PRIMUS GPS BILIARY STENT SYSTEM by EV3 INC

The PRIMUS™ GPS™ Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

AI/ML Overview

The provided text describes a Premarket Notification (510(k)) Summary for the PRIMUS GPSTM Biliary Stent System. This summary indicates that the device is a modified version of a previously cleared stent and delivery system.

Here's an analysis of the acceptance criteria and the study as requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Intended Use	Palliative treatment of malignant neoplasms in the biliary tree.	Remains the same as the predicate device.
Materials	Compatibility and suitability for the intended use.	Remains the same as the predicate device.
Technological Characteristics	Design and functionality of the stent and delivery system. Specific modification: increased cell length of the stent; combined design features from predicates for the delivery balloon catheter.	Substantially equivalent to the predicate device, with described modifications.
Performance (Bench Testing)	Mechanical integrity, expansion characteristics, and other relevant physical properties.	Performance testing (bench) further supports a substantial equivalence claim.
Safety and Effectiveness	Device is safe and effective for its intended use.	The collective evidence (intended use, materials, technological characteristics, and performance testing) provides assurance that the PRIMUS™ GPSTM Biliary Stent System meets the requirements considered acceptable for the intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses bench testing for performance evaluation. It does not mention any clinical or human subject testing. Therefore, there is no information about a "test set" in terms of patient data, sample size, or data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no human subject testing or clinical data analysis is mentioned, there is no discussion of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set involving human data that would require an adjudication method.

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. The device described is a physical medical device (a biliary stent system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. Performance was evaluated through bench testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing, the "ground truth" would be the established engineering specifications and performance standards for biliary stents. This would involve objective measurements and comparisons against predefined criteria for mechanical properties, dimensions, and functionality.

8. The sample size for the training set

Not applicable. The device is a physical medical device, not an AI model requiring a training set of data.

9. How the ground truth for the training set was established

Not applicable. No training set is involved for this type of device.

Summary

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Premarket Notification (510(k)) Summary

510(k) Number:	K061566
Product Name:	PRIMUSTM GPSTM Biliary Stent System (Biliary Indication)
Common Name:	biliary stent
Class:	Class II, 21 CFR 876.5010
Submitter's Name:	ev3 Inc.9600 54 th Avenue NorthPlymouth, MN 55442
Official Contact:	Melissa SommerfeldSr. Regulatory Affairs SpecialistTelephone: 763-398-7612Fax: 763-398-7200
Summary Preparation Date:	June 5, 2006

AUG 3 1 2006This summary is provided in compliance with section 513(1)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the PRIMUS™ Stent and Delivery System.

The PRIMUS™ GPS™ Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The modified device is substantially equivalent* to the previously cleared stent and delivery system in intended use, materials, technological characteristics and performance. The stent was modified to increase cell length. The stent delivery balloon catheter was modified combining design features from the predicates. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the PRIMUS™ GPSTM Biliary Stent 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 36 of the US Code.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the snakes and a base representing the staff. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

AUG 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tamima Itani, Ph.D., R.A.C. Vice President, Clinical & Regulatory Affairs ev3. Inc. 9600 54th Avenue North PLYMOUTH MN 55442-2111

Re: K061566

Trade/Device Name: PRIMUSTM GPSTM Biliary Stent System TM Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 24, 2006 Received: July 25, 2006

Dear Dr. Itani:

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 - Ms. Melissa Sommerfeld

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.

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.

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.

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 (240) 276-0115. 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,

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K061566

Device Name: PRIMUSTM GPSTM Biliary Stent System TM

FDA's Statement of the Indications for Use for device:

The PRIMUS™ GPS™ Biliary Stent System™ is intended as a palliative treatment for malignant neoplasms in the biliary tree.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (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)

David R. Hodgson

(Divisi Divis. roductive. F and Radiolouical Devices ﻟﻠﻌﺐ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

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Regulation Number and Section

§ 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.