(100 days)
The Injection Gold ProbeTM Bipolar Electronemostasis Catheter is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites include the following:
- Peptic Ulcers
- Dieulafoy Lesions
- Mallory-Weiss Tears
- Bleeding Polyp Stalks
- Arteriovenous Malformations (AVMs)
- Angiomata
The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available in a working length of 210 cm with outer diameters of 7F (2.3 mm) and 10F (3.3 mm), compatible with a minimum of 2.8 mm and 3.7 mm scope channels, respectively. The catheter shaft provides firmness for persendicular and tangential use, while the Mediglide coating on the catheter promotes minimal friction during endoscope passage.
I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25 gauge injection needle for injection therapy. The catheter handle contains the injection needle hub. Injection is performed by attaching a luerlock syringe to the "Injection" hub and advancing the needle.
II. Bipolar Electrohemostasis
The gold-spiral electrode on the probe tip provides bipolar electrohemostasis. The Injection Gold Probe Catheter connects directly to the Endostat™ family of Bipolar Electrosurgical Generators. Or utilize the Bipolar Cable Adapter supplied by Boston Scientific for other bipolar electrosurgical generators.
III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator or to a 30 cm3 (30 cc) or 60 cm3 (60 cc) luer-lock syringe or mechanical irrigation system for generators without irrigation capability.
This document describes a Special 510(k) Premarket Notification for the Injection Gold Probe™ Bipolar Electrohemostasis Catheter. The submission focuses on demonstrating substantial equivalence to a predicate device (K110887) by addressing material changes made to the proposed device.
Here's an analysis of the acceptance criteria and supporting study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are biocompatible. | "All biocompatibility tests conducted on the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter passed. Therefore, the Injection Gold ProbeTM Bipolar Electrohemostasis Catheter is considered biocompatible." |
| Bench Testing - Required specifications for the following tests: | "All device bench tests results were acceptable. The data demonstrate that the Injection Gold Probe™ Bipolar Electrohemostasis Catheter meets design specifications and is suitable for its intended use." |
| - Combination Therapy Device | Met required specifications. |
| - Device Irrigation Flow Rate | Met required specifications. |
| - Injection Needle Flow Rate | Met required specifications. |
| - Injection Needle Extension and Retraction | Met required specifications. |
| - Injection Needle Retraction Lock | Met required specifications. |
| - Injection Hub to 22-gauge Hypotube Joint Tensile Strength | Met required specifications. |
| - 25-gauge Injection Needle to the 22-Gauge Hypotube Joint Tensile Strength | Met required specifications. |
| - Needle Specification | Met required specifications. |
Study Information
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Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the individual bench tests. It only states that tests were performed.
- The data provenance is not explicitly mentioned (e.g., country of origin). However, as this is a 510(k) submission to the FDA (USA), the testing would typically be conducted under US or internationally recognized standards. The studies appear to be prospective in nature, designed to evaluate the modified device against predetermined specifications.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes engineering bench testing and biocompatibility testing, not clinical studies involving expert assessment of images or patient outcomes. Therefore, no "experts" in the context of clinical ground truth establishment were utilized or mentioned. The "ground truth" for these tests would be the established engineering specifications and biocompatibility standards.
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Adjudication method for the test set:
- Not applicable as this is not a study requiring adjudication of expert opinions (e.g., image interpretation). Bench tests and biocompatibility tests are evaluated against predefined, objective pass/fail criteria.
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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, an MRMC comparative effectiveness study was not done. This is a submission for a medical device (a catheter) and not an AI/software device that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- For biocompatibility: Adherence to established biocompatibility standards (e.g., ISO 10993 series).
- For bench testing: Established engineering design specifications and performance requirements for the device's functions (e.g., flow rates, tensile strength, extension/retraction mechanisms).
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).