(28 days)
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.
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.
The provided text is a 510(k) summary for the Wilson-Cook OASIS Biliary Stent Introduction System. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through extensive clinical studies comparing its performance against a defined ground truth.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable to this document. The submission focuses on demonstrating the device is substantially equivalent to existing devices.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not specify quantitative acceptance criteria or report performance data against such criteria in the way a clinical trial would for AI model evaluation. The "Performance Data" section states, "We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This implies that the performance characteristics were tested to ensure they were comparable to the predicate device, but no specific metrics or thresholds are provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a medical device submission, not a study evaluating an AI algorithm's performance on a test set. There is no mention of a "test set" in the context of data used to evaluate an AI algorithm. The performance evaluation would likely involve engineering tests, biocompatibility testing, and functional assessments, not an AI test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for AI model evaluation is not relevant here. The "ground truth" in this context would be industrial standards for device performance and safety, which are not established by a panel of medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As there is no AI test set, there is no adjudication method described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a stent introducer system, a physical medical device, not an AI diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. The device is a physical stent introduction system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. "Ground truth" in the context of AI performance evaluation is not relevant for this physical device. The "truth" here revolves around mechanical, material, and functional integrity, and biocompatibility, as per medical device standards.
8. The sample size for the training set
- Not Applicable. There is no AI training set for a physical medical device.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI training set or associated ground truth for a physical medical device.
Summary of Relevant Information from the Provided Text:
The document describes a medical device called the Wilson-Cook OASIS Biliary Stent Introduction System.
Its Intended Use is "for endoscopic biliary stent placement to drain obstructed bile ducts."
The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a predicate device.
The Predicate Device is "Zimmon Endoscopic Biliary Stent Sets (K851962/A)."
The Performance Data section states that the device is believed to be substantially equivalent to the predicate "in terms of Intended Use, performance characteristics tested and biocompatibility." This indicates that tests were performed to ensure comparable performance, but the details of those tests, specific acceptance criteria beyond "substantial equivalence," and the raw results are not provided in this summary. They would typically be in a more detailed submission document.
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FEB 2,0 2004
K040151 Page 1 of 1
د.
ATTACHMENT F: 510(k) Summary of Safety and Effectiveness
| SPONSOR: | Wilson-Cook Medical4900 Bethania Station RoadWinston-Salem, NC 27105 |
|---|---|
| CONTACT/SUBMITTER: | Marge Walls-WalkerRegulatory 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 II21 CFR § 876.5010 78 FGE |
| PREDICATE DEVICES: | Zimmon Endoscopic Biliary Stent Sets(K851962/A) |
| INTENDED USE: | Wilson-Cook's OASIS Biliary Stent IntroducerSystem is for endoscopic biliary stent placementto drain obstructed bile ducts |
| DEVICE DESCRIPTION: | The proposed Stent Introduction system is amodification to Stent Introduction systemscurrently sold by Wilson-Cook. The OASIS StentIntroduction system is supplied sterile andintended for single use only. |
| COMPARISON OF CHARACTERISITICS: | We believe the proposed device to besubstantially equivalent to the currentlymarketed Wilson-Cook biliary stent introductionsystems as cleared by K851962/A |
| PERFORMANCE DATA: | We believe the proposed device to besubstantially equivalent to the named predicatein terms of Intended Use, performancecharacteristics tested and biocompatibility. |
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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.
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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
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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
§ 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.