The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Description

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is an over-the-wire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, dual lumen shaft, and a distal dilatation balloon. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is compatible with guidewires with a maximum diameter of 0.035" and with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon. The catheter is provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm. The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

AI/ML Overview

This is a 510(k) summary for a medical device, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. It's important to understand that this document describes a submission for regulatory clearance, not a scientific study proving clinical effectiveness or diagnostic accuracy in the way an AI algorithm study would.

Therefore, many of the requested categories related to AI performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this type of device submission. This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, primarily through engineering performance testing.

Here's an breakdown of the available information based on your request, with clarifications on why certain categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests performed indicate the areas of acceptance.

Acceptance Criteria Category	Reported Device Performance
Catheter and Balloon Dimensional Testing	Device met the acceptance criteria. (Specific dimensions and tolerances are not provided in this summary but would have been part of the full submission).
Minimum Balloon Burst Strength (RBP)	Device met the acceptance criteria. (Specific RBP values are not provided).
Balloon Compliance	Device met the acceptance criteria.
Balloon Inflation and Deflation Time	Device met the acceptance criteria.
Balloon Fatigue	Device met the acceptance criteria.
Tensile Strength	Device met the acceptance criteria.
Flexibility and Kink Test	Device met the acceptance criteria.
Torque Strength	Device met the acceptance criteria.
Balloon Preparation	Device met the acceptance criteria.
Catheter Body Burst Pressure	Device met the acceptance criteria.
Guidewire Compatibility	Device met the acceptance criteria. (Compatible with guidewires with a maximum diameter of 0.035").
Introducer Sheath Compatibility	Device met the acceptance criteria. (Compatible with 5, 6 or 7 FR introducer sheaths, depending on the diameter/length of the dilatation balloon).
Radiopacity	Device met the acceptance criteria.
Coating Lubricity	Device met the acceptance criteria.
Coating Durability	Device met the acceptance criteria.
Biocompatibility	Requirements were previously met with the predicate device according to ISO 10993 and FDA Blue Book Memorandum #G95-1. (No new materials were used).

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

Sample Size for Test Set: This document does not specify the exact sample sizes used for each of the verification tests. These would typically be determined by engineering and statistical principles relevant to device testing (e.g., number of units tested for burst strength, fatigue, etc.).
Data Provenance: The testing appears to be internal verification testing performed by the manufacturer (Invatec S.p.A.). The country of origin of the data would therefore be Italy (where Invatec S.p.A. is located). This is prospective testing, as it was conducted specifically for this submission to verify the performance of the modified device.

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

Not Applicable. This is a physical medical device. "Ground truth" in the context of expert consensus, as typically applied to AI or diagnostic image analysis, is not relevant here. The "ground truth" for these engineering tests are established physical standards, measurements, and specifications.

4. Adjudication Method for the Test Set

Not Applicable. As explained above, this is physical device testing, not a clinical study requiring expert adjudication of outcomes or diagnostic findings. The results are based on objective measurements against predefined engineering specifications.

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 submission is for a physical medical device (PTA balloon catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI-related effectiveness metrics are not relevant.

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

Not Applicable. As above, this is not an AI algorithm.

7. The Type of Ground Truth Used

Engineering Specifications and Standards: The "ground truth" for this device's performance is based on established engineering specifications, industry standards (e.g., ISO 10993 for biocompatibility), and regulatory requirements. For example, balloon burst strength is measured against a specified pressure value, and dimensions are checked against design blueprints.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI algorithm that requires a "training set."

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

Not Applicable. As above, this is not an AI algorithm.

Summary

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K100921

APR 3 0 2010

510(k) Summary

This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c).

Applicant:

Invatec S.p.A. Via Martiri della Libertá, 7 25030 Roncadelle (Brescia) Italy Peter Muster PhD, VP QA & RA Invatec S.p.A. Tel: +39 030 258 93 11 Fax: +39 030 258 93 12 Email: Peter.Muster@invatec.com

Contact Person:

Invatec Inc., US Emrick Blvd. 3101, Suite 113 Bethlehem, PA 18020 Tel: (610) 625-1429 Fax: (610) 625-1436 Email: john.clay@invatec-us.com

John Clay, Director, RA&QA

April 1, 2010 Date Prepared:

Device Information

Trade Name:	ADMIRAL XTREMET™ PTA Balloon Dilatation Cathete
Common Name:	Percutaneous Transluminal Angioplasty Catheter
Regulation Name:	Percutaneous Catheter

Predicate Device

Invatec ADMIRAL XTREME™ PTA Catheter (K062809)

Device Description

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provided with a hydrophilic coating and is available in useable catheter lengths of 40cm, 80cm and 120cm.

Modified Device Description

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter includes additional balloon lengths of 150 mm, 200 mm, 250 mm and 300 mm. The modified ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is manufactured from the same materials as the predicate ADMIRAL XTREME™ PTA Catheter and has the same Intended Use.

Indication for Use

Technological Characteristics

The ADMIRAL XTREME™ PTA Balloon Dilatation Catheter has the same or similar design, materials and fundamental technology as the previously cleared ADMIRAL XTREME™ PTA Catheter. This modification provides the user with longer balloon lengths to be used in the peripheral arteries.

Performance Testing and Safety

Verification testing of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter demonstrated that the device met the acceptance criteria. Verification testing included catheter and balloon dimensional testing, minimum balloon burst strength (RBP), balloon compliance, balloon inflation and deflation time, balloon fatigue, tensile strength, flexibility and kink test, torque strength, balloon preparation, catheter body burst pressure, guidewire compatibility, introducer sheath compatibility, radiopacity, coating lubricity and coating durability.

There are no new materials used in the manufacture of the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter. Biocompatibility requirements were previously met with the predicate device according to ISO 10993: Biological Evaluation of Medical Devices and the FDA Blue Book Memorandum #G95-1.

Conclusion

Based on the same intended use, similar technological characteristics, and performance characteristics, the ADMIRAL XTREME™ PTA Balloon Dilatation Catheter is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. Inside the circle is a stylized image of an eagle or bird with outstretched wings. The bird is facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 3 0 2010

Invatec S.p.A c/o Peter Muster, Ph.D. Vice President, Quality and Regulatory Via Martiri della Liberta, 7 Roncadelle (Brescia), Italy 25030

Re: K100921

Trade/Device Name: ADMIRAL XTREME™ PTA Balloon Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: April 01, 2010 Received: April 02, 2010

Dear Dr. Muster:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 – Dr. Peter Muster

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r rouse of 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 or any I edelar state as a 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 n you attp://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note and regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

R. V. hmin

Image /page/3/Picture/7 description: The image shows a handwritten symbol or character. It appears to be a cursive letter, possibly a stylized 'f' or 'h', with a loop at the top and a stroke extending to the right at the bottom. The character is drawn with thick lines, suggesting it was written with a pen or marker.

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): K100921

Device Name: ADMIRAL XTREME™ PTA Balloon Dilatation Catheter

Indications for Use:

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Turner

Page 1 of |

ision of Cardiovascular Devices

510(k) Number_K10092 |

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).