(202 days)
Not Found
No
The device description and performance studies focus on the mechanical and biocompatibility aspects of an extension line with check valves, with no mention of AI or ML capabilities.
No
The device is used for delivering diagnostic fluids, not for treating a disease or condition.
No
Explanation: The device is described as an "interface" for "delivering diagnostic fluids," not as a device that performs diagnostic analysis or provides diagnostic information itself. It facilitates the delivery of substances used in diagnostic procedures.
No
The device description and performance studies clearly indicate this is a physical medical device (extension lines with check valves) and not a software-only device. The testing performed includes dimensional, functional (pressure, flow, pull), and biocompatibility tests, which are characteristic of hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver diagnostic fluids to the vascular system. This means the device is used in vivo (within the body) for the administration of substances.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening.
This device is clearly used for direct patient intervention (delivering fluids into the bloodstream), which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
Product codes
DXT
Device Description
The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)
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
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 (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. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance. (Note: Given no change in the luer connectors, no ISO 594 Testing is required.)
b. Functional Verification of the Products:
i. Crack Pressure and Flow Rate
ii. 330psi Pressure Test (Forward and Back)
iii. Pressurize to Failure Test
iv. Pull Test (Bond)
c. 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 (February 12, 2015)
ii. Kligman Maximization Test Pass (March 18, 2015)
iii. Intracutaneous Injection Test Pass (March 23, 2015)
iv. Systemic Injection Test Pass (March 11, 2015)
v. Hemolysis Pass (February 18, 2015)
vi. In Vitro Hemocompatibility Assay Pass (March 10, 2015)
vii. Rabbit Pyrogen Test -Pass (February 27, 2015)
viii. Unactivated Partial Thomboplastin Pass (March 4, 2015)
ix. Complement Activation Assay~ Pass (March 13, 2015)
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)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The graphic is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2015
Coeur, Inc. Debra F. Manning Director, Quality & Regulatory Affairs 100 Physicians Way Suite 200 Lebanon, Tennessee 37090
Re: K150902
Trade/Device Name: 330psi Extension Y-line With Dual Check Valve Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 18, 2015 Received: September 21, 2015
Dear Debra F. Manning:
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
1
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 (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 yours,
M.A. Hillebrand
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K150902
Device Name: 330psi Extension Y-Line with Dual Check Valve
Indications For Use:
The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
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
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Coeur, Inc.
K150902
330psi Extension Y-Line with Dual Check Valve
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: | Debra D. F. Manning, Director of Quality Assurance and | ||
| Regulatory Affairs | |||
| Date: | October 20, 2015 | ||
| 2. | Device: | Trade/Proprietary Name: | 330psi Extension Y-Line with Dual Check Valve |
| 2. | Device: | Trade/Proprietary Name: | 330psi Extension Y-Line with Dual Check Valve |
|---|---|---|---|
| Common/Usual Name: | 330psi Extension Y-Line with Dual Check Valve | ||
| Classification Name: | Accessory, Injector and Syringe, | ||
| Angiographic |
3. Legally Marketed Devices to which Substantial Equivalence is claimed:
- Coeur Disposable 330psi Extension Lines K120892 l
-
- Device Description: The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
- i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
- ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
- iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
- iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)
- Indications for Use: The 330psi Extension Y-Line with Dual Check Valve is to be used as an 5. interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
- Summary of Technological Characteristics as Compared to Predicate Devices: The intended 6. use (injection of contrast media or saline), the method of use (pressure), and the fluid path material types of the proposed device are the same as the legally-marketed device. As compared to the predicate device, the proposed device is essentially combining the Yconnector and 2 check valves (all of which are separate components in the current legallymarketed devices) into a single component (in the proposed device).
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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. Dimensional Evaluation of the Products Inspection of the product to verify dimensional acceptance. (Note: Given no change in the luer connectors, no ISO 594 Testing is required.)
- b. Functional Verification of the Products:
- i. Crack Pressure and Flow Rate
- ii. 330psi Pressure Test (Forward and Back)
- iii. Pressurize to Failure Test
- iv. Pull Test (Bond)
- c. 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 (February 12, 2015)
- ii. Kligman Maximization Test Pass (March 18, 2015)
- iii. Intracutaneous Injection Test Pass (March 23, 2015)
- iv. Systemic Injection Test Pass (March 11, 2015)
- v. Hemolysis Pass (February 18, 2015)
- vi. In Vitro Hemocompatibility Assay Pass (March 10, 2015)
- vii. Rabbit Pyrogen Test -Pass (February 27, 2015)
- viii. Unactivated Partial Thomboplastin Pass (March 4, 2015)
- ix. Complement Activation Assay~ Pass (March 13, 2015)
-
- Clinical Tests Submitted: NA
- Conclusions Drawn from Nonclinical and Clinical Tests Submitted: The conclusions 3. drawn from the nonclinical tests demonstrate that the device is substantially equivalent to the predicate devices identified.