The Pinnacle® RO11 HiFlow 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 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 radiofrequency (RF) welding is used to fuse the two segments together. The band is completely encapsulated within the tubing wall.

The PINNACLE R/O II HiFlow 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 HiFlow 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 The Mini Guide Wire is then withdrawn from the vessel.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 slightly visible under fluoroscopy.

AI/ML Overview

The provided text describes the regulatory clearance (K062446) for the Pinnacle® ROII HiFlow Introducer Sheath. This is a Special 510(k) submission, which means the device is largely similar to a previously cleared predicate device, with some modifications.

The acceptance criteria for this type of device are primarily focused on demonstrating substantial equivalence to the predicate device in terms of intended use, design, principle of operation/technology, materials, and performance.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a Special 510(k), the acceptance criteria are not explicitly numerical thresholds as one might see for a completely novel device. Instead, the criterion for performance is "substantially equivalent" to the predicate device (K003424).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional Performance	Substantial equivalence to predicate device (K003424) in performance.	Equivalence shown through bench testing.
Biocompatibility	Compliance with ISO 10993 for "Externally Communicating Device, Circulating Blood, Prolonged Contact (24hrs to 30 days)".	Blood contacting materials were found to be biocompatible.
Sterilization	Sterility Assurance Level (SAL) of 10^-6 per ANSI/AAMI/ISO 11135-1994.	Sterilization conditions validated to provide a SAL of 10^-6.
Shelf Life	Stability and integrity for a specified duration.	Expiration dating for the device will be 30 months.
Physical Dimensions	Sheath Sizes: 6Fr, 7Fr, 8FrSheath Length: 4-110 cmDilator Length: 5-110 cmGuide Wire OD: 0.021" - 0.038"	The device specifications meet these dimensions. (Implicitly, as they are listed as device specs rather than performance results against a target, but indicate the manufactured product conforms to these dimensions).

2. Sample Size Used for the Test Set and Data Provenance

The primary performance evaluation was conducted through bench testing.

Sample Size: The text does not explicitly state the sample size for the bench testing. In typical medical device bench testing, multiple units would be tested to ensure consistency and reliability, but the specific number is not provided.
Data Provenance: The data comes from laboratory bench testing conducted by the manufacturer, Terumo Medical Corporation. There is no indication of country of origin of the data beyond the manufacturer's location (Elkton, MD, USA). The testing is prospective in the sense that it was conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of submission. The performance comparison is against a physically existing predicate device using objective bench testing parameters, not against expert interpretation of clinical data or images. "Ground truth" in this context refers to the documented performance characteristics of the predicate device and the objective results of the bench tests on the new device.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1 consensus) is not applicable here. Adjudication methods are typically used in studies where human reviewers interpret data (e.g., medical images) and their agreement needs to be resolved to establish ground truth. For bench testing, the results are typically quantitative and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The Pinnacle® ROII HiFlow Introducer Sheath is a physical medical device (an introducer sheath), not an AI diagnostic tool, so such a study would be irrelevant.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a manual medical instrument.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was the established performance characteristics and design specifications of the predicate device (Pinnacle® ROII, K003424). The bench testing data for the new device was compared directly against these known characteristics to affirm equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no "training set" for this physical device.

Summary

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K062446

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

E. PRINCIPLE OF OPERATION / TECHNOLOGY

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

F. DESIGN / MATERIALS

The Pinnacle® ROH Hill low Introducer 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.

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Terumo Medical Corporation Special 510(k) – Pinnacle® ROII HiFlow Introducer Sheath Section II. 510(k) Summary

ਾਂ SPECIFICATIONS

Sheath Sizes:	6Fr. (0.087" nominal lumen size)7Fr. (0.100" nominal lumen size)8Fr. (0.115" 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 HiFlow Introducer Sheath is substantially equivalent to the performance of the predicate device K003424. The equivalence was shown through bench testing.

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Terumo Medical Corporation Special 510(k) – Pinnacle® ROII HiFlow Introducer Sheath Section II. 510(k) Summary

I. ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994 to provide a Sterility Assurance Level of 10-6.

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® ROII HiFlow 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 HiFlow Introducer Sheath will be 30 months.

J. SUBSTANTIAL EQUIVALENCE

The Pinnacle® ROII HiFlow 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 HiFlow Introducer 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

August18, 2006

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2006

Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 125 Blue Ball Road Elkton, MD 21921

Re: K062446

Pinnacle® RO11 HiFlow Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: II Product Code: DYB Dated: September 25, 2006 Received: September 26, 2006

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dina R. Lochner

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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): _

Pinnacle® ROII HiFlow Introducer 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. lahner

Division of Cardiovascular Devices

510(k) Number K 062

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).