(219 days)
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.
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.
The provided document, K061670, is a 510(k) summary for the Lunderquist Wire Guide and Lunderquist DC Wire Guide. It describes the device, its intended use, and the tests performed to demonstrate substantial equivalence to predicate devices. However, it does not include a detailed study with specific acceptance criteria and reported device performance in the format requested. The document primarily focuses on demonstrating that the device is "similar" to existing predicate devices in terms of materials, construction, and indications for use, and that it has undergone general performance tests.
Therefore, much of the requested information regarding specific acceptance criteria, detailed study results, sample sizes, expert involvement, and ground truth establishment, as typically found in clinical efficacy studies, is not present in this 510(k) summary.
Here's a breakdown of what can and cannot be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Testing | Not specified | "reliable design and performance under the specified testing parameters" |
| Flexible Testing | Not specified | "reliable design and performance under the specified testing parameters" |
| Functional Testing | Not specified | "reliable design and performance under the specified testing parameters" |
| Corrosion Testing | Not specified | "reliable design and performance under the specified testing parameters" |
| Radiodetectability | Not specified | "reliable design and performance under the specified testing parameters" |
Rationale: The document states that the devices were "subjected to the following tests to assure reliable design and performance under the specified testing parameters." However, it does not provide specific quantitative acceptance criteria for each test or detailed numerical results. It only offers a general statement that the results "provide reasonable assurance that the devices have been designed and tested to assure conformance to the requirements for their use as guide wires."
2. Sample sizes used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document does not provide details on the number of units tested for each type of test.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given the nature of bench testing, it would inherently be prospective in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The tests performed are engineering and material characteristic tests (e.g., tensile, flexibility, corrosion). These types of tests do not typically involve human expert adjudication for establishing a "ground truth" in the way a clinical study analyzing medical images or patient outcomes would. The "ground truth" for these tests is determined by the physical properties of the materials and device.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. As mentioned above, the tests are primarily objective engineering performance tests, not subjective assessments requiring expert adjudication.
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:
- MRMC Study: No. This document describes a medical device (wire guide), not an AI diagnostic or assistance system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm, so the concept of standalone algorithmic performance is not relevant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Type of Ground Truth: The "ground truth" for these tests would be the established engineering specifications and material properties against which the device's performance is measured. For example, for tensile testing, the ground truth would be the expected tensile strength for the materials used. This is not established by expert consensus, pathology, or outcomes data, but by established engineering standards and material science.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set."
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set.
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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.
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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.
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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.
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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
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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
§ 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.