INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

K133933 · Boston Scientific Corporation · KNS · Apr 2, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133933
• Device Name: INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
• Applicant: Boston Scientific Corporation
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Apr 2, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Injection Gold ProbeTM 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

Catheter provides endoscopic injection therapy and bipolar electrohemostasis; features irrigation capability. Input: pharmacological agents via luer-lock syringe; electrical energy via bipolar electrosurgical generator. Operation: physician advances 25-gauge needle for injection; gold-spiral electrode at probe tip delivers bipolar current for tissue cauterization/coagulation. Used in clinical endoscopic settings. Output: localized tissue effect for hemostasis. Benefits: enables targeted treatment of GI bleeding sites. Design includes Mediglide coating for friction reduction; available in 7F and 10F diameters.

Clinical Evidence

No clinical data. Bench testing only. Tests included irrigation flow rate, needle flow rate, needle extension/retraction, retraction lock, and joint tensile strength. All tests met design specifications.

Technological Characteristics

Catheter with 25-gauge injection needle and gold-spiral bipolar electrode. Materials: PTFE-coated needle hub, hypotube, adhesive bond. Dimensions: 210 cm length, 7F/10F diameters. Energy: Bipolar electrosurgical. Connectivity: Direct connection to Endostat generators or via adapter. Sterilization: Not specified.

Indications for Use

Indicated for patients with gastrointestinal bleeding sites including peptic ulcers, Dieulafoy lesions, Mallory-Weiss tears, bleeding polyp stalks, arteriovenous malformations, and angiomata requiring endoscopic injection therapy or electrohemostasis.

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 (K110887)

Submission Summary (Full Text)

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# APR 0 2 2014

K133933 Page 1 of 3

SECTION 6 510(k) SUMMARY

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## 510(k) SUMMARY

#### 1, Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Ashley Pyle Regulatory Affairs Manager Telephone: [phone] Fax: [phone]

Secondary Contact: Jennifer Kimball Director of Regulatory Affairs Telephone: [phone] Fax: [phone]

Date Prepared: December 20, 2013

#### 2. Proposed Device:

Trade Name: Injection Gold ProbeTM Bipolar Electrohemostasis 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 Binolar Electrohemostasis Catheter Manufacturer and Clearance Number: Boston Scientific Corporation, K 110887 Classification Name: Unit, Electrosurgical, Endoscopic (with accessories) Regulation Number: 876.4300 Product Codc: 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 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.

Special 510(k) Premarket Notification, Injection Gold ProbeTM Bipolar Electrohemostasis Catheter

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- 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.

#### 5. Intended Use/Indications for Use:

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 �
- o Dieulafoy Lesions
- o Mallory-Weiss Tears
- 0 Bleeding Polyp Stalks
- Arteriovenous Malformations (AVMs) o
- 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 PTF : coating on the Injection Cold Probe (IGP) Needle Hub to Hypotube � Assemblies, is changing to a slightly modified PTFE coating.
- The current chemical weld used to attach the hypotube to injection hub, is being replaced o with an adhesive bond.

#### 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™ Binolar Electrohemostasis Catheter (K110887). The proposed device has material differences when compared to the currently marketed Injection Gold Probe™ Bipolar Electrohemostasis Catheter (K110887).

#### 8, Performance Data:

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

0000116

Special 510(k) Premarket Notification, Injection Gold Probe131 Bijolar Electrohemostasis Catheter

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Bench Testing has been performed on the proposed Injection Gold ProbeTM Bipolar Electrohemostasis Cather to demonstrate that the modified device meets the required specifications of the completed tests. The following bench tests were performed:

- o Combination Therapy Device
- o Device Irrigation Flow Rate
- 0 Injection Needle Flow Rate
- o Injection Needle Extension and Retraction
- Injection Needle Retraction Lock 0
- o Injection Hub to 22-gauge Hypotube Joint Tensile Strength
- 25-gauge Injection Needle to the 22-Gauge Hypotube Joint Tensile Strength 0
- o Needle Specification

#### 9. Conclusion:

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.

All device bench tests results were acceptable. The data demonstrate that the Injection Gold Probetal 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 (K110887).

## 000017

Special 510(k) Premarket Notification, Injection Cold Probe131 Bipolar Electrohemostasis Catheter

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 2, 2014

Boston Scientific Corporation Ashley Santos Regulatory Affairs Manager 100 Boston Scientific Way Marlborough, MA 01752

Re: K133933

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: February 28, 2014 Received: March 4, 2014

Dear Ashley Santos,

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 connine. 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). and Cosmetic Act (110) that to nevice, subject to the general controls provisions of the Act. The r ou may, therefore, mans of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition: "Fease note: "Obter ver, 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 If your device is elaboried (controls. Existing major regulations affecting your device can be may be subject to additions, 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 Please oe advised that I Dri 3 issuance of a sudenine complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies.

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Page 2 - Ashley Santos

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 (reporting of medical device-related 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,

Image /page/4/Picture/6 description: The image shows the text "Benjamin Fisher -S". The words are written in a bold, sans-serif font. The letters "DA" are stylized with a geometric pattern. The text is black against a white background.

Benjamin R. Fisher, Ph.D. Director 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):

Device Name:

Indications For Use:

To Be Determined K133933

Injection Gold ProbeTB1 Bipolar Electrohemostasis Catheter

The Injection Gold ProbeTM 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 notential 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 Blectrohemostasis Catheter also has irrigation capability. Any other use is not recommended.

Prescription Use X (Part 21 CPR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NBEDED)

Concurrence of CDRH, Office of Device Bvaluation (ODB)

Beniami 2014.04. 8 -04'00'

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Special 510(k) Premarket Nollfication, Injection Gold Probota Electrohenrostasis Catheter