The Pinnacle® 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.

Device Description

The Pinnacle® Destination® Peripheral Guiding Sheath is designed to perform as a guiding catheter and an introducer sheath. The Peripheral 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 is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath, not a study report, so it does not contain detailed acceptance criteria or a specific study that proves the device meets those criteria in the way a clinical trial or performance study report would.

However, based on the provided text, we can infer the basis of acceptance and the type of "study" conducted for this medical device, which is primarily a demonstration of "substantial equivalence" to a predicate device.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence)

The primary "acceptance criterion" for this 510(k) submission is Substantial Equivalence to the predicate device, the Carotid Guiding Sheath (K012812) manufactured by Terumo Medical Corporation. This means the new device must perform comparably to the predicate device in terms of safety and effectiveness for its intended use.

Acceptance Criterion (Inferred from Substantial Equivalence to Predicate)	Reported Device Performance
Functional Equivalence: Introduction of interventional and diagnostic devices into human vasculature.	Demonstrated through bench and cadaver testing.
Material Equivalence: Use of similar materials, with differences not raising new safety/effectiveness issues.	Stated that "Pinnacle® Destination® Peripheral Guiding Sheath uses similar materials as the predicate device."
Biocompatibility: Blood contacting materials meeting ISO 10993 standards.	Blood contacting materials were tested and found to be biocompatible.
Sterility Assurance: Sterilization validated to ANSI/AAMI/ISO 11135-1994, SAL of 10⁻⁶.	Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10⁻⁶.
Durability/Shelf Life: Expiration dating.	Expiration dating for the device will be 30 months.

Study Information (as inferrable from the 510(k) Summary)

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "bench and cadaver testing" but does not provide details on the number of samples or subjects involved in these tests.
- Data Provenance: The testing was likely conducted in a laboratory or clinical setting (cadaver testing) by the manufacturer (Terumo Medical Corporation). The document does not specify the country of origin of the data beyond the manufacturer's location in Elkton, MD, USA. It is prospective testing designed to support the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a device like a guiding sheath, "ground truth" typically relates to objective physical and mechanical properties, as well as biological responses (biocompatibility), rather than expert interpretation of medical images or diagnostic outcomes. Testing would involve engineers, materials scientists, and possibly medical professionals for cadaver use, but not in the sense of establishing a "ground truth" for diagnostic accuracy.
Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for studies involving subjective human assessment (e.g., image interpretation). This device's evaluation is based on objective measurements and performance in bench and cadaver testing.
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:
- No. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is a manual guiding sheath, not an algorithm. Performance was evaluated through "bench and cadaver testing."
The type of ground truth used:
- For bench testing: Engineering specifications, material properties, and physical performance characteristics (e.g., lubricity, flexibility, burst pressure, tensile strength, flow rates).
- For cadaver testing: Practical usability, navigation capabilities, and potentially observable tissue interaction in a simulated anatomical environment.
- For biocompatibility: Laboratory test results demonstrating compliance with ISO 10993.
- For sterility: Validation results to achieve the specified Sterility Assurance Level (SAL).
The sample size for the training set:
- Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set." The materials and design are based on established engineering principles and comparison to a known predicate device.
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this type of device.

Summary

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SECTION II. 510(k) SUMMARY

A.	Device Name	11
B.	Predicate Device	11
C.	Intended Use	11
D.	Description	11
E.	Principle of Operation / Technology	12
F.	Design / Materials	12
G.	Specifications	12
H.	Performance	12
I.	Additional Safety Information	13
J.	Substantial Equivalence	13
K.	Submitter Information	14

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SECTION II. 510(k) SUMMARY

DEVICE NAME A.

Pinnacle® Destination® Peripheral Guiding Sheath Proprietary Name: Classification Name: Catheter Introducer Common Name: Guiding Sheath

PREDICATE DEVICE B.

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

D. DESCRIPTION

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The Pinnacle® Destination® Peripheral Guiding Sheath and the Carotid Guiding Sheath are operated manually or by a manual process.

F. DESIGN / MATERIALS

The Pinnacle® Destination® Peripheral 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.

్ర SPECIFICATIONS

Sheath Size:	6-7Fr.
Nominal ID / OD:	6Fr.: 0.087" / 0.112"
	7Fr.: 0.100" / 0.122"
Sheath Length:	55-75 cm
Hydrophilic Coating:	Distal 15-55 cm
Distal Shape Configurations:	Straight

H. PERFORMANCE

The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the Carotid Guiding Sheath. The equivalence was shown through bench and cadaver testing.

KOSIGOI

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ADDITIONAL SAFETY INFORMATION I.

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 106

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 Pinnacle® Destination® Peripheral 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 Pinnacle® Destination® Peripheral Guiding Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® Destination® Peripheral 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.

KOS1601

p. 4 of S

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SUBMITTER INFORMATION K.

and the same of the same of the same of the same of the same of the same of

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

June 15, 2005

KOSI601 p. Soft

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

AUG 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051601

Pinnacle Destination Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (Two) Product Code: DYB Dated: June 15, 2005 Received: June 16, 2005

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 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,

Dmna R. Lochner

1Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Pinnacle® Destination® Peripheral Guiding Sheath Device Name:

Indications For Use:

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)

Duna R. bochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_¥05|60 |

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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).