SCUBA BILIARY STENT SYSTEM

K092352 · Invatec S.P.A. · FGE · Mar 16, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K092352
• Device Name: SCUBA BILIARY STENT SYSTEM
• Applicant: Invatec S.P.A.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 16, 2010
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

SCUBA Biliary Stent System consists of balloon-expandable MP35N alloy stent mounted on 5 F over-the-wire (OTW) balloon catheter. Stent diameters range 5-10 mm; lengths 18-75 mm. Device used in biliary tree for palliation of malignant neoplasms. Operated by physicians in clinical setting. Stent deployed via balloon expansion to maintain biliary patency. Benefits include relief of biliary obstruction caused by malignant tumors. Safety/effectiveness for vascular use not established.

Clinical Evidence

Bench testing only. Preclinical bench and biocompatibility testing conducted to evaluate safety and performance. Comparative testing against predicate devices confirmed comparable performance and biocompatibility.

Technological Characteristics

Balloon-expandable stent; material: MP35N (cobalt, nickel, chromium, molybdenum alloy); delivery system: 5 F over-the-wire (OTW) balloon catheter; compatible with 6 or 7 F introducer sheaths and up to 0.035" guidewires; usable length 80 cm.

Indications for Use

Indicated for patients with malignant neoplasms in the biliary tree requiring palliation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

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

Submission Summary (Full Text)

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K092352
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# 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: [phone] Fax: [phone] Email: [e-mail] Contact Person: Steve Camp, VP Clinical & Regulatory Affairs Invatec Inc. 3101 Emrick Blvd., Suite 113 Bethlehem, PA 18020 Tel: [phone] Fax: [phone] Email: [e-mail] 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

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.

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## 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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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 [phone]. 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 [phone] or [phone] 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)

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