(107 days)
Not Found
No
The device description and intended use are for physical medical devices (guide wire, catheter, sheath) used for access during procedures, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is intended for directing catheters and introducing diagnostic/interventional devices, and delivering radiopaque media. While it can deliver "therapeutic agents," its primary function is access and guidance in diagnostic or interventional procedures, not directly providing therapy itself.
No
Explanation: The "Intended Use / Indications for Use" section states that the devices are designed to "direct a catheter to the desired anatomical location" for diagnostic or interventional procedures, used in "angiographic procedures" and to "deliver radiopaque media and therapeutic agents", and for "introduction of interventional and diagnostic devices". While some components may be used with diagnostic devices or during diagnostic procedures, none of the descriptions indicate that these devices themselves perform a diagnostic function (e.g., imaging, measuring, analyzing to determine a medical condition). They primarily facilitate access and delivery.
No
The device description clearly lists multiple physical components (guide wire, catheter, valve, sheath) and mentions sterilization, indicating it is a hardware-based medical device kit.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as guiding catheters, delivering substances, and introducing devices within the human vascular system. This is an in vivo application, meaning it's used directly on or inside a living organism.
- Device Description: The description details components used for accessing and navigating the vascular system. There is no mention of analyzing samples taken from the body (like blood, urine, or tissue) outside of the body.
- Lack of IVD Indicators: There are no mentions of analyzing biological samples, performing tests on samples, or providing diagnostic information based on the analysis of samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is procedural and interventional, not diagnostic in the IVD sense.
N/A
Intended Use / Indications for Use
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.
The GlideCath® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Carotid Access Kit is designed to be used for the introduction of devices during carotid intravascular procedures. The kit consists of a Glidewire® guide wire, GlideCath® XP catheter, Tuohy-Borst Valve (TBV), Destination® Carotid Guiding Sheath and inner sheath. The inner sheath is composed of PTFE and the distal end is tapered to provide a smooth transition from the GlideCath XP to the Destination Carotid Guiding Sheath. All components are STERILE. They are sterilized using Ethylene Oxide (EtO) gas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries, vascular 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 performance of the Carotid Access Kit is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
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JUN 2 9 2006
SECTION V. 510(k) SUMMARY
DEVICE NAME A.
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Proprietary Name: Carotid Access Kit Classification Name: Percutaneous Catheter Common Name: Guide Wire, Catheter, and Introducer
B. PREDICATE DEVICE
The predicate device are:
Product Name: Terumo Radifocus® Guide Wire 510k #: K863138 Manufacaturer: Terumo Corporation
Product Name: Terumo Angiographic Catheter 510k #: K915414 Manufacaturer: Terumo Corporation
Product Name: Pinnacle Destination Carotid Guiding Sheath 510k #: K012812 Manufacaturer: Terumo Medical Corporation
C. INDICATIONS FOR USE
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.
1
The GlideCath® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
D. DESCRIPTION
and the control of the contraction of the control of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of t
The Carotid Access Kit is designed to be used for the introduction of devices during carotid intravascular procedures. The kit consists of a Glidewire® guide wire, GlideCath® XP catheter, Tuohy-Borst Valve (TBV), Destination® Carotid Guiding Sheath and inner sheath. The inner sheath is composed of PTFE and the distal end is tapered to provide a smooth transition from the GlideCath XP to the Destination Carotid Guiding Sheath. All components are STERILE. They are sterilized using Ethylene Oxide (EtO) gas.
E. PRINCIPLE OF OPERATION / TECHNOLOGY
The devices in the Carotid Access Kit are operated manually or by a manual process.
F. DESIGN / MATERIALS
The Carotid Access Kit uses similar materials as the predicate device. Differences in materials between the devices do not raise any new issues of safety and effectiveness.
். SPECIFICATIONS
Glidewire Specifications: 180 to 300 cm length GlideCath XP Specifications: 180 to 300 cm length with H1 and Vitek shaped distal end Destination Carotid Guiding Sheath Specifications: 6 & 7Fr, 90 cm length, Straight and Multipurpose shaped distal end, with Tuohy-Borst Valve and Inner sheath
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PERFORMANCE H.
The performance of the Carotid Access Kit is substantially equivalent to the performance of the predicate devices. The equivalence was shown through bench testing.
Additional Safety Information I.
Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6.
Blood contacting materials were tested in accordance with the test recommendations in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing." The Carotid Access Kit is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.
Expiration dating for the Carotid Access Kit will be dependent on the selflife remaining on the kit components. The maximum shelflife for the kit is 24 months.
SUBSTANTIAL EQUIVALENCE J.
The Carotid Access kit submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the predicate devices, which are manufactured by Terumo Medical Corporation and Terumo Corporation. Differences between the devices do not raise any issues of safety or effectiveness.
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K. SUBMITTER INFORMATION
Name and Address
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921
Contact Person
Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared
March 13, 2006
4
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2006
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Rc: K060666 Carotid Access Kit Regulation Number: 21 CFR 870.1250 Regulation Name: Perculaneous Catheter Regulatory Class: Class II (Two) Product Code: DYB Dated: May 31. 2006 Received: June 1, 2006
Dear Mr. Unterreiner:
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. 1)rug. 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. Iisting 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.
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Page 2 - Mr. Mark Unterreiner
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/cdrl.industry/support/index.html.
Sincerely yours.
Dma R. Valmer
Image /page/5/Picture/5 description: The image contains a handwritten symbol or character that appears to be a combination of a cursive letter and a simple line drawing. The symbol has a loop at the top, a downward stroke, and a curved line at the bottom. To the right of the symbol are the letters 'E' and 'R', which are likely part of a word or abbreviation.
CA Bram D. Zuckerman. M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060666
Device Name: Carotid Access Kit
Indications For Use:
The Glidewire® guide wire is designed to direct a catheter to the desired anatomical location, including but not limited to the carotid arteries, during diagnostic or interventional procedures.
The GlideCath® XP catheter is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the vascular system, including but not limited to the carotid arteries.
The Destination® Carotid Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the carotid arteries.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
R. V. Jones
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0666666
00011