(81 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device description states it is a catheter intended for use in angiographic procedures, which are diagnostic procedures, not therapeutic ones.
Yes
Explanation: The device is used in "angiographic procedures," which are diagnostic procedures to visualize blood vessels. While catheters can also be used for interventional purposes, their primary mention here is within a diagnostic context.
No
The device description clearly details physical components such as a radiopaque tip, stainless steel braided catheter shaft, plastic winged hub, and translucent hub, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "angiographic procedures by physicians trained and experienced in angiographic techniques." Angiography is a medical imaging technique used to visualize the inside of blood vessels and organs of the body, particularly the arteries, veins, and the heart chambers. This is a procedure performed in vivo (within the living body).
- Device Description: The description details a physical catheter designed to be inserted into the body. It mentions features like a radiopaque tip, catheter shaft, hub, and different sizes and configurations. These are characteristics of a device used for direct intervention within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. The provided information does not mention any testing of biological samples or analysis of in vitro reactions.
In summary, the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are designed for use within the body during angiographic procedures, not for testing samples outside the body. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Product codes
DOO
Device Description
The Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are manufactured in lengths of 40. 60. 65. 75. 80. 90. 100. 125. 135 and 150 centimeters and have no distal sideports. Each catheter is manufactured with either a plastic winged hub. mounted on the proximal end of the catheter, indicating the catheter French size and relative endhole diameter, or a translucent hub with a strain relief. The catheters are manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.
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 were performed to demonstrate that the Slip-Cath® Beacon® Tip Catheters and Shuttle Select Slip-Cath® Catheters meet applicable design and performance requirements and support a determination of substantial equivalence. Additionally, appropriate engineering tests were performed on aged product to ensure that the Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters meet the performance reguirements throughout the duration of shelf life.
- . Tensile Strength - Testing shows the tensile strength during proper clinical use should not fracture or rupture the catheter. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Leakage Testing shows there would be no leakage from the catheter during . proper clinical use. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Biocompatibility Testing shows the device is biocompatible. In conformance . with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate and reference devices and supports a determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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K122937 - page 1 of 2
Special 510(k): Device Modification Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Cook Incorporated 21 September 2012
510(k) SUMMARY
Submitted By:
Amber Brown Cook Incorporated 750 Daniels Way Bloomington, IN 47404
Device:
Trade Name:
Proposed Classification:
Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Catheter, Diagnostic Intravascular DOO (21 CFR $870.1200)
Indications for Use:
The Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Predicate and Reference Devices:
Cook Incorporated's Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are similar in terms of intended use and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate and reference devices. The devices, subject of this submission, are substantially equivalent to the Slip-Coat™ Catheters manufactured by Cook Incorporated, which are cleared under. 510(k) number K882796 and the reference device. Cantata Microcatheter, which is cleared under 510(k) number K101450.
Comparison to Predicate and Reference Devices:
It has been demonstrated that the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cathe Catheter are comparable to the predicate and reference devices in terms of design, intended use, materials, fundamental technology, and principles of operation.
Device Description:
The Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are manufactured in lengths of 40. 60. 65. 75. 80. 90. 100. 125. 135 and 150 centimeters and have no distal sideports. Each catheter is manufactured with either a plastic winged hub. mounted on the proximal end of the catheter, indicating the catheter French size and relative endhole diameter, or a translucent hub with a strain relief. The catheters are
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DEC 1 4 2012
1
Special 510(k): Device Modification Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Cook Incorporated 21 September 2012
manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.
Test Data:
The following tests were performed to demonstrate that the Slip-Cath® Beacon® Tip Catheters and Shuttle Select Slip-Cath® Catheters meet applicable design and performance requirements and support a determination of substantial equivalence. Additionally, appropriate engineering tests were performed on aged product to ensure that the Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters meet the performance reguirements throughout the duration of shelf life.
- . Tensile Strength - Testing shows the tensile strength during proper clinical use should not fracture or rupture the catheter. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Leakage Testing shows there would be no leakage from the catheter during . proper clinical use. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Biocompatibility Testing shows the device is biocompatible. In conformance . with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate and reference devices and supports a determination of substantial equivalence.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Cook, Inc. Ms. Amber Brown Regulatory Affairs Specialist 750 Daniels Way Bloomington. IN 47404
DEC 1 4 2012
Re: K122937
Trade Name: Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: November 14, 2012 Received: November 15, 2012
Dear Ms. Brown:
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 – Ms. Amber Brown
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
L
Bram D. Zickerman, M.D. Director / Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ial 510(k): Device Modification athe Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter k Incorporated
21 September 2012
Indications for Use
122937 510(k) Number (if known):
Device Name:
Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter
4
Indications for Use for the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-. Cath® Catheter:
The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Prescription Use XX (Part 21 CFR 801 Subpart D) OR Over-the-Counter Use (21 CFR 801 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-On) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K122937 |