(74 days)
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, a wire guide, facilitates the delivery of other catheters, rather than directly treating a disease or condition itself.
No
Explanation: The device is a wire guide used to facilitate the delivery of catheters, which is an interventional or procedural function, not a diagnostic one. The performance tests listed are related to mechanical integrity and biocompatibility, not diagnostic accuracy.
No
The device description clearly outlines physical components (nitinol mandril, PTFE coating, stainless steel and palladium tip) and physical testing (Tensile Test, Tip Flexibility Test, etc.), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description and Intended Use: The Cook MicroWire Wire Guide is a physical device used inside the body (in vivo) to facilitate the delivery of catheters into the cardiovascular system. It is a tool used during a medical procedure, not a test performed on a sample.
The information provided clearly describes a medical device used for interventional procedures, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Cook MicroWire Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Product codes (comma separated list FDA assigned to the subject device)
DOX
Device Description
The Cook MicroWire Wire Guide is manufactured using a nitinol mandril with a PTFE coating and a stainless steel and palladium distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
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 Cook MicroWire Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
-
- Tensile Test
-
- Tip Flexibility Test
-
- Fracture Test
-
- Flexing Test
-
- Torque Strength Test
-
- Torque Response Test
-
- Biocompatibility Testing
-
- Bioburden Testing
-
- Endotoxin Testing
-
- EtO Residual Testing
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 wire guide.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
Special 510(k) Premarket Nutification Cook MicroWire Wire Guide COOK INCORPORATED
510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
Device:
Trade Name: Proposed Classification:
Cook MicroWire Wire Guide Wire, Guide, Catheter 21 CFR §870.1330
Indications for Use:
The Cook MicroWire Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Predicate Devices:
The Cook MicroWire Wire Guide is similar in terms of intended use, materials of construction and technological characteristics to predicate devices reviewed as devices for facilitating delivery of percutaneous catheters into the cardiovascular system.
Device Description:
The Cook MicroWire Wire Guide is manufactured using a nitinol mandril with a PTFE coating and a stainless steel and palladium distal tip. The maximum outside diameter is 0.0142-inch and will be available in 135, 190 and 300 cm lengths. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
The Cook MicroWire Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the cardiovascular system. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the wire guide support a determination of substantial equivalency.
APR 2 7 2007
1
Test Data:
The Cook MicroWire Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
-
- Tensile Test
-
- Tip Flexibility Test
-
- Fracture Test
-
- Flexing Test
-
- Torque Strength Test
- ર. Torque Response Test
- Biocompatibility Testing 7.
-
- Bioburden Testing
-
- Endotoxin Testing
-
- EtO Residual Testing
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 wire guide.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloominton, IN 47402
APR 2 7 2007
Re: K070410 Cook MicroWire Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: DOX Dated: April 6, 2007 Received: April 9, 2007
Dear Ms. Bradburn:
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 either 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.
3
Page 2 -- Ms. Karen Bradburn
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. 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,
R. haines
Image /page/3/Picture/5 description: The image contains a signature and the words "Br" and "Di" to the right of the signature. The signature is a stylized loop with a line extending from the bottom left. The letters "Br" and "Di" are stacked vertically, with "Br" on top of "Di".
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k) Premarket Notification Cook MicroWire Wire Guide COOK INCORPORATED
510(k) Number (if known):
Device Name: Cook MicroWire Wire Guide
Indications for Use:
Indicated for use in facilitating delivery of percutaneous catheters into the cardiovascular system.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 807 Subpart C)
1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sumer 2. VC. une (Division Sign-Off)
Division of Cardiovascular De
510(k) Number Ko 70410