(85 days)
The proposed kit is indicated for suprapubic bladder drainage and percutancous access for the placement of theminsensor probes in patients undergoing ultrasound-guided urological cryosurgery procedures in accordance with the indications of legally marketed cryosurgery systems.
The kit is comprised of guidewire(s), access needles(s), dilator(s), divinage catheter with connecting tube, scalpel and syringe.
This document is a 510(k) Premarket Notification for a medical device (Percutaneous Introducer System) from 1996. It does not contain the type of detailed study information, acceptance criteria, or performance data that would be relevant to evaluating an AI/ML powered device. The document predates the widespread use of AI/ML in medical devices by decades.
Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to this 1996 device submission.
The document primarily focuses on establishing "substantial equivalence" of the device and its components to already legally marketed devices.
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Boston Scientific Corporation January 10, 1996
JUN 21 1998
510(k) Premarket Notification Percuataneous Introducer System
FOI RELEASABLE
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 Prematket Notification". . . adequate summary of any information respecting safety and effectivencss 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 Corporation480 Pleasant StreetWatertown, MA 02172(508) 650-8000 |
| Contact Person: | Lorraine M. HanleyProject Manager, Regulatory Affairs |
| Device Common Name: | Percutaneous Introducer System |
| Device Trade Name: | To be Determined |
| Classification Name: | Boston Scientific Corporation believes that the PercutaneousIntroducer System is best described by the following deviceclassification names:Catheter Introducer:Class 11, CFR 870.1340Introducer/Drainage Catheter and AccessoriesClass I, 21 CFR 878.4200 |
Device Description & Intended Use:
The kit is comprised of guidewire(s), access needles(s), dilator(s), divinage catheter with connecting tube, scalpel and syringe. The proposed kit is indicated for suprapubic bladder drainage and percutancous access for the placement of theminsensor 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 Percutanous Introducer System is safe and effective, that it will meet the minimum requirencents that are considered acceptable for its intended use, and that a determination of "substantial equivalence" is supported.
§ 878.4350 Cryosurgical unit and accessories.
(a)
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.(b)
Classification. Class II.