INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

K110887 · Boston Scientific Corporation · KNS · Apr 14, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110887
• Device Name: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Apr 14, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Injection Gold Probe Catheter is a multi-functional endoscopic tool for injection therapy, bipolar electrohemostasis, and irrigation. Device features a 25-gauge needle for delivering pharmacological agents (e.g., vasoconstrictors) and a gold spiral electrode at the tip for tissue cauterization and blood coagulation. Irrigation is performed via saline or sterile water delivery. Used in clinical settings by physicians during endoscopic procedures. Device connects to compatible bipolar electrosurgical generators (Symmetry Endostat, Endostat II, Bicap, or Valleylab) via standard or banana plugs. Output is controlled by the physician to manage GI bleeding sites, potentially reducing hemorrhage and improving patient outcomes. Modifications in this version include updated gold thick film conductor paste, replacement of Medi-Glide coating with Teflon on the needle hub/hypo tube, new ceramic tip material, and adjusted needle assembly dimensions.

Clinical Evidence

No clinical data. Substantial equivalence supported by biocompatibility testing and bench testing demonstrating that the modified device meets all design specifications.

Technological Characteristics

Catheter with 25-gauge injection needle and gold spiral electrode for bipolar electrohemostasis. Materials: gold thick film conductor, ceramic tip, Teflon-coated needle hub/hypo tube. Available in 7Fr (2.3mm) and 10Fr (3.3mm) diameters, 210cm length. Energy source: external bipolar electrosurgical generator. Connectivity: standard or banana plug electrical connectors. Irrigation port for saline/water delivery.

Indications for Use

Indicated for endoscopic injection therapy and electrohemostasis of actual or potential GI bleeding sites (peptic ulcers, Dieulafoy lesions, Mallory-Weiss tears, bleeding polyp stalks, AVMs, angiomata) in patients requiring endoscopic intervention.

Regulatory Classification

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.

Predicate Devices

• Injection Gold ProbeTM Bipolar Electrohemostasis Catheter (K961349)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

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:

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

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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:

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.

## 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).

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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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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 [phone] or [phone] 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 <span style="text-decoration: overline;">K110887</span> |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: |
| | <ul><li>Peptic Ulcers</li><li>Dieulafoy Lesions</li><li>Mallory-Weiss Tears</li><li>Bleeding Polyp Stalks</li><li>Arteriovenous Malformations (AVMs)</li><li>Angiomata</li></ul> |
| | The Injection Gold Probe Bipolar Electrohemostasis Catheter also has irrigation capability. Any other use is not recommended. |
| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;">X</span> AND/OR Over-The-Counter Use<br>(21 CFR 807 Subpart C) |
| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) | |
| <div> <img alt="Signature" src="signature.png" width="200"/> </div> Concurrence of CDRH, Office of Device Evaluation (ODE) | |
| (Division Sign-Off) | |
| Division of Reproductive, Gastro-Renal, and Urological Devices | <span style="text-decoration: overline;">K110887</span> |
| 510(k) Number | Special 510(k) Premarket Notification, Injection Gold Probe™ Bipolar Electrohemostasis Catheter 000014 |

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