COEUR 130 ML ANGIOGRAPHIC SYRINGE

K971712 · Coeur Laboratories, Inc. · DXT · Oct 8, 1997 · Cardiovascular

Device Facts

• Record ID: K971712
• Device Name: COEUR 130 ML ANGIOGRAPHIC SYRINGE
• Applicant: Coeur Laboratories, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

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

Device Story

The Coeur 130ML Angiographic Syringe is a six-piece disposable device consisting of a plunger jacket, barrel, retainer, dust cap, and fill tube. It is designed for use with power injectors (Medrad Mark II, III, and IV) to aspirate and inject contrast media during angiographic procedures. The plunger jacket serves as the primary seal for the plunger. This modification introduces chlorobutyl as the material for the plunger jacket, replacing natural rubber. The device is used in clinical settings by healthcare professionals. It functions as a fluid delivery component, ensuring proper sealing and pressure management during contrast media administration, thereby facilitating diagnostic imaging.

Clinical Evidence

Bench testing only. Pre-production functional performance testing of the chlorobutyl plunger jacket was conducted. Biocompatibility testing of the chlorobutyl material was completed with acceptable results. The device was evaluated against the performance of the natural rubber plunger jacket used in the predicate device.

Technological Characteristics

Six-piece syringe assembly (plunger jacket, barrel, retainer, dust cap, fill tube). Materials: chlorobutyl, polycarbonate, polyethylene, and polypropylene. Sterilization: Ethylene Oxide gas. Packaging: Blister tray with Tyvek lid. Mechanical operation via power injector.

Indications for Use

Indicated for use with Medrad Mark II, III, and IV Angiographic Injectors for the delivery of diagnostic fluids during angiographic procedures.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Coeur 130ML Angiographic Syringe (K971712)

Submission Summary (Full Text)

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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:

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.

## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)