(37 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 technologies.
No
The device is described as a 'wire guide' used to facilitate the delivery of percutaneous catheters, not to treat a condition itself. Its function is assist in a medical procedure, not to provide therapy.
No
Explanation: The device is described as a wire guide for facilitating the delivery of percutaneous catheters, which is a procedural/interventional function, not a diagnostic one.
No
The device description clearly states it is a physical wire guide made of stainless steel and PTFE, intended for facilitating catheter delivery. 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 description and intended use clearly state that this device is a wire guide used to facilitate the delivery of catheters into the peripheral vasculature. This is an invasive procedure performed within the body (in vivo).
The device is a tool used in a medical procedure, not a test performed on a sample.
N/A
Intended Use / Indications for Use
The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Product codes
DQX
Device Description
The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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 Approach Pro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:
- Three Point Bend Test
-
- Corrosion Resistance Test
-
- Radiopacity Evaluation
-
- Evaluation of Torque Response and Torque Strength
-
- Tensile Evaluation of the Distal Tip
- Q. Characterization of Loads Required to Deflect the Distal Tip
-
- Evaluation of Resistance to Fracture
-
- Evaluation of Resistance to Fracture after 3-Year Accelerated Aging
- Evaluation of Resistance to Damage by Flexing 9.
- Evaluation of Resistance to Damage by Flexing after 3-Year Accelerated Aging 10.
-
- Biocompatibility Testing
-
- Pyrogen Testing
- Bioburden Testing 13.
-
- 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.
- EtO Residual Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Special 510(K) Premarket Notification Approach Pro ST Wire Guide COOK INCORPORATED January 18, 2011
510(k) Summary
Submitted By:
Aaron Santner, PhD Regulatory Science Associate Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402
Device:
Trade Name: Proposed Classification: Approach Pro ST Wire Guide Wire, Guide, Catheter 21 CFR §870.1330
Indications for Use:
The Approach Pro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
Predicate Devices:
The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007.
Device Description:
The Approach Pro ST Wire Guide consists of a stainless steel core wire coated with polytetrafluoroethylene (PTFE). The outside diameter of the Approach Pro ST Wire Guide is 0.014 inches and the device will be available in 135 cm, 190 cm, and 300 cm lengths. It will be supplied sterile and intended for one-time use.
ર્ડ 4
FEB 2 5 2011
1
Substantial Equivalence:
The Approach Pro ST Wire Guide is similar to many devices in commercial distribution for facilitating delivery of percutaneous catheters into the peripheral vascular system. The Approach Pro ST Wire Guide is a modification of the Approach Pro LT Wire Guide, D.C. #K070410, which was cleared for commercial distribution on April 27, 2007. The Approach Pro LT and Approach Pro ST Wire guides share identical indications for use, principles of operation, technological characteristics, and similar materials of construction, supporting a determination of substantial equivalence.
Test Data:
The Approach Pro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests included:
- Three Point Bend Test 1.
-
- Corrosion Resistance Test
-
- Radiopacity Evaluation
-
- Evaluation of Torque Response and Torque Strength
-
- Tensile Evaluation of the Distal Tip
- Q. Characterization of Loads Required to Deflect the Distal Tip
-
- Evaluation of Resistance to Fracture
-
- Evaluation of Resistance to Fracture after 3-Year Accelerated Aging
- Evaluation of Resistance to Damage by Flexing 9.
- Evaluation of Resistance to Damage by Flexing after 3-Year Accelerated Aging 10.
-
- Biocompatibility Testing
-
- Pyrogen Testing
- Bioburden Testing 13.
-
- 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
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 stylized eagle with three bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Cook Incorporated c/o Aaron Santner, PhD Regulatory Science Associate 750 Daniels Way, PO Box 489 Bloomington, IN 47402
FEB 2 5 2011
Re: K110163
Trade/Device Name: Approach Pro ST Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 18, 2011 Received: January 27, 2011
Dear Dr. Santner:
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 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 - Aaron Santner, PhD
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
D. Zuckerman, M.D. Bra Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(K) Premarket Notification Approach Pro ST Wire Guide
COOK INCORPORATED January 18, 2011
..
510(k) Number (if known): D.C. #K110163
Device Name: Approach Pro ST Wire Guide
Prescription Use __ X
Indications for Use: For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.
1
(Per 21 CFR 801 Subpart D) (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) | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number: | K110 163 |
OR
Over–the-Counter Use
(21 CFR 807 Subpart C)