MMS Guide Catheter

K152625 · Micro Medical Solutions, Inc. · KRA · Mar 9, 2016 · Cardiovascular

Device Facts

• Record ID: K152625
• Device Name: MMS Guide Catheter
• Applicant: Micro Medical Solutions, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 9, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2

Intended Use

The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.

Device Story

MMS Guide Catheter is a small-diameter tubular device used to access peripheral vasculature. Physician inserts device using standard access techniques; advances over guidewire to target location under fluoroscopic or ultrasound visualization. Device serves as a pathway for introducing interventional devices or infusing diagnostic/therapeutic agents. Distal end features standard luer fitting. Benefits include facilitating access to peripheral vascular sites for clinical intervention. Device is for single use.

Clinical Evidence

No human clinical data provided. Evidence consists of non-clinical bench testing (dimensional verification, surface review, leak, tracking, flow, flex/kink, torque, tensile, packaging), animal testing for simulated clinical performance, and cadaver testing in below-the-knee vasculature. All testing met acceptance criteria.

Technological Characteristics

Small-diameter tubular catheter; 3.2 Fr diameter; 40 cm working length. Materials are biocompatible per ISO 10993. Sterilization via ETO. Visualization via fluoroscopy or ultrasound. Single-use device.

Indications for Use

Indicated for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Marksman Catheter (K111490)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure, with three faces in profile. The figure is stylized and appears to be in motion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 9, 2016

Micro Medical Solutions, Inc. Mr. Gregory Mathison Vice President, Regulatory, Clinical & Quality 790 Willard Street, #209 Quincy, MA 02169

Re: K152625 Trade/Device Name: MMS Guide Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 29, 2016 Received: February 3. 2016

Dear Mr. Mathison,

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

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the quality systems (OS) 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 [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 yours,

# Kenneth J. Cavanaugh -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K152625

Device Name MMS Guide Catheter

#### Indications for Use (Describe)

The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image shows the logo for Micro Medical Solutions. The logo has a red DNA-like strand above the company name. The company name is in gray, with "micro medical" in a larger font than "solutions."

## 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

| Applicant: | Micro Medical Solutions, Inc.<br>240 Andover Street<br>Wilmington, MA 01887<br>Tel: [phone] |
|------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name: | MMS Guide Catheter |
| Common Name: | Guide Catheter |
| Classification Name: | Catheter, continuous flush |
| 21CFR Number: | 870.1210 |
| Device Classification: | Class II |
| Product Code: | KRA |
| Predicate Devices: | Marksman Catheter (K111490) |
| Contact: | Greg Mathison<br>VP Regulatory, Clinical & Quality |
| DATE: | March 1, 2016 |

## Substantially Equivalent to:

The MMS Guide Catheter is equivalent in intended use, principal of operation and technological characteristics to the Marksman Catheter (K111490).

### Description of the device subject to premarket notification

The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other

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diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.

## Indications for Use

The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.

#### Materials

All materials used in the manufacture of the MMS Guide Catheter are suitable for this use and have been used in numerous previously cleared products. The MMS Guide Catheter materials were tested per ISO10993 and found to be biocompatible. Testing included the following:

- . Cytotoxicity
- Sensitization
- Acute Systemic Toxicity ●
- Hemolysis Extract ●
- Hemolysis Direct Contact
- Pyrogen
- Complement Activation ●
- Canine Thrombogenicity ●

## Animal Testing

Animal testing was conducted to assess the simulated clinical performance of the Guide Catheter. The product performed to specification.

## Cadaver Experience

Cadaver testing was conducted using the vasculature below the knee to assess the simulated clinical use of the product. The product performed to specification.

## Non-Clinical Testing

Product testing was completed and met all of the acceptance criteria. Testing was conducted on sterile final product. Testing was performed on baseline (non-aged) and aged products. Testing included:

- Dimensional verification
- Surface Review ●
- Leak
- Tracking ●
- Flow ●
- Flex/Kink ●
- Torque ●
- Tensile ●
- Packaging ●

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## Performance Data

All necessary verification and validation testing has been performed for the MMS Guide Catheter to assure substantial equivalence to the predicate devices.

## Basis for Determination of Substantial Equivalence

Upon reviewing the safety information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MMS Guide Catheter is determined to be substantially equivalent to existing legally marketed devices.

| Trade name | MMS Guide Catheter | Marksman Catheter | SE Discussion |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Product code | KRA | KRA | Same product code |
| 510(k) number | K152625 | K111490 | |
| 21CFR | 870.1210 | 870.1210 | Same CFR number |
| Device<br>Classification | II | II | Same - Class II |
| Device<br>description | The MMS Guide Catheter is a<br>small diameter tubular device.<br>It is inserted into the<br>vasculature using standard<br>access techniques and<br>advanced over a guidewire to<br>the physician desired location.<br>The MMS Guide Catheter can<br>be used as a pathway for other<br>diagnostic or therapeutic<br>devices to enter the<br>vasculature. The distal end<br>has a standard luer fitting. | The Marksman Catheter is a<br>variable stiffness, single<br>lumen catheter designed to<br>access small, tortuous vascular<br>areas. The outer surface of the<br>catheter's distal segment is<br>coated with a hydrophilic<br>material to provide lubricity<br>during use. The catheter also<br>incorporates a PTFE liner to<br>facilitate movement of<br>introduction devices passed<br>through its lumen. The<br>Marksman Catheter has a<br>radiopaque marker at the<br>distal tip to facilitate<br>fluoroscopic visualization.<br>The distal tip of the catheter is<br>shapeable.<br>The Marksman Catheter is<br>provided with various working<br>lengths. The Marksman<br>Catheter is for single use only. | The device description is the<br>same. |

## Comparison of Product Features

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| Intended Use | The MMS Guide Catheter is<br>intended for the introduction<br>of interventional devices and<br>infusion of diagnostic or<br>therapeutic agents into the<br>peripheral vasculature. | The Marksman Catheter is<br>indicated for the introduction<br>of interventional devices and<br>infusion of diagnostic or<br>therapeutic agents into the<br>neuro, peripheral and coronary<br>vasculature. | Same Indications for Use |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Length | 40 cm working length | 105cm | Equivalent |
| Diameter | 3.2 Fr | 0.027" | Equivalent |
| Method of<br>visualization | Fluoro / Ultrasound | Fluoro | Equivalent |
| Sterilization | Yes - ETO | Yes - ETO | Both devices are supplied<br>sterile. |
| Single use | Y | Y | Same |
| Shelf life | 22 months after production | Not indicated on submission | This will be on the product<br>label |
| Packaging | Tyvek / Poly pouch | Unknown | Tyvek / Poly heat sealed<br>pouches are common<br>packaging for sterile products |
| Materials | Biocompatible | Biocompatible | Biocompatible |

#### Conclusion

The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.