The Injection Gold Probe™ Bipolar Electrohemostasis 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.

Device Description

The Injection Gold Probe Catheter is an injection therapy and bipolar electrohemostasis catheter with irrigation capabilities. The Injection Gold Probe Catheter is available with two different style electrical connectors (plugs), Standard and Banana. The Injection Gold Probe Catheter is available in a working length of 210cm with outer diameter of 7Fr (2.3mm) and 10Fr (3.3mm) compatible with a minimum working channel of 2.8mm and 3.7mm.

I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25gauge 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 has a standard plug which adapts to Symmetry Endostat, Endostat II and Bicap bipolar electrosurgical generators or Banana plugs which are recommended for use with Valleylab bipolar electrosurgical generator containing female Banana plug receptacles. The Valleylab generators should be used with the appropriate Valleylab accessories, reference the operating manuals for specifications.

III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator for the Standard plug or to a 30ml (30cc) or 60ml (60cc) luer-lock syringe for the Banana plug.

AI/ML Overview

The provided document is a 510(k) summary for the Boston Scientific Injection Gold Probe™ Bipolar Electrohemostasis Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for effectiveness.

Therefore, the document describes bench testing and biocompatibility testing to demonstrate that material and design changes to the proposed device do not negatively impact its safety and effectiveness compared to the predicate. It explicitly states it is not a study to prove device performance against clinical acceptance criteria often seen with AI/algorithm-based devices.

Here's an analysis based on the provided text, addressing your questions where applicable, and noting when the information is not present as it pertains more to an AI/software device evaluation:

Acceptance Criteria and Device Performance Study Analysis

The document describes a 510(k) submission for a physical medical device (catheter) with material and design modifications. The "acceptance criteria" and "device performance" in this context refer to engineering specifications and safety requirements, not clinical diagnostic accuracy or effectiveness metrics typically associated with AI studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description from Document	Reported Device Performance
Biocompatibility	To demonstrate that the material changes made to the proposed device are biocompatible. (Implicit criteria: meeting ISO standards for biocompatibility or similar industry standards for medical devices in contact with tissue)	"All biocompatibility tests conducted on the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter passed. Therefore, the Injection Gold Probe™ Bipolar Electrohemostasis Catheter is considered biocompatible."
Bench Testing (Functional)	To demonstrate that the modified device meets the required specifications of the completed tests. (Implicit criteria: performance metrics related to injection flow, electrohemostasis effectiveness, irrigation flow, mechanical integrity, dimensional tolerances, and electrical safety as per design specifications of the original device and relevant industry standards). Specifically mentioned changes: gold thick film conductor paste, coating, ceramic tip, radius tolerance, hypotube length.	"All device bench test results were acceptable. The data demonstrate that the Injection Gold Probe™ Bipolar Electrohemostasis Catheter meets design specifications and is suitable for its intended use."
Substantial Equivalence	The device must be substantially equivalent to a predicate device (K961349) in terms of intended use, fundamental design, and operating principle, with demonstrated safety and effectiveness of any modifications.	Boston Scientific Corporation has demonstrated that the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed predicate device.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size: Not specified in the document. For bench and biocompatibility testing of a physical device, sample sizes are typically determined by statistical methods for engineering testing (e.g., AQL, confidence interval for reliability), but not explicitly detailed in a 510(k) summary in the same way clinical study sample sizes are.
Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from in vitro (bench) and in vivo (biocompatibility, likely animal or standardized material tests) testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable as this is not an AI/algorithm device requiring expert-established ground truth for performance. The "ground truth" for the bench tests would be the established engineering specifications and performance benchmarks the device is designed to meet. Biocompatibility "ground truth" would be the standard material safety profiles and test protocols.

4. Adjudication Method for the Test Set

Not applicable for the type of testing described (bench and biocompatibility tests). Adjudication methods like 2+1 or 3+1 are used for resolving disagreements in expert assessments for clinical ground truth, which is not relevant here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This type of study is specific to evaluating the impact of an AI system on human reader performance, which is not relevant for this physical medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No standalone study (in the context of an algorithm's performance) was done. The "standalone" performance here would refer to the device's functional performance during bench testing, which was conducted to ensure it meets design specifications.

7. Type of Ground Truth Used

For Biocompatibility: Standards-based toxicological and biological response profiles (e.g., ISO 10993 series).
For Bench Testing: Engineering design specifications, functional requirements, and established performance parameters of the predicate device and relevant industry standards for electrosurgical and injection catheters. This is effectively "engineering ground truth."

8. Sample Size for the Training Set

Not applicable. This submission describes a physical medical device, not an AI/machine learning algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an algorithm, there's no ground truth to establish for it in this context.

In summary: The provided document details a 510(k) submission for a modified physical medical device. The "study" described focuses on demonstrating biocompatibility and meeting design specifications through bench testing to establish substantial equivalence to a predicate device. It does not involve clinical studies or evaluations pertinent to AI performance, expert ground truth, or human-in-the-loop performance improvements typical of AI/CDSS submissions.

Summary

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APR 1 4 2011

SECTION 6 510(k) SUMMARY

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4359 Fax: 508-683-5939

Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: March 29, 2011

2. Proposed Device:

Trade Name: Injection Gold ProbeTM Bipolar Electrohemostatis Catheter Classification Name: Unit. Electrosurgical, Endoscopic (with Accessories) Regulation Number: 876.4300 Product Code: KNS Classification: Class II

3. Predicate Device:

Trade Name: Injection Gold ProbeTM Bipolar Electrohemostatis Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K961349 Classification Name: Unit, Electrosurgical, Endoscopic (with Accessories) Regulation Number: 876.4300 Product Code: KNS Classification: Class II

4. Proposed Device Description:

I. Injection Therapy
Each Injection Gold Probe Catheter contains a 25gauge 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 has a standard plug which adapts to Symmetry Endostat, Endostat II and Bicap bipolar electrosurgical generators or Banana plugs which are recommended for use with Valleylab bipolar electrosurgical generator containing female

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Banana plug receptacles. The Valleylab generators should be used with the appropriate Valleylab accessories, reference the operating manuals for specifications.

III. Irrigation
Irrigation with saline or sterile water is performed by connecting the irrigation hub to the irrigation port of the bipolar generator for the Standard plug or to a 30ml (30cc) or 60ml (60cc) luer-lock syringe for the Banana plug.

5. Intended Use/Indications for Use:

6. Description of Change for this Submission:

The following changes are being made to the proposed Injection Gold Probe Bipolar Electrohemostasis Catheter:

The current gold thick film conductor paste is being replaced with a new gold thick film . conductor paste.
The Medi-Glide™ coating will be eliminated from the inside of the catheter and outside o of the needle hub/hypo tube assembly of the device and replaced with Teflon coating on the outside of the needle hub/hypo tube assembly only.
The current ceramic tip material is being replaced with a new ceramic tip material. .
The tolerance of the "radius" component has been slightly adjusted. o
The length of the hypotube component of the needle assembly was reduced. o

7. Technological Characteristics:

The proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter has the same fundamental design, operating principal and intended use as the predicate Injection Gold Probe™ Bipolar Electrohemostasis Catheter (K961349). The proposed device has material differences and some modifications to needle subassembly when compared to the currently marketed Injection Gold ProbeTM Bipolar Electrohemostasis Catheter (K961349).

8. Performance Data:

Biocompatibility Testing has been performed to demonstrate that the material changes made to the proposed device are biocompatible.

Bench Testing has been performed on the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter to demonstrate that the modified device meets the required specifications of the completed tests.

9. Conclusion:

All biocompatibility tests conducted on the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter passed. Therefore, the Injection Gold Probe™ Bipolar Electrohemostasis Catheter is considered biocompatible.

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All device bench tests results were acceptable. The data demonstrate that the Injection Gold ProbeTM Bipolar Electrohemostasis Catheter meets design specifications and is suitable for its intended use.

Boston Scientific Corporation has demonstrated that the proposed Injection Gold Probe™ Bipolar Electrohemostasis Catheter is substantially equivalent to Boston Scientific Corporation's currently marketed Injection Gold Probe™ Bipolar Electrohemostasis (K961349).

000027

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Ashley Pyle Sr. Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy Division 100 Boston Scientific Way MARLBOROUGH MA 01752 .

APR 1 4 2011

Re: K110887

Trade/Device Name: Injection Gold Probe™ Bipolar Electrohemostasis Catheter Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: KNS Dated: March 29, 2011 Received: March 30, 2011

Dear Ms. Pyle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related

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Page 2

adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Huckel Lemur. MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 5 INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	To Be Determined K110887
Device Name:	Injection Gold Probe™ Bipolar Electrohemostasis Catheter
Indications For Use:	The Injection Gold Probe™ Bipolar Electrohemostasis 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 UlcersDieulafoy LesionsMallory-Weiss TearsBleeding Polyp StalksArteriovenous Malformations (AVMs)Angiomata
	The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended.
Prescription Use(Part 21 CFR 801 Subpart D)	X AND/OR Over-The-Counter Use(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and Urological Devices	K110887
510(k) Number	Special 510(k) Premarket Notification, Injection Gold Probe™ Bipolar Electrohemostasis Catheter 000014

. -*

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).