(85 days)
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No
The summary describes a kit of standard medical devices for drainage and access, with no mention of AI or ML capabilities.
No
The device is used for drainage and access during cryosurgery procedures, which are therapeutic interventions, but the device itself is an accessory used for access and drainage, not for directly treating a disease or condition.
No
This device is for suprapubic bladder drainage and percutaneous access for placement of probes, which are interventional procedures rather than diagnostic ones.
No
The device description explicitly lists physical components such as guidewires, needles, catheters, scalpel, and syringe, indicating it is a hardware-based medical device kit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of this device clearly indicate it is a kit for surgical access and drainage within the body (suprapubic bladder drainage and percutaneous access for probe placement). It is used during a medical procedure, not for testing samples outside the body.
Therefore, based on the provided information, this device falls under the category of a surgical or procedural device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
The kit is comprised of guidewire(s), access needles(s), dilator(s), divinage catheter with connecting tube, scalpel and syringe.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound-guided
Anatomical Site
suprapubic bladder
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
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 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 11, 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), 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.