K Number
K070380
Device Name
PORTACLAMP FLEX
Date Cleared
2007-06-08

(120 days)

Product Code
Regulation Number
870.4450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
Device Description
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.
More Information

Not Found

Not Found

No
The 510(k) summary describes a purely mechanical device for clamping the aorta and contains no mention of AI, ML, image processing, or data-driven performance metrics.

No
A therapeutic device is used to treat or cure a disease or medical condition. This device is used to clamp the aorta, which is a procedural tool for surgery and not directly treating a disease.

No
The device description states it is an "aortic clamping device" used to "clamp the aorta." This describes a therapeutic or surgical instrument, not a device used to identify or analyze a condition.

No

The device description clearly outlines physical components (handle, clamp, guide wire, jaws, mandrel) that are used to perform a physical action (clamping the aorta). This indicates a hardware-based medical device, not a software-only one.

Based on the provided information, the Portaclamp® Flex is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Portaclamp® Flex Function: The Portaclamp® Flex is a surgical instrument used inside the body (in vivo) to physically clamp the aorta during cardiac surgery. It does not analyze or test any biological specimens.

The description clearly indicates its use as a surgical tool for a specific procedure, not for diagnostic testing of samples.

N/A

Intended Use / 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.

Product codes

DXC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

aorta

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Portaclamp®, Cosgrove Vascular Clamp

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

510(k) Summary

JUN - 8 2007

| Submitter Name:
Submitter Address: | Cardio Life Research s.a.
Rue de Clairvaux 40/203
B1348 Louvain la Neuve
Belgium |
|--------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number:
Fax Number: | 011 32 10 480 490
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,
Number &
Product Code: | Clamp, Vascular
870.4450
DXC |
| Predicate Devices: | Portaclamp®, Cosgrove Vascular Clamp |
| Device Description
and Statement of
Intended Use | 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 Portaclamp® Flex is indicated to clamp the aorta during minimally
invasive cardiac surgery implying the usage of an extra-corporeal
circulation. |
| Summary of
Technological
Characteristics | The Portaclamp® Flex system consists of two separate flexible jaws to
be positioned on either side of the aorta with the help of a supplied
flexible and straight guidewire, and a sliding metallic mandrel integrating
a manual grip to secure the jaws. The sliding mandrel consists of 2
detachable elements, it is delivered separately from the jaws and guide
wire, and it is reusable. |

:

1

1070380
Submitter:
Cardio Life ResearchPortaclamp Flex
Premarket Notification: Traditional 510(k)
A table comparing the Portaclamp® Flex to the predicate devices is
attached.
ConclusionThe information discussed above demonstrates that Portaclamp® Flex is
as safe, as effective, and performs as well as or better than the
predicate devices.
DeclarationsThis summary includes only information that is also covered in the
o
body of the 510(k).
This summary does not contain any puffery or unsubstantiated
O
labeling claims.
This summary does not contain any raw data, i.e., contains only
O
summary data.
This summary does not contain any trade secret or confidential
O
commercial information.
This summary does not contain any patient identification information.

2

Summary of Technical Characteristics

| Feature | Portaclamp Flex | Portaclamp | Cosgrove Vascular
Clamp |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Cardio Life Research | K033085 | K974769 |
| Manufacturer | Cardio Life Research | Cardio Life Research | Allegiance Healthcare
Corp. |
| Classification # &
Product Code | 870.4450
DXC | 870.4450
DXC | 870.4450
DXC |
| Intended Use | Temporary clamping of
aorta during minimally
invasive endoscopic
cardiac surgery implying
the usage of an extra-
corporeal circulation | Temporary clamping of
aorta during minimally
invasive endoscopic
cardiac surgery implying
the usage of an extra-
corporeal circulation | Temporary occlusion of
blood vessels during
pulmonary and
gastrointestinal
procedures, peripheral
clamping, minimally
invasive and standard
open cardiovascular and
cardiothoracic procedures
such as occlusion of the
aorta and vena cava,
cross clamping of the
aorta, etc. |
| Mode of Action | Flexible jaws with rigid
distal portion applied
around aorta using
guidewire and closed
with a sliding mandrel
that can be removed
after clamping and
reattached as needed.
Proximal portion of
jaws can de bent out of
way. | Rigid jaws applied
around aorta using
guidewire and closed
with an integral sliding
mandrel | Jaws applied around
aorta at the end of a
flexible shaft which can
be bent out of way. |
| Reusable | Clamps - No
Mandrel - Yes | No | Yes |
| Method of Clamp
Introduction | Through thoracic port
during minimally invasive
endoscopic procedure | Through thoracic port
during minimally invasive
endoscopic procedure | Through standard open
or minimally invasive
incision |
| Method of occlusion | Clamp jaws around
vessel | Clamp jaws around
vessel | Clamp jaws around
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