(115 days)
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.
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 provided text is a 510(k) summary for the Stryker Ureteral Illumination System IV. It describes the device's intended use and claims substantial equivalence to a predicate device, the Stryker Ureteral Illuminator System III (K982542).
However, the document does NOT contain any information regarding specific acceptance criteria for performance, a study detailing device performance against those criteria, sample sizes, expert ground truth establishment, or any of the other detailed study parameters requested in your prompt.
The 510(k) summary primarily focuses on:
- Device Name and Classification: Identifying the device and its regulatory classification.
- Intended Use: Stating what the device is for (transilluminating the ureter during surgical procedures).
- Technological Characteristics: Describing the components (catheter, guidewire compatibility, materials, hydrophilic coating, fiberoptic light guide) and sterilization method.
- Substantial Equivalence Claim: Asserting that the device is as safe and effective as the predicate device and that technological differences do not affect safety or efficacy.
- Standards Conformance: Listing general safety and performance standards the device will conform to (e.g., ISO, AAMI, ASTM).
Therefore, I cannot populate the requested table or answer most of your detailed questions based on the provided text, as this information is not present. The 510(k) process often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical performance data against specific acceptance criteria for a novel device.
Summary of available information from the text:
- Acceptance Criteria & Reported Device Performance: Not explicitly stated or detailed. The submission relies on claiming substantial equivalence to a predicate device.
- Sample Size (test set) & Data Provenance: Not mentioned. No specific "test set" or performance study is described.
- Number of experts and qualifications for ground truth: Not applicable, as no ground truth establishment for a performance study is described.
- Adjudication method for test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone (algorithm only) performance: Not applicable; this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
{0}------------------------------------------------
San Jose, CA 95138 t: 408 754 2000 f: 408 754 2521
SEP 28 2006
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 orStryker Universal U-Kit orStryker Ureteral Illumination System IV orFiberoptic light ureteral catheters |
| Classification Name: | Fiberoptic light ureteral catheter (Class II, 876.4020, ProductCode 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
{1}------------------------------------------------
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
{2}------------------------------------------------
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 (800) 638-2041 or (240) 276-3150
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
{3}------------------------------------------------
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
§ 876.4020 Fiberoptic light ureteral catheter.
(a)
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.(b)
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.