(26 days)
Not Found
No
The summary describes a physical medical device (a guiding sheath) and its intended use and components. There is no mention of software, algorithms, image processing, AI, or ML.
No
The device is described as a guiding sheath and introducer sheath for interventional and diagnostic devices, which suggests it is an accessory device used during procedures, rather than a device that directly provides therapy itself.
No
Explanation: The device is described as a "guiding sheath" and "guiding catheter" used for introducing other interventional and diagnostic devices, implying it is not performing a diagnostic function itself but rather facilitating the use of other devices that may be diagnostic.
No
The device description explicitly lists physical components (Sheath, Dilator, Hemostatic Valve, Dilator Retaining Clip) and describes bench and cadaver testing, 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 the introduction of interventional and diagnostic devices into the human vasculature. This describes a device used in vivo (within the body) for accessing and delivering other devices.
- Device Description: The description details a physical sheath, dilator, and valve, which are components of a device used for accessing 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.) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve analyzing biological samples in vitro (outside the body).
Therefore, the Destination Carotid Guiding Sheath is a medical device used for vascular access and delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Destination® Carotid Guiding Sheath is designed to be used 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 Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries
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 Destination® Carotid Guiding Sheath is substantially equivalent to the performance of the predicate device K012812. The equivalence was shown through bench and cadaver 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).
0
Image /page/0/Picture/1 description: The image shows handwritten text. The first line reads "K052185". The second line reads "p. 1 of 24". The text is written in black ink on a white background and appears to be part of a document or label.
Terumo Medical Corporation Special 510(k) Premarket Notification - Destination® Carotid Guiding Sheath Section II: 510(k) Summary
SECTION II. 510(k) SUMMARY
A. DEVICE NAME
2017年07月17日 10:00 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Destination® Carotid Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath
B. PREDICATE DEVICE
The predicate device is the Carotid Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Carotid Guiding Sheath is cleared through the premarket notification process (K012812).
C. INTENDED USE
The Destination® Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.
Note: This is the same intended use as the Carotid Guiding Sheath, K012812.
D. DESCRIPTION
The Destination® Carotid Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Carotid Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (dilator retaining clip is only available with codes containing the touhy-borst valve).
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Principle of Operation / Technology E.
The Destination® Carotid Guiding Sheath is operated manually or by a manual process.
F. Design / Materials
The Destination® Carotid Guiding Sheath uses similar materials as the predicate device. Differences in materials between the two devices do not raise any new issues of safety and effectiveness.
G. SPECIFICATIONS
| Sheath Size: | 6-7Fr. |
|---|---|
| Nominal ID / OD: | 6Fr.: 0.087" / 0.112" |
| 7Fr.: 0.100" / 0.122" | |
| Sheath Length: | 80-110 cm |
| Hydrophilic Coating: | Distal 15 cm |
| Distal Shape Configurations: | Straight, Angled |
H. PERFORMANCE
The performance of the Destination® Carotid Guiding Sheath.is substantially equivalent to the performance of the predicate device K012812. The equivalence was shown through bench and cadaver testing.
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I. ADDITIONAL SAFETY INFORMATION
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 Destination® Carotid Guiding Sheath is categorized as "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)". The blood contacting materials were found to be biocompatible.
Expiration dating for the Destination® Carotid Guiding Sheath will be 30 months.
J. SUBSTANTIAL EQUIVALENCE
The Destination® Carotid Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Carotid Guiding Sheath (K012812), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.
Terumo's statement of substantial equivalence is done solely to comply with the requirements of the Federal Food, Drug and Cosmetic Act and is not intended whatsoever to be the basis for a patent infringement action.
Kosz185
p. 3cty
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K052185
p. 4 of 4
K. SUBMITTER INFORMATION
Name and Address
Terumo Medical Corporation 950 Elkton Blvd. Elkton, MD 21921
Contact Person
Mr. Mark Unterreiner Regulatory Affairs Specialist Ph: 410-392-7213 Fax: 410-398-6079 Email: mark.unterreiner@terumomedical.com
Date Prepared
August 10, 2005
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
SEP - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Terumo Medical Corporation c/o Mr. Mark Unterreiner Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921
Re: K052185
Destination® Carotid Guiding Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DYB Dated: August 10, 2005 Received: August 11, 2005
Dear Mr. Unterreiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 910(x) presidentially equivalent (for the indications for relerenced above and nave decemined and seed predicate devices marketed in interstate commerce use stated in the encrosure/ to regary interest date of the Medical Device Amendments, or to devices that proof to May 26, 1770, the onecthers and the provisions of the Federal Food, Drug, and Cosmetic have occh recuired in asserval of a premarket approval application (PMA). You may, Act (Act) that do not require apprect to the general controls provisions of the Act. The general therefore, mailier the defree, backed we annual registration, listing of devices, good Controls provisions or allabeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may be subject to sam adon 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Durna R. Valumer
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Destination Carotid Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the carotid arteries.
Prescription Use × (Part 21 CFR 801 Subpart D)
:
ﺎ
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)
P. vochner
vision Sign-Off) ivision of Cardiovascular Devices
10(k) Number K052185
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