The SCUBA Biliary Stent System consists of a balloon-expandable MP35N (cobalt, nickel, chromium molybdenum alloy) stent mounted on a 5 F over-the-wire (OTW) balloon catheter. The stent is provided in nominal expanded diameters of 5 mm to 10 mm, and stent lengths of 18 to 75 mm. The SCUBA Biliary Stent System has an 80 cm usable length and is compatible with 6 or 7 F introducer sheaths, and guidewires up to 0.035" diameter.

AI/ML Overview

The provided text does not contain specific acceptance criteria or an explicit study description with detailed performance metrics.

The "Performance Data" section states:
"Preclinical bench and biocompatibility testing was conducted to evaluate the safety and performance of the SCUBA Biliary Stent System. Testing included comparative testing with the predicate devices. Test results indicate that the SCUBA Biliary Stent System is safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible."

This is a general statement and lacks the quantitative data, sample sizes, and detailed methodology typically found in a study proving device meets acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can and cannot be answered based on the provided document:

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

Acceptance Criteria	Reported Device Performance
Not specified	"safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible."

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

Sample Size: Not specified.
Data Provenance: Not specified (the testing was "preclinical bench and biocompatibility testing," implying laboratory tests, not clinical data from specific countries or patients).
Retrospective/Prospective: Not specified.

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. The testing described is preclinical bench and biocompatibility testing, which typically does not involve human experts establishing ground truth in the way clinical studies do.

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

Not applicable. (See #3)

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

No, an MRMC study was not done (the device is a physical medical device, not an AI-powered diagnostic tool).

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

Not applicable (the device is a physical medical device, not an algorithm).

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

Not applicable. For preclinical bench and biocompatibility testing, "ground truth" would be established by validated testing methods and reference standards for material properties, mechanical integrity, and biological response, rather than medical expert consensus or patient outcomes.

8. The sample size for the training set

Not applicable (the device is a physical medical device, not an AI model that requires a training set).

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

Not applicable (See #8).

Summary

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K092352
page 1 of 2

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

Applicant: Invatec S.p.A. MAR 1 6 2010 Via Martiri della Libertá. 7 25030 Roncadelle (Brescia) Italy Peter Muster PhD, VP QA & RA Invatec S.p.A. Tel: +39 030 258 93 11 Fax: +39 030 258 93 12 Email: Peter.Muster@invatec.com Contact Person: Steve Camp, VP Clinical & Regulatory Affairs Invatec Inc. 3101 Emrick Blvd., Suite 113 Bethlehem, PA 18020 Tel: (610) 625-1402 Fax: (610) 625-1436 Email: steve.camp@invatec-us.com July 30, 2009 Date Prepared: Device Information Trade Name: SCUBA™ Biliary Stent System Common Name: Biliary Stent Classification Name: Diagnostic Biliary Catheter (21 CFR 876.5010, Product Code FGE) Classification: II

Predicate Devices

Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO . .035" Delivery System (K012590, K033394)
. Medtronic RACER Biliary Stent System (K032768)

Device Description

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Image /page/1/Picture/0 description: The image shows the text "K0923552 page 2 of 2". The text appears to be handwritten. The first line contains a combination of letters and numbers, while the second line indicates that it is page 2 of 2.

Indication for Use

The SCUBA™ Biliary Stent System is indicated for use in the palliation of malignant neoplasms in the biliary tree

Technological Characteristics

The SCUBA™ Biliary Stent System has the same design characteristics and intended use as the predicate devices. All of the stent systems are balloon-expandable stents mounted on an OTW delivery catheter. Diameters and lengths of the SCUBA Biliary Stent are within the size range of the predicate stents. The SCUBA Biliary Stent is manufactured from the same material used to manufacture the Medtronic RACER Biliary Stent.

Performance Data

Preclinical bench and biocompatibility testing was conducted to evaluate the safety and performance of the SCUBA Biliary Stent System. Testing included comparative testing with the predicate devices. Test results indicate that the SCUBA Biliary Stent System is safe and effective for the intended purpose, has comparable performance to the predicate devices, and is biocompatible.

Conclusion

The SCUBA Biliary Stent System is substantially equivalent to the Cordis PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA™ PRO .035" Delivery System, and the Medtronic RACER Biliary Stent System, with respect to indication for use, stent material, and technological and performance characteristics,

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Steve Camp Vice President, Clinical and Regulatory Affairs INVAtec, Inc. 3101 Emrick Blvd., Suite 113 BETHLEHEM PA 18020

MAR 1 5 2010

Re: K092352

Trade/Device Name: SCUBA Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 5, 2010 Received: March 8, 2010

Dear Mr. Camp:

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. Steve Camp

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 (301) 796-5484. 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) 796-5857 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

B. Zimmerman for

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

Enclosure

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Indications for Use

510(k) Number (if known): K092352

Device Name: SCUBA Biliary Stent System

Indications For Use: SCUBA Biliary Stent System is indicated for the palliation of malignant neoplasms in the biliary tree.

6 Prescription Use (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)

Seuul Houll
(Division Sign-Off)

Page 1 of 1

(Division Sign-Off)
Division of Reproductive) Abdominal,
and Radiological Devi
510(k) Number K092352

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.