(153 days)
Not Found
No
The device description and performance studies focus on the physical components and their functional verification, with no mention of AI or ML.
No
The device is described as an MR Syringe for the injection of contrast media or saline, and its predicate devices are also injection systems and syringes. This indicates its function as a delivery mechanism rather than a device for treating a disease or condition.
No
The device is described as an MR Syringe for the injection of contrast media or saline, which is a therapeutic or imaging-supportive function, not a diagnostic one. Its purpose is to administer substances, not to diagnose a condition.
No
The device description explicitly lists physical components (syringes, lines, needle spikes) and the performance studies focus on nonclinical tests of these physical components (visual, dimensional, functional, age, biocompatibility). There is no mention of software as the primary or sole component.
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 an injector system. This is a direct medical intervention on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The components are syringes, lines, and needle spikes, all designed for delivering substances into the body.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely in vivo (within the body).
N/A
Intended Use / Indications for Use
For use with the LF OptiStar Injector for injection of contrast media or saline.
Product codes
DXT
Device Description
The MR Syringe is a pack that includes two 60ml MR Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes.
The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike.
Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.
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 considering both the original and the alternate configurations, including:
a. Visual Evaluation of the Products Inspection of the product to verify visual acceptance (such as presence of all components).
b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance (such as ISO 594 luer compliance).
c. Functional Verification of the Products:
i. Dynamic testing where the syringe, spike and Y -Line were tested using higher flow rates (which cause higher pressures) to ensure appropriate function when injection was simulated such that the maximum pressure capability of the injector (150psi) was challenged.
ii. Static testing was also conducted where the syringe was held at the maximum capability of the injector for an extended period of time.
d. Age Verification Based on the packaging and the components use in the proposed device, the expiration of 3 years is leveraged under the 510k submissions and labeling of products as previously cleared and/or marketed.
e. Biocompatibility Biocompatibility testing was conducted on the kit to verify it meets the requirements of ISO 10993 for an external communicating, indirect contact, less than 24 hour duration device. The components of the kit met the requirements for such a device.
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
Biocompatibility test results:
i. Cytotoxicity Pass (March 13, 2014)
ii. Kligman Maximization Test Pass (April 10, 2014)
iii. Intracutaneous Injection Test Pass (March 11, 2014)
iv. Systemic Injection Test Pass (March 10, 2014)
v. Hemolysis -- Pass (March 11, 2014)
vi. In Vitro Hemocompatibility Assay Pass (April 10, 2014)
vii. Rabbit Pvrozen Test -Pass (March 6, 2014)
viii. J Jnactivated Partial Thomboplastin Pass (March 6, 2014)
ix. Complement Activation Assay Pass (March 9, 2014)
Predicate Device(s)
K984088, K051799, K852580, K072696
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
Coeur, Inc.
MR Syringe Dual Pack
JUL 2 8 2014 K140469
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: | February 20, 2014 | ||
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- Device: Trade/Proprietary Name: MR Syringe Dual Pack Common/Usual Name: MR Syringe Kit Classification Name: Accessory, Injector and Syringe, Angiographic
Legally Marketed Devices to which Substantial Equivalence is claimed: 8.
- Optistar Injection System, Mallinckrodt, K984088 ﺘ
- Disposable CT/MR Syringes for Nemoto Injectors, Coeur, Inc., K051799 ﺳ
- Monoject 60cc Syringes, Sherwood Medical, K852580 ﺘ
- -ANT Angiographic Syringes, Shenzhen Ant Hi-Tech, K072696
- The MR Syringe is a pack that includes two 60ml MR Device Description: 4. Syringes, a 96" coiled Y-Line, and two Lateral Flow Needle Spikes.
· The alternate configuration of the MR Syringe is a pack that includes one 60mL MR Syringe, a 60" Coiled Line, and one Lateral Flow Needle Spike.
Each of the components to be used in the proposed device has been cleared for marketing under previous 510(k) submissions.
- Intended Use of Device: For use with the LF OptiStar Injector for injection of 5. contrast media or saline.
- Summary of Technological Characteristics As Compared to Predicate Devices: The 6. intended use, the method of use, and the materials of the proposed device are exactly the same as those of legally-marketed devices (as they are the same devices packaged together for sterilization).
Given Substantial Equivalence was based on an Assessment of Performance Data, the following information is also provided:
1
-
- Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device considering both the original and the alternate configurations, including:
- a. Visual Evaluation of the Products Inspection of the product to verify visual acceptance (such as presence of all components).
- b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance (such as ISO 594 luer compliance).
- c. Functional Verification of the Products:
- i. Dynamic testing where the syringe, spike and Y -Line were tested using higher flow rates (which cause higher pressures) to ensure appropriate function when injection was simulated such that the maximum pressure capability of the injector (150psi) was challenged.
- ii. Static testing was also conducted where the syringe was held at the maximum capability of the injector for an extended period of time.
- d. Age Verification Based on the packaging and the components use in the proposed device, the expiration of 3 years is leveraged under the 510k submissions and labeling of products as previously cleared and/or marketed.
- e. Biocompatibility Biocompatibility testing was conducted on the kit to verify it meets the requirements of ISO 10993 for an external communicating, indirect contact, less than 24 hour duration device. The components of the kit met the requirements for such a device. The results are as follows:
- i. Cytotoxicity Pass (March 13, 2014)
- Kligman Maximization Test Pass (April 10, 2014) 11.
- Intracutaneous Injection Test Pass (March 11, 2014) 111.
- Systemic Injection Test Pass (March 10, 2014) İV.
- Hemolysis -- Pass (March 11, 2014) V.
- vi. In Vitro Hemocompatibility Assay Pass (April 10, 2014)
- Rabbit Pvrozen Test -Pass (March 6, 2014) vii.
- I Jnactivated Partial Thomboplastin Pass (March 6, 2014) VIII.
- ix. Complement Activation Assay Pass (March 9, 2014)
- Clinical Tests Submitted: 2. NA
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: 3. The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.
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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 consists of a stylized eagle with three stripes extending from its wing. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2014
Coeur, Inc. Ms. Erin C. Rheinscheld Regulatory Analyst 100 Physicians Way, Suite 200 Lebanon, TN 37090
Re: K140469
Trade/Device Name: MR Syringe Dual Pack Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: June 24, 2014 Received: June 25, 2014
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 I no general over in a 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 or my I vith 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
3
Page 2 - Ms. Erin C. Rheinscheld
device-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.fca.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
M. A. Stillman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K140469
Device Name: MR Syringe Dual Pack
Indications For Use:
For use with the LF OptiStar Injector for injection of contrast media or saline.
Prescription Use V (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)
MDA
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