(37 days)
The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication):
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria or detailed performance metrics from a clinical study are not explicitly stated or provided in a table format. The submission focuses on substantial equivalence to a predicate device.
However, the text implies a general acceptance criterion related to maintaining the performance characteristics of the predicate device, especially with the addition of a new size. The "performance" assessment is described as *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.
Here's an inferred attempt to structure this, recognizing that specific quantitative values are missing:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Maintain intended use, materials, and technological characteristics of the predicate device. | Met: "The modified device is substantially equivalent to the currently marketed stent and delivery system in intended use, materials, technological characteristics..." |
| Mechanical Performance | Demonstrate equivalent or acceptable mechanical performance, especially with the added 10mm diameter stent. | Met: "Performance testing (bench) further supports a substantial equivalence claim." |
| Safety and Effectiveness | Provide assurance of safety and effectiveness for the palliative treatment of malignant neoplasms in the biliary tree, equivalent to predicate. | Met: "The collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent and Delivery System meets the requirements that are considered acceptable for the intended use." |
| Indications for Use (Specific) | Palliative treatment for malignant neoplasms in the biliary tree. | Met: "The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not mention a clinical test set sample size or its provenance (e.g., country of origin, retrospective/prospective). The submission primarily relies on "bench performance testing" to demonstrate substantial equivalence, rather than a clinical study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the document does not describe a clinical study involving experts establishing ground truth for a test set. The claim for substantial equivalence is based on bench testing and comparison to an existing device.
4. Adjudication Method for the Test Set
This information is not applicable as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study involving human readers or AI assistance is not mentioned or described in the provided text. The document refers to a medical device (stent and delivery system), not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical stent and delivery system, not an algorithm or AI.
7. The Type of Ground Truth Used
For the bench testing that was performed, the "ground truth" would be established by engineering specifications, material science standards, and mechanical testing protocols to verify characteristics such as expansion force, radial strength, fatigue resistance, and deployment accuracy when compared to the predicate device. The document does not specify which specific standards or metrics were used, only that "Performance testing (bench) further supports a substantial equivalence claim."
8. The Sample Size for the Training Set
This information is not applicable as the device is a medical stent and delivery system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as the device is a medical stent and delivery system, not an AI model.
Summary of Device Evaluation Approach:
The Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System received 510(k) clearance based on demonstrating substantial equivalence to a previously marketed predicate device. This approach primarily involved:
- Confirming identical intended use, materials, and technological characteristics.
- Conducting bench performance testing to support the substantial equivalence claim, specifically mentioning that a 10mm diameter stent had been added and its performance was evaluated this way.
The clearance decision by the FDA explicitly included a limitation on labeling, stating, "The safety and effectiveness of this device for use in the vascular system have not been established," reinforcing that its clearance was specifically for the biliary indication.
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NOV 2 1 2003
Premarket Notification (510(k)) Summary
| 510(k) Number: | K033314 |
|---|---|
| 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: | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 |
| Official Contact: | Glen D. SmytheRegulatory Affairs AssociateTelephone: 763-398-7391Fax: 763-398-7200 |
| Summary Preparation Date: | 14 October 2003 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and
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 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. A 10mm diameter stent has been added. 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 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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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract emblem resembling an eagle or bird in flight, composed of three curved lines representing the wings and a stylized head and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 1 2003
Mr. Glen D. Smythe Regulatory Affairs Associate ev3. Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K033314
Trade/Device Name: Protégé® GPS™ 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: November 13, 2003 Received: November 14, 2003
Dear Mr. Smythe:
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 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 described above is added to your labeling.
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), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K033314
Device Name: ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System (Biliary Indication)
FDA's Statement of the Indications For Use for device:
The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Prescription Use _ V (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, A and Radiological Devic 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.