(63 days)
No
The device description and performance studies focus on physical characteristics and material properties, with no mention of AI or ML.
No.
The document states that the device is an introducer for a safety wire guide, which is used prior to endourological procedures. Its function is to facilitate the placement of another device, not to treat a disease or condition itself.
No
Explanation: The device is described as an introducer for placing a safety wire guide before procedures, indicating it is an interventional or procedural device, not one used for diagnosis. Its description and performance studies focus on mechanical and material properties rather than diagnostic accuracy.
No
The device description explicitly details physical components (obturator and sheath) made of polyethylene with specific dimensions and features, and the performance studies include physical and material testing (dimensional, tensile strength, kinking, tip rollback, radiopacity, biocompatibility, sterilization, packaging, shelf-life). This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "antegrade placement of a safety wire guide prior to endourological procedures." This describes a surgical or interventional procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is a physical instrument (obturator and sheath) used to facilitate the placement of another device (a wire guide) within the body. This is characteristic of a surgical or procedural device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring substances in a sample
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is clearly intended for use during a medical procedure to aid in the placement of another device within the patient's body. This falls under the category of a medical device used for treatment or intervention, not an in vitro diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
Product codes
EZN
Device Description
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures. The Safety Wire Guide Introducer includes an obturator and sheath. The radiopaque polyethylene obturator is 7.0 French, 25.7 cm in length, and has a 1 cm taper along the distal tip of the device. It can be inserted through the radiopaque polyethylene introducer sheath that is 12.0 French, 22.2 cm in length, and tapers 6 mm from the distal end of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable performance standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- Dimensional Testing
- Tensile Strength ●
- Assembly After Kinking Testing ●
- Obturator/Sheath Tip Rollback Testing ●
- Radiopacity Testing
- Biocompatibility Testing shows that the subject device conforms to the ● biocompatibility requirements based on its intended use. All evaluation criteria were met. The following biological effects were evaluated:
- o Cytotoxicity
- Sensitization O
- Irritation/Intracutaneous Reactivity o
- Acute Systemic Toxicity о
- Material-mediated Pyrogenicity o
- Sterilization ●
- Package integrity and stability ●
- Shelf-life ●
All predetermined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
May 24, 2018
COOK Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, IN 47404
Re: K180756
Trade/Device Name: Safety Wire Guide Introducer Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: March 21, 2018 Received: March 22, 2018
Dear Carly Powell:
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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|------------------------------------------------------------------------------------------------|------------|---------------------------------------------------------------------------------------------------|
| 510(k) Number | (if known) | |
| K180756 | | |
| Device Name | | |
| Safety Wire Guide Introducer | | |
Indications for Use (Describe)
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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2
Company Confidential
3
Image /page/3/Picture/1 description: The image shows the Cook Medical logo, which is a red square with the word "COOK" in white letters at the top and the word "MEDICAL" in white letters at the bottom. Below the logo is the text "2.0 510(k) Summary" in black letters. The text is likely a heading or title for a document or section of a document.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Safety Wire Guide Introducer As required by 21 CFR 807.92 Date Prepared: May 23, 2018
Cook Incorporated
Cook Incorporated 750 Daniels Way
(812) 339-2235
(812) 332-0281
Andrew Breidenbach
Bloomington, IN 47404
Carly Powell
Traditional 510(k) Premarket Notification
Submitted By:
Submission: Applicant: Contact:
Applicant Address:
Contact Phone: Contact Fax:
Device Information:
Trade Name: Common Name: Classification Name: Regulation, Class: Product Code, Panel:
Predicate Device:
Ureteral dilator Ureteral Dilator 21 CFR §876.5470. Class II EZN, Gastroenterology/Urology
Safety Wire Guide Introducer
The predicate device is Boston Scientific's 8/10 Dilator/Sheath Set, cleared for commercial distribution under 510(k) number K851144.
Device Description:
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures. The Safety Wire Guide Introducer includes an obturator and sheath. The radiopaque polyethylene obturator is 7.0 French, 25.7 cm in length, and has a 1 cm taper along the distal tip of the device. It can be inserted through the radiopaque polyethylene introducer sheath that is 12.0 French, 22.2 cm in length, and tapers 6 mm from the distal end of the device.
Indications for Use:
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
4
Cook Incorporated - Traditional 510(k) Safety Wire Guide Introducer March 21, 2018
Comparison to Predicate Device:
The subject device has similar indications for use, methods of operation, and fundamental technological characteristics to the predicate device. Differences between the subject device and the predicate devices include dimensional variations and slight variations in materials. Characteristics of the subject device that differ from the predicate devices are supported by testing. These differences do not raise any new questions of safety and/or effectiveness.
Performance Data:
The subject device underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable performance standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- Dimensional Testing
- Tensile Strength ●
- Assembly After Kinking Testing ●
- Obturator/Sheath Tip Rollback Testing ●
- Radiopacity Testing
- Biocompatibility Testing shows that the subject device conforms to the ● biocompatibility requirements based on its intended use. All evaluation criteria were met. The following biological effects were evaluated:
- o Cytotoxicity
- Sensitization O
- Irritation/Intracutaneous Reactivity o
- Acute Systemic Toxicity о
- Material-mediated Pyrogenicity o
- Sterilization ●
- Package integrity and stability ●
- Shelf-life ●
All predetermined acceptance criteria were met.
Conclusion:
The data included in this submission indicate that the subject device does not raise new questions of safety or effectiveness compared to the predicate device (K851144), which supports a determination of substantial equivalence.