HEART CATH TRAY, STERILE, DISPOSABLE by TRINITY LABORATORIES, INC.

Trinity's Heart Cath Tray is a sterile prepackaged disposable unit. It contains the non-reinforced gowns, femoral angio drape, OR cloth towels, absorbent towels, 16 oz sponge bowl, 32 oz sponge bowls, bowl guidewire with lid, 2 oz medicine cups, gauze sponges, straight mosquito forceps, 25 ga x 5/8" needle, 22 ga x 1 1/2" needle, 5cc L/L syringe, 10cc L/L syringe, 20cc L/L syringe, 10cc L/S syringes, towel clips, #11 blade scalpel, table cover, and band bag, neccessary for the performance of the Heart Cath surgical procedure..

Device Description

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Heart Cath Tray". It is not a study report or a technical document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which means its safety and effectiveness are considered to be similar to devices already on the market. However, it does not provide details of specific performance criteria or the results of a study to demonstrate those criteria.

To answer your questions, I would need a technical report, a clinical study summary, or a comprehensive PMA/510(k) submission that details the performance data and acceptance criteria for the device.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 1998

Ms. Partha Basumallik Trinity Laboratories, Inc. 201 Kiley Drive P.O. Box 1818 Salisbury, MD 21802

Re: K981441 Heart Cath Tray, Sterile, Disposable Cat. No. 70350 Regulatory Class: II (two) Product Code: 74 DQO Dated: April 16, 1998 Received: April 21, 1998

Dear Ms. Basumallik:

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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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.

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Page 2 - Ms. Partha Basumallik

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,

Thomas J. Callahan

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

Enclosure

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Page 1 Of _1

510 (k) Number (if Known): _

Device Name: Heart Cath Tray

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻠﺴﻢ

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use _

(Optional Format 1-2-96)

Tk. A. R

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K981441

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).