The Absolute® Pro .035 Biliary Self-Expanding Stent System includes a selfexpanding nickel titanium stent that is pre-mounted on an over-the-wire Delivery System. A total of 12 (6 at each end) radiopaque markers made of a radiopaque nickel titanium alloy are located at the ends of the stent. The Absolute Pro .035 Biliary Self-Expanding Stent System utilizes a 0.035" (0.89 mm) guide wire. The system includes radiopaque markers that identify the stent location.

The catheter comprises a retractable sheath that covers the stent during delivery. a radiopaque tip, an I-Beam to support the stent during deployment with an internal guide wire lumen, a detachable outer jacket, and a handle assembly with a safety lock and retraction features. With the handle in the unlocked position, rolling back the thumbwheel deploys the stent.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Absolute® Pro .035 Biliary Self-Expanding Stent System:

Summary of Acceptance Criteria and Device Performance for Absolute® Pro .035 Biliary Self-Expanding Stent System

This 510(k) submission (K072708) relies on demonstrating substantial equivalence to predicate devices rather than meeting specific quantifiable performance acceptance criteria for a novel AI device. The "device performance" reported is that the new device is equivalent to its predicates based on various tests.

Acceptance Criteria Category	Acceptance Criteria (based on predicate equivalence)	Reported Device Performance
Intended Use	The device must be intended for the same use as the predicate devices: palliation of malignant strictures in the biliary tree.	The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree, matching the predicate.
Technological Characteristics	The technological characteristics (e.g., self-expanding nickel titanium stent, pre-mounted delivery system, radiopaque markers, 0.035" guide wire compatibility, catheter components) must be sufficiently similar to the predicate devices to demonstrate equivalence.	A comparison of technological characteristics was performed, and the results demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is equivalent to the predicate devices.
Performance (In Vitro Bench Tests/Analyses)	The device must perform comparably to the predicate devices in relevant in vitro bench tests and analyses to ensure similar safety and effectiveness. (Specific performance metrics are not detailed in this summary, but implied to be sufficient for equivalence). The document explicitly states that the device's safety and effectiveness for use in the vascular system have not been established.	The results of the in vitro bench tests and analyses demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent in performance to the Absolute® .035 Biliary Self-Expanding Stent System (one of the predicates).

Study Information (Based on the provided text):

The provided text describes a 510(k) submission for a medical device (a biliary stent system), not an AI/ML diagnostic or prognostic device. Therefore, many of the typical AI study parameters (sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of submission.

Here's an attempt to address the points based on what's available and an understanding of traditional medical device submissions:

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" are effectively the demonstration of substantial equivalence to the predicate devices based on intended use, technological characteristics, and performance data (primarily in vitro).
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable in the AI sense. This submission is for a physical medical device. The "test set" would be the units of the device subjected to in vitro bench testing. The text does not specify the number of samples used for these bench tests.
- Data Provenance: The data would be derived from internal laboratory testing conducted by Abbott Vascular. The country of origin for the data is implicitly the USA (Abbott Vascular, Santa Clara, CA). This is generally prospective testing of the manufactured device.
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 in the AI sense. For a physical device like a stent, "ground truth" is established through engineering specifications, material science standards, and established medical device testing methodologies. The "experts" would be the R&D engineers, metallurgists, and quality control professionals who design and test the device against these standards. Their qualifications are not specified but are presumed to be appropriate for medical device engineering and testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable in the AI sense. The "adjudication method" for traditional device testing involves adherence to predefined test protocols, acceptance limits, and quality control procedures. It's not a consensus-based review by experts of clinical cases.
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:
- No. This is a physical device, not an AI diagnostic tool. MRMC studies are not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro performance data, the "ground truth" would be the engineering specifications and performance characteristics of the predicate devices, as well as relevant industry standards and design requirements for biliary stents (e.g., radial force, fatigue resistance, deployment accuracy, material biocompatibility, etc., though not detailed in this summary). The goal is to demonstrate that the new device meets or exceeds these established performance benchmarks found in the predicates.
The sample size for the training set:
- Not applicable in the AI sense. There is no "training set" for a physical device in this context. The design and manufacturing process would involve extensive engineering studies and prototypes, but not a "training set" like that used for machine learning.
How the ground truth for the training set was established:
- Not applicable in the AI sense. See point 8.

Summary

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RC72768 PAGE 1 CF 2

(Posted November 13, 2003)

510(k) Summary

AUG 1 8 2008

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Abbott Vascular
Submitter's Address:	3200 Lakeside DriveSanta Clara, CA 95054
Telephone:Fax:	408-845-0613408-845-0921
Contact Person:Date Prepared:	Michelle Grossman, Senior Regulatory Affairs AssociateSeptember 24, 2007
Device Trade Name:	Absolute® Pro .035 Biliary Self-Expanding Stent System
Device Common Name:Device Classification Name:	Biliary StentBiliary Catheter
Device Classification:	Class II

Summary of Substantial Equivalence:

The Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent to the Absolute® 035 Biliary Self-Expanding Stent System (K033393, cleared 11/10/03); and Xceed Nitinol Self Expanding Transhepatic Biliary Stent System (K050501, cleared 3/14/05).

Device Description:

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XC727C8 PAGE 2 OF 2

Intended Use:

The Absolute® Pro .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

Technological Characteristics Compared to Predicate:

A comparison of the technological characteristics of the Absolute® Pro .035 Biliary Self-Expanding Stent System and the predicate devices have been performed. The results of this comparison demonstrate that the Absolute® Pro .035 Biliary Self-Expanding Stent System is equivalent to the predicate devices.

Performance Data:

The results of the in vitro bench tests and analyses demonstrates that the Absolute® Pro .035 Biliary Self-Expanding Stent System is substantially equivalent in performance to the Absolute® .035 Biliary Self-Expanding Stent System.

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Image /page/2/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 its wings spread, and three horizontal bars below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle Grossman AUG 1 8 2008 Regulatory Affairs Abbott Vascular - Vascular Solutions 3200 Lakeside Drive SANTA CLARA CA 95054

Re: K072708

Trade/Device Name: Absolute® Pro .035 Biliary Self-Expanding Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 15, 2008 Received: July 16, 2008

Dear Ms. Grossman:

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. Michelle Grossman

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 (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.

Christy Foreman for

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

Enclosure

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Indications for Use

510(k) Number (if known): K072708

Absolute® Pro .035 Biliary Self-Expanding Stent System Device Name: The Absolute® Pro .035 Biliary Self-Expanding Stent Indications for Use: System is intended for palliation of malignant strictures

in the billiary tree.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and	Page
Radiological Devices

(017)

510(k) Number

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.