(21 days)
The Protégé® RX GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon lo elour porthe constrained stent self-expands to conform to the duct inner luminal surface.
The provided text is a 510(k) Premarket Notification summary and accompanying FDA correspondence for the Protégé® Rx GPS™ Self-Expanding Nitinol Stent (Biliary Indication). This document does not describe a study involving device performance metrics against acceptance criteria in the way typically associated with AI/software devices.
Instead, this is a traditional medical device submission focused on demonstrating substantial equivalence to a previously marketed device. The "device performance" referred to in the document relates to bench testing to support the substantial equivalence claim, rather than clinical performance metrics in a study with a test set, ground truth, or expert review.
Therefore, many of the requested fields cannot be filled based on the provided text, as they pertain to studies typically conducted for AI/ML or diagnostic devices where performance is measured against a ground truth.
Here's an attempt to answer the questions based only on the provided text, noting where information is absent for an AI/ML context:
Analysis of Acceptance Criteria and Device Performance for Protégé® Rx GPS™ Self-Expanding Nitinol Stent
The provided documentation does not detail quantitative acceptance criteria or a specific study proving the device meets particular performance metrics in the way an AI/ML or diagnostic device would. This submission is for a conventional medical device (biliary stent) and relies on demonstrating substantial equivalence to a predicate device, supported by bench testing and similar design/materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as quantitative for clinical performance) | Reported Device Performance (Summary from text) |
|---|---|
| Substantial equivalence to predicate device (Protégé® GPS™ Self-Expanding Nitinol Stent) in design, materials, technological characteristics, and performance. | "The modified device is substantially equivalent to the currently marketed stent and modified as to size, materials, technological characteristics and performance." |
| Functional integrity after modification (delivery system changed to rapid exchange). | "Performance testing (bench) further supports a substantial equivalence claim." |
| Suitable for the intended use (palliative treatment of malignant neoplasms in the biliary tree). | "The collective evidence therefore provides assurance that the Protégé Rx GPS Self-Expanding Nitinol Stent meets the requirements that are considered acceptable for the intended use." |
Note: The FDA letter explicitly notes a limitation: "The safety and effectiveness of this device for use in the vascular system have not been established." This implies the acceptance criteria (and supporting data) were focused solely on the biliary indication.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document mentions "Performance testing (bench)" but does not specify a sample size for any clinical test set or experimental data in patients. The evaluation is based on substantial equivalence to a predicate device and bench testing for device characteristics.
- Data Provenance: Not applicable for a clinical test set. The bench testing would have been conducted by the manufacturer, ev3 Inc., likely in the USA (where the company is based).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. There is no mention of a test set requiring expert-established ground truth. This is a physical device, and its performance evaluation (for substantial equivalence) would involve engineering tests, material characterization, and comparisons to the predicate device, not expert adjudication of diagnostic outcomes.
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring adjudication in the context of diagnostic or AI performance is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is a medical device (stent), not an AI/ML diagnostic or assistive technology for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (stent), not an algorithm.
7. The Type of Ground Truth Used
- For the substantial equivalence claim: The "ground truth" implicitly used is the established performance and safety profile of the predicate device (Protégé® GPS™ Self-Expanding Nitinol Stent). The modified device is compared against the characteristics and performance of this existing, legally marketed device.
- For bench testing: The ground truth would be engineering specifications, material standards, and functional requirements for a biliary stent.
8. The Sample Size for the Training Set
- Not applicable. This is a medical device (stent), not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. No AI/ML training set is involved.
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Premarket Notification (510(k)) Summary
| 510(k) Number: | K051379 |
|---|---|
| Product Name: | Protégé® Rx GPS™ Self-Expanding Nitinol Stent (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 |
| Official Contact: | Glen D. SmytheSr. Regulatory Affairs SpecialistTelephone: 763-398-7391Fax: 763-398-7200 |
| Summary Preparation Date: | May 26, 2005 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket
sunimatized the barer a modification to the Protégé® GPS™ Self-Expanding Nitinol Stent.
The Protégé® Rx GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon lo elour porthe constrained stent self-expands to conform to the duct inner luminal surface.
The modified device is substantially equivalent* to the currently marketed stent and The modified as roo is becount, materials, technological characteristics and performance. denvory system was modified to rapid exchange. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé Rx GPS Self-Expanding Nitino! Stent meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 2005
Mr. Glen D. Smythe Senior Regulatory Affairs Specialist ev3, Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K051379
K051379
Trade/Device Name: ev3 Protégé® RX GPS™ Self-Expanding Nitinol Stent (Biliary Indication) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 26, 2005 Received: May 27, 2005
Dear Mr. Smythe:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 710(x) prematic is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivals we referenced above and nave decembined the arresed predicate devices marketed in interstate for use stated in the enclosure) to regally manced produced Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chaculeur and othe Federal Food. Drug, devices that have been recrassified in accordance , subject to the general controls provisions of the and Cosmetic Act (Act). You may, therefore, thanker and ontrols provisions of the survisions of the provisions of the Act and the immations described of devices, good manufacturing practice,
Act include requirements for annual registration, listing of the stim Act merude requirentions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this such u The Office of Device Evaluation has detectified in the proposed labeling and that such use device will be used for an michaed as Intended as Included to 13(i)(i)(E) of the Act, the following could cause nami. "Therefere, Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, Furthermore, the Indication for onlary ass mast of promotions for use, and other promotional materials, in
including pouch, box, and carton labels, instructions for hold prin including pouch, box, and carten inotics, includes, includes point size, and in bold print.
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Page 2 – Mr. Glen D. Smythe
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act, Please note that the above labeling innfations are required by a views of ( ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate The FDA finding of substantial equivalence or your device and permits your device to proceed to the device results in a classification for your device and perined your Section on section
market. This letter will allow you to begin marketing your devices and added to your market. I his letter will anow you to ocgin manceling your as received above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (See above) into entire regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affection if may be subject to additional controls: Existing majors 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of I edefal Regarations) your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issualited of a substinat equirements of the Act
that FDA has made a determination that your device with other requires . You must that FDA nas made a decemination mac your as roo be other Federal agencies. You must and list or any Federal statutes and regulations daministered to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: set comply with all the Act s requirements, more and manufacturing practice requirements as setting CFR Part 807); labeling (21 CFR Part 801); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicab forth in the quality systems (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific information about the application of other labeling requirements to your If you desire specific information about the upplication of Compliance at (240) 276-0115. Also,
device (21 CFR Part 801), please contact the Office of Compliance at (240) 27 device (21 CFR Part 801), picase contact and office of premarket notification" (21
please note the regulation entitled, "Misbranding by reference anyaya responsibilities unde please note the regulation entitled, "Misorananing of your responsibilities under the CFR Part 807.97). You may bound other general micriational, and Consumer Assistance at its Act from the DrVision of St.2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
NOCATN
B. D. Tillman, Ph.D.
Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K051379
Device Name: ev3 Protégé® RX GPS™ Self-Expanding Nitinol Stent (Biliary Indication)
Indications For Use:
.
The Protégé® RX GPS™ Self-Expanding Nitinol Stent is intended as a palliative The Protegoe malignant neoplasms in the biliary tree.
Prescription Use ___X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Hodgson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Page 1 of 1_
§ 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.