INJECTION GOLD PROBE

K961349 · Boston Scientific Corp · KNS · May 15, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K961349
• Device Name: INJECTION GOLD PROBE
• Applicant: Boston Scientific Corp
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Injection Gold Probe and Injection Gold Probe Direct are 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; 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 Story

Catheter-based device for endoscopic use; delivers pharmacological injection agents and provides bipolar electrohemostasis for GI bleeding sites. Features irrigation capability. Operated by physicians during endoscopic procedures. Device inputs include electrical energy for cauterization/coagulation and liquid agents for injection. Output is localized tissue treatment. Benefits include control of GI hemorrhage and potential bleeding sites.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. No clinical data provided.

Technological Characteristics

Bipolar electrosurgical catheter; stainless steel 25G needle; 7-10F shaft diameter; 210-350cm length. Features irrigation port. Sterilized via ethylene oxide gas per AAMI protocol. Packaging: styrene tray with spun-bonded polyolefin lid.

Indications for Use

Indicated for endoscopic injection therapy and electrohemostasis of GI tract bleeding sites (peptic ulcers, Mallory-Weiss tears, AVMs, Dieulafoy lesions, bleeding polyp stalks, angiomata) in patients requiring endoscopic intervention. Contraindications: non-focal bleeding, esophageal/gastric varices, diffuse lesions, allergies to injection agents.

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 Probe (K942301)

Submission Summary (Full Text)

{0}

K961349

MAY 15 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 Probe™
- 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)<br/>Gastro-Renal (GRDB)

- OWNER/OPERATOR: Boston Scientific Corporation<br/>One Boston Scientific Place<br/>Natick, MA 01760<br/>Owner/Operator No. 9912058

- CONTACT PERSON: Daniel J. Dillon, Senior Regulatory Affairs Specialist

# INDICATIONS FOR USE

The Modified Injection Gold Probe and Injection Gold Probe Direct are 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; 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.

# 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.

Premarket Notification Modified Injection Gold Probe

Proprietary and Confidential Information of Boston Scientific Corporation

{1}

# 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 ulcers; 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 Injection 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.

Premarket Notification Modified Injection Gold Probe
Proprietary and Confidential Information of Boston Scientific Corporation

{2}

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) |
| --- | --- | --- |

USE

| Indication | Endoscopic injection therapy and electrohemostasis of actual or potential bleeding 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

| Bipolar Tip | Yes | ← Same |
| --- | --- | --- |

INJECTION THERAPY

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

IRRIGATION CAPABILITY

| Irrigation Capability | Yes | ← Same |
| --- | --- | --- |

Premarket Notification Modified Injection Gold Probe
Proprietary and Confidential Information of Boston Scientific Corporation