The Coeur syringe is a six piece device (plunger jacket, barrel, retainer, dust cap, fill tube) which is used in conjunction with power injectors to inject diagnostic fluids associated with angiographic procedures. In particular, the plunger jacket acts as the seal when the plunger is moved to aspirate or inject the contrast media solution. This premarket notification describes the modification to the Coeur syringe, which is a material change to the plunger jacket. The new material Coeur intends to use for the plunger jacket is chlorobutyl.

AI/ML Overview

This document is a 510(k) summary for a medical device submitted to the FDA, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the same way a new drug or novel medical device might.

Based on the provided text, the acceptance criteria and study information are quite limited, as the submission focuses on a material modification to an existing device (changing the plunger jacket material from natural rubber to chlorobutyl). The performance evaluation is primarily comparative to the original device.

Here's an attempt to extract and interpret the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Functional Performance	Perform as well as natural rubber (current material for plunger jacket).	"Pre-sterilization test results passed all test criteria."
	Maintain intended function with Medrad Mark II, III, and IV Angiographic Injectors.	"functional performance of the chlorobutyl plunger jacket within the Coeur syringe" was evaluated. "At this time the chlorobutyl material performs as well as natural rubber".
Biocompatibility	Acceptable biocompatibility for chlorobutyl material.	"Biocompatability testing has been conducted on the chlorobutyl material and all test results are acceptable."
Sterilization	Withstand Ethylene Oxide gas sterilization with acceptable post-sterilization functional performance.	"Currently the test product is being sterilized so that post sterilization functional performance can be evaluated." (This indicates it was in progress at the time of the summary, but the final FDA clearance implies it was found acceptable.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The text mentions "Pre-production testing" and "the test product," but does not specify the number of syringes or tests conducted.
Data Provenance: Not explicitly stated, but implied to be internal testing conducted by Coeur Laboratories, Inc. (the manufacturer). This would be considered retrospective testing of internal manufacturing and material changes. There is no mention of country of origin for the data, but the company is based in Raleigh, NC, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable/Not mentioned. This type of submission (material change to a syringe) does not typically involve expert consensus to establish "ground truth" in the way clinical diagnostic devices do. The "truth" is established by adherence to functional and biocompatibility standards.

4. Adjudication Method for the Test Set

Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic accuracy, which is not the focus here. The performance was assessed against predefined functional and biocompatibility criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study is not relevant for a material change to a syringe. MRMC studies are used for diagnostic accuracy involving human readers interpreting images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device (syringe), not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering and biocompatibility standards and benchmarks, specifically comparing the chlorobutyl material's performance to the previously used natural rubber, and ensuring it meets established functional requirements for angiographic syringes, along with acceptable biocompatibility profiles according to recognized tests. This is a conformance to specifications approach rather than a diagnostic "ground truth."

8. The Sample Size for the Training Set

Not applicable/Not mentioned. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not mentioned. See point 8.

Summary

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Konniz

Image /page/0/Picture/1 description: The image shows the logo for Coeur Laboratories Inc. The logo consists of a stylized heart-shaped symbol on the left, followed by the word "COEUR" in bold, sans-serif font. A registered trademark symbol is placed to the upper right of the word. Below "COEUR" is the text "LABORATORIES INC" in a smaller, sans-serif font.

OCT - 8 1997

510(k) Summary Coeur 130ml Syringe with Chlorobutyl Material April 30, 1997

Official Contact:	Christine L. Panzl, Manager Quality Assurance
	Coeur Laboratories, Inc.
	5301 Departure Drive
	Raleigh, NC 27616

Proprietary Name: Coeur 130ML Angiographic Syringe

Common Name: Syringe

Classification Name: Syringe, Angiographic

Predicate Devices: Coeur 130ML Angiographic Syringe

Device Description:

Intended Use:

USE: for use with Medrad Mark II, III and IV Angiographic Injectors.

Technological Characteristics:

Materials: The Coeur 130ml syringe contains all plastic components molded from chlorobutyl, polycarbonate, polyethylene, and polypropylene.

Packaging/Sterilization: The syringe is individually packaged in a blister tray with Tyvek lid. A case of 50 syringes are sterilized with Ethylene Oxide gas.

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Performance Test Data/Conclusions:

Pre-production testing was conducted to evaluate functional performance of the chlorobutyl plunger jacket within the Coeur syringe. Pre-sterilization test results passed all test criteria. Currently the test product is being sterilized so that post sterilization functional performance can be evaluated.

Biocompatability testing has been conducted on the chlorobutyl material and all test results are acceptable.

At this time the chlorobutyl material performs as well as natural rubber, which is the current material for the plunger jacket. Functional testing and biocompatability testing have been completed and results are acceptable.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

OCT - 8 1997

Ms. Christine L. Panzel Ouality Assurance Manager Coeur Laboratories, Inc. 5301 Departure Drive Raleigh, North Carolina 27604

Re : K971712 Coeur 130ml Angiographic Syringe Regulatory Class: II (two) Product Code: DXT September 17, 1997 Dated: September 22, 1997 Received:

Dear Ms. Panzel:

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 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 reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Regulations, 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.

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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) 594-4648. 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/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

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

Enclosure

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510(k) Number (if known):__ K971712

Coeur 130 ML Angiographic Syringe Device Name:

Indications For Usc:

For use with Medrad Mark II, III,and IV Angiographic Injectors.

T A-R

(Division Sigr .- Off) Division of are ovascular, Respiratory, and Noordogical Devices

1971 510(k) Numocr ________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.