(270 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of AI or ML.
No
The intended use states that the device is "To facilitate the placement of devices during diagnostic or interventional procedures," indicating it is a tool for procedure guidance rather than for treatment itself.
No
The device's intended use is "to facilitate the placement of devices during diagnostic or interventional procedures," indicating it is a tool for guiding other devices, not for diagnosing conditions itself.
No
The device description explicitly details physical components made of stainless steel, nitinol, palladium, or platinum, and the performance studies focus on physical properties like biocompatibility, corrosion, flexing, fracture, tensile strength, and radiopacity. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To facilitate the placement of devices during diagnostic or interventional procedures." This describes a tool used during a medical procedure, not a device used to perform tests on samples taken from the body (which is the definition of an IVD).
- Device Description: The description details a physical wire guide used for placement, not a reagent, instrument, or kit for analyzing biological samples.
- Performance Studies: The performance studies listed (Biocompatibility, Corrosion, Flexing, Fracture, etc.) are all related to the physical and mechanical properties of the device, not its ability to accurately measure or detect substances in biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other elements typically associated with IVD devices.
Therefore, the Mandril Wire Guide is a medical device used for procedural guidance, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
To facilitate the placement of devices during diagnostic or interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The Mandril Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a stainless steel or nitinol mandril design with a stainless steel, palladium, or platinum distal spring coil anchored over the distal portion of the mandril. The Mandril Wire Guide is available with outside diameters ranging from 0.015 inches to 0.018 inches and lengths ranging from 25 centimeters (cm) to 180 cm. The tip portion of the subject device is either straight or angled. The Mandril Wire Guide is a packaged, sterile device intended for single patient use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- Corrosion Testing - Tested in accordance with Annex B of ISO 11070:2014. The pre-determined acceptance criteria were met.
- Flexing Test – Tested in accordance with the Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Fracture Testing - Tested in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- Tensile Testing - Tested in accordance with the applicable values of BS EN ISO 11070:2014, Annex H. The pre-determined acceptance criteria were met.
- Tip Flexibility Testing (Tip Deflection) – Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
- Torqueability Testing (Rotational Response) – Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.
- Torque Strength Testing - Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
- Radiopacity Testing - Tested in accordance with ASTM F640-12. The predetermined acceptance criteria were met.
- Surface Examination - Tested in accordance with BS EN ISO 11070:2014 Section 4.3. The pre-determined acceptance criteria were met.
- Dimensional Measurement Testing – Tested in accordance with an approved study protocol. The pre-determined acceptance criteria were met.
- Catheter Compatibility Testing - Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- Acute Performance Evaluation - Evaluation of device performance in an animal model under conditions intended to simulate clinical use. All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Given studies are primarily bench and animal testing, no specific metrics like Sensitivity, Specificity, PPV, NPV are provided. The key results reported are that "The pre-determined acceptance criteria were met" for all tests, and "All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters." for the animal model.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Spring Coil Guidewire (Neometrics, Inc., K143135)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ASAHI Peripheral Guide Wires (Asahi Intecc Co., LTD., K150445)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
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 a larger font and 'ADMINISTRATION' in a smaller font, both in blue.
March 30, 2018
Cook Incorporated Ms. Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K171997
Trade/Device Name: Mandril Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: February 23, 2018 Received: February 26, 2018
Dear Ms. Allman:
We have reviewed vour 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. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
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,
Nicole G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171997
Device Name Mandril Wire Guide
Indications for Use (Describe)
To facilitate the placement of devices during diagnostic or interventional procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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5.0 510(k) SUMMARY
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-0489 U 39.2235 TOLLEREE: 800.457 WWW.COOKMEDICAL.COM
K171997 Page 1 of 3
Mandril Wire Guide 21 CFR §807.92 Date Prepared: February 23, 2018
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Contact: | Jennifer L. Allman |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone Number: | (812) 335-3575 x104280 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Mandril Wire Guide |
|---|---|
| Common Name: | Wire, Guide, Catheter |
| Classification Name: | Catheter guide wire |
| Regulation: | 21 CFR §870.1330 |
| Product Code: | DQX |
Predicate Device:
The predicate device is the Spring Coil Guidewire (Neometrics, Inc., K143135) cleared for market on February 20, 2015.
Reference Device:
The reference device is the ASAHI Peripheral Guide Wires (Asahi Intecc Co., LTD., K150445) cleared for market on June 30, 2015.
4
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Page 2 of 3
Device Description:
The Mandril Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a stainless steel or nitinol mandril design with a stainless steel, palladium, or platinum distal spring coil anchored over the distal portion of the mandril. The Mandril Wire Guide is available with outside diameters ranging from 0.015 inches to 0.018 inches and lengths ranging from 25 centimeters (cm) to 180 cm. The tip portion of the subject device is either straight or angled. The Mandril Wire Guide is a packaged, sterile device intended for single patient use.
Intended Use:
The intended use of the Mandril Wire Guide is to facilitate the placement of devices during diagnostic and interventional procedures.
Comparison to Predicate:
The Mandril Wire Guide, subject of this submission, is substantially equivalent to the predicate device, the Spring Coil Guidewire (K143135), in that these devices have identical indications for use. Although the Mandril Wire Guide utilizes a shorter coil configuration and additional coil materials as compared to the Spring Coil Guidewire (K143135), the subject device and the predicate device have similar technological characteristics and the same therapeutic effect.
Technological Characteristics:
The following tests were performed to demonstrate that the Mandril Wire Guide, subject of this submission, met applicable design and performance requirements and support a determination of substantial equivalence.
- Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- . Corrosion Testing - Tested in accordance with Annex B of ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Flexing Test – Tested in accordance with the Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Fracture Testing - Tested in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
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Page 3 of 3
- . Tensile Testing - Tested in accordance with the applicable values of BS EN ISO 11070:2014, Annex H. The pre-determined acceptance criteria were met.
- . Tip Flexibility Testing (Tip Deflection) – Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
- . Torqueability Testing (Rotational Response) – Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The predetermined acceptance criteria were met.
- . Torque Strength Testing - Testing in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995). The pre-determined acceptance criteria were met.
- . Radiopacity Testing - Tested in accordance with ASTM F640-12. The predetermined acceptance criteria were met.
- Surface Examination - Tested in accordance with BS EN ISO 11070:2014 Section 4.3. The pre-determined acceptance criteria were met.
- . Dimensional Measurement Testing – Tested in accordance with an approved study protocol. The pre-determined acceptance criteria were met.
- . Catheter Compatibility Testing - Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995).
- . Acute Performance Evaluation - Evaluation of device performance in an animal model under conditions intended to simulate clinical use. All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.
Conclusion:
The results of these tests support a conclusion that the Mandril Wire Guide, subject of this submission, met the design input requirements based on the intended use and support the conclusion this device does not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Spring Coil Guidewire (K143135).