(58 days)
NAMIC ClearaCIL Contrast Injection Lines
Not Found
No
The device description and performance studies focus on the physical properties and fluid management function of the injection lines, with no mention of AI or ML.
No.
The device facilitates fluid passage but does not directly treat a disease or condition.
No
Explanation: The device is described as lines used to establish a conduit for the passage of fluids from an injector to a catheter, indicating a fluid management function rather than diagnosis. There is no mention of it being used to gather information about a patient's health condition.
No
The device description clearly indicates it is a physical product (injection lines with Luer fittings) used to establish a conduit for fluids, not a software application.
Based on the provided information, the NAMIC ClearaCIL Contrast Injection Lines are not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to be used in fluid management procedures," specifically for injecting contrast agents into a patient's vascular system. This is a procedure performed in vivo (within a living organism), not in vitro (outside of a living organism, typically on biological samples).
- Device Description: The description reinforces the in vivo use by stating it establishes a conduit for fluids from a power injector to a catheter, which is then inserted into the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is a medical device used in a clinical procedure, but it does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures.
Product codes
DQO
Device Description
The NAMIC ClearaCIL Contrast Injection Lines are used to establish a conduit for the passage of fluids from a vascular power injector to a catheter. The Luer fittings are used to establish a secure, leak-free connection to the injector and catheter.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed NAMIC ClearaCIL Contrast Injection Lines and the predicate NAMIC ClearaCIL Contrast Injection Lines are substantially equivalent to the specific predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include:
- Luer Bond Flex Strength
- Luer Bond Tensile Strength
- Air Leak Resistance
- Tubing Transparency
- Hydrodynamic Fluid Leak Resistance
- Biocompatibility per ISO 10993-1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NAMIC ClearaCIL Contrast Injection Lines
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
AngioDynamics, Inc. Teri Juckett Regulatory Affairs Manager 10 Glens Falls Technology Park Glens Falls, New York 12801
Re: K163141
Trade/Device Name: NAMIC ClearaCIL Contrast Injection Lines Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: November 8, 2016 Received: November 9, 2016
Dear Teri Juckett:
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 (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.
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,
Sincerely,
Fernando
Aguel
Fernando Aguel-S
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) K163141
Device Name
NAMIC ClearaCIL Contrast Injection Lines
Indications for Use (Describe)
NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures.
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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Image /page/3/Picture/0 description: The image shows the logo for Angiodynamics. The logo consists of a stylized symbol on the left and the word "angiodynamics" on the right. The symbol is made up of two interlocking shapes, one in blue and one in red. The word "angiodynamics" is written in blue.
510(k) Summary
Date Prepared: 06 January 2017
A. Submitter Information:
AngioDynamics Inc.
10 Glens Falls Technology Park
Glens Falls, New York 12801
| Tel: | (518) 795-1142 |
|---|---|
| Fax: | (518) 742-4323 |
| Contact: | Teri Juckett, |
| Manager, Regulatory Affairs | |
| Email: | tjuckett@angiodynamics.com |
Proposed Device: B.
| Trade Name: | NAMIC ClearaCIL Contrast Injection Lines |
|---|---|
| Common Name: | High Pressure Lines |
| Classification Name: | Diagnostic Intravascular Catheter |
| Product Code: | DQO, 870.1200 |
| Class: | II |
C. Predicate Device:
| Trade Name: | NAMIC ClearaCIL Contrast Injection Lines |
|---|---|
| Common Name: | High Pressure Lines |
| Classification Name: | Diagnostic Intravascular Catheter |
| Product Code: | DQO, 870.1200 |
| Class: | II |
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D. Device Description
The NAMIC ClearaCIL Contrast Injection Lines are used to establish a conduit for the passage of fluids from a vascular power injector to a catheter. The Luer fittings are used to establish a secure, leak-free connection to the injector and catheter.
-
ட். Indications for Use
NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures. -
F. Summary of Similarities and Differences in Technological Characteristics and Performance
The proposed devices have similar materials, design, and technical characteristics as the predicate devices. The purpose of this 510(k) submission is to introduce into commercial distribution a modified NAMIC ClearaCIL Contrast Injection Lines which includes a material change. -
G. Performance Data
The proposed NAMIC ClearaCIL Contrast Injection Lines and the predicate NAMIC ClearaCIL Contrast Injection Lines are substantially equivalent to the specific predicate devices based on a comparison of technological characteristics and the results of non-clinical performance and material testing, which include: -
Luer Bond Flex Strength
-
. Luer Bond Tensile Strength
-
. Air Leak Resistance
-
. Tubing Transparency
-
Hydrodynamic Fluid Leak Resistance
-
. Biocompatibility per ISO 10993-1
-
H. Conclusion
The results of non-clinical testing and a comparison of similarities and differences demonstrate that the proposed and predicate devices are substantially equivalent.