(466 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of the catheters, with no mention of AI or ML capabilities.
No
Explanation: The device is described as an angiographic catheter used for diagnostic purposes by delivering contrast media to help physicians diagnose occlusion or stenosis. It is not intended for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" states that the catheters are used in "angiographic procedures" and the "Device Description" section states they "can help physicians diagnose occlusion or stenosis," which are diagnostic purposes. Angiography itself is a diagnostic imaging technique.
No
The device description clearly details physical components such as a nylon catheter shaft, braided stainless steel, and a radiopaque tip, indicating it is a hardware device. The performance studies also focus on physical properties like burst pressure, tensile strength, and leakage.
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 catheters are for use in the peripheral and coronary vascular system for angiographic procedures. This involves direct interaction with the patient's body.
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body). IVDs are typically used for diagnostic testing on these types of samples.
The device described is a medical device used in vivo (within the body) for diagnostic imaging procedures (angiography) by delivering contrast media. This falls under the category of interventional or diagnostic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Product codes (comma separated list FDA assigned to the subject device)
DOO
Device Description
The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations.
The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations.
Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vascular system including the carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians trained and experienced in angiographic techniques.
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)
- Dynamic Flow Rate and Burst Pressure Evaluation - This study is for characterization purposes; therefore no acceptance criteria apply.
- Static Burst Pressure Testing - Testing verified that, in accordance with ISO 10555-2:1996(E), the test articles withstood a minimum of 1200 psig static pressure for at least 2 seconds without failure. The predetermined acceptance criterion was met.
- Evaluation of Dynamic Pressure During Injection after Three Years Accelerated Aging – Testing verified that the test articles achieved a flow rate of at least 12 mL/sec when pressurized to 1215 psig ± 15 psig without failure. The predetermined acceptance criterion was met.
- Biocompatibility Testing Per ISO 10993-1:2009, the proposed devices were classified as external communicating devices in contact with circulating blood for a limited (≤ 24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Implantation, Partial Thromboplastin Time, C3a Completement Activation, SC5b-9 Complement Activation, Mutagenicity, Pyrogenicity.
- Tensile testing - Testing verified that, under proper clinical use, the peak load values would be greater than 10N, in accordance with ISO 10555-1:2009. The predetermined acceptance criterion was met.
- Liquid Leakage Testing Testing verified that, in accordance with ISO 10555-1:2013, the catheter maintained a pressure of 300 kPa for 30 seconds without leaking between the catheter shaft and hub. The predetermined acceptance criterion was met.
- Air Leakage Testing Testing verified that, in accordance with ISO 10555-1:2013, there was no leakage of air between the catheter shaft and hub when subjected to a negative pressure for 15 seconds. The predetermined acceptance criterion was met.
- Particulate Testing This study is for characterization purposes; therefore no acceptance criteria apply.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9, 2015
Cook, Inc. David Chadwick, PhD, RAC Director, Regulatory Affairs/Regulatory Science 750 Daniels Way Bloomington, Indiana 47404
Re: K133130
Trade/Device Name: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: December 8, 2014 Received: December 9, 2014
Dear David Chadwick, Phd., Rac,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K133130
Device Name
Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter
Indications for Use (Describe)
The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, block letters at the top, and the word "MEDICAL" is written in white, block letters at the bottom.
COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
510(k) SUMMARY
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | David E. Chadwick, Ph.D., RAC, FRAPS |
| Email: | david.chadwick@cookmedical.com |
| Contact Phone Number: | (812) 335-3575 x102330 |
| Contact Fax Number: | (812) 332-0281 |
| Device Information: |
Trade Name:
Common Name: Classification Name:
Class: Device Panel: Date Prepared:
Indications for Use:
Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter Diagnostic Intravascular Catheter Catheter, Diagnostic Intravascular DQO (21 CFR §870.1200) Class II Cardiovascular January 5. 2015
The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Predicate Devices:
Cook Incorporated's Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters have an identical intended use and are similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate devices. The devices, subject of this submission, are substantially equivalent to the Slip-Cath® Beacon Tip Catheters and the Shuttle® Select Slip-Cath® Catheters, and the Slip-Coat™ Catheters manufactured by Cook Incorporated, which are cleared under 510(k) numbers K122937 and K882796. respectively. They are also substantially equivalent to the Imager II 5F Selective Angiography Catheter manufactured by Boston Scientific Corporation, which is cleared under 510(k) number K121694.
4
Comparison to Predicate Devices:
It has been demonstrated that the Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are comparable to the predicate devices in terms of design, intended use, materials, fundamental technology, and principles of operation.
Device Description:
The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations.
The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations.
Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
Test Data:
The following tests were performed to demonstrate that the Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- Dynamic Flow Rate and Burst Pressure Evaluation - This study is for characterization purposes; therefore no acceptance criteria apply.
- Static Burst Pressure Testing - Testing verified that, in accordance with ISO 10555-2:1996(E), the test articles withstood a minimum of 1200 psig static pressure for at least 2 seconds without failure. The predetermined acceptance criterion was met.
- Evaluation of Dynamic Pressure During Injection after Three Years Accelerated . Aging – Testing verified that the test articles achieved a flow rate of at least
5
Image /page/5/Picture/0 description: The image is a logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half of the rectangle. There is a registered trademark symbol after the word "COOK". The bottom half of the rectangle has a smaller red rectangle that is angled to the left. The word "MEDICAL" is in white, sans-serif font on the smaller rectangle.
12 mL/sec when pressurized to 1215 psig ± 15 psig without failure. The predetermined acceptance criterion was met.
- Biocompatibility Testing Per ISO 10993-1:2009, the proposed devices were ● classified as external communicating devices in contact with circulating blood for a limited (≤ 24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Implantation, Partial Thromboplastin Time, C3a Completement Activation, SC5b-9 Complement Activation, Mutagenicity, Pyrogenicity.
- . Tensile testing - Testing verified that, under proper clinical use, the peak load values would be greater than 10N, in accordance with ISO 10555-1:2009. The predetermined acceptance criterion was met.
- Liquid Leakage Testing Testing verified that, in accordance with ISO 10555-● 1:2013, the catheter maintained a pressure of 300 kPa for 30 seconds without leaking between the catheter shaft and hub. The predetermined acceptance criterion was met.
- Air Leakage Testing Testing verified that, in accordance with ISO 10555-● 1:2013, there was no leakage of air between the catheter shaft and hub when subjected to a negative pressure for 15 seconds. The predetermined acceptance criterion was met.
- Particulate Testing This study is for characterization purposes; therefore no ● acceptance criteria apply.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.