CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER by CORDIS CORP.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way modern AI/software device submissions would.

This document is a 510(k) premarket notification for a medical device (Cordis Maxi LD Large Diameter Balloon Dilatation Catheter) from the year 2000. For devices of this type and era, the FDA approval process primarily focused on demonstrating substantial equivalence to a predicate device already on the market, rather than a detailed performance study with quantifiable acceptance criteria for a novel algorithm.

Therefore, many of the requested details related to AI/software device studies (like performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are not applicable and not present in this document.

Here's a breakdown of what information can be extracted and what is explicitly not available from the provided text, in the context of the questions asked:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for this 510(k) submission was demonstrating substantial equivalence to predicate devices through pre-clinical testing.
Reported Device Performance: The document states "The equivalence was confirmed through pre-clinical testing." No specific performance metrics (e.g., dilatation force, burst pressure, etc.) or their results are provided in this summary.

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

Not Applicable/Not Available. The document refers to "pre-clinical testing" but does not provide details on the sample size of subjects, cases, or the nature of this testing (e.g., in-vitro, animal, human). No information on data provenance (country of origin, retrospective/prospective) is given.

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

Not Applicable/Not Available. This concept is relevant for AI/software devices where expert consensus often establishes truth. For this mechanical device, "ground truth" would be related to physical properties measured in a lab, not expert interpretations of data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable/Not Available. This is a method for resolving discrepancies in expert labeling for AI/software device ground truth. It's not relevant to the submission for a balloon catheter.

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

No. This is a mechanical device, not an AI/software device. MRMC studies are not applicable.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable/Not Available. For this type of device, "ground truth" would relate to objectively measured physical and mechanical properties from pre-clinical testing (e.g., burst pressure measured by instrumentation, dimensions measured by calipers). The document does not specify these.

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI/software device that requires a training set.

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

Not Applicable. As no training set exists, this question is not relevant.

In summary, the provided document is a 510(k) clearance letter for a conventional medical device (esophageal dilator balloon catheter) based on substantial equivalence as of January 2000. It does not contain the detailed performance study information, acceptance criteria, or AI/software-specific elements requested in the prompt.

Summary

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

K993720

JAN 1 8 2000

Summary of Safety and Effectiveness

General Provisions

The name of the device is:

Proprietary Name	Common or Usual Name
Cordis Maxi LD Large Diameter Balloon Dilatation Catheter	Esophageal Dilator

Name of Predicate Devices

The device is substantially equivalent to:

Cordis Maxi LD PTA Balloon Catheter
Boston Scientific XXL Balloon Dilatation Catheter

Classification	Class II.
Performance Standards	Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Indications for Use	The intended use of the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is for the dilatation of strictures of the esophagus.
Device Description	The device is an over the wire balloon catheter, with a distal balloon and a proximal hub. The balloon features two radiopaque marker bands.
Biocompatibility	All materials used in the Cordis Maxi LD Large Diameter Balloon Dilatation Catheter are biocompatible.
Summary of Substantial Equivalence	The Cordis Maxi LD Large Diameter Balloon Dilatation Catheter is substantially equivalent to the predicate devices. The equivalence was confirmed through pre-clinical testing.

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

Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

JAN 1 8 2000

Ms. Ariel MacTavish, RAC Manager Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

Re: K993720

Cordis Maxi LD Large Diameter Balloon Dilatation Catheter for the Esophaqus Dated: November 1, 1999 Received: November 3, 1999 Regulatory Class: II 21 CFR §876.5365/Procode: 78 KNQ

Dear Ms. MacTavish:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use Statement

510(k) Number(if known)	K993720
Device Name	Cordis Maxi LD Large Diameter Balloon Dilatation Catheter
Indications forUse	The intended use of the Cordis Maxi LD Large Balloon DilatationCatheter is for the dilatation of strictures of the esophagus.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K993720

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Cordis Maxi LD Large Diameter Balloon Dilatation Catheter November, 1999

Regulation Number and Section

§ 876.5365 Esophageal dilator.

(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.