(120 days)
The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
The provided text is a 510(k) summary for the Portaclamp® Flex, a vascular clamp. However, it does not contain information on acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert opinions, or statistical analysis typically associated with AI/algorithm performance studies.
The document focuses on demonstrating substantial equivalence to predicate devices for mechanical characteristics and intended use, rather than the performance of an AI or algorithm.
Therefore, I cannot provide details on the following based on the provided text:
- A table of acceptance criteria and reported device performance (for an AI/algorithm)
- Sample sizes used for test/training sets or data provenance
- Number of experts or their qualifications
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used
- How ground truth was established
The current document describes a traditional medical device (a vascular clamp), not an AI/algorithm-based device, and therefore the requested information regarding AI/algorithm performance studies is not present.
If you have a different document describing an AI/algorithm-based medical device, please provide that, and I can then attempt to extract the requested information.
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510(k) Summary
JUN - 8 2007
| Submitter Name:Submitter Address: | Cardio Life Research s.a.Rue de Clairvaux 40/203B1348 Louvain la NeuveBelgium |
|---|---|
| Phone Number:Fax Number: | 011 32 10 480 490011 32 10 456 926 |
| Contact Person: | Michel Joie |
| Date Prepared: | 31 January 2007 |
| Device Trade Name: | Portaclamp® Flex |
| Common Name | Aortic Clamp |
| Classification Name,Number &Product Code: | Clamp, Vascular870.4450DXC |
| Predicate Devices: | Portaclamp®, Cosgrove Vascular Clamp |
| Device Descriptionand Statement ofIntended Use | The Portaclamp® Flex is an aortic clamping device composed of adetachable, reusable handle and a single-use, disposable clamp. It isdesigned to be used through a standard thoracic port to clamp the aortaduring minimally invasive cardiac bypass procedures. The PortaclampFlex consists of a flexible guide wire, two jaws that are passed over theguide wire and positioned on each side of the aorta, and a mandrel thatis slid along the length of the jaws to compress the jaws and clamp theaorta.The Portaclamp® Flex is indicated to clamp the aorta during minimallyinvasive cardiac surgery implying the usage of an extra-corporealcirculation. |
| Summary ofTechnologicalCharacteristics | The Portaclamp® Flex system consists of two separate flexible jaws tobe positioned on either side of the aorta with the help of a suppliedflexible and straight guidewire, and a sliding metallic mandrel integratinga manual grip to secure the jaws. The sliding mandrel consists of 2detachable elements, it is delivered separately from the jaws and guidewire, and it is reusable. |
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| 1070380 | |||
|---|---|---|---|
| Submitter:Cardio Life Research | Portaclamp FlexPremarket Notification: Traditional 510(k) | ||
| A table comparing the Portaclamp® Flex to the predicate devices isattached. | |||
| Conclusion | The information discussed above demonstrates that Portaclamp® Flex isas safe, as effective, and performs as well as or better than thepredicate devices. | ||
| Declarations | This summary includes only information that is also covered in theobody of the 510(k).This summary does not contain any puffery or unsubstantiatedOlabeling claims.This summary does not contain any raw data, i.e., contains onlyOsummary data.This summary does not contain any trade secret or confidentialOcommercial information.This summary does not contain any patient identification information. |
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Summary of Technical Characteristics
| Feature | Portaclamp Flex | Portaclamp | Cosgrove VascularClamp |
|---|---|---|---|
| 510(k) Number | Cardio Life Research | K033085 | K974769 |
| Manufacturer | Cardio Life Research | Cardio Life Research | Allegiance HealthcareCorp. |
| Classification # &Product Code | 870.4450DXC | 870.4450DXC | 870.4450DXC |
| Intended Use | Temporary clamping ofaorta during minimallyinvasive endoscopiccardiac surgery implyingthe usage of an extra-corporeal circulation | Temporary clamping ofaorta during minimallyinvasive endoscopiccardiac surgery implyingthe usage of an extra-corporeal circulation | Temporary occlusion ofblood vessels duringpulmonary andgastrointestinalprocedures, peripheralclamping, minimallyinvasive and standardopen cardiovascular andcardiothoracic proceduressuch as occlusion of theaorta and vena cava,cross clamping of theaorta, etc. |
| Mode of Action | Flexible jaws with rigiddistal portion appliedaround aorta usingguidewire and closedwith a sliding mandrelthat can be removedafter clamping andreattached as needed.Proximal portion ofjaws can de bent out ofway. | Rigid jaws appliedaround aorta usingguidewire and closedwith an integral slidingmandrel | Jaws applied aroundaorta at the end of aflexible shaft which canbe bent out of way. |
| Reusable | Clamps - NoMandrel - Yes | No | Yes |
| Method of ClampIntroduction | Through thoracic portduring minimally invasiveendoscopic procedure | Through thoracic portduring minimally invasiveendoscopic procedure | Through standard openor minimally invasiveincision |
| Method of occlusion | Clamp jaws aroundvessel | Clamp jaws aroundvessel | Clamp jaws aroundvessel |
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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
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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
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4.1 Indications for Use Statement
510(k) Number (if known):
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).