The Peripheral AVE Biliary Stent System is intended for use in patients who are eligible for percutaneous transluminal angioplasty (PTA) to maintain patency of a biliary duct which is occluded by tumor.

The Peripheral AVE Bilairy Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.

Device Description

The Peripheral AVE Bilairy Stent System consists of a balloon-expandable intraluminal stent premounted onto the balloon of an over-the-wire delivery catheter. The Peripheral AVE Bilairy Stent System has two radiopaque platinum markers imbedded in the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75 cm to 90 cm. The Peripheral AVE Bilairy Stent System is provided enclosed in a sterile package.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format with specific thresholds. Instead, the "acceptance criteria" are implied by the purpose of each test, which is to demonstrate "substantial equivalence" to a predicate device or to verify internal specifications. The reported performance is the conclusion of each study, stating whether substantial equivalence was achieved or if specifications were met.

Acceptance Criteria (Implied from Purpose)	Reported Device Performance (Results)
Balloon Performance Study:
- Compare minimum burst pressure to predicate.	- The test proved substantial equivalence.
- Compare deflation times to predicate.
Two Plane Crush Strength Study:
- Determine and compare radial strengths to predicate (graphical representation of force to crush to 50% deployed diameter).	- The test proved substantial equivalence.
Dimensional Verification and Stent Uniformity at Nominal Deployment:
- Verify that processed stents meet diameter specifications after deployment.	- The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length.
- Verify that processed stents meet length specifications after deployment.
Biocompatibility:
- Meet biocompatibility standards.	- The materials employed in the Peripheral AVE Biliary Stent Delivery System passed all biocompatibility tests.
Sterilization (SAL):
- Achieve an SAL of 10^-6.	- The Sterility Assurance Level or SAL for the validated AVE stent systems is 10^-6.
Pyrogen Testing:
- Be "pyrogen free" (LAL testing in compliance with FDA guidelines).	- The Peripheral AVE Biliary Stent System is labeled "pyrogen free". LAL testing is performed daily, in compliance with FDA guideline... as part of Peripheral AVE's product release criteria.

2. Sample sizes used for the test set and the data provenance

The document does not specify the sample sizes used for any of the performance tests (Balloon Performance, Crush Strength, Dimensional Verification).

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention a country of origin. However, given the nature of the tests (benchtop comparisons and verification), the data is most likely generated in a laboratory setting by the manufacturer, Peripheral AVE, to support their 510(k) submission.

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

This information is not applicable and therefore not mentioned in the provided document. The studies conducted are primarily benchtop engineering and material science tests, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication method for the test set

This information is not applicable and therefore not mentioned in the provided document. Adjudication methods are relevant for clinical studies where multiple reviewers assess ambiguous data. The tests described are objective, quantitative measurements.

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

There was no MRMC comparative effectiveness study mentioned, as this device is a physical medical device (a stent), not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation.

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

This information is not applicable. The device is a physical stent and does not involve an algorithm or AI.

7. The type of ground truth used

The "ground truth" for the benchtop performance tests is the measured physical properties and performance characteristics of the Peripheral AVE Biliary Stent System and the predicate device (PALMAZ™ Balloon-Expandable Stent), as well as predefined specifications.

For the Balloon Performance Study and Crush Strength Study, the ground truth for comparison was the measured performance of the predicate device.
For the Dimensional Verification, the ground truth was the labeled specifications for stent diameter and length.
For Biocompatibility, Sterilization, and Pyrogen Testing, the ground truth refers to adherence to established industry standards and regulatory guidelines (e.g., ANSI/AAMI/ISO 11137-1994, FDA guidelines for LAL testing).

8. The sample size for the training set

This information is not applicable. The device is a physical medical device; there is no "training set" in the context of machine learning or AI. The tests conducted are design verification and validation tests rather than algorithm training.

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

This information is not applicable for the reasons stated in point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Peripheral AVE. The logo consists of the word "Peripheral" in a simple, sans-serif font, followed by the letters "AVE" in a more stylized font. Below the text is a graphic element that resembles a stylized wave or swoosh, adding a dynamic visual element to the logo.

Peripheral AVE Biliary Stent System

510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 4983008

GENERAL INFORMATION

Applicant:

Date:	27 August, 1998
Name:	Peripheral AVE
Address:	2330A Circadian WaySanta Rosa, CA 95407
Contact:	Paul A. Meyer, P.E., RAC
Phone Number:	(707) 541-3254
FAX Number:	(707) 543-5454

Trade Name:

Device Name:	Peripheral AVE Biliary Stent System
Model Numbers:	TBD
Classification Name:	Catheter, Biliary and accessories

Section 513 Device Classification:

Classification	Class II
Classification Panel:	78FGE

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EQUIVALENCE

Peripheral AVE claims substantial equivalence to the Johnson & Johnson Interventional Systems' PALMAZ™ Balloon-Expandable Stent.

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INTENDED USE

The Peripheral AVE Bilairy Stent System is indicated for palliative treatment of biliary duct strictures caused by malignant tumors.

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DEVICE DESCRIPTION

Size Range:

Diameters - 6.0 mm to 10.0 mm Lengths -- 17 mm to 60 mm

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Comparison to Predicate Device:

Per 807.92(a)(6), the 510(k) summary contains a summary of the technological characteristics of your device compared to
the predicate device.

CharacteristicCompared	AVE Bridge™ Stent System	PALMAZ™ Balloon-ExpandableStent
Intended Use:	The Peripheral AVE Biliary StentSystem is intended for use in patientsto maintain patency of a biliary ductwhich is occluded by tumor.The Peripheral AVE Biliary StentSystem is indicated for palliativetreatment of biliary duct stricturescaused by malignant tumors.	The device is a permanent implantintended to maintain patency of a bile ductwhich is obstructed by scar tissue or tumor.
PhysicalCharacteristics(Stent):	316L stainless steel balloonexpandable stent - premountedDiameters - 6 mm to 10 mmLengths - 16 mm to 60 mm	316L stainless steel balloon expandablestent - premounted or unmountedDiameters - 4 mm to 12 mmLengths - 9 mm to 40 mm
PhysicalCharacteristics(Delivery catheter):	balloon delivery system - PTA catheter5.3-5.8 F shaft size75 cm to 90 cm length0.035 in. Guidewire diameter	balloon delivery system - PTA catheter 5 F to 7 F shaft size75 cm length0.035 in. Guidewire diameter for unmounted stents - Medi-tech PE-MT™PTA balloon catheters 5 F to 9 F shaft size60 cm to 120 cm length0.035 in. Guidewire diameter
Anatomical Sites:	Biliary Ducts	Biliary Ducts
Target Population:	Patients with biliary duct obstructioncaused by malignant tumor	Patients with biliary duct obstructioncaused by tumor or scar tissue

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Performance Testing:

Per 807.92(b)(1) If the determination of substantial equivalence is also based on an assessment of performance data, the summary includes a brief discussion of the non clinical tests and how their results support a determination of substantial equivalence

1. Peripheral AVE Biliary Stent System vs JJIS Palmaz™ Balloon-Expandable Stent - Balloon Performance Study

Purpose:

To compare the minimum burst pressure and deflation times of the Peripheral AVE Biliary Stent System balloons to the PALMAZ™ Balloon-Expandable Stent balloons. The data gathered will support a premarket notification for the Peripheral AVE Biliary Stent System.

Results:

The test proved substantial equivalence.

2. Peripheral AVE Biliary Stent System vs JJIS Palmaz™ Balloon-Expandable Stent - Two Plane Crush Strength Study

Purpose:

To determine and compare the radial strengths of the Peripheral AVE Biliary Stent and the PALMAZ™ Balloon-Expandable Stent by graphically representing the amount of force required to crush a stent to fifty percent (50%) of its deployed diameter. The data gathered will support a premarket notification for the Peripheral AVE Biliary Stent System.

Results:

The test proved substantial equivalence.

3. Peripheral AVE Biliary Stent Dimensional Verification and Stent Uniformity at Nominal Deployment

Purpose:

To verify that processed Peripheral AVE Biliary Stents meet diameter and length specifications after deployment. The data gathered will support a premarket notification for the Peripheral AVE Biliary Stent System.

Results:

The results conclude that the stents tested meet the labeled specifications for stent diameter and stent length.

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CONCLUSIONS:

The Peripheral AVE Biliary Stent vs the JJIS Palmaz™ Balloon-Expandable Stent performance testing results prove that the Peripheral AVE Biliary Stent is substantially equivalent to the JJIS Palmaz™ Balloon-Expandable Stent

Additional Information:

Per 807.92(d), the summary includes any other information reasonably deemed necessary by FDA.

BIOCOMPATIBILITY

The materials employed in the Peripheral AVE Biliary Stent Delivery System passed all biocompatibility tests.

STERILIZATION INFORMATION

The Peripheral AVE Biliary Stent System is provided sterile.

The Peripheral AVE Biliary Stent System is not intended for sterilization or reuse/ resterilization by the user.

Validation

Peripheral AVE validates the sterilization method, for its stent delivery system products, quarterly each year according to the ANSI/ AAMI/ ISO 11137 - 1994, Method I. Sterilization of Healthcare Products - Requirements for Validation and Routine Control -Radiation Sterilization.

Sterility Assurance Level (SAL)

The Sterility Assurance Level or SAL for the validated AVE stent systems is 106.

Pyrogen Testing

The Peripheral AVE Biliary Stent System is labeled "pyrogen free". LAL testing is performed daily, in compliance with FDA guideline on Validation of Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices - Section V - 2 Inhibition and Enhancement Testing, as part of Peripheral AVE's product release criteria.

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Image /page/7/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 25 1998

Mr. Paul A. Mever RA/QA/CA Manager Peripheral AVE 2330A Circadian Way Santa Rosa, California 95407

Re: K983008

Peripheral AVE Biliary Stent System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: August 27, 1998 Received: August 28, 1998

Dear Mr. Mever:

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 predicte 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. Paul A. Meyer

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Susan Alpert, Ph.D., M. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): K983008

Device Name:_ Peripheral AVE Biliary Stent System

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

The Peripheral AVE Biliary Stent System is intended to maintain patency of biliary duct which is occluded by a malignant tumor.

ho'cau Yh
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal ENT, and Radiological Devi 510(k) Number

Prescription Use OR
(Per 21 CFR 801.109)

Over-The-Counter Use_

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.