(258 days)
Not Found
No
The device description and performance studies focus on mechanical function and standard testing, with no mention of AI/ML terms or capabilities.
No.
The device is used for diagnostic purposes (aspiration biopsy) and for the introduction of other biopsy instruments, not for treating a disease or condition.
Yes
The device is used for aspiration biopsy, which is a procedure to collect cells for diagnostic purposes.
No
The device description clearly outlines physical components like tubing, a needle, and hubs, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is a device used to collect a sample (cells) from the biliary system within the body. It is a tool for obtaining the sample, not for analyzing it in vitro.
- Lack of In Vitro Analysis: The description focuses on the process of obtaining the sample (aspiration biopsy) and potentially introducing other instruments. There is no mention of any analysis or testing of the collected sample being performed by the device itself.
Therefore, this device is a surgical/biopsy instrument used for sample collection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is used for aspiration biopsy in the biliary system, and if desired for the introduction of other biopsy instruments.
Product codes (comma separated list FDA assigned to the subject device)
78FCG
Device Description
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle consists of double lumen tubing, a 22 gauge needle and proximal hubs. This device is designed for insertion through the accessory channel of an endoscope, and may be placed over a previously positioned .035" wire guide. The catheter is advanced through the accessory channel, positioning the side ramp below the biopsy site. The needle is advanced and cells are aspirated using a 20 cc syringe. After cell collection, if desired, the needle can be removed, leaving the inner catheter in place for the introduction of other conventional biopsy instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices.
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle has been subjected to our internal standard operating procedures for product qualification and process validation. Samples were subjected to visual, dimensional and functional analysis. All samples were deemed acceptable, in that test specifications were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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Page 12 of 14
PREMARKET NOTIFICATION FOR THE WILSON-COOK BILIARY RE: INTRODUCER with ASPIRATION BIOPSY NEEDLE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS J.
Submitted By:
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-Salem, NC 27105
Device Description:
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle consists of double lumen tubing, a 22 gauge needle and proximal hubs. This device is designed for insertion through the accessory channel of an endoscope, and may be placed over a previously positioned .035" wire guide. The catheter is advanced through the accessory channel, positioning the side ramp below the biopsy site. The needle is advanced and cells are aspirated using a 20 cc syringe. After cell collection, if desired, the needle can be removed, leaving the inner catheter in place for the introduction of other conventional biopsy instruments.
| Trade Name: | Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle | ||
|---|---|---|---|
| Common/Usual Name: | Aspiration Biopsy Needle | ||
| Classification Name: | Set, Biopsy Needle and Needle, Gastro-Urology | 78FCG | |
| Classification: | FDA has classified similar devices as Class II, per 21 CFR § 876.1075. This device falls within the purview of the Gastroenterology and Urology Devices Panel. | ||
| Performance Standards: | To the best of our knowledge, performance standards for this device do not exist. | ||
| Sterility: | Validated EO cycle, following the AAMI Overkill Method to SAL 10-6. | ||
| Intended Use: | The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle is used for aspiration biopsy in the biliary system, and if desired for the introduction of other biopsy instruments. |
Predicate Device:
| PREDICATE DEVICE | MANUFACTURER | DOCUMENT CONTROL
NUMBER |
|------------------------------------------------------|--------------------------|----------------------------|
| Wilson-Cook Biliary and
Gastric Aspiration Needle | Wilson-Cook Medical Inc. | K895900 |
1
PREMARKET NOTIFICATION FOR THE WILSON-COOK BILIARY RE: INTRODUCER with ASPIRATION BIOPSY NEEDLE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) J.
| DEVICE
CHARACTERISTIC | WILSON-COOK
BILIARY
INTRODUCER with
ASPIRATION BIOPSY
NEEDLE [Subject of
510(K)] | WILSON-COOK
BILIARY & GASTRIC
ASPIRATION NEEDLES
(K895900) |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Intended Use | Needle aspiration biopsy in
the biliary system and if
desired introduction of
biopsy instruments. | Needle aspiration biopsy in
the biliary system. |
| Introducer Catheter/Sheath | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Needle | 304 Stainless Steel | 304 Stainless Steel |
| French Size | Introduction Catheter: 10
French
Introduction Catheter Tip: 6
French
Inner Catheter (Needle): 5
French | 7 French |
| Length | 200 cm | 190 cm |
| Needle Gauge | 22 GA | 22 GA |
| Needle Extension | 7 mm | 7.5 mm |
| Number of Lumens | 2 | 1 |
| Sterility | Sterile, disposable | Sterile, disposable |
Testing: Biocompatibility has been established for the patient contacting materials through a history of use in other similar medical devices.
The Wilson-Cook Biliary Introducer with Aspiration Biopsy Needle has been subjected to our internal standard operating procedures for product qualification and process validation. Samples were subjected to visual, dimensional and functional analysis. All samples were deemed acceptable, in that test specifications were met.