PORTACLAMP FLEX

{0}------------------------------------------------ ## 510(k) Summary JUN - 8 2007 | Submitter Name:<br>Submitter Address: | Cardio Life Research s.a.<br>Rue de Clairvaux 40/203<br>B1348 Louvain la Neuve<br>Belgium | |--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Phone Number:<br>Fax Number: | 011 32 10 480 490<br>011 32 10 456 926 | | Contact Person: | Michel Joie | | Date Prepared: | 31 January 2007 | | Device Trade Name: | Portaclamp® Flex | | Common Name | Aortic Clamp | | Classification Name,<br>Number &<br>Product Code: | Clamp, Vascular<br>870.4450<br>DXC | | Predicate Devices: | Portaclamp®, Cosgrove Vascular Clamp | | Device Description<br>and Statement of<br>Intended Use | The Portaclamp® Flex is an aortic clamping device composed of a<br>detachable, reusable handle and a single-use, disposable clamp. It is<br>designed to be used through a standard thoracic port to clamp the aorta<br>during minimally invasive cardiac bypass procedures. The Portaclamp<br>Flex consists of a flexible guide wire, two jaws that are passed over the<br>guide wire and positioned on each side of the aorta, and a mandrel that<br>is slid along the length of the jaws to compress the jaws and clamp the<br>aorta.<br>The Portaclamp® Flex is indicated to clamp the aorta during minimally<br>invasive cardiac surgery implying the usage of an extra-corporeal<br>circulation. | | Summary of<br>Technological<br>Characteristics | The Portaclamp® Flex system consists of two separate flexible jaws to<br>be positioned on either side of the aorta with the help of a supplied<br>flexible and straight guidewire, and a sliding metallic mandrel integrating<br>a manual grip to secure the jaws. The sliding mandrel consists of 2<br>detachable elements, it is delivered separately from the jaws and guide<br>wire, and it is reusable. | : {1}------------------------------------------------ | | 1070380 | | | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | Submitter:<br>Cardio Life Research | Portaclamp Flex<br>Premarket Notification: Traditional 510(k) | | | | | A table comparing the Portaclamp® Flex to the predicate devices is<br>attached. | | | | Conclusion | The information discussed above demonstrates that Portaclamp® Flex is<br>as safe, as effective, and performs as well as or better than the<br>predicate devices. | | | | Declarations | This summary includes only information that is also covered in the<br>o<br>body of the 510(k).<br>This summary does not contain any puffery or unsubstantiated<br>O<br>labeling claims.<br>This summary does not contain any raw data, i.e., contains only<br>O<br>summary data.<br>This summary does not contain any trade secret or confidential<br>O<br>commercial information.<br>This summary does not contain any patient identification information. | | | {2}------------------------------------------------ ## Summary of Technical Characteristics | Feature | Portaclamp Flex | Portaclamp | Cosgrove Vascular<br>Clamp | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | Cardio Life Research | K033085 | K974769 | | Manufacturer | Cardio Life Research | Cardio Life Research | Allegiance Healthcare<br>Corp. | | Classification # &<br>Product Code | 870.4450<br>DXC | 870.4450<br>DXC | 870.4450<br>DXC | | Intended Use | Temporary clamping of<br>aorta during minimally<br>invasive endoscopic<br>cardiac surgery implying<br>the usage of an extra-<br>corporeal circulation | Temporary clamping of<br>aorta during minimally<br>invasive endoscopic<br>cardiac surgery implying<br>the usage of an extra-<br>corporeal circulation | Temporary occlusion of<br>blood vessels during<br>pulmonary and<br>gastrointestinal<br>procedures, peripheral<br>clamping, minimally<br>invasive and standard<br>open cardiovascular and<br>cardiothoracic procedures<br>such as occlusion of the<br>aorta and vena cava,<br>cross clamping of the<br>aorta, etc. | | Mode of Action | Flexible jaws with rigid<br>distal portion applied<br>around aorta using<br>guidewire and closed<br>with a sliding mandrel<br>that can be removed<br>after clamping and<br>reattached as needed.<br>Proximal portion of<br>jaws can de bent out of<br>way. | Rigid jaws applied<br>around aorta using<br>guidewire and closed<br>with an integral sliding<br>mandrel | Jaws applied around<br>aorta at the end of a<br>flexible shaft which can<br>be bent out of way. | | Reusable | Clamps - No<br>Mandrel - Yes | No | Yes | | Method of Clamp<br>Introduction | Through thoracic port<br>during minimally invasive<br>endoscopic procedure | Through thoracic port<br>during minimally invasive<br>endoscopic procedure | Through standard open<br>or minimally invasive<br>incision | | Method of occlusion | Clamp jaws around<br>vessel | Clamp jaws around<br>vessel | Clamp jaws around<br>vessel | {3}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 8 2007 Cardio Life Research c/o Mr. William Greenrose President, Qserve America, Inc. 220 River Road Claremont, NH 03743 Re: K070380 Portaclamp® Flex Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: DXC Dated: May 29, 2007 Received: May 31, 2007 Dear Mr. Greenrose: 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. 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 {4}------------------------------------------------ ## Page 2 - Mr. William Greenrose 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); 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 vour 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 vours. B. Zimmerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ 4.1 Indications for Use Statement 510(k) Number (if known): K070380 Device Name: Portaclamp® Flex Indications for Use: The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH; Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) Bhumima (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K070380