The Pinnacle® ROII Introducer Sheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.

Device Description

The PINNACLE R/O II Introducer Sheath is comprised of an introducer sheath and a dilator. The introducer sheath has a radiopaque marker that is highly visible under fluoroscopy. The marker is a band that is located approximately 5 mm from the sheath's distal tip. The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall. The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer. The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed. The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

AI/ML Overview

The KOR2847 document describes the "Pinnacle® ROII Introducer Sheath," a medical device designed to facilitate placing catheters into veins or arteries.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the performance of the Pinnacle® ROII Introducer Sheath is substantially equivalent to the performance of its predicate device (K003424). It doesn't list specific quantitative acceptance criteria for this device (like tensile strength values or flow rates) but rather relies on the equivalence to the predicate.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Intended Use Equivalence: Facilitate placing a catheter through the skin into a vein or artery.	The device has the same intended use as the predicate device (K003424).
Design Equivalence: Similar design, materials, and components.	Uses the same materials and design as the predicate device.
Principle of Operation / Technology Equivalence: Manual operation.	Operates manually, same as the predicate.
Material Biocompatibility: Non-toxic and safe for blood contact.	Blood contacting materials were tested and found to be biocompatible, following FDA and ISO 10993 guidelines.
Sterility: Achieve a certain sterility assurance level.	Sterilization conditions validated to achieve a Sterility Assurance Level of 10⁻⁶ (ANSI/AAMI/ISO 11135-1994).
Shelf Life/Expiration Dating: Stable over a specified period.	Expiration dating for 30 months.
Physical Dimensions/Specifications (Matching Predicate)	Sheath Sizes: 4Fr., 5Fr., 9Fr. (nominal lumen sizes: 0.055", 0.068", 0.122") Sheath Length: 4-110 cm Dilator Length: 5-110 cm Guide Wire OD: 0.021"-0.038"
Overall Performance Equivalence: No new issues of safety and effectiveness.	Performance shown to be substantially equivalent to the predicate device (K003424) through bench testing. Differences do not raise any issues of safety or effectiveness.

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

Sample Size: The document does not explicitly state the sample size used for the bench testing.
Data Provenance: The testing was conducted as "bench testing" by the manufacturer, Terumo Medical Corporation. The country of origin of this data is not specified, but the manufacturer is based in Elkton, MD, USA. The testing is considered prospective as it's part of the pre-market notification process for the new device.

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

This information is not provided in the document. The study involved bench testing rather than clinical performance evaluation that would typically involve expert assessment against ground truth. The "ground truth" here is adherence to engineering specifications and performance parameters set to achieve substantial equivalence.

4. Adjudication method for the test set:

This information is not provided. As it was bench testing, there was likely no "adjudication" in the sense of expert consensus on clinical outcomes.

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:

No. This study is not a multi-reader multi-case comparative effectiveness study. It's a 510(k) submission for a non-AI medical device, focusing on substantial equivalence to a predicate device through bench testing. There is no AI component involved.

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

No. This device is a manual introducer sheath, not an algorithm or AI system. Therefore, standalone algorithm performance is not applicable.

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

The "ground truth" for this submission is based on engineering specifications, regulatory standards (e.g., ISO 10993 for biocompatibility, ANSI/AAMI/ISO 11135-1994 for sterilization), and the established performance characteristics of the predicate device (K003424). The testing aims to demonstrate that the new device meets these specifications and performs equivalently to the predicate.

8. The sample size for the training set:

Not applicable. This submission is for a physical medical device (introducer sheath), not an AI/machine learning algorithm that requires a training set.

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

Not applicable. As above, no training set is relevant for this device.

Summary

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KOR2847

SECTION II. 510(K) SUMMARY

A.	Device Name	17
B.	Predicate Device	17
C.	Intended Use	17
D.	Description	17
E.	Principle of Operation / Technology	17
F.	Design / Materials	19
G.	Specifications	19
H.	Performance	19
I.	Additional Safety Information	20
J.	Substantial Equivalence	20
K.	Submitter Information	21

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SECTION II. 510(K) SUMMARY

A. DEVICE NAME

Proprietary Name:	Pinnacle® ROII Introducer Sheath
Classification Name:	Introducer, Catheter
Common Name:	Introducer Sheath

B. PREDICATE DEVICE

The predicate device is the Pinnacle® ROII, which is manufactured by Terumo Medical Corporation. The Pinnacle® ROII is cleared through the premarket notification process (K003424).

C. INTENDED USE

Note: This is the same intended use as the Pinnacle® ROII, K003424.

D. DESCRIPTION

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The introducer sheath consists of 2 pieces of ETFE tubing -- a long segment and a short tip segment. The band is sandwiched between the two segments and fused together. The band is completely encapsulated within the tubing wall.

The PINNACLE R/O II Introducer Sheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the device. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.

The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The PINNACLE R/O II Introducer Sheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Introducer Sheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted.

The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.

The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.

E. PRINCIPLE OF OPERATION / TECHNOLOGY

The Pinnacle® ROII Introducer Sheaths operated manually or by a manual process.

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F. Design / Materials

The Pinnacle® ROII Introducer Sheath uses the same materials and design as the predicate device. There are no new issues of safety and effectiveness related to design or materials.

் SPECIFICATIONS

Sheath Sizes:	4Fr. (0.055" nominal lumen size)5Fr. (0.068" nominal lumen size)9Fr. (0.122" nominal lumen size)
Sheath Length:	4-110 cm
Dilator Length:	5-110 cm
Guide Wire OD:	0.021"-0.038"

H. Performance

The performance of the Pinnacle® ROII Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench testing.

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I. ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10°.

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® ROII Introducer Sheath is categorized as "Externally Communicating Device, Circulating Blood, Prolonged Contact (24hrs to 30 days)". The blood contacting materials were found to be biocompatible.

Expiration dating for the Pinnacle® ROII Introducer Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® ROII Introducer Sheath submitted in this 510(k) is substantially equivalent in intended use, design, principle of operation / technology, materials and performance to the Pinnacle® ROII (K003424), which is also manufactured by Terumo Medical Corporation. Differences between the devices do not raise any issues of safety or effectiveness.

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Terumo Medical Corporation Special 510(k) - Pinnacle® ROII Introducer 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

Date Prepared September 25, 2008

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2008

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

Re: K082847

Pinnacle ROII Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: September 25, 2008 Received: September 29, 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencics. 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 Biometrics' (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.

R. Volmer

o 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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Indications for Use

510(k) Number (if known):

K082847

Pinnacle® ROII Introducer Sheath Device Name:

Indications For Use:

Prescription Use (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)

Donna R. Vachner

(Division Simn-Off) Division of Cardiovascular Devices

510(k) Number_KO82847

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).