← Product Code [GEH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH) · K961219 # PERCUTANEOUS INTRODUCER SYSTEM (K961219) _Boston Scientific Corp · GEH · Jun 21, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K961219 ## Device Facts - **Applicant:** Boston Scientific Corp - **Product Code:** [GEH](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH.md) - **Decision Date:** Jun 21, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4350 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## Indications for Use The proposed kit is indicated for suprapubic bladder drainage and percutaneous access for the placement of thermosensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems. ## Device Story Percutaneous Introducer System kit; includes guidewires, access needles, dilators, drainage catheter with connecting tube, scalpel, and syringe. Used by clinicians during ultrasound-guided urological cryosurgery. Facilitates suprapubic bladder drainage and placement of thermosensor probes. Provides percutaneous access to target site. Enables monitoring during cryosurgical procedures. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Kit components: guidewires, needles, dilators, drainage catheter, connecting tube, scalpel, syringe. Mechanical device; no energy source or software. ## Regulatory Identification (1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 06/17/96 12:14 508 650 8935 3SC REG. DEPT. 005 Boston Scientific Corporation January 10, 1996 JUN 21 1996 510(k) Premarket Notification Percutaneous Introducer System # FOI RELEASABLE K961219 # 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. Date: January 10, 1996 Owner Operator Submitting this Premarket Notification: Boston Scientific Corporation 480 Pleasant Street Watertown, MA 02172 (508) 650-8000 Contact Person: Lorraine M. Hanley Project Manager, Regulatory Affairs Device Common Name: Percutaneous Introducer System Device Trade Name: To be Determined Classification Name: Boston Scientific Corporation believes that the Percutaneous Introducer System is best described by the following device classification names: Catheter Introducer: Class II, CFR 870.1340 Introducer/Drainage Catheter and Accessories Class I, 21 CFR 878.4200 ## Device Description & Intended Use: The kit is comprised of guidewire(s), access needles(s), dilator(s), drainage catheter with connecting tube, scalpel and syringe. The proposed kit is indicated for suprapubic bladder drainage and percutaneous access for the placement of thermosensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems. ## Substantial Equivalence: All components of the proposed kit are either legally marketed preamendment devices, exempt form 510(k) Premarket Notification or have been found to be substantially equivalent through the 510(k) process for the uses for which the kit is intended. ## Conclusions: Based on the information presented in this current premarket notification, Boston Scientific Corporation believes that the proposed Percutaneous Introducer System is safe and effective, that it will meet the minimum requirements that are considered acceptable for its intended use, and that a determination of "substantial equivalence" is supported. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K961219](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEH/K961219) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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