MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER by INVATEC INNOVATIVE TECHNOLOGIES, S.R.L.

The AMPHIRION™ DEEP 0.014" OTW PTA Balloon 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 AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014". The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter. It's a submission to the FDA to demonstrate that the modified device is "substantially equivalent" to an already marketed device, meaning it's equally safe and effective.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Study Details:

The provided document does not detail specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) or a study proving these criteria were met using those metrics. Instead, the document focuses on demonstrating "substantial equivalence" to a predicate device through performance testing (bench testing) and similarity in intended use, materials, and technological characteristics.

Therefore, a table of acceptance criteria and reported device performance, and most of the detailed questions about studies, cannot be directly answered from the provided text as they relate to clinical effectiveness studies with human subjects or AI algorithm performance.

However, based on the available information, we can infer the acceptance criteria for a 510(k) submission of this type:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Description (Inferred)	Reported Device Performance
Substantial Equivalence	The modified device must be substantially equivalent to a legally marketed predicate device in intended use, materials, and technological characteristics.	The document explicitly states: "The modified device is substantially equivalent to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance." This claim is made based on the comparison to the predicate.
Performance (Bench)	The device's physical and functional properties must meet established design specifications and demonstrate performance consistent with its intended use and comparative to the predicate device.	"Performance testing (bench) further supports a substantial equivalence claim." While specific numerical results are not provided, the testing was deemed sufficient to support the claim.
Safety & Effectiveness	The device must be safe and effective for its intended use.	The collective evidence (substantial equivalence in characteristics and performance testing) "provides assurance that the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use."

Important Note: The document focuses on demonstrating substantial equivalence, not on providing efficacy and safety data from clinical trials in the way an AI algorithm or a novel drug might. The "acceptance criteria" here are primarily satisfied by demonstrating that the device is fundamentally the same as a previously approved device.

The following questions relate to performance studies, often associated with AI/ML devices or clinical trials. Since this document is a 510(k) for a physical medical device (a balloon catheter) demonstrating substantial equivalence, these specific types of studies are not described or relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to bench testing, not a clinical test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 a physical medical device, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set from patient data. The "ground truth" for the bench testing would be engineering specifications and predicate device performance.
8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of AI/ML or statistical modeling from data.
9. How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

NOV - 4 2005

Premarket Notification (510(k)) Summary

510(k) Number:	K052791
Product Name:	AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter
Common Name:	Peripheral Transluminal Angioplasty Catheter
Class:	Class II, 21 CFR Sec 870.1250, Product Code DQY
Submitter's Name:	ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442
Official Contact:	Stephanie K. Isgrigg RobinsonRegulatory Affairs SpecialistTelephone: 763-398-7036
Summary Preparation Date:	September 30, 2005

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter

The AMPHIRION™ DEEP 0.014" OTW PTA Balloon 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.

The modified device is substantially equivalent* to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use.

This document uses the term "substantial equivalence" as intended in 21 CFR 807.87. and not as defined in Title 35 of the US Code.

ﺮ

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ev3 Inc. c/o Ms. Stephanie K. Isgrigg Robinson Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442

Re: K052791

Trade Name: AMPHIRION DEEP PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2005 Received: October 03, 2005

Dear Ms. Isgrigg Robinson:

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.

NOV - 4 2005

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.

{2}------------------------------------------------

Page 2 - Ms. Stephanie K. Isgrigg Robinson

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 vr (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

iener R. bochner

Image /page/2/Picture/5 description: The image contains a signature on the left and the letters 'E' and 'I' on the right. The signature appears to be a stylized combination of curved and angular lines. The letters 'E' and 'I' are in a simple, sans-serif font and are positioned next to the signature.

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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Kos279 )

AMPHIRION DEEP™ Peripheral Transluminal Angioplasty (PTA) Balloon Catheter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

DRung R. Vachner

AND/OR

Division Sign-Off) Division ... Cardiovascular Devices

510(K) Number_K6527 41

Page 1 of

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).