The PINNACLE R/O 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

Pinnacle™ R/O 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 tip. The introducer sheath consists of 2 layers. Both layers are ETFE and the outer laver entirely covers the inner laver.

Pinnacle™ R/O 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 Pinnacle™ R/O. The Inserter does not contact blood and is used strictly for quiding 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 (comprised of the Sheath and the Dilator) 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 The Mini Guide Wire is then withdrawn from the vessel.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 Pinnacle™ R/O 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 filing for the PINNACLE™ R/O or RADIFOCUS® Introducer R/O device, seeking substantial equivalence to a predicate device (RADIFOCUS® Introducer II, K954234). The information provided is for a traditional medical device (introducer sheath), not an AI/ML powered device. As such, many of the typical acceptance criteria and study details for an AI-powered device, such as those related to diagnostic performance metrics, ground truth establishment, or human-in-the-loop studies, are not applicable here.

Therefore, the response will focus on the acceptance criteria and performance data relevant to this type of medical device as presented in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Test)	Device Performance (Result)
Kink Resistance	Performed. Data does not raise new issues of safety and effectiveness.
Sheath-to-Housing Joint Strength	Performed. Data does not raise new issues of safety and effectiveness.
Sheath Tip Penetration	Performed. Data does not raise new issues of safety and effectiveness.
Sterility Validation	Performed. Data does not raise new issues of safety and effectiveness. Manufacturing controls include sterility tests.
Radiopacity	Performed. Device contains a radiopaque marker (band 5mm from tip) and components (Sheath, Dilator, Obturator) contain bismuth for visibility. Data does not raise new issues of safety and effectiveness.
Biocompatibility	Blood contacting materials tested in accordance with ISO-10993 (FDA G95-1). Results demonstrate blood contacting materials are biocompatible.

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

The document does not explicitly state the sample sizes used for each verification test. The tests (Kink Resistance, Sheath-to-Housing Joint Strength, Sheath Tip Penetration, Sterility Validation, Radiopacity, and Biocompatibility) are typically conducted on a representative sample of manufactured devices or materials.

The data provenance is from internal testing conducted by Terumo Medical Corporation for regulatory submission to the FDA. The tests are focused on the physical and material properties of the device itself, not on patient-specific data or diagnostic images.

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

Not applicable. This device is a traditional medical introducer sheath, and its performance criteria are based on engineering specifications, material properties, and biological compatibility testing, not on interpretation of images or clinical diagnoses requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are primarily objective measurements against specifications, not subjective interpretations requiring adjudication.

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 is not an AI-powered device, so MRMC studies or human reader improvement with AI assistance are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance acceptance is based on:

Engineering Specifications: Defined parameters for physical properties like Kink Resistance, Sheath-to-Housing Joint Strength, and Sheath Tip Penetration.
International Standards: Compliance with ISO-10993 for biocompatibility testing.
Radiopacity Requirements: Ensuring visibility under fluoroscopy.
Sterility Standards: Ensuring the device meets sterile conditions.

These are objective standards and measurements, not subjective evaluations or clinical outcomes in the same way an AI diagnostic device would have.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML powered device, so there is no "training set."

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

Not applicable. There is no training set as this is not an AI/ML powered device.

Summary

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SUMMARY AND CERTIFICATION ll.

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE

A. Device Name

Proprietary Name	Classification Name	Common Name
PINNACLE™ R/O orRADIFOCUS® Introducer R/O(comprised of a Sheath & Dilator)	Introducer, Catheter	Introducer, Catheter

B. Intended Use

The Pinnacle™ R/O 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.

Note: This is the same intended use as the RADIFOCUS® Introducer II, K954234.

C. Device Description

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

D. Substantial Equivalence

The Pinnacle™ R/O submitted in this 510(k) is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the cleared RADIFOCUS® Introducer II, K954234.

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Principle Of Operation / Technology E.

The Pinnacle™ R/O and its accessories are operated manually or by a manual process.

F. Design / Materials

Differences in materials between the Pinnacle™ R/O and the RADIFOCUS® Introducer II, K954234, raise no new issues of safety and effectiveness.

G. Specifications

Part	Pinnacle™ R/O	Introducer II , K954234
Introducer SheathSizeLength	4 - 11 French5 - 110 cm	4 - 11 French5 – 100 cm
DilatorLength	6 - 110 cm	6 - 110 cm
Guide Wire OD	0.021" - 0.038"	0.021" - 0.038"

i H Performance

The Pinnacle" R/O is comprised of an introducer sheath with radiopaque marker and a dilator. Only the introducer sheath was modified. The dilator was not modified.

The following verification tests were performed to demonstrate the substantial equivalence of the Introducer Sheath with the radiopaque marker to the Introducer Sheath without the radiopaque marker.

Kink Resistance .
Sheath-to-Housing Joint Strength .
Sheath Tip Penetration .
. Sterility Validation
. Radiopacity

None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.

Therefore the performance of the Pinnacle™ R/O is substantially equivalent to the performance of the RADIFOCUS® Introducer II, cleared under K954234.

l. Additional Safety Information

Manufacturing controls include visual, functional, dimensional and sterility tests.

The Pinnacle™ R/O is classified as an Externally Communicating Device, Circulating Blood, Prolonged Contact (24 hrs to 30 days). The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing". Results of the testing demonstrate that the blood contacting materials are biocompatible.

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J. Conclusion

The Pinnacle™ R/O is substantially equivalent in intended use, design, technology / principles of operation, materials and performance to the RADIFOCUS® Introducer II, cleared under K954234. Differences between the two devices do not raise any significant issues of safety or effectiveness.

Date Prepared:	November 14, 1998
Prepared By:	Yuk-Ting LewisSenior Regulatory Affairs Specialist
Prepared For:	Terumo Medical Corporation125 Blue Ball RoadElkton, MD 21921Phone: (410) 392-7213 or (410) 392-7231Fax: (410) 398-6079

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 26 1999

Ms. Yuk-Ting Lewis Senior Requlatory Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921

Re: K984260

Trade Name: PINNACLE™ R/O or RADIFOCUS® Introducer R/O Requlatory Class: II Product Code: DYB Dated: January 6, 1999 Received: January 11, 1999

Dear Ms. Lewis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation

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Page 2 -- Ms. Yuk-Ting Lewis

you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Note: This is excerpted from the original 510k, K954234

510(k) Number (if known):	k9842660
---------------------------	----------

PINNACLE™ R/O or RADIFOCUS® Introducer R/O Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Use

Chr. Ayler Stern for TJC

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K984260

Page 4

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).