(132 days)
No
The device description and performance studies focus on the physical components and mechanical performance of syringes and extension lines, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device's stated intended use is for "MR Injection of contrast media or saline to the vascular system for diagnostic purposes," not for therapeutic treatment.
No
The device is a syringe intended for injecting contrast media or saline for diagnostic purposes, not a diagnostic device itself.
No
The device description clearly outlines physical components (syringes, extension lines, spikes, tubes) and the performance studies focus on physical properties and function (visual verification, dimensional evaluation, pressure testing, 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 injecting contrast media or saline into the vascular system for diagnostic purposes. This is an in vivo (within a living organism) application, not an in vitro (in glass or outside the body) test.
- Device Description: The device is described as an angiographic syringe used with an injection system to inject fluids into a patient. This aligns with in vivo procedures.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) outside the body to obtain diagnostic information. IVDs typically involve reagents, test strips, analyzers, or other components designed for laboratory or point-of-care testing of samples.
The device is a medical device used to facilitate a diagnostic imaging procedure, but it is not an IVD itself.
N/A
Intended Use / Indications for Use
For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.
Product codes (comma separated list FDA assigned to the subject device)
DXT
Device Description
The MR Syringes for Solaris Injectors (65mL and 115mL syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
- C853-2201 65mL and 115mL Syringe with 96" Coiled extension Y~Line and Fill Spikes
- C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
- C853-2203 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Fill Spikes
- C853-2204 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Contrast and Saline Spikes
- C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension Y~Line and Fill Tube
- C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Submitted: Testing used to verify substantial equivalence including an assessment of Performance Data for the proposed device, including:
a. Visual Verification of the Products Inspection of the product for conformance to visual requirements.
b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance.
i. ISO 594-2:1998 Evaluation to applicable requirements of the ISO 594 standard.
ii. Injector Fit –Evaluation of fit and function with the Medrad Spectris® Solaris™ MR Injection System.
iii. Volume -Evaluation of volume accuracy.
c. Functional Verification of the Products:
i. Pressure testing was conducted where the syringe was held at 350psi for 10 seconds and the Extension Line was held at 400psi for 2.5 minutes.
ii. Failure testing followed pressure testing, where syringes and Extension Lines are pressurized under increasing pressure until failure is observed.
d. Age Verification Based on use of the same packaging and component material as used in currently marketed devices, the expiration of 1 year is leveraged for the proposed device.
e. Biocompatibility The proposed device is made of the same materials in contact with the fluid path as that cleared under K971712 and K051799 in formulation, processing, and sterilization, and no other chemicals have been added (e.g. plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
K971712, K051799, K120892, K140469, K062449
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).
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Coeur, Inc. Priscilla Clinner Regulatory Analyst 100 Physicians Way Lebanon, Tennessee 37090
Re: K161471
Trade/Device Name: MR Syringe Dual Pack for Solaris Injectors Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 2, 2016 Received: September 6, 2016
Dear Priscilla Clinner:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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 yours,
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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) K161471
Device Name
MR Syringe Dual Pack for Solaris Injectors
Indications for Use (Describe)
For use with the Medrad Spectris® Solaris™ MR Injection of contrast media or saline to the vascular system for diagnostic purposes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Coeur, Inc.
MR Syringes for Solaris Injectors
K161471 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: | Priscilla Clinner, Regulatory Analyst | ||
| Date: | October 5, 2016 | ||
| 2. | Device: | Trade/Proprietary Name: | MR Syringe Dual Pack for Solaris Injectors |
| Common/Usual Name: | MR Syringe Dual Pack for Solaris Injectors |
Accessory, Injector and Syringe,
Angiographic
3. Legally Marketed Devices to which Substantial Equivalence is claimed:
Primary Predicate Device
Medrad: Syringe Included in Spectris Solaris MR Injection System (K033247)
Referenced Devices
Coeur:
- Coeur 130mL Syringe (K971712) ●
- Coeur Syringes for Nemoto Injectors (K051799)
- Coeur 330psi Extension Lines (K120892) ●
Classification Name:
- Coeur MR Syringe Dual Pack (K140469) ●
- E-Z-EM Empower MR Injector System and Fastload MR Syringe Pack ● (K062449)
- Device Description: The MR Syringes for Solaris Injectors (65mL and 115mL 4. syringe) falls into the Cardiovascular Devices Category and are classified as Angiographic Syringes within the classification of Angiographic Injectors and Syringes. The syringe is intended for use with Medrad Spectris® Solaris™ MR Injection System to inject diagnostic fluids (such as contrast media and saline) into a patient. The MR Syringe Dual Pack for Solaris Injectors will be sold as a Dual Pack. The following configurations may be offered:
- i. C853-2201 65mL and 115mL Syringe with 96" Coiled extension Y~Line and Fill Spikes
- ii. C853-2202 65mL and 115mL Syringe with 96" Coiled extension Y-Line and Contrast and Saline Spikes
- iii. C853-2203 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Fill Spikes
- iv. C853-2204 65mL and 115mL Syringe with 96" Coiled extension Y~Line, Prime Tube, and Contrast and Saline Spikes
4
- v. C853-2205 ~ 65mL and 115mL Syringe with 96" Coiled Extension Y~Line and Fill Tube
- vi. C853-2206 65mL and 115mL Syringe with 96" Coiled Extension Y~Line, Prime Tube, and Fill Tube
-
- Indications for Use of Device: For use with the Medrad Spectris® Solaris™ MR Injection System for the injection of contrast media or saline to the vascular system for diagnostic purposes.
-
- Summary of Technological Characteristics as Compared to Predicate Devices: The intended use (injection of contrast media or saline for diagnostic purposes), the method of use (pressure injection with power injectors), and the fluid path materials (PET barrel, synthetic rubber jacket, extension lines, fill tubes, and spikes) of the proposed device are the same as the legally-marketed 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:
- a. Visual Verification of the Products Inspection of the product for conformance to visual requirements.
- b. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance.
- i. ISO 594-2:1998 Evaluation to applicable requirements of the ISO 594 standard.
- ii. Injector Fit –Evaluation of fit and function with the Medrad Spectris® Solaris™ MR Injection System.
- iii. Volume -Evaluation of volume accuracy.
- c. Functional Verification of the Products:
- i. Pressure testing was conducted where the syringe was held at 350psi for 10 seconds and the Extension Line was held at 400psi for 2.5 minutes.
- ii. Failure testing followed pressure testing, where syringes and Extension Lines are pressurized under increasing pressure until failure is observed.
- d. Age Verification Based on use of the same packaging and component material as used in currently marketed devices, the expiration of 1 year is leveraged for the proposed device.
- e. Biocompatibility The proposed device is made of the same materials in contact with the fluid path as that cleared under K971712 and K051799 in formulation, processing, and sterilization, and no other chemicals have been added (e.g. plasticizers, fillers, color additives, cleaning agents, mold release agents, etc.).
-
- Clinical Tests Submitted: NA
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The 3. conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.