(30 days)
No
The document describes a standard angiographic catheter with marker bands for measurement. There is no mention of AI, ML, image processing, or any computational analysis of data. The performance studies focus on physical and material properties, not algorithmic performance.
No
This device is for "placement of vascular access sheaths, angiographic catheters and wire guides," meaning it facilitates procedures rather than directly treating a disease or condition.
No.
The device is intended for use in angiographic procedures for placement of vascular access sheaths, angiographic catheters, and wire guides, and for anatomical measurements with marker bands, which are functional and procedural uses, not diagnostic.
No
The device description clearly outlines physical components such as catheters, luer lock adapters, connecting caps, and a single lumen shaft, indicating it is a hardware device. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the catheters being used in vivo (within the body) for angiographic procedures, specifically for placement of vascular access sheaths, angiographic catheters, and wire guides, and for anatomical measurements. IVDs are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details physical catheters designed for insertion into the vascular system. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
The device is clearly intended for use within the body during medical procedures, which is the definition of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Beacon Tip Catheters are intended for use 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.
The Beacon Tip Sizing Catheters are intended for use 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. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.
Product codes
DOO
Device Description
The Beacon Tip Catheters and Beacon Tip Sizing Catheters subject of this submission are sterile, single use devices designed for use in vascular and non-vascular angiographic procedures. There are three related but unique subfamilies of Beacon Tip Catheters, including: Beacon® Tip Torcon NB® Advantage Catheter, Slip-Cath® Beacon® Tip Catheter, and Shuttle® Select Slip-Cath® Catheter. There are three related but unique subfamilies of Beacon Tip Sizing Catheters, including: Beacon® Tip Centimeter Sizing Catheter, Beacon® Tip Cava Vessel Sizing Catheter, Beacon® Tip White Vessel Sizing Catheter. The subject Beacon Tip Catheters are available in 5.0, 5.5, 6.0 or 6.5 French sizes and are manufactured in lengths of 40 to 125 centimeters. The subject Beacon Tip Sizing Catheters are available in a 5.0 French size and are manufactured in lengths of 70 to 100 centimeters. Each configuration of the subject devices includes a luer lock adapter, connecting cap, and a single lumen shaft. The subject Beacon Tip Sizing Catheters also come with gold marker bands placed at intervals along the distal end of the catheter shaft.
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
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
The following tests have been conducted to ensure reliable design and performance under the specified design requirements. These tests include:
- Acute Performance Testing verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- Biocompatibility testing cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time
- Catheter air and liquid leakage - Testing verified that under proper clinical use of the catheter, each test article shall not leak when tested in accordance with BS EN ISO 10555-1, Annex C and D. The predetermined acceptance criteria were met.
- Cyclic bend testing - Testing verified no material degradation after a predetermined set of flex cycles. The predetermined acceptance criteria were met.
- Dimensional verification testing Testing verified component compatibility and dimensional tolerances.
- Dynamic and static burst testing - Testing verified that under proper clinical use the device can withstand appropriate pressures without signs of failure. The predetermined acceptance criteria were met.
- Packaging performance testing - Testing verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- Radiopacity testing Testing verified that performance parameters were acceptance for clinical use. The predetermined acceptance criterion was met.
- Tensile testing - Testing verified that under proper clinical use of the catheter, the peak load values shall be in accordance with the applicable values of BS EN ISO 10555-1. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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November 15, 2017
Cook Incorporated David Chadwick Director of Regulatory Affairs Science 750 Daniels Way Bloomington, Indiana 47402
Re: K173289
Trade/Device Name: Beacon Tip Torcon NB Advantage Catheter (HNBR), Slip-Cath Beacon Tip Catheter (SCBR), Shuttle Select Slip-Cath Catheter (SCBR-/-SHTL), Beacon Tip Centimeter Sizing Catheter (CSC), Beacon Tip Cava Vessel Sizing Catheter (CAVA), Beacon Tip White Vessel Sizing Catheter (WSC) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: October 13, 2017 Received: October 16, 2017
Dear David Chadwick:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kenneth J. Cavanaugh -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)
K173289
Device Name
Beacon Tip Torcon NB Advantage Catheter (HNBR) Slip-Cath Beacon Tip Catheter (SCBR) Shuttle Select Slip-Cath Catheter (SCBR-/-SHTL)
Beacon Tip White Vessel Sizing Catheter (WSC) Beacon Tip Centimeter Sizing Catheter (CSC) Beacon Tip Cava Vessel Sizing Catheter (CAVA)
Indications for Use (Describe)
The Beacon Tip Catheters (HNBR, SCBR, SCBR-/-SHTL) are in angiographic procedures by physicians trained and experienced in angiographic techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
The Beacon Tip Sizing Catheters (WSC, CSC, CAVA) are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
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K173289 – 510(k) SUMMARY
| Submitted By: | David E. Chadwick, Ph.D., RAC, FRAPS |
|---|---|
| Cook Incorporated | |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone: (812) 335-3575 x102330 | |
| Fax: (812) 332-0281 | |
| Date Prepared: 13 October 2017 |
Device:
| Trade Name: | Beacon® Tip Torcon NB® Advantage Catheter (HNBR) |
|---|---|
| Slip-Cath® Beacon® Tip Catheter (SCBR) | |
| Shuttle® Select Slip-Cath® Catheter (SCBR-/-SHTL) | |
| Beacon® Tip Centimeter Sizing Catheter (CSC) | |
| Beacon® Tip Cava Vessel Sizing Catheter (CAVA) | |
| Beacon® Tip White Vessel Sizing Catheter (WSC) | |
| Common Name: | Beacon Tip Catheters and Beacon Tip Sizing Catheters |
| Classification Name: | Catheter, Intravascular, Diagnostic |
| DQO (21 CFR §870.1200) | |
| Class/Panel: | Class II, Cardiovascular |
Indications for Use:
The Beacon Tip Catheters are intended for use 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.
The Beacon Tip Sizing Catheters are intended for use 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. Beacon Tip Sizing Catheters have marker bands that can be used for anatomical measurements.
Predicate Devices:
The subject Beacon Tip Catheter family (Beacon® Tip Torcon NB® Advantage Catheter, Slip-Cath® Beacon® Tip Catheter, and Shuttle® Select Slip-Cath® Catheter) are substantially equivalent to the predicate device, the Slip-Cath® Beacon® Tip Catheter and
4
Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters, with a registered trademark symbol after it. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters. The background is a solid red color.
the Shuttle® Select Slip-Cath® Catheter cleared on 14 December 2012 under 510(k) Premarket Notification Number K122937.
The subject Beacon Tip Sizing Catheter family (Beacon® Tip Centimeter Sizing Catheter, Beacon® Tip Cava Vessel Sizing Catheter, and Beacon® Tip White Vessel Sizing Catheter) are substantially equivalent to the predicate devices, the White Sizing Catheter, the Aurous Centimeter Sizing Catheter, and the Cava Vessel Sizing Catheter cleared on 26 May 2017 under 510(k) Premarket Notification Number K162448.
Comparison to Predicate Device:
The subject Beacon Tip Catheters and Beacon Tip Sizing Catheters are identical to the predicates (K122937 and K162448, respectively), in that these devices are identical in terms of intended use, principle of operation, basic technological characteristics, and have similar materials of construction. The modifications, which are subject of this submission, include the bonded tip material and packaging.
Device Description:
The Beacon Tip Catheters and Beacon Tip Sizing Catheters subject of this submission are sterile, single use devices designed for use in vascular and non-vascular angiographic procedures. There are three related but unique subfamilies of Beacon Tip Catheters, including: Beacon® Tip Torcon NB® Advantage Catheter, Slip-Cath® Beacon® Tip Catheter, and Shuttle® Select Slip-Cath® Catheter. There are three related but unique subfamilies of Beacon Tip Sizing Catheters, including: Beacon® Tip Centimeter Sizing Catheter, Beacon® Tip Cava Vessel Sizing Catheter, Beacon® Tip White Vessel Sizing Catheter. The subject Beacon Tip Catheters are available in 5.0, 5.5, 6.0 or 6.5 French sizes and are manufactured in lengths of 40 to 125 centimeters. The subject Beacon Tip Sizing Catheters are available in a 5.0 French size and are manufactured in lengths of 70 to 100 centimeters. Each configuration of the subject devices includes a luer lock adapter, connecting cap, and a single lumen shaft. The subject Beacon Tip Sizing Catheters also come with gold marker bands placed at intervals along the distal end of the catheter shaft.
Test Data:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements. These tests include:
5
- Acute Performance Testing verified that performance parameters were . acceptable for clinical use. The predetermined acceptance criterion was met.
- Biocompatibility testing cytotoxicity, sensitization, intracutaneous reactivity, . systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time
- . Catheter air and liquid leakage - Testing verified that under proper clinical use of the catheter, each test article shall not leak when tested in accordance with BS EN ISO 10555-1, Annex C and D. The predetermined acceptance criteria were met.
- Cyclic bend testing - Testing verified no material degradation after a predetermined set of flex cycles. The predetermined acceptance criteria were met.
- Dimensional verification testing Testing verified component compatibility and . dimensional tolerances.
- . Dynamic and static burst testing - Testing verified that under proper clinical use the device can withstand appropriate pressures without signs of failure. The predetermined acceptance criteria were met.
- . Packaging performance testing - Testing verified that performance parameters were acceptable for clinical use. The predetermined acceptance criterion was met.
- Radiopacity testing Testing verified that performance parameters were . acceptance for clinical use. The predetermined acceptance criterion was met.
- . Tensile testing - Testing verified that under proper clinical use of the catheter, the peak load values shall be in accordance with the applicable values of BS EN ISO 10555-1. The predetermined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device