(49 days)
Not Found
Not Found
No
The description focuses on the physical properties and mechanical performance of a guide wire, with no mention of AI or ML.
No.
The device is described as a wire guide intended for diagnostic and interventional procedures, used to facilitate the introduction of other devices, rather than directly providing a therapeutic effect.
Yes
The "Intended Use" section explicitly states that the device is "intended for complex diagnostic and interventional procedures."
No
The device description clearly describes a physical wire guide made of stainless steel with a TFE coating, indicating it is a hardware medical device. The performance studies also focus on physical properties like bending, flexing, and tensile strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "wire guide" for "complex diagnostic and interventional procedures." This indicates it's used within the body to guide other instruments, not to test samples outside the body.
- Device Description: The description details a physical wire guide with specific dimensions and materials, consistent with a medical device used for navigation within the body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing biological samples (blood, urine, tissue, etc.).
- Detecting or measuring substances in samples.
- Providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural.
N/A
Intended Use / Indications for Use
The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is 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 Extra Stiff Double Curved Exchange Wire Guide has an outer diameter of .035 inches and is 260 cm long. The Lunderquist is a TFE-coated stainless steel wire guide with a double curved tip design, and a tapered, soft proximal end to ease device introduction. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Lunderquist Extra Stiff Double Curved Exchange Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- 4-Point Bend Testing 1.
- Flexing/Straightening Force 2.
- Tensile Testing 3.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a guide wire.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
K04261d
NOV 12 2004
COOK®
Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: 800 468-1379 www.cookgroup.com
510(k) Summary
Submitted By:
WILLIAM COOK EUROPE APS Sandet 6, dk-4632 Bjaeverskov, DENMARK
Contact:
Earl E. Knight III, MPA Regulatory Affairs Phone: (812) 339-2235 Fax: (812) 322-0281
Date Prepared:
September 23, 2004
Device:
| Trade Name: | Lunderquist Extra Stiff Double Curved Exchange Wire Guide |
|---|---|
| Proposed Classification: | 870.1330 DQX Class II, Cardiovascular |
Predicate Devices:
The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is 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 Extra Stiff Double Curved Exchange Wire Guide has an outer diameter of .035 inches and is 260 cm long. The Lunderquist is a TFE-coated stainless steel wire guide with a double curved tip design, and a tapered, soft proximal end to ease device introduction. The double curved distal tip has 4 cm of tip flexibility.
1
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Fins device will of manis device will undergo packaging similar to the devices currently Assurance I rogram. This aoWolliam Cook Europe. This device will undergo sterilization marketod and distributed ourrently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
Test Data:
The Lunderquist Extra Stiff Double Curved Exchange Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- 4-Point Bend Testing 1.
- Flexing/Straightening Force 2.
- Tensile Testing 3.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a guide wire.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three wing-like shapes extending from its back.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2 2004
Cook Incorporated c/o Mr. Earl E. Knight III, MPA Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
Re: K042611
K042011
Trade/Device Name: Lunderquist Extra Stiff Double Curved Exchange Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: October 22, 2004 Received: October 25, 2004
Dear Mr. Knight:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren or clay fee device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to togens and ment date of the Medical Device Amendments, or to commerce provision of May 20, 1978, as encordance with the provisions of the Federal Food, Drug, de vices mat have been recuire approval of a premarket approval application (PMA). and Costinetter (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, mererore, mans of the Act include requirements for annual registration, listing of general controls pro first ring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may or subject to back as a subations, 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 r hat 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
3
Page 2 -- Mr. Earl E. Knight III, MPA
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
s (21 CFR) (21) (2006) (2006) (21 CFR (21 (2) 21 CFR 1000-1050 forth in the quality systems (QS) regulation (21 -51 -542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 53 1-542 of the Action Section 5 product radiation control provisions (Scetions 35 described in your Section 510(k)
This letter will allow you to begin marketing your device to a legal This letter will allow you to begin marketing your article of your device of your device to a legally
premarket notification. The FDA finding of sybstantial equiracy and the premarket notification. The FDA iniding of substantial equive 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 If you desire specific advice for your ac vice on one of the regulation entitled.
contact the Office of Compliance at (240) 276-0120. Also, please note confact the Office of Colliphance at (240) 276 - 1207 (21CFR Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by relefence to premarket notified.com the Division of Small
other general information on your responsibilities under the Act from the (800) 638-200 other general information on your responsible in toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-Kdamamain html Manufacturers, International and Consultion in Losswate agos/cdrh/dsma/dsmamain.html
Sincerely yours,
Dianne D. Lochner
GA Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K042611
Device Name: Lunderquist Extra Stiff Double Curved Exchange Wire Guide
Indications For Use:
The Lunderquist Extra Stiff Double Curved Exchange Wire Guide is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide are needed.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
umma D. bechmel
(Division Sign-Off) Division of Cardiovascular Devices
510(K) Number_K042611