(269 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guide wire intended to facilitate placement of other diagnostic and interventional devices, not to provide therapy itself.
No
The device is a wire guide intended to facilitate the placement of other devices used during diagnostic and interventional procedures, but it is not itself a diagnostic device.
No
The device description clearly states it is a physical wire guide consisting of a mandril, spring coil, and cannula, and the performance studies listed are for physical properties like biocompatibility, corrosion, and tensile strength, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use states the device is "intended to facilitate placement of devices used during diagnostic and interventional procedures." This describes a tool used during procedures, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a physical wire guide used for navigating within the body. This is consistent with an interventional or diagnostic tool used in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with IVD devices.
- Classification: The device is classified under 21 CFR §870.1330, which is for "Wire, Guide, Catheter." This classification is for devices used within the body, not for in vitro testing.
In summary, the Lunderquist Fixed Core Wire Guide is a medical device used to assist in placing other devices during procedures performed on a patient, not a device used for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
Product codes
DQX
Device Description
The Lunderquist® Fixed Core 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 mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core 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
The following tests were performed to demonstrate that the Lunderquist® Fixed Core Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.
- Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The predetermined acceptance criteria were met.
- Corrosion Testing – Tested in accordance with Annex B of ISO 11070:2014. The predetermined 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.
- Surface Examination – Tested in accordance with BS EN ISO 11070:2014 Section 4.3. 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 Guidance (1995). The pre-determined acceptance criteria were met.
- Radiopacity Testing - Tested in accordance with ASTM F640-12. The pre-determined acceptance criteria were met.
- Dimensional Measurement and Catheter Compatibility Testing Tested in accordance with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995) and with an approved study protocol. The pre-determined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 15, 2019
Cook Incorporated Ms. Jennifer Allman, RAC Regulatory Affairs Project Manager 750 Daniels Way Bloomington, IN 47402
Re: K181353
Trade/Device Name: Lunderquist® Fixed Core Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 15, 2019 Received: January 15, 2019
Dear Ms. Allman:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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,
Digitally signed by Lydia S. Glaw -S Lydia S. Glaw -S. Date: 2019.02.15 15:30:39 -05'00'
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) K181353
Device Name Lunderquist® Fixed Core Wire Guide
Indications for Use (Describe)
The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image features the logo for Cook Medical. The logo consists of the word "COOK" in a bold, sans-serif font, stacked above the word "MEDICAL" which is in a smaller, sans-serif font. The word "COOK" also has the registered trademark symbol to the right of it. The background is a solid red color, while the text is white.
510(k) SUMMARY
Lunderquist® Fixed Core Wire Guide 21 CFR §807.92 Date Prepared: May 21, 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: | Lunderquist® Fixed Core 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 Mandril Wire Guides (Cook, Inc., K171997) cleared for market on March 30, 2018.
Reference Device:
The reference device is the Fixed Core Wire Guides (Cook Inc., K171764) cleared for market on March 9, 2018.
4
Image /page/4/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background. The red background for "MEDICAL" is a rectangle that is slightly offset from the red background for "COOK".
Device Description:
The Lunderquist® Fixed Core 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 mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core Wire Guide is a packaged, sterile device intended for single patient use.
Intended Use:
The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.
Comparison of Technological Characteristics to Predicate:
The Lunderquist® Fixed Core Wire Guide, subject of this submission, is substantially equivalent to the predicate device, the Mandril Wire Guide (K171997), in that both devices have identical indications for use. The subject device is similar in technological characteristics (i.e., design and materials) to the predicate device with the addition of a 0.038 inch diameter configuration and a proximal cannula design.
Performance Data:
The following tests were performed to demonstrate that the Lunderquist® Fixed Core Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.
- . Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The predetermined acceptance criteria were met.
- . Corrosion Testing – Tested in accordance with Annex B of ISO 11070:2014. The predetermined 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.
- . Surface Examination – Tested in accordance with BS EN ISO 11070:2014 Section 4.3. 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.
5
Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, set against a red background. The background is a red rectangle.
- . Tip Flexibility Testing (Tip Deflection) – Tested in accordance with the FDA Coronary and Cerebrovascular Guidance (1995). The pre-determined acceptance criteria were met.
- . Radiopacity Testing - Tested in accordance with ASTM F640-12. The pre-determined acceptance criteria were met.
- Dimensional Measurement and Catheter Compatibility Testing Tested in accordance . with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995) and with an approved study protocol. The pre-determined acceptance criteria were met.
Conclusion:
The results of these tests support a conclusion that the Lunderquist® Fixed Core Wire Guide, subject of this submission, met the design input requirements based on the device's intended use and support the conclusion this device does not raise new questions of safety and/or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Mandril Wire Guides (K171997).