(258 days)
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.
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.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Needle aspiration biopsy in the biliary system and if desired introduction of biopsy instruments. |
| Biocompatibility | Established through history of use in other similar medical devices. |
| Visual Analysis | All samples deemed acceptable, test specifications met. |
| Dimensional Analysis | All samples deemed acceptable, test specifications met. |
| Functional Analysis | All samples deemed acceptable, test specifications met. |
| Sterility | Validated EO cycle, following the AAMI Overkill Method to SAL 10-6. |
2. Sample Size for Test Set and Data Provenance:
The document does not specify a distinct "test set" sample size. Instead, it mentions that "Samples were subjected to visual, dimensional and functional analysis." The exact number of samples tested is not provided. The data provenance is internal to Wilson-Cook Medical Inc., conducted according to their "internal standard operating procedures for product qualification and process validation." No information is given regarding the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the use of experts to establish a ground truth. The evaluation appears to be based on internal product qualification and process validation, likely conducted by internal quality control or engineering personnel.
4. Adjudication Method:
No adjudication method is described. The acceptance seems to be based on individual samples meeting "test specifications."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or indicated. The document focuses solely on the device's own performance against internal specifications, not against human readers or other devices.
6. Standalone Performance (Algorithm Only):
This question is not applicable. The device is a physical medical instrument (Biliary Introducer with Aspiration Biopsy Needle), not an algorithm or software. Therefore, there is no "standalone" algorithmic performance to report.
7. Type of Ground Truth Used:
The ground truth for the device's performance appears to be based on internal test specifications and established engineering parameters for visual, dimensional, and functional analysis. For biocompatibility, the ground truth is "history of use in other similar medical devices." For sterility, it's adherence to the "AAMI Overkill Method to SAL 10-6."
8. Sample Size for Training Set:
The document does not refer to a "training set" in the context of device development or testing. The testing described is for product qualification and validation.
9. How Ground Truth for Training Set Was Established:
This question is not applicable as there is no mention of a "training set" for the device described.
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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 CONTROLNUMBER |
|---|---|---|
| Wilson-Cook Biliary andGastric Aspiration Needle | Wilson-Cook Medical Inc. | K895900 |
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PREMARKET NOTIFICATION FOR THE WILSON-COOK BILIARY RE: INTRODUCER with ASPIRATION BIOPSY NEEDLE
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (continued) J.
| DEVICECHARACTERISTIC | WILSON-COOKBILIARYINTRODUCER withASPIRATION BIOPSYNEEDLE [Subject of510(K)] | WILSON-COOKBILIARY & GASTRICASPIRATION NEEDLES(K895900) |
|---|---|---|
| Intended Use | Needle aspiration biopsy inthe biliary system and ifdesired introduction ofbiopsy instruments. | Needle aspiration biopsy inthe biliary system. |
| Introducer Catheter/Sheath | Polytetrafluoroethylene | Polytetrafluoroethylene |
| Needle | 304 Stainless Steel | 304 Stainless Steel |
| French Size | Introduction Catheter: 10FrenchIntroduction Catheter Tip: 6FrenchInner Catheter (Needle): 5French | 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.
§ 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.