(152 days)
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No
The description focuses on a material change to a syringe component and functional testing, with no mention of AI or ML.
No.
The document describes the device as a syringe used for injecting diagnostic fluids, not for treating a disease or condition. The focus is on a material change to a component of the syringe.
No
The device is a syringe used to inject diagnostic fluids, but it is not itself a diagnostic device; it is a tool for administering substances related to diagnostic procedures.
No
The device description clearly outlines a physical, multi-component syringe with a material change to one of its parts (the plunger jacket). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use with Medrad Mark II, III,and IV Angiographic Injectors" to "inject diagnostic fluids associated with angiographic procedures." This describes a device used to deliver substances into the body for imaging purposes, not a device used to examine specimens from the body to diagnose conditions.
- Device Description: The description focuses on the mechanical function of the syringe in injecting fluids. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Detecting or measuring specific substances (analytes) in these specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on the analysis of specimens.
The device is clearly intended for use in a medical imaging procedure (angiography) to facilitate the visualization of blood vessels by injecting contrast media. This falls under the category of medical devices used for diagnostic imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
For use with Medrad Mark II, III,and IV Angiographic Injectors.
Product codes (comma separated list FDA assigned to the subject device)
DXT
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Coeur 130ML Angiographic Syringe
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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:
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.
1
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.
2
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)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)