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.

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).

AI/ML Overview

This is not an AI review. The document is for a medical device called "Destination Guiding Sheath" and pertains to its 510(k) premarket notification to the FDA. The submission seeks to establish substantial equivalence to previously marketed predicate devices, not an AI or algorithm. Therefore, the questions related to AI acceptance criteria, training sets, test sets, and expert adjudication are not applicable to this document.

However, I can provide the available information regarding the device's performance criteria and testing based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "The Destination® Guiding Sheath tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." Specific numerical acceptance criteria are not detailed in the summary, but the types of tests performed and the general outcome are provided.

Test Item	Acceptance Criteria (General)	Reported Device Performance (General)
Lubricity and Durability/Adhesion	Met in-house standard	Met the predetermined acceptance criteria and results support a determination of substantial equivalence.
Simulated Use and Particulate	Met FDA Guidance Doc 1608	Met the predetermined acceptance criteria and results support a determination of substantial equivalence.
Simulated Use Coating Integrity Evaluation	Met FDA Guidance Doc 1608	Met the predetermined acceptance criteria and results support a determination of substantial equivalence.
Biocompatibility	Conforms to FDA Guidance / EN ISO 10993-1	Tested and results demonstrate biocompatibility of the finished device.
Sterilization	Achieves SAL 10-6 (ISO 11135:2014)	Sterilization process validated, achieved SAL 10-6.
Residual EO/ECH	Do not exceed 4 mg (EO) and 9 mg (ECH) daily	Level of residual EO and ECH do not exceed an average daily dose of 4 mg and 9 mg respectively.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the provided text for non-clinical performance tests.
Data Provenance: The tests were conducted internally ("In-house standard") or against FDA guidance documents. The document doesn't specify country of origin for the test data, but the manufacturer is Terumo Medical Corporation with locations in Somerset, NJ and Elkton, MD, suggesting U.S.-based testing or oversight. The studies were non-clinical (laboratory/bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the document describes a traditional medical device (catheter introducer), not an AI/ML device that requires expert ground truth for image or data interpretation. Performance was evaluated against engineering standards and regulatory guidelines.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable, as this refers to adjudication for expert-labeled ground truth in AI/ML studies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable, as this is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical tests was established by predefined engineering specifications, applicable FDA guidance documents, and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization).

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and thus does not involve a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device and thus does not involve a training set or its ground truth establishment.

Summary

{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® 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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))

{5}------------------------------------------------

F. INDICATIONS FOR USE (807.92(a)(5))

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}------------------------------------------------

DeviceCharacteristic	New Device:Destination® GuidingSheath (Carotid,Peripheral and Renal)	Primary Predicate:Destination® CarotidGuiding Sheath	Predicate:Destination® PeripheralGuiding Sheath	Predicate:Destination® RenalGuiding Sheath
510(k)	None	K052185	K091329	K081045
Manufacturer	Terumo MedicalCorporation	Same	Same	Same
Intended Use /Indications forUse	Carotid: SamePeripheral: SameRenal: Same	The Destination® CarotidGuiding Sheath isdesigned to be used forthe introduction ofinterventional anddiagnostic devices into thehuman vasculature,including but not limitedto the carotid arteries.	The Destination®Peripheral Guiding Sheathis designed to be used forthe introduction ofinterventional anddiagnostic devices into thehuman vasculature,including but not limitedto lower extremity accessvia a contralateralapproach.	The Destination® RenalGuiding Sheath isintended for theintroduction ofinterventional anddiagnostic devices intothe human vasculatureincluding but not limitedto the renal arteries.
OperationPrinciple	Operated manually or bya manualprocess;	Same	Same	Same
Design /Construction	Sheath, Dilator,Hemostatic Valve withside tube and three-waystopcock, and DilatorRetaining Clip	Same	Same	Same
DeviceCharacteristic	New Device:Destination® GuidingSheath (Carotid,Peripheral and Renal)	Primary Predicate:Destination® CarotidGuiding Sheath	Predicate:Destination® PeripheralGuiding Sheath	Predicate:Destination® RenalGuiding Sheath
Materials	Sheath AssemblySame except for thematerials grade changes	Sheath AssemblyTubing: PTFE – SSL coil –NylonTip: NylonHydrophilic Coating:Polyvinylpyrrolidone-basedcoatingHub: NylonRadiopaque Band:Gold	Sheath AssemblySame	Sheath AssemblySame
	Dilator AssemblySame	Dilator AssemblyTubing: Polypropylene/Thermoplastic Elastomer BlendHub: PolypropyleneCoating:Reactive SiliconeCaulking Pin:Stainless steel	Dilator AssemblySame	Dilator AssemblySame
	Tuopy-Borst Valve(TBV):Same	Tuopy-Borst Valve(TBV):Y-Connector Assembly:Polycarbonate,SiliconeSide Tube/3-Way StopcockAssembly:Polybutadiene,Polycarbonate,High Density PolyethyleneBase Resin and HDPEcolorants,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
DeviceCharacteristic	New Device:Destination® GuidingSheath (Carotid,Peripheral and Renal)	Primary Predicate:Destination® CarotidGuiding Sheath	Predicate:Destination® PeripheralGuiding Sheath	Predicate:Destination® RenalGuiding Sheath
Specifications	Carotid: SamePeripheral: SameRenal: Same	Sheath Size: 6-7Fr.Nominal ID/OD:6Fr.: 0.087"/0.111" 7Fr.:0.101"/0.122"Sheath Length:80-110 cmHydrophilic Coating:Distal 15 cmDistal Shapes: ST, MPDilator 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 cmHydrophilic Coating:Distal 15-60 cmDistal Shapes: STDilator 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 lengthsup to 75cm,5 cm for sheaths longerthan 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 cmHydrophilic Coating:Distal 5 cmDistal Shapes: ST, HS,MP, RDC, LIMADilator ID/OD (nominal):5Fr.: 0.045”/0.072"6Fr.: 0.045"/0.084"7Fr.: 0.045”/0.097"Dilator Extended Length:2 cm
DeviceCharacteristic	New Device:Destination® GuidingSheath (Carotid,Peripheral and Renal)	Primary Predicate:Destination® CarotidGuiding Sheath	Predicate:Destination® PeripheralGuiding Sheath	Predicate:Destination® RenalGuiding Sheath
Sterilization	Ethylene Oxide(validated in accordancewith ANSI / AAMI / ISO11135-1 to achieve SAL10-6)	Same	Same	Same
Shelf life	6 months	30 months	30 months	30 months
DisposableSingle 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 andDurability/Adhesion	In-house standard	Sheath
Simulated Use andParticulate	FDA Guidance Doc 1608	Sheath,Dilator,CCV
Simulated Use CoatingIntegrity 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).

The following tests are recommended by FDA and ISO 10993-1 to be performed for this device classification:

1. Cytotoxicity
1. Sensitization
1. Intracutaneous Reactivity
1. Systemic Toxicity (Acute)
1. Pyrogenicity
1. Hemocompatibility
1. Thrombogenicity
1. Complement Activation (Immunology)*
1. Physiochemical Testing

{12}------------------------------------------------

*Complement activation tests are not a requirement for ISO 10993-4 for external communicating devices, circulating blood with limited exposure (<24 hours). This testing was completed since FDA has previously requested this testing for similar devices. ISO 10993-4/Amd 1: 2006 indicated complement activation testing should be evaluated for devices with prolonged exposure (>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

Regulation Number and Section

§ 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).