(219 days)
Not Found
Not Found
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 device is described as a "wire guide" intended for "complex diagnostic and interventional procedures," not for treating a disease or condition. Its function is to facilitate procedures, not to provide therapy itself.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for complex diagnostic and interventional procedures".
No
The device description clearly details physical components made of stainless steel and PTFE, and the performance studies involve physical testing (tensile, flexible, corrosion, etc.), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for "complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed." This describes a device used within the body to facilitate medical procedures, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a physical wire guide made of stainless steel with a PTFE coating and a radiopaque tip. This is consistent with a medical device used for navigation and support during procedures, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes or markers
- Providing diagnostic information about a patient's health status based on sample analysis
The tests performed (Tensile Testing, Flexible Testing, Functional Testing, Corrosion Testing, Radiodetectability) are all related to the physical performance and safety of a medical device used within the body, not the analytical performance of a diagnostic test.
N/A
Intended Use / Indications for Use
The Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.
Product codes
DQX
Device Description
The Lunderquist Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 90 to 300 cm lengths. For lengths 260-300 cm , a radiopaque gold coil is provided on the flexible distal tip. The distal tip has 4 or 7 cm of flexibility comes straight or as a J-curve with a 3 or 7.5 mm radius.
The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 260-300 cm lengths. A radiopaque gold coil is provided on the flexible distal tip. The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with a double curved tip design. The double curved distal tip has 4 cm of tip flexibility.
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 Lunderquist Wire Guide and Lunderquist DC Wire Guide were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of: - Tensile Testing 1. - 2. Flexible Testing - 3. Functional Testing - 4. Corrosion Testing - 5. Radiodetectability The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their use as guide wires.
Key Metrics
Not Found
Predicate Device(s)
To be inferred based on information from the device description and substantial equivalence.
Reference Device(s)
Not Found
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
COOK®
William Cook Europe ApS Sandet 6, 4632 Bjaeverskov DENMARK Phone: +45 56 86 86 86 Fax: +45 56 86 86 96 CVR No. 83 74 23 13 www.cookgroup.com
JAN 1 9 2007
510(k) Summary
Submitted By:
Tina H. Andersen WILLIAM COOK EUROPE APS Sandet 6. DK-4632 Bjaeverskov, DENMARK +45 56 86 87 60
June 09, 2006
Device:
Trade Name: Proposed Classification: Lunderquist Wire Guide/Lunderquist DC Wire Guide 870.1330 DQX Class II, Cardiovascular
Predicate Devices:
The Lunderquist Wire Guide and Lunderguist DC Wire Guide are similar in terms of intended use, materials of construction and technological characteristics to predicate devices designed for diagnostic and interventional procedures.
Device Description:
The Lunderquist Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 90 to 300 cm lengths. For lengths 260-300 cm , a radiopaque gold coil is provided on the flexible distal tip. The distal tip has 4 or 7 cm of flexibility comes straight or as a J-curve with a 3 or 7.5 mm radius.
The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with an outer diameter of .035 inches and comes in 260-300 cm lengths. A radiopaque gold coil is provided on the flexible distal tip. The Lunderquist DC Wire Guide is a PTFE-coated stainless steel wire guide with a double curved tip design. The double curved distal tip has 4 cm of tip flexibility.
1
Substantial Equivalence:
These devices will be manufactured according to specified process controls and a Quality Assurance Program. These devices will undergo packaging similar to the devices currently marketed and distributed by William Cook Europe ApS. These devices will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, these devices meets the requirements for section 510(k) substantial equivalence.
Test Data:
The Lunderquist Wire Guide and Lunderquist DC Wire Guide were subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile Testing 1.
-
- Flexible Testing
-
- Functional Testing
-
- Corrosion Testing
-
- Radiodetectability
The results of these tests provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their use as guide wires.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle-like symbol with three overlapping, curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
William Cook Europe ApS c/o Ms. Tina H. Andersen Regulatory Affairs Coordinator Sandet 6. 4632 Bjaeverskov DENMARK
JAN 1 9 2007
Re: K061670
Trade/Device Name: Lunderquist Wire Guide and Lunderquist DC Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: January 8, 2007 Received: January 10, 2007
Dear Ms. Andersen:
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.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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): 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.
3
Page 2 – Ms. Tina H. Andersen
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 (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. 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/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Instructions for Use
510(k) Number (if known):
Device Name:
Lunderquist Wire Gulde and Lunderquist DC Wire Guide
Indications for Use:
The Lunderquist Wire Guide and the Lunderquist DC Wire Guide are intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED:
Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Va. Aumes
Division Sign-Off) livision of Cardiovascular Devices
10(k) Number_K0616 40