← Product Code [GBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX) · K082725 # GRAFTGUARD PRESSURE CONTROLLING SYRINGE (K082725) _Maquet Cardiovascular, LLC · GBX · Dec 17, 2008 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K082725 ## Device Facts - **Applicant:** Maquet Cardiovascular, LLC - **Product Code:** [GBX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX.md) - **Decision Date:** Dec 17, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4200 - **Device Class:** Class 1 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K043515.md)) - DMC Saphenous Vein System ([K000704](/device/K000704.md)) - DLP Pressure Sensing Syringe ([K853586](/device/K853586.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Kof2725 ## 510(k) SUMMARY | | DEC 17 2008 | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | MAQUET Cardiovascular | | Submitter's
Address | 170 Baytech Road
San Jose, CA 95134 | | Telephone | (408) 635-6824 | | Fax | (408) 635-3907 | | Contact Person | Christina L. Rowe | | Date Prepared | September 16, 2008 | | Device Trade
Name | VASOSHIELD Pressure Controlling Syringe | | Device
Common Name | Distention and irrigation syringe | | Device
Classification
Name | Introduction/drainage catheter and accessories | | Device
Classification | Class II | | Summary of
substantial
equivalence | The design, materials, method of delivery, features, and intended use of the
VASOSHIELD Pressure Controlling Syringe are substantially equivalent to the
predicate devices: InPress Syringe, (K043515, cleared on March 31, 2005), the
DMC Saphenous Vein System (K000704, cleared on May 19, 2000), and the
DLP Pressure Sensing Syringe (K853586, cleared on November 14, 1985). | | Device
description | The VASOSHIELD Pressure Controlling Syringe is identical to the InPress
Syringe in design, materials, principles of operation, and manufacturing process.
The syringe is comprised of 10 biocompatible components including a syringe, a
syringe stopper, ball, stainless steel pin, spring and rod, green acetal ring, black
acetal pusher, a white acetal knob and body. The syringe has three
predetermined pressure settings of 150 mm Hg, 250 mm Hg, and 350 mm Hg.
The syringe is a single use device, supplied sterile. | | Indications for
Use | The device is indicated for controlling pressure during the preparation and
irrigation of bypass grafts prior to use in bypass surgery. | | Technological
characteristics | The VASOSHIELD Pressure Controlling Syringe is identical to the InPress
Syringe and features similar fundamental scientific technology as its other
predicate devices. | | Performance
data | The results of testing and data review demonstrate that the VASOSHIELD
Pressure Controlling Syringe meets the established acceptance criteria and
performs in a manner equivalent to the predicate devices. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circle around the eagle. The eagle is black, and the text is in a simple, sans-serif font. The logo is simple and recognizable. 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. {2}------------------------------------------------ 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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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 {3}------------------------------------------------ ## 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K082725](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GBX/K082725) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com