MOERAE VEIN PREPARATION KIT

K131659 · Moerae Matrix, Inc. · GBX · Mar 3, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K131659
• Device Name: MOERAE VEIN PREPARATION KIT
• Applicant: Moerae Matrix, Inc.
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Mar 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1

Intended Use

The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Device Story

VasoPrep Vein Preparation Kit is a convenience kit used by clinicians during bypass surgery to prepare bypass grafts. The kit includes a pressure relief valve, bulldog clamp, vessel cannula, introducer, stopcock, syringes, extension tube, vein cup, and drapes. The device functions by allowing the clinician to control and maintain appropriate pressure during the irrigation and preparation of the vein graft. By preventing over-distension through pressure regulation, the device helps ensure the integrity of the graft before implantation. It is a manual, non-powered surgical accessory.

Clinical Evidence

Bench testing only. In-vitro testing performed to evaluate valve cracking pressure and system leakage. Biocompatibility testing conducted in accordance with ISO 10993-1 and FDA Guidance Memo G-95.

Technological Characteristics

Convenience kit containing pressure relief valve, bulldog clamp, vessel cannula, introducer, stopcock, syringes, extension tube, vein cup, and drapes. Materials meet ISO 10993-1 biocompatibility requirements. Manual operation; no energy source. Sterilized device.

Indications for Use

Indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Regulatory Classification

Identification

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

Predicate Devices

• DMC Saphenous Vein Distension System (K000704)
• Vasoshield Pressure Controlling Syringe (K082725)

Submission Summary (Full Text)

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# 510(K) SUMMARY

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

Date Prepared: February 28, 2014

510(k) number: K131659

### Applicant Information:

VasoPrep Surgical LLC 55 Madison Avenue, Suite 400 Morristown, NJ 07960

## Contact Person

Robert J. Chin Ph.D. Phone Number: [phone]

#### Device Information:

VasoPrep Vein Preparation Kit Trade Name: 878.4200 Classification: Classification Name (Code): Irrigation Catheter (GBX)

## Physical Description:

The VasoPrep Vein Preparation Kit is a convenience kit that consists of a pressure relief valve, bulldog clamp, vessel cannula and introducer, stopcock, syringes, extension tube, vein cup and drapes used in the preparation of bypass grafts prior to use in bypass surgery.

#### Intended Use:

The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

#### Equivalent Device:

The VasoPrep Vein Preparation Kit is substantially equivalent in intended use and/or method of operation to the DMC Saphenous Vein Distension System (K000704) and the Vasoshield Pressure Controlling Syringe (K082725).

# Test Results:

#### Performance

Results of in-vitro testing, including valve cracking pressure and system leakage, demonstrate that the VasoPrep Vein Preparation Kit is safe and effective for its intended use.

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# Biocompatibility

The materials used in the VasoPrep Vein Preparation Kit meet the requirements of ISO 10993-1 in accordance with FDA Guidance Memo G-95.

# Summary:

Based on the intended use, product, performance, sterilization and biocompatibility information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices identified.

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Public Health Service

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

March 3, 2014

VasoPrep Surgical c/o Dr. Robert Chin Regulatory Consultant 55 Madison Avenue, Suite 400 Morristown, NJ 07960

Re: K131659

Trade/Device Name: VasoPrep Vein Preparation Kit Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/Drainage Catheter and Accessories Regulatory Class: Class II Product Code: GBX Dated: January 17, 2014 Received: January 24, 2014

Dear Dr. Chin:

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

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Page 2 - Robert J. Chin, PhD

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 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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Biometrics/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

FDA

for Bram 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 STATEMENT

510(k) Number (if known): K131659

Device Name: VasoPrep Vein Preparation Kit

Indications for Use:

The VasoPrep Vein Preparation Kit is a sterilized convenience kit indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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