(189 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functional performance of a syringe for contrast media injection, with no mention of AI or ML.
No.
The device is a syringe for injecting contrast media or saline, which are substances used to enhance imaging, not for treating a disease or condition.
No
Explanation: The device is a syringe used for injecting contrast media or saline, which are substances used to enhance images in diagnostic procedures. The syringe itself is not designed to diagnose a condition, but rather to administer a substance that may aid in diagnostic imaging.
No
The device description and performance studies clearly indicate this is a physical syringe and associated accessories, not a software-only device. The testing focuses on physical properties, fit, function with injectors, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of contrast media or saline" using specific injectors. This describes a device used in vivo (within the body) for administering substances, not for examining specimens in vitro (outside the body).
- Device Description: The description details syringes and associated components for injection, which aligns with in vivo use.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), diagnostic testing, or any of the typical characteristics of an IVD device.
- Performance Studies: The performance studies focus on the physical and functional characteristics of the syringe and its compatibility with the injectors, not on the accuracy or performance of a diagnostic test.
Therefore, this device is intended for administering substances into a patient, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.
Product codes
DXT
Device Description
The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
i. 125mL Syringe and Fill Tube
ii. 125mL Syringe with Coiled Line and Spike
iii. 2 125mL Syringes with 2 Spikes
iv. 125mL Syringe and Coiled Extension Line
v. 2 125mL Syringes with Extension Y-Line and 2 Spikes
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device, including:
- Visual Verification of the Products Inspection of the product for a. conformance to visual requirements.
- Dimensional Evaluation of the Products Inspection of the product to b. verify dimensional acceptance.
- i. ISO 594-2:1998 Syringe evaluation to dimensional requirements of the ISO 594-2 standard using go/no go gage.
- ii. Injector Fit:
-
- Evaluation of product for fit and function with the Optivantage DH Injector.
-
- Evaluation of product for fit and function with the CT 9000ADV Injector.
-
- iii. Volume Evaluation for volume accuracy when used with injectors.
c. Functional Verification of the Products:
- i. Dynamic testing where the syringe is tested at a minimum of 330psi in simulated injections.
- ii. Failure testing follow dynamic testing, where syringes are pressurized under increasing pressures until failure is observed.
d. Other - i. ISO 594-2:1998 Syringe evaluation to requirements of the ISO 594-2 standard
- ii. ISO 7886-2:1996 Syringe evaluation to applicable requirements of the ISO 7886 standard.
e. Age Verification Based on the packaging and testing of accelerated aged samples, the initial expiration of the device is 2 years. The methods and testing used to support new shelf life claims will be the same as those defined to support the 2-year shelf life identified in the submission
f. Biocompatibility - While the proposed device is made of the same materials in contact with the fluid path as that cleared under K971712, biocompatibility testing was conducted on the device. Other accessories are identical to previously marketed accessories or biocompatibility testing was also conducted.
Clinical Tests Submitted: NA
Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2015
Coeur, Inc. Ms. Erin Rheinscheld Regulatory Analyst 100 Physicians Way Suite 200 Lebanon. Tennessee 37090
Re: K142745
Trade/Device Name: 125ml CT Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: February 12, 2015 Received: February 18, 2015
Dear Ms. Rheinscheld.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
M.R. Hilleman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K142745
Device Name: 125mL CT Syringe
Indications For Use:
For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.
Prescription Use _√ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
3
Coeur, Inc.
125mL CT Syringe
510(k) Summary
| 1. | Submitter: | Name: | Coeur, Inc. |
|---|---|---|---|
| Address: | 100 Physicians Way, Suite 200 | ||
| Lebanon, TN 37090 | |||
| Owner/Operator Number: | 9038672 | ||
| Phone: | (615) 547-7923 (Corporate Office) | ||
| Fax: | (615) 547-7937 (Corporate Fax) | ||
| Contact: | Erin Rheinscheld, Regulatory Analyst | ||
| Date: | March 23, 2015 | ||
| 2. | Device: | Trade/Proprietary Name: | 125mL CT Syringe |
| Common/Usual Name: | 125mL CT Syringe | ||
| Classification Name: | Accessory, Injector and Syringe |
3. Legally Marketed Device to which Substantial Equivalence is claimed:
Coeur 130mL Syringe, K971712
-
- Device Description: The 125mL CT Syringe will be sold as a single syringe. The following configurations may also be offered:
- i. 125mL Syringe and Fill Tube
- ii. 125mL Syringe with Coiled Line and Spike
- iii. 2 125mL Syringes with 2 Spikes
- iv. 125mL Syringe and Coiled Extension Line
- v. 2 125mL Syringes with Extension Y-Line and 2 Spikes
Angiographic
-
- Intended Use of Device: For use with the Liebel-Flarsheim Optivantage and Liebel-Flarsheim CT 9000 ADV Injectors for the injection of contrast media or saline.
-
- Summary of Technological Characteristics As Compared to Predicate Devices: The intended use (injection of contrast media or saline), the method of use (pressure), and the fluid path materials of the proposed device are the same as the legallymarketed device. The components (accessories) are also the same as legallymarketed devices.
If Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:
-
- Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device, including:
4
- Visual Verification of the Products Inspection of the product for a. conformance to visual requirements.
- Dimensional Evaluation of the Products Inspection of the product to b. verify dimensional acceptance.
- i. ISO 594-2:1998 Syringe evaluation to dimensional requirements of the ISO 594-2 standard using go/no go gage.
- ii. Injector Fit :
-
- Evaluation of product for fit and function with the Optivantage DH Injector.
-
- Evaluation of product for fit and function with the CT 9000ADV Injector.
-
- iii. Volume Evaluation for volume accuracy when used with injectors.
c. Functional Verification of the Products:
- i. Dynamic testing where the syringe is tested at a minimum of 330psi in simulated injections.
- ii. Failure testing follow dynamic testing, where syringes are pressurized under increasing pressures until failure is observed.
- d. Other
- i. ISO 594-2:1998 Syringe evaluation to requirements of the ISO 594-2 standard
- ii. ISO 7886-2:1996 Syringe evaluation to applicable requirements of the ISO 7886 standard.
- e. Age Verification Based on the packaging and testing of accelerated aged samples, the initial expiration of the device is 2 years. The methods and testing used to support new shelf life claims will be the same as those defined to support the 2-year shelf life identified in the submission
- f. Biocompatibility - While the proposed device is made of the same materials in contact with the fluid path as that cleared under K971712, biocompatibility testing was conducted on the device. Other accessories are identical to previously marketed accessories or biocompatibility testing was also conducted.
2. Clinical Tests Submitted: NA
-
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.