The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloonexpandable and self-expanding stents in the peripheral vasculature.

Device Description

The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distal DURALYN™ inflatable balloon. The catheter utilizes a Rapid Exchange design, consisting of a single inflation lumen and a distal guide wire lumen. The guide wire lumen begins at the distal tip and terminates at the guide wire exit port. The guide wire exit port (hole) is approximately 25 cm from the distal tip. The maximum guide wire diameter that may be used is printed on the package label. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. The balloon is inflated by injecting diluted contrast medium through this hub. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement. The nominal balloon diameter and length are printed on the identification band near the hub. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. Consult the compliance table incorporated with the product, for diameters of the balloon at given pressures. The design of this catheter does not incorporate a lumen for distal dye injection. The balloon catheter with a usable shaft length of 142 cm has two proximal shaft markers (90 cm and 100 cm from the distal tip). Both indicate the relative position of the catheter tip to the distal end of the guiding catheter. An additional marker is located at the distal port exit notch and aids in locating the guide wire exit.

AI/ML Overview

The provided text describes the Cordis AMIIA PTA Balloon Dilatation Catheter and its substantial equivalence to predicate devices, focusing on its intended use and safety. It does not contain information about specific acceptance criteria, device performance metrics, or a formal study with a test set, ground truth, or statistical analysis (like MRMC studies) as requested in the prompt. The document explicitly states that "No biocompatibility test was required, as the original device has not changed and there was no change in the vascular application of the device" and that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses." This suggests that the approval was based on engineering and design verification rather than a clinical performance study with human subjects.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is an attempt to answer the questions based only on the provided information, noting where information is absent:

A table of acceptance criteria and the reported device performance
The document does not explicitly list quantitative acceptance criteria or reported device performance metrics from a formal study. It broadly states that safety and effectiveness were demonstrated through "non-clinical design verification tests and analyses."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable (N/A). The document indicates that safety and effectiveness were demonstrated via "non-clinical design verification tests and analyses" rather than a clinical test set. No sample size for a test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable (N/A). There is no mention of experts or ground truth establishment for a test set. The approval is based on substantial equivalence and non-clinical design verification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable (N/A). No test set requiring adjudication is mentioned.
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 (N/A). The device is a physical medical catheter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable (N/A). The device is a physical medical catheter, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable (N/A). The document refers to "non-clinical design verification tests and analyses" for safety and effectiveness, implying engineering and performance specifications rather than clinical ground truth like pathology or outcomes data. The basis for approval is substantial equivalence to predicate devices.
The sample size for the training set
Not applicable (N/A). No training set is mentioned as this is a physical medical device.
How the ground truth for the training set was established
Not applicable (N/A). No training set or associated ground truth establishment is mentioned.

Summary

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		K063563p. 1 of 3
		FDA 510(k) Notification
		Cordis AMIIA PTA Balloon Dilatation Catheter
Section 3:	510(k) Summary (21 CFR 807.92)		MAR 07 2007
Submitter &Contactperson:	Cordis Europa, N.V.Harm Hovinga, Senior Regulatory Affairs AssociateOosteinde 89301 LJ Roden,The Netherlands
	Tel: +31 50 50 22479Fax: +31 50 50 22456e-mail: hhovinga@crdnl.jnj.com
AlternateContact:	Cordis CorporationJoan Martin, Manager Regulatory Affairs7 Powder Horn DriveWarren, NJ 07059USA
	Tel: (+1) 908 412 7250Fax: (+1) 908 412 3915e-mail: jmartin@crdus.jnj.com
Date Prepared	November 23, 2006.
Trade Name	Cordis AMIIA™ Percutaneous Transluminal Angioplasty (PTA) BalloonDilatation Catheter.
PredicateDevice(s)	The predicate devices for the subject Cordis AMIIA PTA Balloon DilatationCatheter are:> Cordis AMIIA PTA Balloon Dilatation Catheter, which wasdetermined substantially equivalent by FDA (ref. 510(k) number#K050645, dated April 1, 2005).> Boston Scientific Sterling Monorail PTA Balloon DilatationCatheter. This device was determined substantially equivalent by FDA(ref. 510(k) number #K053118, dated December 16, 2005.
Devicedescription	The Cordis AMIIA PTA Balloon Dilatation Catheter is a catheter with a distalDURALYNTM inflatable balloon. The catheter utilizes a Rapid Exchangedesign, consisting of a single inflation lumen and a distal guide wire lumen.The guide wire lumen begins at the distal tip and terminates at the guide wireexit port. The guide wire exit port (hole) is approximately 25 cm from thedistal tip. The maximum guide wire diameter that may be used is printed onthe package label. The catheter tip is tapered to facilitate crossing of tightlesions.The proximal hub is used as a balloon inflation port. The balloon is inflatedby injecting diluted contrast medium through this hub. Two radiopaquemarker bands within the balloon indicate the dilating section of the balloonand aid in balloon placement. The nominal balloon diameter and length areprinted on the identification band near the hub.The working pressure range for the balloon is between the nominal pressureand the rated burst pressure. All balloons distend to sizes above the nominalsize at pressures greater than the nominal pressure. Consult the compliancetable incorporated with the product, for diameters of the balloon at givenpressures. The design of this catheter does not incorporate a lumen for distaldye injection.The balloon catheter with a usable shaft length of 142 cm has two proximalshaft markers (90 cm and 100 cm from the distal tip). Both indicate therelative position of the catheter tip to the distal end of the guiding catheter.An additional marker is located at the distal port exit notch and aids inlocating the guide wire exit.

Classification Name & Device Classification

Classification Name: Percutaneous Catheter (21 CFR 870.1250) Classification: Class II FDA Classification Panel: Cardiovascular Product Code: LIT 1

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FDA 510(k) Notification

Cordis AMIIA PTA Balloon Dilatation Catheter

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FDA 510(k) Notification Cordis AMIIA PTA Balloon Dilatation Catheter The Cordis AMIIA PTA Balloon Dilatation catheter is intended for Intended Use Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature. The safety and effectiveness of the subject Cordis AMIIA PTA Balloon Safety and Dilatation Catheter has been demonstrated via data collected from non-Performance clinical design verification tests and analyses. No biocompatibility test was Data required, as the original device has not changed and there was no change in the vascular application of the device [circulating blood contact with limited duration (< 24h.)]. In summary, the subject Cordis AMIIA PTA Balloon Dilatation Catheter is, Substantial in our opinion, substantial equivalent to the predicate devices with respect to Equivalence intended use, materials, fundamental design and technology, sterility and operating principles. A statement of substantial equivalence to another product is required by 21 Substantial CFR 807.87 and relates only to whether the present product can be marketed Equivalence without prior reclassification or clinical approval. Statement The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated: "A determination of substantial 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 determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2007

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

Re: K063563

Trade/Device Name: Cordis AMIIA PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: February 8, 2007 Received: February 9, 2007

Dear Mr. Hovinga:

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.

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.

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Page 2 - Mr. Harm Hovinga

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 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

R. buhnes

A 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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FDA 510(k) Notification

Cordis AMIIA PTA Balloon Dilatation Catheter

Section 2: Intended Use Statement Page 1 of 1

510(k) Number (if known): K063563

Device Name:

Cordis AMIIA PTA Balloon Dilatation Catheter

Indications for Use Statement

Prescription Use:_ X

OR Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Va. Lunes

rdiovascular Devices

(K) Number_

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).