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® Renal Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Guiding Sheath is packaged with the following components: a Sheath, a Dilator, a Hemostatic Valve, and a Dilator Retaining Clip.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Destination® Renal Guiding Sheath." This is a medical device, and the evaluation focuses on its substantial equivalence to a predicate device, not on complex AI performance metrics. Therefore, many of the requested fields are not applicable in this context.

Here's the breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

For a traditional medical device like a guiding sheath, "acceptance criteria" are typically related to meeting established performance standards (e.g., sterilization, biocompatibility, mechanical integrity) and demonstrating equivalence to a predicate device. Performance is shown through bench and vessel model testing, not statistical metrics like sensitivity/specificity for disease detection.

Acceptance Criteria / Performance Category	Device Performance (Reported)
Intended Use	Introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the Renal Arteries. (Substantially equivalent to predicate)
Design / Materials	Uses similar materials to the predicate device. Differences do not raise new safety/effectiveness issues. (Substantially equivalent to predicate)
Principle of Operation / Technology	Operated manually or by a manual process. (Substantially equivalent to predicate)
Sterilization	Validated in accordance with EN ISO 11135-1 to provide a Sterility Assurance Level of 10-6.
Biocompatibility	Blood contacting materials tested in accordance with FDA G95-1 (ISO 10993). Found to be biocompatible for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)".
Mechanical Performance	Demonstrated through bench and vessel model testing. (Substantially equivalent to predicate)
Expiration Dating	30 months.
Specifications (Physical)	Sheath Size: 5Fr., Sheath Length: 45-55 cm, Hydrophilic Coating: Distal 5 cm, Distal Shape Configurations: Straight, HS, RDC, LIMA, MP. (Implied to meet design specifications)

Studies that Prove the Device Meets Acceptance Criteria:

The document states:

"The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing."
"Sterilization conditions have been validated in accordance with EN ISO 11135-1..."
"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..."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the summary. For a medical device 510(k), especially one comparing physical characteristics to a predicate, specific "test set" sample sizes or data provenance in the way one would describe for an AI/ML study are not typically detailed in this type of summary document. The "bench and vessel model testing" implies laboratory testing rather than human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable and not provided. The ground truth for device performance in this context would be engineering specifications, physical measurements, and biological compatibility standards, not expert consensus on medical images or diagnoses.

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

This is not applicable and not provided. Adjudication methods are relevant for studies where human interpretation (e.g., of medical images) generates a "ground truth" that needs to be resolved by multiple experts. For physical device performance, this concept doesn't apply.

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

This is not applicable. This device is a physical medical instrument (a guiding sheath), not an AI algorithm or a diagnostic tool that involves human readers interpreting data assisted by AI.

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

This is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and biocompatibility standards, and measurable physical properties. For example:

Sterility: Achieves a measured Sterility Assurance Level (SAL) of 10^-6, verified by laboratory testing according to EN ISO 11135-1.
Biocompatibility: Meets the requirements outlined in ISO 10993 for limited contact with circulating blood, verified by laboratory testing.
Physical Performance (e.g., torqueability, pushability, trackability): Assessed through "bench and vessel model testing" against a predicate device. The ground truth here would be engineering metrics and comparison to the predicate's established performance.

8. The sample size for the training set

This is not applicable and not provided. This device does not involve a "training set" in the context of machine learning.

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

This is not applicable and not provided. This device does not involve machine learning or a training set.

Summary

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K08/045 100% Lot 4

Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary

MAY 2 8 2008

SECTION II. 510(k) SUMMARY

A. DEVICE NAME

Proprietary Name: Destination® Renal Guiding Sheath Classification Name: Catheter Introducer Common Name: Guiding Sheath

B. PREDICATE DEVICE

The predicate device is the Renal Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Renal Guiding Sheath is cleared through the premarket notification process (K012854).

C. INTENDED USE

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.

D. DESCRIPTION

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E. PRINCIPLE OF OPERATION / TECHNOLOGY

The Destination® Renal Guiding Sheath is operated manually or by a manual process.

F. DESIGN / MATERIALS

The Destination® Renal 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:	5Fr.
Sheath Length:	45-55 cm
Hydrophilic Coating:	Distal 5 cm
Distal Shape Configurations:	Straight, HS, RDC, LIMA, MP

H. PERFORMANCE

The performance of the Destination® Renal Guiding Sheath is substantially equivalent to the performance of the unmodified Renal Guiding Sheath. The equivalence was shown through bench and vessel model testing.

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Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary

I. ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated in accordance with EN ISO 11135-1 "Sterilization of health care products – Ethylene Oxide – Part 1 : requirements for development, validation and routine control of sterilization process for medical devices." 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® Renal 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® Renal Guiding Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Destination® Renal Guiding Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Renal Guiding Sheath (K012854), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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KOE 1045 page let y

Terumo Medical Corporation Special 510(k)- Destination® Renal Guiding Sheath Section II. 510(k) Summary

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

. "A

. . .

Date Prepared

April 11, 2008

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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 features a stylized depiction of an eagle or bird-like figure, with its wings forming a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2008

Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Blvd. Elkton, MD 21921

Re: K081045

Trade/Device Name: Destination Renal Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class; Class II (two) Product Code: DYB Dated: May 19, 2008 Received: May 20, 2008

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, 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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

uma R.v.luhner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):	K081045
---------------------------	---------

Destination® Renal Guiding Sheath Device Name:

Indications For Use:

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.

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)

Anna R. Kirchner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ Ko81045

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).