The ParaMount™ Mini 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 ParaMount™ Mini Stent and Delivery System (Biliary Indication). This document focuses on demonstrating substantial equivalence to a previously cleared device, not on proving new acceptance criteria through a study with specific performance metrics.

Therefore, many of the requested categories for AI/device performance studies are not applicable to this 510(k) submission, as it is a regulatory document addressing device modifications rather than a clinical trial report for new technology.

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

This document does not provide specific quantitative acceptance criteria or reported device performance in the manner of an AI diagnostic study. The "acceptance criteria" for a 510(k) are typically met by demonstrating substantial equivalence to a predicate device, which is implied by the successful review by the FDA.

Acceptance Criterion (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance/Evidence
Intended Use	The modified device has the same intended use: "palliative treatment of malignant neoplasms in the biliary tree."
Materials	The modified device uses the same materials: "balloon expandable stainless steel stent with an open lattice design. The stent is electropolished."
Technological Characteristics	The modified device has similar technological characteristics to the previously cleared stent and delivery system. Modifications include "additional diameters and lengths" for the stent, and for the delivery catheter: "smaller profile and additional guidewire compatibilities."
Performance (Bench Testing)	"Performance testing (bench) further supports a substantial equivalence claim." No specific quantitative results are provided in this summary. The collective evidence from these points provides "assurance that the ParaMount™ Mini Stent and Delivery Device meet the requirements that are considered acceptable for the intended use."

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 510(k) submission refers to "performance testing (bench)" which implies laboratory or engineering tests, not a clinical test set with patient data. No details on sample size or data provenance are provided for such bench tests.

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 assessment by experts in a clinical context is not relevant to a 510(k) submission focused on demonstrating substantial equivalence through bench testing for device modifications.

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

Not applicable. Adjudication methods for ground truth establishment are not relevant to this type of regulatory submission focusing on bench test performance and substantial equivalence.

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 is not an AI device, and no MRMC study or comparative effectiveness study involving human readers or AI assistance is mentioned.

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

Not applicable. This is a medical device (stent and delivery system), not an algorithm or AI. Standalone performance as an algorithm is not relevant.

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

Not applicable. The concept of "ground truth" in the context of clinical disease diagnosis or outcomes is not directly applicable to the "performance testing (bench)" mentioned for this device's modifications. The "ground truth" for the bench tests would be engineering specifications or simulated physiological conditions.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no concept of a "training set" in this context.

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

Not applicable. As above, this is not an AI/machine learning device, so there is no training set or associated ground truth establishment.

Summary

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NOV 17 2003

Premarket Notification (510(k)) Summary

510(k) Number:	K033134
Product Name:	ParaMount™ Mini 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: 651-697-4815Fax: 651-697-2080
Summary Preparation Date:	29 September 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 notification submission for a modification to the ParaMount" Mini Stent and Delivery System.

The ParaMount™ Mini Stent and Delivery Device 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 provide additional diameters and lengths. The stent delivery balloon catheter was modified to allow for smaller profile and additional guidewire compatibilities. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the ParaMount™ Mini Stent and Delivery Device 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 36 of the US Code.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle, with its wings spread and its head turned to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2003

Mr. Glen D. Smythe Regulatory Affairs Associate ev3, Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920

Re: K033134

Trade/Device Name: Paramount™ Mini Stent and Delivery System Regulation Number: 21 CFR 8876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: October 30, 2003 Received: October 31, 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 (OS) 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): 1033 134

Device Name: ParaMount™ Mini Stent and Delivery System

Indications for Use:

The ParaMount™ Mini Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use __

Marvin Brogdon

iii

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.