The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

Device Description

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is an over-thewire percutaneous transluminal angioplasty (PTA) catheter consisting of a proximal hub, coaxial dual lumen shaft, and a distal dilatation balloon. Hydrophilic coating covers the distal 240 mm of the catheter and radiopaque markers indicate the proximal and distal dilating surface of the balloon and facilitate placement across the stenosis. The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is compatible with 4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than a standalone study with specific acceptance criteria and detailed performance data often found in AI/Reader studies.

Therefore, many of the requested categories (2, 3, 4, 5, 7, 8, 9) are not applicable or cannot be extracted from this type of regulatory submission. The information provided primarily pertains to the general performance data and conclusion.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Bench test acceptance criteria for the device	Demonstrated that the device could meet the bench test acceptance criteria, and was comparable to the predicate devices.
Biocompatibility testing in accordance with ISO 10993-Part 1	Biocompatibility testing was previously performed in accordance with ISO 10993-Part 1 (for related devices, as this is a new model/length).

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

Not applicable. This is a 510(k) submission based on bench testing and comparison to predicate devices, not a clinical study on a test set of data.

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

Not applicable. No expert ground truth establishment for a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No test set adjudication is mentioned.

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 physical medical device (balloon catheter), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device. The device (catheter) performance was evaluated via bench testing.

7. The type of ground truth used

For bench testing, the "ground truth" would be established engineering specifications, performance standards, and the performance characteristics of the predicate devices. The study compares the new device's physical and mechanical properties against these established benchmarks.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The design, materials, and fundamental technology are stated to be "same or similar" to previously cleared devices.

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

Not applicable. There is no "ground truth for a training set" as it's not an AI/machine learning device.

Summary

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K083914

MAR 13 2009

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, 725030 Roncadelle (Brescia) ItalyPeter Muster PhD, VP QA & RA Invatec S.p.ATel: +39 030 258 93 11Fax: +39 030 258 93 12Email: Peter.Muster@invatec.com
Contact Person:	Steve Camp, VP QA&RAInvatec Inc., USEmrick Blvd. 3101, Suite 113Bethlehem, PA 18020Tel: (610) 625-1402Fax: (610) 625-1436Email: steve.camp@invatec-us.com
Date Prepared:	December 30, 2008

Device Information

Trade Name:	AMPHIRION DEEP 0.014"OTW PTA Balloon DilatationCatheter
Common Name:	Percutaneous Transluminal Angioplasty Catheter
Regulation Name:	Percutaneous Catheter

Predicate Devices

Invatec AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters . (K042624, K050073 & K052791)
Clearstream Technologies SLEEK PTA Catheter (K072947) .

Device Description

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4 F introducer catheters and 0.014" diameter guidewires. The catheter is provided with useable catheter lengths of 120 cm and 150 cm.

Indication for Use

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

Technological Characteristics

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter has the same or similiar design, materials and fundamental technology as the previously cleared AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, and balloon lengths similar to the predicate Clearstream Technologies SLEEK PTA Catheter.

Performance Data

Bench testing of the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter demonstrated that the device could meet the bench test acceptance criteria, and was comparable to the predicate devices. Biocompatibility testing was previously performed in accordance with ISO 10993-Part 1.

Conclusion

Based on similar intended use, technological characteristics, and performance characteristics, the AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2009

Invatec. Inc. c/o Mr. Steve Camp Vice President, Clinical and Regulatory Affairs 3101 Emrick Boulevard, Suite 113 Bethlehem, PA 18020

K083919 Re:

Trade/Device Name: AMPHIRON DEEP 0.014" PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 30, 2008 Received: December 31, 2008

Dear Mr. Camp:

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 for ass surfall 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, devices that have been rout 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 general obtarely provision 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 it may be subject to bach of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can or found in ther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Steve Camp

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 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,

er D. Vachner

$\delta_v$

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

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Indications for Use

510(k) Number (if known): K083919

Device Name: AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheter

Indications for Use:

The AMPHIRION DEEP 0.014" OTW PTA Balloon Dilatation Catheters, with 150 mm and 210 mm balloon lengths, are intended to dilate stenoses in the femoral, popliteal, and infra-popliteal arteries.

× Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dummer 2. Volunt

Page 1 of 1

Division Cinn. a novascular Devices A *** ****

510(K) Number_Ko8391 9

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).