R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.

Device Description

The R2P™ Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated, and is available in 6Fr with a length of 75cm, 85cm, 95cm, 105cm, 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the "R2P™ Destination Slender™ Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML-based medical device.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device cannot be extracted from this document because this document is about a physical medical device (guiding sheath) and does not involve AI/ML technology or related performance studies.

The document primarily focuses on:

Device Description: A guiding sheath used for introducing other medical devices into the human vasculature.
Comparison to Predicate Device: Demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K171491 R2P™ Destination Slender™ Guiding Sheath). This equivalence is based on intended use, technology/principle of operation, materials, and performance.
Non-Clinical Testing: Performance tests (e.g., Ovalization, Simulated Use and Particulate, Coating Integrity, Torque Strength) conducted to ensure the device meets applicable design and performance requirements and supports substantial equivalence.
Biocompatibility and Sterilization: Addressing these aspects based on previous testing of the predicate device, as the new device is essentially the same in composition and manufacturing, with only variations in length.
Absence of Clinical Tests: Explicitly stating that this 510(k) does not include data from clinical tests.

To answer your prompt about acceptance criteria and study data for an AI/ML device, a different type of FDA submission (e.g., a De Novo request or a 510(k) for an AI/ML device) would be required, which would contain performance data derived from clinical or scientific studies involving algorithms and data sets.

Summary

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January 6, 2020

Terumo Medical Corporation Liang Lu Senior Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, Maryland 21921

Re: K193125

Trade/Device Name: R2P Destination Slender Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 11, 2019 Received: November 12, 2019

Dear Liang 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K193125

Device Name R2PTM Destination Slender™ Guiding Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

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 265 Davidson Avenue, Suite 320 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

January 3, 2020 Date prepared:

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B. DEVICE NAME (807.92(a)(2))

Proprietary Name:	R2P TM Destination SlenderTM Guiding Sheath	DeviceCharacteristic	Predicate Device:R2PTM Destination Slender™Guiding Sheath (K171491)	Proposed Device:R2PTM Destination Slender™Guiding Sheath
Common Name:	Guiding Sheath	Manufacturer	Terumo Medical Corporation	Same
Classification Name:	Catheter Introducer	Intended Use /Indications forUse	R2PTM Destination Slender™Guiding Sheath is indicated to beused for the introduction ofinterventional and diagnosticdevices in the lower extremities ofthe peripheral vasculature throughan access site, including but notlimited to the radial artery.	R2PTM Destination Slender™Guiding Sheath is indicated for theintroduction of interventional anddiagnostic devices into the humanvasculature through an access site,including but not limited to theradial artery.
Classification Panel:	Cardiovascular	OperationPrinciple	Operated manually or by a manualprocess	Same
Regulation:	21 CFR 870.1340	Design /Construction	Sheath, Dilator, Hemostatic Valvewith side tube and three-waystopcock	Same
Product Code:	DYB	Materials	Sheath AssemblyTubing:Inner Layer: PTFEMiddle Coil Layer: Stainless SteelOuter Layer: NylonRadiopaque Tip: Nylon withTungstenHydrophilic Coating:Polyvinylpyrrolidone- basedcoatingHub: NylonAnti-kink protector: Nylon	Sheath AssemblySame
Classification:	Class II		Dilator AssemblyTubing: PolypropyleneHub: Polypropylene//Thermoplastic Elastomer BlendCoating: SiliconeCaulking Pin: Stainless steel	Dilator AssemblySame
	Cross Cut Valve (CCV)Valve Assembly:Housing: PolypropyleneCap: PolypropyleneLuer Lock Collar: PolycarbonateValve: Silicone Rubber ElastomerSidetube: polybutadieneSilicone: Non-reactive silicone oil1000cst	Cross Cut Valve (CCV)Valve Assembly:Same

C. PREDICATE DEVICE (807.92(a)(3))

The legally marketed device(s) to which substantial equivalence is claimed is:

Predicate Device: K171491 R2P™ Destination Slender™ Guiding Sheath, ● manufactured by Terumo Medical Corporation, USA

D. REASON FOR 510(k) SUBMISSION

This premarket notification (510(k)) is being submitted for the R2PTM Destination Slender™ 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))

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

G. SUBSTANTIAL EQUIVALENCE COMPARISON (807.92(a)(6))

The R2PTM Destination Slender™ 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 in the table below.

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	Side Tube Assembly: Body:Polybutadiene	Side Tube Assembly:Same
	3Way (3WSC) StopcockAssembly:Body: PolycarbonateLocking Pin: PolyethyleneCap: Polyethylene and ColorantHandle: Polyethylene andColorant	3Way (3WSC) StopcockAssembly: Same
Package	Unit PouchShelf BoxShipping Carton	Same
Specifications	Sheath Size: 6 Fr.Sheath ID/OD (nominal):6Fr.: 0.087"/0.100" (2.2mm/2.5mm)	Sheath Size: SameSheath ID/OD (nominal):Same
	Sheath Length:119cm, 149cm	Sheath Length:75cm, 85cm, 95cm, 105cm,119cm, and 149cm
	Hydrophilic Coating: full effectivelength	Hydrophilic Coating: Same
	Distal Shape: Straight	Distal Shape: Same
	Dilator ID/OD (nominal):0.039"/0.086"	Dilator ID/OD (nominal):Same
	Dilator Extended Length: 5cm	Dilator Extended Length: Same
Sterilization	Ethylene Oxide (validated inaccordance with ANSI / AAMI /ISO 11135-1 to achieve SAL 10-6)	Same
Shelf life	30 months	Same
Disposable SingleUse	Yes	Same

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H. NON-CLINICAL TESTS (807.92(b)(1)) Performance

Performance testing was conducted to ensure that the R2P™ Destination Slender™ 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 R2PTM Destination Slender™ Guiding Sheath.

Test Item	Reference	Component(Sheath,Dilator, CCVAssembly)
Ovalization	In-house standard	Sheath
Simulated Use andParticulate	FDA Guidance Doc 1608	Sheath, Dilator,CCV
Coating Integrity	FDA Guidance Doc 1608	Sheath
Torque Strength	FDA Guidance Doc 1608	Sheath

Table 5.2: Summary of Performance Testing

The R2PTM Destination Slender™ 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 R2PTM Destination Slender™ Guiding Sheath demonstrates the substantial equivalence to the predicate device.

Biocompatibility

Biocompatibility classification is based on the FDA Guidance Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing within a Risk Management Process. "

The R2PTM Destination Slender™ Guiding Sheath is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours).

The predicate guiding sheaths (119cm and 149cm) have fulfilled all testing required per ISO 10993-1 and FDA Guidance document "Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"

No changes in the materials, design, manufacturing processes, or packaging materials were made from the predicate device. The new additional four (4) shorter guiding sheaths (75cm, 85cm, 95cm, and 105cm) have the same contact nature and duration as the existing predicate guiding sheaths (119cm and 149cm). The predicate guiding sheaths (119cm and 149cm) have higher surface areas, which is the worstcase when compared to the new additional guiding sheaths (75cm, 85cm, and 105cm).

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The subject device is covered by the previously completed biocompatibility and chemistry testing done on the 149cm guiding sheath. Therefore, the subject devices (75cm, 85cm, 95cm, 105cm, 149cm, and 119cm) are considered to be biocompatible for the intended use and no additional biocompatibility testing is required.

Sterilization

The sterility of the predicate devices (119cm and 149cm) are 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 previously validated utilizing the overkill half cycle approach to provide a Sterility Assurance Level (SAL) of 10-6.

The predicate devices (119cm and 149cm) are limited exposure devices. 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.

The subject devices (75cm. 85cm. 95cm. 105cm. 119cm. and 149cm) have the same configuration, materials of the construct, and manufacturing process as the predicate products: the only change is the length of the device. The manufacturing process will occur in the same manufacturing environment and use the same manufacturing process and materials. The length change to 75cm. 85cm, 95cm, and 105cm, will not affect the efficacy of the current sterilization process and will not create a greater challenge to the cycle than the existing validated process challenge device. Therefore, the subject devices (75cm, 85cm, 95cm, 119cm, and 149cm) are covered by the previously completed sterilization validation and no additional sterilization validation is required.

CLINICAL TESTS (807.92(b)(2)) I.

This 510(k) does not include data from clinical tests.

J. CONCLUSION (807.92(b)(3))

In summary, the R2PTM Destination Slender™ 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:

Predicate Device: K171491 R2PTM Destination Slender™ Guiding Sheath, . manufactured by Terumo Medical Corporation, USA

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).