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.

Device Description

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.

AI/ML Overview

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.

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.
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.
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.
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.
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.
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 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.
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

Summary

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MAY 1 5 1996

SECTION 9 510(K) SUMMARY

FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification "…adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

Common/Usual Names: Electrohemostasis and Injection Therapy Catheter
TRADE/PROPRIETARY NAME: Injection Gold Probes™
Classification Name &

DEVICE CLASSIFICATION:	Class I/II/III
	Name	Number	21 CFR Ref
	Unit, Electrosurgical, Endoscopic(with Accessories)	78 KNS	876.4300
	Endoscope and/or Accessories	78 KOG	876.1500
> DEVICE PANEL/BRANCH:	Gastroenterology-Urology (GU)Gastro-Renal (GRDB)
> OWNER/OPERATOR:	Boston Scientific CorporationOne Boston Scientific PlaceNatick, MA 01760Owner/Operator No. 9912058
> CONTACT PERSON:	Daniel J. Dillon, Senior Regulatory Affairs Specialist

INDICATIONS FOR USE

CONTRAINDICATIONS

Contraindications for this device are those specific to injection therapy and bipolar electrohemostasis treatments. These contraindications include, but are not limited to: non-focal bleeding sites; esophageal/gastric varices; diffuse lesions; allergies to injection agents.

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POTENTIAL COMPLICATIONS

Possible complications include, but may not be limited to: perforation; bleeding, post-injection ulceration with delayed bleeding; aspiration pneumonia; pleural effusion; other respiratory difficulties; hepatic failure; septicemia/infection; chest pain; esophageal strictures; dysphagia, fulguration, burns, stimulation and cardiac arrhythmias

Descriptive And Technological Characteristics OF Proposed And Predicate Devices

Boston Scientific Corporation believes that the Modified linjection Gold Probe is substantially equivalent to the currently-marketed Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products.

PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Modified Injection Gold Probe to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Modified Injection Gold Probe with satisfactory results.

Packaging, Sterilization, And Pyrogenicity

The Modified Injection Gold Probe will be packaged in a styrene tray with a spun-bonded polyolefin lid. Modified Injection Gold Probe will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

CONCLUSION

Boston Scientific Corporation believes that Modified Injection Gold Probe is substantially equivalent to the currently-marketed Modified Injection Gold Probe. Figure 9-1 compares the descriptive characteristics of these products. As demonstrated in Figure 9-1. the Modified Injection Gold Probe is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Modified Injection Gold Probe will meet the minimum requirements that are considered acceptable for its intended use.

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Figure 9-1: Comparison of Modified Injection Gold Probe and Injection Gold Probe

	Modified Injection Gold Probe(This 510(k))	Injection Gold Probe(510(k) No. K942301)
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USE

Indication	Endoscopic injection therapy andelectrohemostasis of actual or potentialbleeding sites in the gastrointestinal tract.	«- Same
Route of Administration	Endoscopic	«- Same

CATHETER SHAFT

Usable Length	210 - 350 cm	← Same
Shaft OD	7 - 10 F	← Same

BIPOLAR HEMOSTASIS

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INJECTION THERAPY

Needle Material	Stainless Steel	<-- Same
Needle Gauge	25 Gauge	<-- Same
Needle Extension Length	4 - 6 mm	<-- Same

IRRIGATION CAPABILITY

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Regulation Number and Section

§ 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).