The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and.for the treatment of lomoral, popilisal, mostive or synthetic arteriovenous dialysis fistulae.

Device Description

The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. The Cordis I Info I I T I causs indicate the dilatation section of the balloon description I wo facilopaque marker bands the balloon dimensions are indicated on the and ald in banoon pracements eter configuration has two proximal shaft nub 1D band. The 112 cm cm from the distal tip to indicate the relative markers at 90 cm and 100 on fistal end of the guiding catheter. An additional position of the catheror to the dist. exit and aids in locating the exit location of the guide wire. the guide wire. A flushing needle is packaged with the catheter as an accessory for flushing A husining necure is packaged with use as indicated in the Instructions for Use

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study proving that the Cordis AMIIA .014" PTA Balloon Catheter meets specific acceptance criteria. The document is a 510(k) summary primarily focused on establishing substantial equivalence to predicate devices (Cordis AVIATOR and Cordis M3 PTA Balloon Catheters).

However, it does mention some general information related to device validation:

Device performance: The "Safety and Performance Data" section states that the safety and effectiveness were "demonstrated via data collected from non-clinical design verification tests and analyses." It also states that "all materials used in this modified device have been verified according to the 1993-Part 1 and were found biocompatible."
Intended Use: The device is intended to "dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and for the treatment of native or synthetic arteriovenous dialysis fistulae."
Substantial Equivalence: The primary "proof" of the device's market readiness is its substantial equivalence to previously approved predicate devices, not through a separate study against established performance acceptance criteria.

Therefore, I cannot populate the requested table or answer most of the questions because the document does not provide this specific information. It focuses on demonstrating equivalence rather than detailed performance metrics against specific acceptance criteria.

Summary of what cannot be provided from the text:

Table of acceptance criteria and reported device performance: Not present.
Sample size and data provenance for test set: Not present. The testing mentioned is "non-clinical design verification tests and analyses."
Number and qualifications of experts for ground truth: Not applicable/present.
Adjudication method for test set: Not applicable/present.
MRMC comparative effectiveness study: Not mentioned.
Standalone algorithm performance: Not applicable (this is a physical medical device, not an AI algorithm).
Type of ground truth used: Not applicable in the context requested. The "ground truth" for this device would be its physical properties and biocompatibility, verified against standards.
Sample size for training set: Not applicable (not an AI algorithm).
How ground truth for training set was established: Not applicable.

Summary

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FDA Special 510(k) Notification

Koso645

Cordis AMIIA .014" PTA Balloon Catheter

Attachment B:

510(k) Summary of Safety and Effectiveness

Submitter & Contact person:	Cordis Europa, N.V., a Johnson & Johnson CompanyHarm Hovinga,Oosteinde 8NL-9300 LJ Roden,The NetherlandsTel: +31 (5050) 22479Fax: +31 (5050) 22456e-mail: hhovinga@crdnl.jnj.com
Date Prepared	March 11, 2005
Trade Name	Cordis AMIIA™ Percutaneous Transluminal Angioplasty (PTA) Catheter
Classification Name & Device Classification
Classification Name:	Percutaneous Catheter (21 CFR 870.1250)
Classification:	Class II
FDA Classification Panel:	Cardiovascular
Product Code:	LIT
Predicate Device(s)	The predicate devices in this submission are the Cordis AVIATOR (510(k) #K013581) and the Cordis M3 PTA Balloon Catheters (510(k) #K003920,which have been determined substantial equivalent on November 28, 2001 and June 15, 2001 respectively.

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FDA Special 510(k) Notification Cordis AMIIA .014" PTA Balloon Catheter The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. Device The Cordis I Info I I T I causs indicate the dilatation section of the balloon description I wo facilopaque marker bands the balloon dimensions are indicated on the and ald in banoon pracements eter configuration has two proximal shaft nub 1D band. The 112 cm cm from the distal tip to indicate the relative markers at 90 cm and 100 on fistal end of the guiding catheter. An additional position of the catheror to the dist. exit and aids in locating the exit location of the guide wire. the guide wire.

A flushing needle is packaged with the catheter as an accessory for flushing A husining necure is packaged with use as indicated in the Instructions for Use The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, Intended Use The Cordils AMILA I Pre catalogin fra popliteal and renal arteries and for the temoral, ino-remoral; popilious of native or synthetic arteriovenous dialysis fistulae. The safety and effectiveness of the subject Cordis AMIIA PTA Balloon Safety and The Safety and Criocavonstrated via data collected from non-clinical design Performance Calletel has been demonstrated 11 materials used in this modified device have Data vertification tests and analyses. 1993-Part 1 and were found biocompatible. In summary, the subject Cordis AMIIA PTA Catheter is, in our opinion, Substantial In summal y, the subject Cordis devices with respect to intended Equivalence substantial equivalent to the prechedle O, sterility and operating principles.

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FDA Special 510(k) Notification

Cordis AMIIA .014" PTA Balloon Catheter

A statement of substantial equivalence to another product is required by Substantial 21 CFR 807.87 and relates only to whether the present product can be Equivalence marketed without prior reclassification or clinical approval. Statement The present submission is therefore not related to the coverage of any I he present submission serpreted as an admission or used as evidence in patcht and is not to not lawsuit. As the commissioner of the FDA stated: a patcht mirringement in equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The lawraily markees a t intended to have any bearing whatsoever on the deter inmation is not infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2005

Cordis Europa N.V. c/o Mr. Harm Hovinga Senior Regulatory Affairs Associate Oosteinde 8, 9301 LJ Postbus 38, 9500 AA Roden The Netherlands

Re: K050645

AMIIA .014" PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: March 11, 2005 Received: March 14, 2005

Dear Mr. Hovinga:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) it the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, are except and entitle provisions of the Federal Food, Drug, devices mat nave occh receasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provision gractice, 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 If your device is chassified (over as a virols. Existing major regulations affecting your device can may oc subject to sach address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous ocements concerning your device in the Federal Register.

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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 or any i 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. production 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 (301) 594-4648. 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bimmerman for

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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APPENDIX A:

Indications for Use

K050645 510(k) Number (if known):

Cordis AMIA PTA Catheter 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)

Blumena

Sign-Off) Division of Cardiovascular Devices 510(k) Number Kosovati

Page 1 of 1

0019

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).