(55 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a guiding sheath, with no mention of AI or ML capabilities.
No.
The device is described as a guiding sheath used for the introduction of interventional and diagnostic devices, not for directly treating a condition or disease.
No
The device is a guiding sheath designed to introduce other devices (both interventional and diagnostic) into the vasculature. Its function is to facilitate the placement of these devices, not to perform a diagnosis itself.
No
The device description clearly outlines physical components like tubing, coil reinforcement, valves, and coatings, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "introduction of interventional and diagnostic devices into the human vasculature." This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a physical sheath with components like a valve, marker, and coating, designed for insertion into blood vessels. This aligns with an invasive medical device, not an IVD.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to facilitate the use of other devices within the body.
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.
The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The Destination® Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Destination® Guiding Sheath is a 3-layer tubing with a Stainless-Steel coil reinforcement sandwiched between layers of PTFE Teflon and Nylon Pebax, a hemostatic valve at the proximal end, a radiopaque marker near the distal end, and a hydrophilic coating on the distal portion of the tubing of varying lengths based on the product code. The sheath is available in multiple French sizes, useable lengths and distal shape configurations. The Destination® Guiding Sheaths are packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (only available with codes that contain the Tuohy-borst valve).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human vasculature, carotid arteries, lower extremity, renal 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)
Performance testing was conducted to ensure that the Destination® Guiding Sheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
The following table provides a list of the performance tests that were performed on the proposed Destination® Guiding Sheath.
Test Item: Lubricity and Durability/Adhesion; Reference: In-house standard; Component: Sheath
Test Item: Simulated Use and Particulate; Reference: FDA Guidance Doc 1608; Component: Sheath, Dilator, CCV
Test Item: Simulated Use Coating Integrity Evaluation; Reference: FDA Guidance Doc 1608; Component: Sheath
The Destination® Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed Destination® Guiding Sheath is substantially equivalent for its intended use.
The Destination Guiding Sheaths were evaluated for biological safety based on its body contact and duration per FDA Guidance on Use of International Standard ISO 10993-1 and EN ISO 10993-1.
The Destination Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (24 hours).
Results of the testing demonstrate biocompatibility of the finished Destination® Guiding Sheath.
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
Destination® Guiding Sheath is a limited exposure device. After 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
November 21, 2017
Terumo Medical Corporation Mr. Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd Elkton, Maryland 21921
Re: K172995
Trade/Device Name: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 19, 2017
Received: September 27, 2017
Dear Mr. Lu:
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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 mediation-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)
K172995
Device Name Destination® Carotid Guiding Sheath Destination® Peripheral Guiding Sheath Destination® Renal Guiding Sheath
Indications for Use (Describe)
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.
The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
A. SUBMITTER INFORMATION (807.92(a)(1))
Prepared by:
Liang Lu Senior Regulatory Affairs Specialist Terumo Medical Corporation Tel. (410) 392-7321 Fax (410) 398-6079
Prepared for: Owner/Operator Terumo Medical Corporation 2101 Cottontail Lane Somerset, NJ 08873, USA Registration Number: 2243441
Manufacturer (510(k) Applicant)
Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Registration Number: 1118880
Sterilization Facility
Steris Isomedix Services Inc. 3459 South Clinton Ave South Plainfield, NJ 07080 Registration Number: 2246552
Contact Person: Liang Lu
Senior Regulatory Affairs Specialist Terumo Medical Corporation 950 Elkton Boulevard, Elkton, MD 21921 Tel. (410) 392-7321 Fax (410) 398-6079 E-mail: liang.lu@terumomedical.com
Date prepared: July 20, 2017
4
B. DEVICE NAME (807.92(a)(2))
| Proprietary Name: | Destination® Carotid Guiding Sheath |
|---|---|
| Destination® Peripheral Guiding Sheath | |
| Destination® Renal Guiding Sheath | |
| Common Name: | Guiding Sheath |
| Classification Name: | Catheter Introducer |
| Classification Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Classification: | Class II |
C. PREDICATE DEVICE (807.92(a)(3))
The legally marketed device(s) to which substantial equivalence is claimed are:
- Predicate Device: K052185 Destination® Carotid Guiding Sheath, ● manufactured by Terumo Medical Corporation
- . Predicate Device: K091329 - Destination® Peripheral Guiding Sheath, manufactured by Terumo Medical Corporation
- . Predicate Device: K081045 - Destination® Renal Guiding Sheath, manufactured by Terumo Medical Corporation
The primary predicate device is K052185.
D. REASON FOR 510(k) SUBMISSION
This premarket notification (510(k)) is being submitted for the Destination® Guiding Sheath, manufactured by Terumo Medical Corporation, for the purposes of establishing substantial equivalence to a legally marketed predicate device.
E. DEVICE DESCRIPTION (807.92(a)(4))
The Destination® Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Destination® Guiding Sheath is a 3-layer tubing with a Stainless-Steel coil reinforcement sandwiched between layers of PTFE Teflon and Nylon Pebax, a hemostatic valve at the proximal end, a radiopaque marker near the distal end, and a hydrophilic coating on the distal portion of the tubing of varying lengths based on the product code. The sheath is available in multiple French sizes, useable lengths and distal shape configurations. The Destination® Guiding Sheaths are packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip (only available with codes that contain the Tuohy-borst valve).
5
F. INDICATIONS FOR USE (807.92(a)(5))
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.
The Destination® Peripheral Guiding Sheath is designed to be used for the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to lower extremity access via a contralateral approach.
The Destination® Renal Guiding Sheath is intended for the introduction of interventional and diagnostic devices into the human vasculature including but not limited to the renal arteries.
G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))
The Destination® Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device. manufactured by Terumo Medical Corporation.
A comparison of the technological characteristics is summarized on the table below.
Table 5.1: Summary of Substantial Equivalence
6
| Device
Characteristic | New Device:
Destination® Guiding
Sheath (Carotid,
Peripheral and Renal) | Primary Predicate:
Destination® Carotid
Guiding Sheath | Predicate:
Destination® Peripheral
Guiding Sheath | Predicate:
Destination® Renal
Guiding Sheath |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | None | K052185 | K091329 | K081045 |
| Manufacturer | Terumo Medical
Corporation | Same | Same | Same |
| Intended Use /
Indications for
Use | Carotid: Same
Peripheral: Same
Renal: Same | 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. | The Destination®
Peripheral Guiding Sheath
is designed to be used for
the introduction of
interventional and
diagnostic devices into the
human vasculature,
including but not limited
to lower extremity access
via a contralateral
approach. | The Destination® Renal
Guiding Sheath is
intended for the
introduction of
interventional and
diagnostic devices into
the human vasculature
including but not limited
to the renal arteries. |
| Operation
Principle | Operated manually or by
a manual
process; | Same | Same | Same |
| Design /
Construction | Sheath, Dilator,
Hemostatic Valve with
side tube and three-way
stopcock, and Dilator
Retaining Clip | Same | Same | Same |
| Device
Characteristic | New Device:
Destination® Guiding
Sheath (Carotid,
Peripheral and Renal) | Primary Predicate:
Destination® Carotid
Guiding Sheath | Predicate:
Destination® Peripheral
Guiding Sheath | Predicate:
Destination® Renal
Guiding Sheath |
| Materials | Sheath Assembly
Same except for the
materials grade changes | Sheath Assembly
Tubing: PTFE – SSL coil –
Nylon
Tip: Nylon
Hydrophilic Coating:
Polyvinylpyrrolidone-based
coating
Hub: Nylon
Radiopaque Band:Gold | Sheath Assembly
Same | Sheath Assembly
Same |
| | Dilator Assembly
Same | Dilator Assembly
Tubing: Polypropylene/
Thermoplastic Elastomer Blend
Hub: Polypropylene
Coating:
Reactive Silicone
Caulking Pin:
Stainless steel | Dilator Assembly
Same | Dilator Assembly
Same |
| | Tuopy-Borst Valve
(TBV):
Same | Tuopy-Borst Valve
(TBV):
Y-Connector Assembly:
Polycarbonate,
Silicone
Side Tube/3-Way Stopcock
Assembly:
Polybutadiene,
Polycarbonate,
High Density Polyethylene
Base Resin and HDPE
colorants,
Polypropylene | Tuopy-Borst Valve
(TBV):
Same | Tuopy-Borst Valve
(TBV):
Same |
| | | | | |
| Device | New Device: | Primary Predicate: | Predicate: | Predicate: |
| Characteristic | Destination® Guiding | Destination® Carotid | Destination® Peripheral | Destination® Renal |
| | Sheath (Carotid, | Guiding Sheath | Guiding Sheath | Guiding Sheath |
| | Peripheral and Renal) | | | |
| | Cross Cut Valve | Cross Cut Valve (CCV): | Cross Cut Valve (CCV): | Cross Cut Valve |
| | (CCV): | Valve Assembly: | Same | (CCV): |
| | Same | Polypropylene, | | Same |
| | | Polycarbonate, | | |
| | | Silicone Rubber | | |
| | | Elastomer, | | |
| | | Non-reactive silicone oil | | |
| | | 1000cst | | |
| | | Side Tube/3-Way Stopcock | | |
| | | Assembly: | | |
| | | Same as TBV | | |
| | Dilator Retaining Clip | Dilator Retaining Clip | Dilator Retaining Clip | Dilator Retaining Clip |
| | Same | LDPE | Same | Same |
| Package | Unit Pouch | Same | Same | Same |
| | Shelf Box | | | |
| | Shipping Carton | | | |
| Device
Characteristic | New Device:
Destination® Guiding
Sheath (Carotid,
Peripheral and Renal) | Primary Predicate:
Destination® Carotid
Guiding Sheath | Predicate:
Destination® Peripheral
Guiding Sheath | Predicate:
Destination® Renal
Guiding Sheath |
| Specifications | Carotid: Same
Peripheral: Same
Renal: Same | Sheath Size: 6-7Fr.
Nominal ID/OD:
6Fr.: 0.087"/0.111" 7Fr.:
0.101"/0.122"
Sheath Length:
80-110 cm
Hydrophilic Coating:
Distal 15 cm
Distal Shapes: ST, MP
Dilator ID/OD (nominal):
6Fr.: 0.045"/0.084" 7Fr.:
0.045"/0.097"
Dilator Extended Length:
5cm | Sheath Size: 5-8 Fr.
Nominal ID/OD:
5Fr.: 0.076"/0.098"
6Fr.: (45cm):
0.087"/0.109"
6Fr.: (65cm, 90cm):
0.087"/0.111"
7Fr.: 0.101"/0.122"
8Fr.: 0.115"/0.136"
Sheath Length:
45-110 cm
Hydrophilic Coating:
Distal 15-60 cm
Distal Shapes: ST
Dilator ID/OD (nominal):
5Fr.: 0.045"/0.072"
6Fr.: 0.045"/0.084"
7Fr.: 0.045”/0.097"
8Fr.: 0.045"/0.111"
Dilator Extended Length:
2.5 cm for sheaths lengths
up to 75cm,
5 cm for sheaths longer
than 75cm | Sheath Size: 5-7 Fr.
Nominal ID/OD:
5Fr.: 0.076"/0.098"
6Fr.: 0.087"/0.109"
7Fr.: 0.101" /0.122"
Sheath Length:
45-55 cm
Hydrophilic Coating:
Distal 5 cm
Distal Shapes: ST, HS,
MP, RDC, LIMA
Dilator ID/OD (nominal):
5Fr.: 0.045”/0.072"
6Fr.: 0.045"/0.084"
7Fr.: 0.045”/0.097"
Dilator Extended Length:
2 cm |
| Device
Characteristic | New Device:
Destination® Guiding
Sheath (Carotid,
Peripheral and Renal) | Primary Predicate:
Destination® Carotid
Guiding Sheath | Predicate:
Destination® Peripheral
Guiding Sheath | Predicate:
Destination® Renal
Guiding Sheath |
| Sterilization | Ethylene Oxide
(validated in accordance
with ANSI / AAMI / ISO
11135-1 to achieve SAL
10-6) | Same | Same | Same |
| Shelf life | 6 months | 30 months | 30 months | 30 months |
| Disposable
Single Use | Yes | Same | Same | Same |
7
8
9
10
11
H. NON-CLINICAL TESTS (807.92(b)(1)) Performance
Performance testing was conducted to ensure that the Destination® Guiding Sheath met the applicable design and performance requirements throughout the shelf life, verify conformity to the applicable external and internal standards, and demonstrate substantial equivalence to the predicate device.
The following table provides a list of the performance tests that were performed on the proposed Destination® Guiding Sheath.
| Test Item | Reference | Component |
|---|---|---|
| Lubricity and | ||
| Durability/Adhesion | In-house standard | Sheath |
| Simulated Use and | ||
| Particulate | FDA Guidance Doc 1608 | Sheath, |
| Dilator, | ||
| CCV | ||
| Simulated Use Coating | ||
| Integrity Evaluation | FDA Guidance Doc 1608 | Sheath |
Table 5.2: Summary of Performance Testing
The Destination® Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence. Based on the results of the performance testing, the proposed Destination® Guiding Sheath is substantially equivalent for its intended use.
Biocompatibility
The Destination Guiding Sheaths were evaluated for biological safety based on its body contact and duration per FDA Guidance on Use of International Standard ISO 10993-1 and EN ISO 10993-1.
The Destination Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (24 hours).
Results of the testing demonstrate biocompatibility of the finished Destination® Guiding Sheath.
Sterilization
The sterility of the device is assured using a sterilization method validated in accordance with ISO 11135:2014. Sterilization of health-care products - Ethvlene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
The sterilization process was validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.
Destination® Guiding Sheath is a limited exposure device. After 24 hours of heated aeration, the level of residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) do not exceed an average daily dose of 4 mg and 9 mg respectively per EN ISO 10993-7:2008.
I. CLINICAL TESTS (807.92(b)(2))
This 510(k) does not include data from clinical tests.
J. CONCLUSION (807.92(b)(3))
In summary, the Destination® Guiding Sheath, subject of this 510(k), is substantially equivalent in its intended use, technology/principal of operation, materials, and performance to the predicate device(s):
- . Predicate Device: K052185 - Destination® Carotid Guiding Sheath, manufactured by Terumo Medical Corporation
- Predicate Device: K091329 Destination® Peripheral Guiding Sheath, ● manufactured by Terumo Medical Corporation
- . Predicate Device: K081045 - Destination® Renal Guiding Sheath, manufactured by Terumo Medical Corporation