(62 days)
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System 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 deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The provided text is a 510(k) summary for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication). This document focuses on demonstrating substantial equivalence to a previously marketed device rather than presenting a de novo study with acceptance criteria and performance data in the typical sense for a new clinical device.
Here's an analysis based on the provided text, addressing your questions with the information available:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, there are no explicit acceptance criteria or specific device performance metrics (e.g., accuracy, sensitivity, specificity, or specific clinical outcomes like stent patency rates) reported. The submission relies on demonstrating substantial equivalence to a predicate device. The "acceptance criteria" can be inferred as fulfilling the evidence required by the FDA for a 510(k) submission to establish substantial equivalence.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance |
|---|---|
| Substantial equivalence in: | Reported as Substantially Equivalent |
| - Intended use | Yes |
| - Materials | Yes |
| - Technological characteristics | Yes |
| - Performance (bench testing) | Yes |
| Lower profile of delivery system | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
The text does not mention a clinical test set or patient data for this specific 510(k) submission. The evaluation was primarily based on "Performance testing (bench)" which implies laboratory or engineering tests. Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective). This is common for devices seeking substantial equivalence where the modifications are minor and validated through non-clinical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Since there was no clinical test set or patient data described for this submission, there would be no ground truth established by medical experts for device performance. The assessment was based on engineering and material characteristics to demonstrate equivalence.
4. Adjudication Method
Not applicable. As no clinical test set with corresponding ground truth was used, there was no need for an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not mention an MRMC study or any comparison of human readers with or without AI assistance. This device is a physical medical device (stent), not an AI diagnostic tool.
6. Standalone Performance Study
No. The submission describes "Performance testing (bench)" which likely refers to engineering verification and validation tests for the physical device, not an algorithm's standalone performance.
7. Type of Ground Truth Used
The "ground truth" for this submission was the established performance and characteristics of the predicate device and the results of bench testing on the modified device to confirm it met design specifications and remained equivalent. There was no clinical ground truth (e.g., pathology, outcomes data) generated for this specific 510(k).
8. Sample Size for the Training Set
Not applicable. Since this is a physical medical device and not an AI/ML algorithm, there is no concept of a "training set" in the context you're asking.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
Summary of the Study and Acceptance:
The FDA 510(k) submission K032580 for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication) focused on demonstrating substantial equivalence to an already marketed device. The "study" consisted primarily of bench performance testing to show that a minor modification (lower profile delivery system) did not alter the intended use, materials, technological characteristics, or overall performance such that it would raise new questions of safety or effectiveness compared to the predicate.
The acceptance criteria were implicitly met by providing sufficient evidence (bench testing results and comparison to the predicate) to convince the FDA that the modified device was substantially equivalent to the predicate, thus allowing it to be marketed for the palliative treatment of malignant neoplasms in the biliary tree. The FDA's 'substantially equivalent' determination served as the acceptance of the submission. The letter from the FDA explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device..." subject to specific labeling requirements regarding vascular use.
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Premarket Notification (510(k)) Summary
| 510(k) Number: | K032580 |
|---|---|
| Product Name: | Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | Official Contact: |
| ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 | Glen D. SmytheRegulatory Affairs AssociateTelephone: 763-398-7391Fax: 763-398-7200 |
| Summary Preparation Date: | 20 August 2003 |
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
summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé® GPS™ Self-Expanding Nitinol Stent with StarPort" Delivery Technology.
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System 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 deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The modified device is substantially equivalent* to the currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. The delivery system was modified to provide a lower profile. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent and Delivery System meet 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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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 eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 2 2003
Mr. Glen D. Smythe Regulatory Affairs Associate ev3. Inc. 4600 Nathan Lane North. PLYMOUTH MN 55442
Re: K032580
Trade/Device Name: Protégé® GPSTM Self-Expanding Nitinol Stent and Delivery System -- Biliary Indication Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: September 18, 2003 Received: September 22, 2003
Dear Mr. Smythe:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the 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, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 - Mr. Glen Smythe
If your device is classified (see above) into either 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Daniel G. Schultz, M.D.
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K032580
Device Name: Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System - Biliary Indication
FDA's Statement of the Indications For Use for device:
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System -- Biliary Indication is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy C Brogdon
(Division Sign-Off)
Tinn of Reproduct Radiological Dev 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.