(28 days)
K851962/A
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on a mechanical stent introduction system.
Yes
The device is used for "biliary stent placement to drain obstructed bile ducts," which describes treatment of a disease or condition, fitting the definition of a therapeutic device.
No
Explanation: The device is an "Introduction System" for placing biliary stents to drain obstructed bile ducts, indicating a therapeutic or interventional function rather than a diagnostic one. It doesn't mention any capability to identify, analyze, or monitor a medical condition.
No
The device description explicitly states it is a "Stent Introduction system" and mentions it is supplied sterile and intended for single use, indicating it is a physical medical device used for endoscopic procedures, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "endoscopic biliary stent placement to drain obstructed bile ducts." This describes a procedure performed on the patient's body to treat a condition, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The description focuses on the physical device used for the procedure.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests in vitro (outside the body), or providing diagnostic information based on sample analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
Wilson-Cook's OASIS Biliary Stent Introducer System is for endoscopic biliary stent placement to drain obstructed bile ducts
The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The device is supplied sterile and intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The proposed Stent Introduction system is a modification to Stent Introduction systems currently sold by Wilson-Cook. The OASIS Stent Introduction system is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary stent placement, obstructed bile ducts
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)
We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility.
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.
K851962/A
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
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
FEB 2,0 2004
K040151 Page 1 of 1
د.
ATTACHMENT F: 510(k) Summary of Safety and Effectiveness
| SPONSOR: | Wilson-Cook Medical
4900 Bethania Station Road
Winston-Salem, NC 27105 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT/SUBMITTER: | Marge Walls-Walker
Regulatory Affairs Specialist
[336] 744-0157 Ex.290 |
| DATE OF SUBMISSION: | January 22, 2004 |
| DEVICE: | OASIS Biliary Stent Introduction System |
| Trade Name: | OASIS Biliary Stent Introduction System |
| Common Name: | Stent Introducer |
| Classification: | Catheter, Biliary, Surgical, Class II
21 CFR § 876.5010 78 FGE |
| PREDICATE DEVICES: | Zimmon Endoscopic Biliary Stent Sets
(K851962/A) |
| INTENDED USE: | Wilson-Cook's OASIS Biliary Stent Introducer
System is for endoscopic biliary stent placement
to drain obstructed bile ducts |
| DEVICE DESCRIPTION: | The proposed Stent Introduction system is a
modification to Stent Introduction systems
currently sold by Wilson-Cook. The OASIS Stent
Introduction system is supplied sterile and
intended for single use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to be
substantially equivalent to the currently
marketed Wilson-Cook biliary stent introduction
systems as cleared by K851962/A |
| PERFORMANCE DATA: | We believe the proposed device to be
substantially equivalent to the named predicate
in terms of Intended Use, performance
characteristics tested and biocompatibility. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2004
Ms. Marge Walls-Walker Regulatory Affairs Specialist Wilson-Cook Medical GI Endoscopy 4900 Bethania Station Road WINSTON-SALEM NC 27105
Re: K040151
Trade/Device Name: Wilson-Cook OASIS®-Onc Action Stent Introduction System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 22, 2004 Received: January 23, 2004
Dear Ms. Walls-Walker:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass battled in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou more s provisions of the Act include requirements for annual registration, listing of general connects production practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (sec above) into cither class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that 1 Dr its al statutes and regulations administered by other Federal agencies. You must or uny I outher banate and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k)
The all and the more of the first of substantial equivalence of your device to a This letter will allow you to begin matketing your actives of your device of your device to a legally
premarket notification. The FDA indines from for your device and thus premarket notification. The FDA inding of substantial equivations of your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our laboling regarders, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your devices, please contact the Additionally, for questions on the promotion and are mote the regulation entitled, "Misbranding
Office of Compliance at (301) 594-4639. Increase note the regulation of ther s Office of Compliance at (301) 394-4037. Also, products and obtain. Other general
by reference to premarket notification" (21CER Part 807.97) you may obtain. Other program by reference to premarket nouncation (21C) it it its of the Schained from the Division of Small
information on your responsibilities under the Act may be obtained from the Un information on your responsibilities and its the result-free namber (800) 638-2041 or
Manufacturers, International and Colsum Assistance at its toll-free managemann html. Manufacturers, International and Colisumer Fisistance at to 10
(301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(核(Number (if known): K040151
Device Name: Wilson-Cook OASIS- One Action Stent Introduction System
Indications for Use:
The OASIS Biliary Stent Introduction System is intended for endoscopic biliary stent placement to drain obstructed bile ducts.
The device is supplied sterile and intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) ** ﻴﺔ ﻭﺍﻟﺘﻘﺎﻟﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺘﻮﻗﻒ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍ ;;
E
Prescription Use Only (Per 21 CFR § 801.109
OR
Over-the-Counter
Gevid h. Llymm
(Division Sign-Off) Abdominal Division of Reproductive and Radiological Devices 510(k) Number