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 (Devices with TBV Valve only).

AI/ML Overview

The provided document is a 510(k) summary for the Pinnacle® Destination® Peripheral Guiding Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria for device performance as would be expected for a novel device.

Therefore, many of the requested details regarding acceptance criteria, study design parameters (sample size, data provenance, expert adjudication, MRMC study, standalone performance), and ground truth establishment are not applicable or not provided in this document because it's a submission for a substantially equivalent medical device, not a new clinical trial of a diagnostic or AI-driven aid.

Here's a breakdown of the available information:

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

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Performance	Equivalent performance to the predicate device in intended use.	"The performance of the Pinnacle® Destination® Peripheral Guiding Sheath is substantially equivalent to the performance of the unmodified Peripheral Guiding Sheath. The equivalence was shown through bench and vessel model testing." (Section H)
Biocompatibility	Blood contacting materials meet ISO 10993 "Biological Evaluation of Medical Devices - Part I: Evaluation and Testing" for "Externally Communicating Device, Circulating Blood, Limited Contact (≤24hrs)".	"The blood contacting materials were found to be biocompatible." (Section I)
Sterilization	Sterilization conditions validated to provide a Sterility Assurance Level (SAL) of 10^-6 in accordance with EN ISO 11135-1.	"Sterilization conditions have been validated in accordance with EN ISO 11135-1...to provide a Sterility Assurance Level of 10^-6." (Section I)
Shelf Life/Expiration	Device maintains safety and effectiveness for a specified period.	"Expiration dating for the Pinnacle® Destination® Peripheral Guiding Sheath will be 30 months." (Section I)
Design/Materials	Differences in materials from the predicate device do not raise new safety or effectiveness issues.	"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." (Section F)
Substantial Equivalence	Device is substantially equivalent in intended use, design, principle of operation/technology, materials, and performance to the predicate device, and any differences do not raise new issues of safety or effectiveness. (This is the overarching acceptance criteria for a 510(k) approval).	"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 Pinnacle® Destination® Peripheral Guiding Sheath (K051601 and K080415)...Differences between the devices do not raise any issues of safety or effectiveness." (Section J)

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

The document mentions "bench and vessel model testing" but does not specify sample sizes for these tests.
Data provenance is not specified. These would typically be laboratory-based tests.

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)

Not applicable / not provided. The testing described (bench and vessel models, biocompatibility, sterilization) does not involve expert interpretation or ground truth establishment in the way a diagnostic imaging study would.

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

Not applicable / not provided. Adjudication is relevant for interpreting subjective assessments, which is not the primary mode of testing for this type of device (an introducer sheath).

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. This device is a manual catheter introducer, not an AI-assisted diagnostic or interventional tool. Therefore, an MRMC study with AI assistance is entirely irrelevant.

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

Not applicable. This device is a physical medical instrument operated manually, not an algorithm.

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

For performance testing (bench and vessel models), the "ground truth" would be established engineering and biomechanical specifications and measurements compared to the predicate device's performance.
For biocompatibility, the ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) according to ISO 10993.
For sterilization, the ground truth is established by microbiological challenge testing validating the sterilization cycle to achieve the specified SAL.

8. The sample size for the training set

Not applicable / not provided. No "training set" is relevant for a device like this, which is compared to a predicate based on physical and material properties and performance in bench/vessel models.

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

Not applicable / not provided. As there is no training set for this type of device, ground truth establishment for it is not relevant.

In summary: The document is a 510(k) submission for a substantially equivalent medical device. The "study" described is a series of bench and vessel model tests, along with biocompatibility and sterilization validations, to demonstrate equivalence to a previously cleared predicate device. It does not involve human readers, AI algorithms, or extensive clinical trials with detailed statistical endpoints that would require the typical "acceptance criteria" breakdown seen for diagnostic devices or AI-driven systems.

Summary

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.K091329 page 1 of 4

MAY 2 9 2009

SECTION II. 510(k) SUMMARY

A. DEVICE NAME

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

B. PREDICATE DEVICE

The predicate device is the Pinnacle® Destination® Peripheral Guiding Sheath, which is manufactured by Terumo Medical Corporation. The Pinnacle® Destination® Peripheral Guiding Sheath is cleared through the premarket notification process (K051601 and K080415).

C. INTENDED USE

D. DESCRIPTION

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PRINCIPLE OF OPERATION / TECHNOLOGY E.

The Pinnacle® Destination® Peripheral Guiding Sheath is 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.

G SPECIFICATIONS

Sheath Size:	8Fr.
Sheath Length:	45-110 cm
Hydrophilic Coating:	Distal 15-60 cm
Distal Shape Configurations:	Straight

H. PERFORMANCE

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

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ADDITIONAL SAFETY INFORMATION I.

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 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 Pinnacle® Destination® Peripheral Guiding Sheath (K051601 and K080415), which is manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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K091329 page 4 of 4

Terumo Medical Corporation Terumo Medical Corporation® Peripheral Guiding Sheath Section II. 510(k) Summary

SUBMITTER INFORMATION K.

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

Date Prepared

May 1, 2009

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2009

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

Re: K091329

Pinnacle® Destination® Peripheral Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: May 1, 2009 Received: May 5, 2009

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 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); medical device reporting (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

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

Enclosure

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page 1 of 1

Indications for Use

510(k) Number (if known): K0241329

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)

Division star. Ore

(Division Sign-Off) ardiovascular Devloes of C 510(k) Numbe

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).