GRAFTGUARD PRESSURE CONTROLLING SYRINGE

K082725 · Maquet Cardiovascular, LLC · GBX · Dec 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082725
• Device Name: GRAFTGUARD PRESSURE CONTROLLING SYRINGE
• Applicant: Maquet Cardiovascular, LLC
• Product Code: GBX · General, Plastic Surgery
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery.

Device Story

VASOSHIELD Pressure Controlling Syringe; manual syringe device for bypass graft preparation/irrigation. Input: manual pressure applied by clinician. Mechanism: internal spring-loaded pressure control system with three settings (150, 250, 350 mm Hg) to prevent over-distention of grafts. Output: controlled pressure delivery during irrigation. Used in clinical settings by surgical staff. Benefit: prevents graft damage during preparation, improving graft integrity for bypass surgery. Single-use, sterile device.

Clinical Evidence

Bench testing only. Results demonstrate the device meets established acceptance criteria and performs in a manner equivalent to the predicate devices.

Technological Characteristics

Manual syringe assembly comprising 10 biocompatible components: syringe, stopper, ball, stainless steel pin, spring, rod, green acetal ring, black acetal pusher, white acetal knob, and body. Features three predetermined pressure settings (150, 250, 350 mm Hg). Single-use, supplied sterile.

Indications for Use

Indicated for patients undergoing bypass surgery, specifically for the preparation and irrigation of bypass grafts.

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

• InPress Syringe (K043515)
• DMC Saphenous Vein System (K000704)
• DLP Pressure Sensing Syringe (K853586)

Submission Summary (Full Text)

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Kof2725

## 510(k) SUMMARY

| | DEC 17 2008 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | MAQUET Cardiovascular |
| Submitter's<br>Address | 170 Baytech Road<br>San Jose, CA 95134 |
| Telephone | [phone] |
| Fax | [phone] |
| Contact Person | Christina L. Rowe |
| Date Prepared | September 16, 2008 |
| Device Trade<br>Name | VASOSHIELD Pressure Controlling Syringe |
| Device<br>Common Name | Distention and irrigation syringe |
| Device<br>Classification<br>Name | Introduction/drainage catheter and accessories |
| Device<br>Classification | Class II |
| Summary of<br>substantial<br>equivalence | The design, materials, method of delivery, features, and intended use of the<br>VASOSHIELD Pressure Controlling Syringe are substantially equivalent to the<br>predicate devices: InPress Syringe, (K043515, cleared on March 31, 2005), the<br>DMC Saphenous Vein System (K000704, cleared on May 19, 2000), and the<br>DLP Pressure Sensing Syringe (K853586, cleared on November 14, 1985). |
| Device<br>description | The VASOSHIELD Pressure Controlling Syringe is identical to the InPress<br>Syringe in design, materials, principles of operation, and manufacturing process.<br>The syringe is comprised of 10 biocompatible components including a syringe, a<br>syringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, black<br>acetal pusher, a white acetal knob and body. The syringe has three<br>predetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg.<br>The syringe is a single use device, supplied sterile. |
| Indications for<br>Use | The device is indicated for controlling pressure during the preparation and<br>irrigation of bypass grafts prior to use in bypass surgery. |
| Technological<br>characteristics | The VASOSHIELD Pressure Controlling Syringe is identical to the InPress<br>Syringe and features similar fundamental scientific technology as its other<br>predicate devices. |
| Performance<br>data | The results of testing and data review demonstrate that the VASOSHIELD<br>Pressure Controlling Syringe meets the established acceptance criteria and<br>performs in a manner equivalent to the predicate devices. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 2008

Maquet Cardiovascular, LLC. c/o Ms. Christina L. Rowe Principal Regulatory Affairs Associate 170 Baytech Drive San Jose, CA 95134

Re: K082725

VASOSHIELD Pressure Controlling Syringe Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: Class II (two) Product Code: GBX Dated: September 16, 2008 Received: September 25, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Ms. Christina L. Rowe

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 l'ederal 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

\$\gamma\$

Bram D. Zickerman, 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) | K082725 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Device name | VASOSHIELD Pressure Controlling Syringe |
| Indications for Use | The device is indicated for controlling pressure during the preparation and irrigation of bypass grafts prior to use in bypass surgery. |

Prescription Use _ X (21 CFR 801 Subpart D) OR

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devises 510(k) Number 0 X