MODIFIED CONCENTRIC MICROCATHETER

K131437 · Concentric Medical, Inc. · DQO · Oct 11, 2013 · Cardiovascular

Device Facts

• Record ID: K131437
• Device Name: MODIFIED CONCENTRIC MICROCATHETER
• Applicant: Concentric Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Oct 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Device Story

Modified Concentric Microcatheter is a single-lumen, braided shaft, variable stiffness catheter. It serves as a line extension to the predicate device with smaller shaft diameters and longer effective length. Used in peripheral, coronary, and neuro vasculature; operated by physicians during diagnostic or therapeutic procedures. Input: manual manipulation by clinician. Transformation: provides a conduit for delivery of fluids, devices, or agents. Output: delivery of therapeutic/diagnostic agents to target site. Radiopaque shaft and distal marker allow fluoroscopic visualization. Hydrophilic coating reduces friction. Includes rotating hemostasis valve with side-arm adapter. Benefits patient by enabling precise, minimally invasive access to complex vascular anatomy.

Clinical Evidence

No clinical data. Evidence consists of bench-top design verification testing (kink, leak, flexibility, tensile, torque, coating, dimensional) and design validation via simulated use testing in a porcine model to confirm intended use.

Technological Characteristics

Single-lumen, braided shaft, variable stiffness catheter. Features hydrophilic coating. Includes rotating hemostasis valve. Dimensions: 2.4F outer diameter, .017" inner diameter, 157 cm length. Radiopaque shaft and distal marker for fluoroscopic visualization. Sterilization method same as predicate.

Indications for Use

Indicated for patients requiring selective placement of fluids, devices, or agents into peripheral, coronary, or neuro vasculature for diagnostic or therapeutic procedures.

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

• Concentric Microcatheter (K113260)

Submission Summary (Full Text)

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Concentric Medical, Inc. Traditional 510(k) Submission, K131437

#### 5. 510(k) Summary

| Trade Name: | Modified Concentric Microcatheter | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Common Name: | Diagnostic Intravascular Catheter | |
| Classification Name: | Diagnostic Intravascular Catheter, 21CFR 870.1200 - Class II | |
| Product Code: | DQO, DQY and KRA | |
| Submitter: | Concentric Medical, Inc.<br>301 E. Evelyn Avenue<br>Mountain View, CA 94041<br>Tel [phone]<br>Fax [phone]<br>Facility Registration #2954917 | OCT 1 1 2013 |
| Contact: | Christina Rowe<br>Manager, Regulatory Affairs | |
| Date Prepared: | September 6, 2013 | |
| Predicate Device: | Concentric Microcatheter (K113260) | |

#### Device Description

The Modified Concentric Microcatheter is a line extension to the existing Concentric Microcatheter, cleared under K113260. Like the predicate device, the Modified Concentric Microcather is a single-lumen, braided shaft, variable stiffness catheter designed for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures. A luer hub on the proximal end of the shaft enables connection to the rotating hemostasis valve included in the package. The radiopaque shaft and distal marker facilitate fluoroscopic visualization. The catheter shaft is coated with a hydrophilic coating to reduce friction during use. The Modified Concentric Microcatheter differs from its predicate in that it has smaller shaft diameters and a longer effective shaft length. Device dimensions and configuration are shown on the product label. A rotating hemostasis valve with side-arm adapter is provided with each microcatheter.

#### Indications for Use

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

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#### Concentric Medical, Inc. Traditional 510(k) Submission, K131437

#### Technological Characteristics

The Modified Concentric Microcatheter has the same technological characteristics as compared to the predicate device (K113260). The Modified Concentric Microcatheter differs from the predicate device in that its shaft diameters are smaller and its effective shaft length is longer. The device design, materials used, function, physical properties and composition have not been changed. A comparison of the subject device with predicate device is summarized in the table below.

| Feature | Results |
|------------------------------------------|--------------------------------------------------------------------------|
| Indications for Use | Same |
| Device Description | Same except smaller shaft diameters and longer<br>effective shaft length |
| Target Population | Same |
| Accessory Devices Provided | Same |
| Materials | Same |
| Labeled shaft outer diameter | Smaller (2.4F vs. 2.7F) |
| Labeled shaft inner diameter | Smaller (.017" vs. .021") |
| Overall Length | Longer (157 cm vs. 150 cm) |
| Packaging Materials and<br>Configuration | Same |
| Sterilization Method | Same |
| How Supplied | Same |

### Product Feature Comparison of Subject Device with Predicate Device

### Testing Summary

The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device. The test methods applied were similar to those previously submitted for the predicate Concentric Microcatheter.

Specifically, the following tests were performed on the proposed device:

#### Design verification testing:

- Kink Resistance the device's ability to withstand kinking when flexed was successfully � evaluated.
- Leak Resistance the device's leak resistance when subjected to both high pressure and . vacuum was successfully evaluated.
- Flexibility Testing the device's ability to navigate tight bends was successfully evaluated. .
- Tensile Testing the device's mechanical integrity under tensile loads was successfully . evaluated.
- Torque Testing the device's mechanical integrity when subjected to torsion was . successfully evaluated.
- . Coating Testing - the durability and lubricity of the device coating was successfully evaluated.

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Concentric Medical, Inc. Traditional 510(k) Submission, K131437

In addition, dimensional verification testing was performed as part of design verification tests for the proposed device.

#### Design validation testing:

- . Radiopacity Testing - the visibility of the device under fluoroscopy was successfully evaluated.
- . Design Validation Simulated Use Testing – testing was performed in a porcine model to confirm that the proposed device meets its intended use.

The Modified Concentric Microcatheter uses the same materials and processes as the predicate device. Biocompatibility and sterilization tests were performed on the predicate device; results for all tests met the pre-determined acceptance criteria and apply to the Modified Concentric Microcatheter.

## Summary of Substantial Equivalence

The Modified Concentric Microcatheter is substantially equivalent to the predicate device with regard to device design, materials, intended use, and patient population. The results of verification and validation conducted on the Modified Concentric Microcatheter demonstrate that it performs as designed, is suitable for its intended use and is as safe, as effective, and performs as well as or better than the legally marketed device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6U9 Silver Spring, MD 20993-0002

October 11, 2013

Concentric Medical, Inc. c/o Ms. Christina Rowe Manager. Regulatory Affairs 301 E. Evelyn Ave. Mountain View, CA 94041

Rc: K131437

Trade/Device Name: Modified Concentric Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO, DQY and KRA Dated: September 9, 2013 Received: September 10, 2013

Dear Ms. Rowe:

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 ar any Federal statutes and regulations administered by other Federal agencies. You must or any vith 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 device-related 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 form in radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Christina Rowe

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Biometries/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincercly yours.

# Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 510(k) Number (if known): K131437

Device Name:

Modified Concentric Microcatheter

Indications For Use:

The Modified Concentric Microcatheter is indicated for use in the selective placement of fluids and/or other devices or agents into the peripheral, coronary and neuro vasculature during diagnostic and/or therapeutic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S

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