The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038".

AI/ML Overview

The provided text describes a submission for a medical device, the "Cordis Tempo™ Angiography Catheters," seeking clearance through the 510(k) pathway. This pathway establishes substantial equivalence to a predicate device rather than proving novel efficacy through detailed performance studies with acceptance criteria in the typical sense for an AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (like sample size for test sets, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission.

However, I can extract the relevant information regarding the device's intended use and the predicate device it is compared against, which serves as the "acceptance criteria" in a substantial equivalence context.

Here's the information formatted as requested, with "N/A" for inapplicable fields:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from Predicate Device)	Reported Device Performance (Cordis Tempo™ Angiography Catheters)
Intended Use: Delivery of radiopaque contrast medium to selected sites in the vasculature.	Intended Use: Delivery of radiopaque contrast medium to selected sites in the vasculature. (Matches predicate)
Device Description (Predicate - K973401): Cordis Tempo Catheters (65 to 125 cm length).	Device Description (New Device): Cordis Tempo™ Angiography Catheters (40 to 125 cm length). (Extended length range while maintaining core design and materials)
Materials: Polyamide (body, intermediate, distal tip), Polyurethane (brite tip), proximal strain relief and hub. Biocompatible.	Materials: Polyamide (body, intermediate, distal tip), Polyurethane (brite tip), proximal strain relief and hub. Biocompatible. (Matches predicate)
Compatibility: Compatible with Guidewires with diameters of 0.035" and 0.038".	Compatibility: Compatible with Guidewires with diameters of 0.035" and 0.038". (Matches predicate)
Classification: Class II.	Classification: Class II. (Matches predicate)
Performance Standards: No FDA-established performance standards under section 514 (implied for predicate to be accepted).	Performance Standards: No FDA-established performance standards under section 514. (Consistent with predicate)
Safety: General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding/adulteration).	Safety: Assumed compliance with Current Good Manufacturing Practice requirements (21 CFR Part 820). General controls provisions apply. (Implied by clearance)

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" is a 510(k) Premarket Notification submission, which establishes substantial equivalence to a previously cleared predicate device.

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

Sample Size: N/A (This is a 510(k) submission for a physical medical catheter, not an AI/ML device requiring a test set of data samples for algorithm performance validation).
Data Provenance: N/A

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

Number of Experts: N/A
Qualifications of Experts: N/A

4. Adjudication method for the test set:

Adjudication Method: N/A

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:

MRMC Study: No.
Effect Size: N/A

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

Standalone Performance Study: No.

7. The type of ground truth used:

Ground Truth Type: N/A. The "ground truth" for this submission is the established safety and effectiveness profile of the predicate device (Cordis Tempo™ Angiography Catheters, K973401), to which the new device is compared for substantial equivalence.

8. The sample size for the training set:

Training Set Sample Size: N/A

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

Ground Truth for Training Set: N/A

Summary

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MAY 2 6 jggg

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Attachment 4

Summary of Safety and Effectiveness

GeneralProvisions	Trade Name: Cordis Tempo™ Angiography CathetersCommon/Classification Name: Diagnostic Intravascular Catheter
Name ofPredicateDevices	Cordis Tempo™ Angiography Catheters (K973401)
Classification	Class II.
PerformanceStandards	Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
Intended Useand DeviceDescription	Cordis Tempo Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.The device description of Cordis Tempo Angiography Catheters is as follows:The Tempo catheters are single lumen catheters consisting of Polyamide (body, intermediate and distal tip) and Polyurethane (brite tip) materials with a proximal strainrelief and hub. The catheters are available in various diameters and tip configurations. They are compatible with Guidewires with diameters of 0.035" and 0.038".
Biocompatibility	All materials used in the Tempo Angiographic Catheters are biocompatible.
Summary ofSubstantialEquivalence	The Cordis Tempo™ Angiography Catheters (40 to 125 cm length) are substantially equivalent to the previously cleared Cordis Tempo Catheters (65 to 125 cm length).

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. 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 three lines representing its wings and body. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 1999

Ariel MacTavish, RAC Sr. Requlatory Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014

K991673 Re :

4F Tempo™ Angiography Catheters Trade Name: Requlatory Class: II Product Code: DQO Dated: May 14, 1999 Received: May 17, 1999

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 (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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Reqister. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices

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Page 2 - Ms. Ariel MacTavish

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) 594-4586. 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" (21CFR 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number (if known)
Device Name	Tempo TM Angiography Catheter
Indications for Use	Cordis Tempo TM Angiography Catheters are intended for the delivery of radiopaque contrast medium to selected sites in the vasculature.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ohiton Smith Ar TC

Divisi and N 510(k)

Prescription Use __
(Per 21 CFR 801.109)

Over-The-Counter Use_

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).