MICROVASIVE INJECTION GOLD PROBE

{0} Boston Scientific Corporation May 10, 1994 510(k) Premarket Notification Microvasive® Injection Gold Probe™ K942301 NOV 2 1994 Section V # **FOI RELEASABLE** # **510(k) Summary** Page 41 of 159 {1} Boston Scientific Corporation May 10, 1994 510(k) Premarket Notification Microvasive® Injection Gold Probe™ # FOI RELEASABLE K942301 ## 510(k) Summary 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. ### A. GENERAL INFORMATION | Owner Operator Submitting this Premarket Notification: | Boston Scientific Corporation 480 Pleasant Street Watertown, MA 02172 (617) 923-1720 | | --- | --- | | Contact Person: | Sheri D. O'Brien Senior Regulatory Affairs Specialist | | --- | --- | | Device Generic Name: | Electrohemostasis and Injection Therapy Catheter | | --- | --- | | Device Trade Name: | Microvasive® Injection Gold Probe™ | | --- | --- | | Classification Name: | Boston Scientific Corporation believes that the Injection Gold Probe is best described by the following device classification names: | | --- | --- | | Unit, Electrosurgical, Endoscopic (with Accessories): | 78KNS | | --- | --- | | Endoscope and/or Accessories: | 78KOG | Device Classification: Although the Injection Gold Probe has not been specifically classified under 21 CFR § 876, the status of the classification names presented below supports a Class II device classification. | Endoscope Electrosurgical Unit and Accessories: | Class II, 21 CFR § 876.4300 | | --- | --- | | Endoscope and Accessories: | Class II, 21 CFR § 876.1500 | ### B. INDICATIONS FOR USE The Microvasive Injection Gold Probe is indicated for use in endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract, including, but not limited to: the esophagus, stomach, duodenum, and colon. These sites include the following: peptic ulcers; Mallory-Weiss tears; arteriovenous malformations (AVMs); Dieulafoy lesions; bleeding polyp stocks; and angiomata. ### C. 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; and use of the Injection Gold Probe with monopolar electrosurgical generators Page 42 of 159 {2} Boston Scientific Corporation May 10, 1994 510(k) Premarket Notification Microvasive® Injection Gold Probe™ # D. POTENTIAL COMPLICATIONS Potential 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; and dysphagia. # E. DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES Boston Scientific Corporation believes that the proposed Microvasive Injection Gold Probe is substantially equivalent to the currently marketed Microvasive Gold Probe™ and Microvasive Variject™ Clear Injection Therapy Needle catheter. Table 1 compares the descriptive characteristics of these products. ) ) Page 43 of 159 {3} Boston Scientific Corporation May 10, 1994 510(k) Premarket Notification Microvasive® Injection Gold Probe™ Table 1: Similarities and Differences between the Proposed Microvasive Injection Gold Probe and the Predicate Microvasive Gold Probe and Variject Clear Injection Therapy Needle Catheter | Device Characteristic | Microvasive® Gold Probe™ (Predicate Device) (K885005) | Microvasive® Variject™ Clear Injection Therapy Needle Catheter (Predicate Device) (K854238) | Microvasive® Injection Gold Probe™ (Proposed Device) (This 510(k)) | | --- | --- | --- | --- | | Indications for Use | Endoscopic electrohemostasis of visible bleeding and non-bleeding sites in the gastrointestinal tract. | Used endoscopically to introduce a sclerosing agent or vasoconstrictor into selected sites to control actual or potential bleeding lesions in the digestive system. | Endoscopic injection therapy and electrohemostasis of actual or potential bleeding sites in the gastrointestinal tract. | | **Catheter Shaft:** | | | | | Material | Confidential | Confidential | Confidential | | Usable Length | 290 cm - 350 cm | 200 cm | 210 - 350 cm | | Shaft OD | 7 - 10 F | 5.4 F (1.8 mm) | 7 - 10 F | | Coating | Confidential | NA | Confidential | | **Bipolar Electrohemostasis:** | | | | | Bipolar Ceramic Tip | Confidential | NA | Confidential | | Electrical Wires | Confidential | NA | Confidential | | Generator Connector | Bipolar Erbe Connector | NA | Bipolar Erbe Connector | | Electrical Bifurcation | Confidential | NA | Confidential | | **Injection Therapy:** | | | | | Needle Material | NA | Confidential | Confidential | | Needle Gauge | NA | 23 & 25 Gauge | 25 Gauge | | Needle Extension Length | NA | 5 mm | 4 - 6 mm | | Needle Luer Hub Material | NA | Confidential | Confidential | | **Irrigation Capability:** | | | | | Irrigation Capability | Yes | No | Yes | | Irrigation Luer Hub Material | Confidential | NA | Confidential | Page 44 of 159 {4} Boston Scientific Corporation May 10, 1994 510(k) Premarket Notification Microvasive® Injection Gold Probe™ # F. PERFORMANCE CHARACTERISTICS In vitro laboratory testing regarding both clinical performance characteristics and product integrity was performed on finished, sterilized Injection Gold Probe catheters to verify the device's safety and effectiveness. In addition, Full Tripartite Biocompatibility testing was performed on the Injection Gold Probe with satisfactory results. # G. PACKAGING, STERILIZATION, AND PYROGENICITY The package is the same as that presently used for the currently marketed Microvasive Gold Probe. The 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. # H. CONCLUSION Boston Scientific Corporation believes that the proposed Microvasive Injection Gold Probe is substantially equivalent to the Microvasive Gold Probe and Variject catheters. As demonstrated in Table 1, the Injection Gold Probe combines their indications for use, while combining their designs. In addition, BSC has presented Laboratory and Biocompatibility Testing data to verify the safety and effectiveness of the proposed Injection Gold Probe. Based on the information presented, Boston Scientific Corporation believes that the proposed Microvasive Injection Gold Probe is safe and effective and it will meet the minimum requirements that are considered acceptable for its intended use. Injection Gold Probe is a trademark of Boston Scientific Corporation. Gold Probe is a trademark of Boston Scientific Corporation. Variject is a trademark of Boston Scientific Corporation. Microvasive is a registered trademark of Boston Scientific Corporation. Page 45 of 159 {5} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service NOV 2 1994 Food and Drug Administration 1390 Piccard Drive Rockville MD 20850 Ms. Sheri D. O'Brien Senior Regulatory Affairs Specialist Boston Scientific Corporation 480 Pleasant Street Watertown, MA 02172-2414 Re: K942301/B Microvasive Injection Gold Probe Dated: October 19, 1994 Received: October 20, 1994 Regulatory Class: II 21 CFR 876.4300 Procode: 78 KNS Dear Ms. O'Brien: We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to 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). 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations. This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Lillian Yin Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health