(58 days)
NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures.
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.
This document is a 510(k) premarket notification for the NAMIC ClearaCIL Contrast Injection Lines. It does not describe a study involving AI or human readers, but rather a submission for a medical device that facilitates the passage of fluids. Therefore, I cannot provide information related to sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these concepts are not applicable to the context of this device and submission.
The document discusses performance data obtained through non-clinical testing. Here's a breakdown of the acceptance criteria and reported device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test Name | Reported Device Performance |
|---|---|
| Luer Bond Flex Strength | Performance demonstrates substantial equivalence to predicate device |
| Luer Bond Tensile Strength | Performance demonstrates substantial equivalence to predicate device |
| Air Leak Resistance | Performance demonstrates substantial equivalence to predicate device |
| Tubing Transparency | Performance demonstrates substantial equivalence to predicate device |
| Hydrodynamic Fluid Leak Resistance | Performance demonstrates substantial equivalence to predicate device |
| Biocompatibility (per ISO 10993-1) | Performance demonstrates substantial equivalence to predicate device |
2. Study that Proves the Device Meets Acceptance Criteria
The document states that the device meets the acceptance criteria through non-clinical performance and material testing. The purpose of this 510(k) submission is to introduce a modified version of the NAMIC ClearaCIL Contrast Injection Lines with a material change, and the testing was conducted to demonstrate substantial equivalence to the legally marketed predicate device.
Specifically, the document states: "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..."
Given the nature of the device (contrast injection lines) and the type of submission (510(k)), the "study" is a series of laboratory-based, non-clinical tests rather than a clinical trial involving human subjects or data analysis of medical images.
Additional Information Not Applicable to this Document:
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components of the device, not a set of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical tests would be established by engineering standards and measurement techniques, not expert consensus on medical images or diagnoses.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a medical device, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This is a physical medical device.
- The type of ground truth used: For the physical tests, the "ground truth" would be the established engineering specifications and measurement outcomes for parameters like bond strength, leak resistance, and biocompatibility, as referenced by standards like ISO 10993-1.
- The sample size for the training set: Not applicable. There is no algorithm being trained.
- How the ground truth for the training set was established: Not applicable.
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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.
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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.
§ 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).