NAMIC ClearaCIL Contrast Injection Lines

K163141 · AngioDynamics, Inc. · DQO · Jan 6, 2017 · Cardiovascular

Device Facts

• Record ID: K163141
• Device Name: NAMIC ClearaCIL Contrast Injection Lines
• Applicant: AngioDynamics, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

NAMIC ClearaCIL Contrast Injection Lines are intended to be used in fluid management procedures.

Device Story

NAMIC ClearaCIL Contrast Injection Lines serve as a conduit for fluid transfer between a vascular power injector and a catheter. The device features Luer fittings to ensure secure, leak-free connections. Used in clinical settings during fluid management procedures, the lines are operated by healthcare professionals. The device facilitates the delivery of contrast media or other fluids, supporting diagnostic or interventional procedures. The current iteration introduces a material change compared to the predicate device.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included Luer bond flex strength, Luer bond tensile strength, air leak resistance, tubing transparency, hydrodynamic fluid leak resistance, and biocompatibility per ISO 10993-1.

Technological Characteristics

High-pressure fluid conduit with Luer fittings. Materials modified from predicate; biocompatibility verified per ISO 10993-1. Mechanical design for secure, leak-free connection to injectors and catheters.

Indications for Use

Indicated for patients undergoing fluid management procedures requiring a conduit for fluid delivery from a vascular power injector to a catheter.

Regulatory Classification

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.

Predicate Devices

• NAMIC ClearaCIL Contrast Injection Lines (K163141)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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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## 510(k) Summary

## Date Prepared: 06 January 2017

### A. Submitter Information:

AngioDynamics Inc.

10 Glens Falls Technology Park

Glens Falls, New York 12801

| Tel: | [phone] |
|----------|----------------------------------------------|
| Fax: | [phone] |
| Contact: | Teri Juckett,<br>Manager, Regulatory Affairs |
| Email: | [e-mail] |

### 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.