beyond the company's location in Republic of Korea. All testing appears to be prospective testing of the Bio Protech device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring expert interpretation of medical images or patient data to establish ground truth.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the studies are bench performance and material characterization tests, not studies requiring adjudication of medical interpretations.
-
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:
- No MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or described in this document. This device is a disposable needle electrode, not an imaging or diagnostic AI device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was conducted. This device is a physical medical device (needle electrodes), not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance testing, the "ground truth" or reference was based on established industry standards (e.g., DIN 13097 for mechanical and electrical properties, ASTM F 1980 for aging, ISO 10993 for biocompatibility, ISO 10993-7 for EO residuals) and direct comparison to the performance characteristics of the legally marketed predicate devices.
-
The sample size for the training set:
- This question is not applicable as there is no mention of a training set or an algorithm in this submission.
-
How the ground truth for the training set was established:
- This question is not applicable as there is no mention of a training set or an algorithm in this submission.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).