STRYKER URETERAL ILLUMINATION SYSTEM IV

K061548 · Stryker Corp. · FCS · Sep 28, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061548
• Device Name: STRYKER URETERAL ILLUMINATION SYSTEM IV
• Applicant: Stryker Corp.
• Product Code: FCS · Gastroenterology, Urology
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4020
• Device Class: Class 2

Intended Use

The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038"-guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

Device Story

Stryker Ureteral Illumination System IV consists of open-ended ureteral catheter; Pellethane construction with hydrophilic coating; incorporates fiberoptic light guide. Used with InfraVision IR Illuminator to transilluminate ureter during surgery. Compatible with up to 0.038" guidewire. Open surgical access utilizes InfraVision Detector Probe; laparoscopic access utilizes InfraVision Camera. Sterile, single-use disposable. Enables visualization of ureter to assist surgeons during procedures; helps prevent accidental injury to ureter.

Clinical Evidence

Bench testing only. Device validated for EtO sterilization to a SAL of 10^-6. Conformance to voluntary safety and performance standards including ISO 10993, ANSI/AAMI/ISO 11135, and various ASTM packaging/mechanical standards.

Technological Characteristics

Pellethane catheter with hydrophilic coating; fiberoptic light guide. Compatible with 0.038" guidewire. Sterile, single-use. EtO sterilization (SAL 10^-6). Standards: ISO 10993, G95-1, ANSI/AAMI/ISO 11135, EN 550, ASTM D4169, D999, D1140, D4332, D4728, D5276, F88, EN 868-1, ISO 11607, FPA SPMC 005-96.

Indications for Use

Indicated for patients undergoing surgical procedures requiring ureteral transillumination during open or laparoscopic access.

Regulatory Classification

Identification

A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.

Special Controls

*Classification.* Class II (special controls). The device 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

• Stryker Ureteral Illumination System III (K982542)

Submission Summary (Full Text)

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San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521

SEP 28 2006

K061548

**stryker**®

Endoscopy

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## Device Name:

| Proprietary Name: | Stryker Ureteral Illumination System IV |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common and Usual Name: | Stryker Universal Ureteral Kit or<br>Stryker Universal U-Kit or<br>Stryker Ureteral Illumination System IV or<br>Fiberoptic light ureteral catheters |
| Classification Name: | Fiberoptic light ureteral catheter (Class II, 876.4020, Product<br>Code FCS, Gastroenterology-Urology Devices Panel) |

The Stryker Ureteral Illumination System IV with the InfraVision IR Illuminator is intended to transluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038" guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

The Stryker Ureteral IIIumination System IV consists of an open-ended ureteral catheter, which allows the use of a guidewire (up to 0.038" dia), is composed of Pellethane™ with a hydrophilic coating to ease insertion into the ureters and incorporates a fiberoptic light guide that is used with the InfraVision IR llluminator to transluminate the ureter during surgical procedures. It can be used for either open surgical or laparoscopic access and is distributed as a sterile, single use disposable product. The device is validated for EtO sterilization to a SAL of 10°.

The Stryker Ureteral Illumination System IV is substantially equivalent in terms of safety and effectiveness to the currently marketed Stryker Ureteral III (ref: K982542). The Styker Universal U-Kit will conform to the following voluntary safety and performance standards: ISO 10993, Blue Book Memorandum G95-1, ANSI/AAMI/ISO 11135, EN 550, ASTM D4169, ASTM D999, ASTM D1140, ASTM D4332, ASTM D4728, ASTM D5276, ASTM F88, EN 868-1, ISO 11607, and FPA SPMC 005-96.

The technological differences between the Stryker Ureteral Illumination System IV and the identified predicate devices (Stryker Ureteral Illuminator System III, K982542) do not affect the safety and efficacy of the product; therefore, the Stryker Ureteral Illumination System IV is substantially equivalent to the identified predicate devices.

Date:

By:

Erica A. Walters Sr. Requlatory Representative Stryker Endoscopy

Stryker Ureteral Illumination System IV

Page 6 of 48

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff and two snakes intertwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

、

SEP 2 8 2006

Ms. Erica A. Walters Sr. Regulatory Representative Stryker Endoscopy 5900 Optical Court SAN JOSE CA 95138

K061548 Re:

Trade/Device Name: Stryker Ureteral Illumination System IV Regulation Number: 21 CFR §876.4020 Regulation Name: Fiberoptic light ureteral catheter Regulatory Class: II Product Code: FCS Dated: August 28, 2006 Received: August 30, 2006

Dear Ms. Walters:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) presidentially equivalent (for the indications for referenced above and have determined the devices marketed in interstate commerce
use stated in the enclosure) to legally marketed predicated in interstate on to devices that use stated in the enclosure) to legally man Riccal Device Amendments, or to devices that prior to May 28, 1976, the enactment uith the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Febral Food, have been reclassified in accordance with the provisions and application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of the Ac Act (Act) that do not require apploval of a prematice approvisions of the Act. The general
therefore, market the device, subject to the general someration, listing of device therefore, market the device, subject to the generalion, fish registration, listing of devices, good
controls provisions of the Act include requirements for annon registratio controls provisions of the Act metade requirements see

If your device is classified (see above) into cither class II (Special Controls) or class III (Prematice)
President (see and to Microsoft of the street - Evigine major reaul If your device is classified (see above) microls. Existing major regulations affecting your Approval), it may be subject to such additions. Title 21, Pars 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Paris 800 lo 89 device can be found in the Code of Pederal Regarities in the Federal Register.

Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Inside the circle, the letters "FDA" are prominently displayed above the word "Centennial". Three stars are located at the bottom of the circle. The logo appears to be a commemorative emblem for the FDA's centennial anniversary.

romoting Public 9

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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.

This letter will allow you to begin marketing your device as described in your Section 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 (31 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C Hodgon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

Device Name: Stryker Ureteral Illumination System IV

Indications for Use:

The InfraVision Ureteral Kit with the InfraVision IR Illuminator is intended to transilluminate the ureter during surgical procedures. The Catheter accepts up to a 0.038"-guidewire. The Kit can be used for either open surgical (with the InfraVision Detector Probe) or laparoscopic (with the InfraVision Camera) access.

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

text
Nancyc Broadon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number X061548

Stryker Ureteral Illumination System IV