(37 days)
The Modified Injection Gold Probe and Injection Gold Probe Direct are indicated for use in endoscopic injection therapy (to deliver pharmacological injection arents, 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; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. The Modified Injection Gold Probe and Injection Gold Probe Direct also have irrigation capability.
The Modified Injection Gold Probe is substantially equivalent to the currently-marketed Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products.
Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Modified Injection Gold Probe) | Reported Device Performance (Injection Gold Probe - K942301) |
|---|---|---|
| Indication | Endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract. | Same |
| Route of Administration | Endoscopic | Same |
| Usable Length | 210 - 350 cm | Same |
| Shaft OD | 7 - 10 F | Same |
| Needle Material | Stainless Steel | Same |
| Needle Gauge | 25 Gauge | Same |
| Needle Extension Length | 4 - 6 mm | Same |
Study to Prove Device Meets Acceptance Criteria:
The provided document describes a 510(k) summary for the "Modified Injection Gold Probe." This submission claims substantial equivalence to a previously marketed device, the "Injection Gold Probe" (510(k) No. K942301). The study proving the device meets its acceptance criteria is not a clinical trial with human subjects, but rather a set of laboratory and biocompatibility tests designed to demonstrate that the new device is as safe and effective as the predicate device.
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Sample Size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" in the context of clinical data for performance evaluation in the way one would for an AI/ML device. Instead, it refers to "laboratory testing regarding characteristics" performed on the Modified Injection Gold Probe. The number of units tested is not explicitly stated.
- Data Provenance: The testing was conducted internally by Boston Scientific Corporation. The specific country of origin for the data is not mentioned beyond the company's address in Natick, MA, USA. This appears to be a retrospective analysis of laboratory test results.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for demonstrating substantial equivalence is based on engineering specifications, material properties, and functional performance as verified through laboratory testing against established criteria for the predicate device, not through expert interpretation of clinical cases.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. There was no clinical test set requiring expert adjudication.
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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 MRMC comparative effectiveness study was conducted or is relevant for this device. This device is a medical instrument (catheter), not an AI/ML diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is established through:
- Engineering specifications and design comparisons: The new device must meet the same design parameters (e.g., usable length, shaft OD, needle gauge) as the predicate device, as presented in Figure 9-1.
- Functional performance testing: Laboratory tests were performed to verify safety and performance (e.g., electrohemostasis capabilities, injection therapy function).
- Biocompatibility assessment: Performed on patient- and fluid-contact materials.
- Sterilization and Pyrogenicity testing: To ensure the device is sterile and non-pyrogenic.
- The acceptance criteria are essentially derived from the known safe and effective performance of the predicate device (Injection Gold Probe, K942301).
- The "ground truth" for this submission is established through:
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The sample size for the training set:
- This is not applicable. There is no "training set" in the context of this device's development or regulatory submission, as it is a medical instrument and not an AI/ML model.
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How the ground truth for the training set was established:
- This is not applicable for the reasons stated 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).