(63 days)
The Safety Wire Guide Introducer is used for antegrade placement of a safety wire guide prior to endourological procedures.
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.
The provided document is a 510(k) premarket notification for a medical device called the "Safety Wire Guide Introducer." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive studies or defining strict performance acceptance criteria in the same way one might for an AI/ML device.
Therefore, the information required to fully answer the request (especially regarding acceptance criteria, study details, expert involvement, and comparative effectiveness studies for AI) is not present in the provided document. The device is a physical medical instrument, not an AI/ML algorithm.
However, I can extract the available performance data and how it demonstrates "acceptance" in the context of a 510(k) submission:
1. A table of acceptance criteria and the reported device performance:
In a 510(k) for a physical device, "acceptance criteria" are typically the successful completion of specified engineering and biocompatibility tests in accordance with recognized standards and FDA guidance. The document states that "All predetermined acceptance criteria were met." Specific numerical criteria are not detailed in this summary, but the categories of testing performed are listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Testing | Met |
| Tensile Strength | Met |
| Assembly After Kinking Testing | Met |
| Obturator/Sheath Tip Rollback Testing | Met |
| Radiopacity Testing | Met |
| Biocompatibility Testing | Met (conforms to requirements; all evaluation criteria met for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Material-mediated Pyrogenicity) |
| Sterilization | Met |
| Package integrity and stability | Met |
| Shelf-life | Met |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified. For engineering and biocompatibility tests, sample sizes are typically determined by relevant ISO standards or internal statistical rationale, but these details are not provided in this 510(k) summary.
- Data provenance: Not explicitly stated, but these tests would have been conducted in a controlled laboratory environment by the manufacturer (Cook Incorporated) or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not directly applicable to the testing of a physical device like a wire guide introducer. "Ground truth" in this context would refer to the physical properties measured and assessed against engineering specifications, which are determined by instrumentation and established test methods, not expert consensus in the diagnostic sense.
4. Adjudication method for the test set:
Not applicable in the context of physical device testing. Results are typically quantitative measurements compared against predefined engineering specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a physical medical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument.
7. The type of ground truth used:
For the listed performance tests, the "ground truth" would be the objective measurement of physical properties (e.g., length, tensile strength, radiopacity, biological reaction) compared against predefined engineering specifications and biocompatibility standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in that sense.
9. How the ground truth for the training set was established:
Not applicable.
In summary, the provided document is a 510(k) summary for a conventional, physical medical device. It details the engineering and biocompatibility testing performed to demonstrate substantial equivalence to a predicate device, rather than the performance characteristics of an AI/ML system.
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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.
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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)
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Company Confidential
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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.
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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.
§ 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).