ULTRAFLEX DIAMOND

K962899 · Boston Scientific Corp · FGE · May 20, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K962899
• Device Name: ULTRAFLEX DIAMOND
• Applicant: Boston Scientific Corp
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: May 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

Device Story

Self-expanding biliary stent system; used for palliative treatment of malignant biliary strictures. Device consists of nitinol stent and sliding sheath delivery system. Operated by physicians via endoscopic route. Stent provides mechanical support to maintain patency in obstructed bile ducts. Radiopaque markers on stent and delivery system assist in placement. Benefits include relief of obstructive jaundice. Bench testing and biocompatibility assessments performed to verify safety and performance.

Clinical Evidence

Bench testing only. Biocompatibility assessment performed on patient- and fluid-contact materials with satisfactory results. No clinical trial data provided.

Technological Characteristics

Self-expanding nitinol stent; monofilament twisted construction. Delivery system uses sliding sheath design. Dimensions: 10 mm OD, 40-80 mm length. Compatible with 0.035" guidewires. Sterilized via ethylene oxide gas per AAMI protocol. Packaged in Tyvek/Polyester-polyethylene pouch.

Indications for Use

Indicated for palliative treatment of patients with malignant biliary strictures. Contraindicated for benign biliary strictures, obstructions preventing cholangiography, perforated bile ducts, or patients where endoscopic/percutaneous procedures are contraindicated.

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

• Schneider Wallstent® Endoscopic Biliary Endoprosthesis (K925406)

Submission Summary (Full Text)

{0}

MAY 20 1997
X962899
Page 1 of 3

# ATTACHMENT 10
## 510(K) SUMMARY

## FOI RELEASABLE

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Boston Scientific Corporation is required to submit with this Premarket Notification “...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person.” Boston Scientific Corporation chooses to submit a summary of information respecting safety and effectiveness.

- COMMON/USUAL NAMES: Biliary Stent, Biliary Stent System
- TRADE/PROPRIETARY NAME: Ultraflex™ Diamond
- CLASSIFICATION NAME & DEVICE CLASSIFICATION: Class II

| Name | Number | 21 CFR Ref. |
| --- | --- | --- |
| Biliary Catheter and Accessories 78 FGE | | 876.5010 |

- DEVICE PANEL/BRANCH: Gastroenterology-Urology (GU)<br/>Gastro-Renal (GRDB)
- OWNER/OPERATOR: Boston Scientific Corporation<br/>One Boston Scientific Place<br/>Natick, MA 01760<br/>Owner/Operator No. 9912058
- CONTACT PERSON: Daniel J. Dillon, Senior Regulatory Affairs Specialist

## INDICATIONS FOR USE

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

## CONTRAINDICATIONS

The Ultraflex™ Diamond Biliary Stent System is contraindicated for biliary duct strictures of benign etiology; biliary obstruction preventing either endoscopic or percutaneous cholangiography; concurrent perforated bile duct, those patients for whom endoscopic or percutaneous procedures are contraindicated; any use other than those specifically outlined under Indications for Use.

## POTENTIAL COMPLICATIONS

The following complications have been reported in the literature for plastic and metal biliary stent placement. Procedural: infection, bleeding, perforation of the duodenum or bile duct, pain, aspiration, oxygen desaturation related to sedation, stent misplacement, pancreatitis, Post-Stent Placement: stent migration, stent occlusion due to sludge formation, stent occlusion due to tumor ingrowth, stent occlusion due to tumor overgrowth of stent ends, stent occlusion due to excessive hyperplastic tissue ingrowth, recurrent obstructive jaundice related to stent occlusion or migration, infection, bleeding, bile duct ulceration and/or perforation

000049

{1}

K962899
Page 2 of 3

# DESCRIPTIVE AND TECHNOLOGICAL CHARACTERISTICS OF PROPOSED AND PREDICATE DEVICES

Boston Scientific Corporation believes that the Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Schneider Wallstent® Endoscopic Biliary Endoprosthesis. Table 10-1 compares the descriptive characteristics of these products.

## PERFORMANCE CHARACTERISTICS

Laboratory testing regarding characteristics was performed on Ultraflex™ Diamond Biliary Stent System to verify its safety and performance. A biocompatibility assessment was performed on the patient- and fluid-contact materials of the Ultraflex™ Diamond Biliary Stent System with satisfactory results.

## PACKAGING, STERILIZATION, AND PYROGENICITY

The Ultraflex™ Diamond Biliary Stent System will be packaged in a Tyvek/Polyester-polyethylene pouch. The Ultraflex™ Diamond Biliary Stent System will be sterilized using ethylene oxide gas using the AAMI protocol for ethylene oxide sterilization. Pyrogenicity testing will be performed on a periodic basis to monitor bacterial endotoxin levels.

## CONCLUSION

Boston Scientific Corporation believes that Ultraflex™ Diamond Biliary Stent System is substantially equivalent to the currently-marketed Ultraflex™ Diamond Biliary Stent System. Table 10-1 compares the descriptive characteristics of these products. As demonstrated in Table 10-1, the Ultraflex™ Diamond Biliary Stent System is equivalent in its indications for use, while being very similar in design and materials. In addition, Boston Scientific Corporation has presented laboratory testing and biocompatibility information. The information presented provides assurance that the Ultraflex™ Diamond Biliary Stent System will meet the minimum requirements that are considered acceptable for its intended use.

000050

{2}

K962899
Page 3 of 3

TABLE 10-1: SIMILARITIES AND DIFFERENCES BETWEEN ULTRAFLEX™ DIAMOND BILIARY STENT SYSTEM AND SCHNEIDER WALLSTENT® ENDOSCOPIC BILIARY ENDOPROSTHESIS

| | Ultraflex Diamond Biliary Stent System
(This 510(k)) | Schneider Wallstent® Endoscopic Biliary Endoprosthesis
(K925406) |
| --- | --- | --- |

USE

| Indication | Malignant Biliary Strictures | ← Same |
| --- | --- | --- |
| Route of Administration | Endoscopic | ← Same |

STENT

| Overall OD | 10 mm | 8 - 12 mm |
| --- | --- | --- |
| Overall Length | 40 -80 mm | ← Same |
| Material | Nitinol | Stainless Steel |
| Construction Method | Monofilament, Twisted | Monofilament, Braided |
| Expansion Mode | Self-Expanding | ← Same |
| RO Marker Location | Stent and Delivery System | Delivery System |

DELIVERY SYSTEM

| Design | Sliding Sheath | ← Same |
| --- | --- | --- |
| Usable Length | 194 cm | 195 cm |
| Shaft OD | 2.7 mm - 3.02 mm | 2.5 mm |
| Compatible Guidewire | 0.035" | 0.035" - 0.038" |

000051

{3}

DEPARTMENT OF HEALTH &amp; HUMAN SERVICES
Public Health Service
MAY 20 1997
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Daniel J. Dillon
Senior Regulatory Affairs Specialist
Boston Scientific Corporation
One Boston Scientific Place
Natick, Massachusetts 01760-1537

Re: K962899
Ultraflex™ Diamond Biliary Stent System
Dated: February 25, 1997
Received: February 26, 1997
Regulatory class: II
21 CFR §876.5010/Product code: 78 FGE

Dear Mr. Dillon:

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 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. 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.

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

{4}

05/09/97 14:46 508 650 8935 BSC REG. DEPT. 003

# SECTION 1
## INDICATIONS FOR USE

510(k) Number: To Be Determined

Device Name: Ultraflex™ Diamond Biliary Stent System

Indication for Use:

The Ultraflex™ Diamond Biliary Stent System is indicated for palliative treatment of patients with malignant biliary strictures.

(Rolev D. Pattley)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number: K 962899

Prescription Use ☑
(Per 21 CFR 801.109)

Over-the-Counter Use