CARDIO VISION MICS AORTIC CLAMPS

K123571 · Cardiomedical GmbH · DXC · Aug 1, 2013 · Cardiovascular

Device Facts

• Record ID: K123571
• Device Name: CARDIO VISION MICS AORTIC CLAMPS
• Applicant: Cardiomedical GmbH
• Product Code: DXC · Cardiovascular
• Decision Date: Aug 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

Device Story

Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular clamps designed for temporary or partial vessel occlusion during surgery. The device features a DeBakey tooth design and is available in three models: a ring-handled clamp with ratchet closure, a handleless clamp with manual screw mechanism, and a handleless clamp with screw mechanism. The surgeon positions and removes the clamp using an applicator; the device remains within the thorax throughout the procedure. The closure mechanism allows the surgeon to adjust the tension applied to the vessel. The device is provided non-sterile and requires steam sterilization by the user. By providing controlled occlusion, the clamps assist surgeons in managing blood flow during operative procedures, potentially reducing tissue trauma and improving surgical site visibility.

Clinical Evidence

Bench and animal testing performed. Testing assessed clamp force and aortic tissue damage. Comparison testing included Wexler Vascular Clamp Series (K110148), Transthoracic Aortic Clamp (K982365), and Cygnet Clamp (K010727).

Technological Characteristics

Material: Stainless steel. Principle: Mechanical clamping with DeBakey tooth design. Closure: Ratchet or manual screw mechanism. Form factor: Three models (ring-handled or handleless). Sterilization: Steam (user-performed). Reusable.

Indications for Use

Indicated for temporary or partial occlusion of blood vessels during surgical procedures in patients requiring vascular clamping.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Wexler Vascular Clamp Series (K110148)
• Edwards Fogarty Soft Jaw Clip (K810162)
• Edwards Fogarty Soft Jaw Clip (K832554)

Reference Devices

• Transthoracic Aortic Clamp (K982365)
• Cygnet Clamp (K010727)

Submission Summary (Full Text)

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## 510(k) SUMMARY

K123571

Date: July 24, 2013 Submitter: Name: Cardiomedical GmbH Address: Industriestraße 3a D-30855 Langenhagen Germany Wolfgang Wiedenbein Contact Person: Telephone: [phone] Product: Trade Name: Cardio Vision® MICS Aortic Clamps Common Name: Vascular Clamp Vascular Clamp Classification Name: Product Code: DXC Regulation No: 870.4450 Predicate Device: K110148 - Wexler Vascular Clamp Series o K810162, K832554 - Edwards Fogarty Soft Jaw Clip o Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular Device Description: clamps provided with DeBakey tooth design. The closure mechanisms permit the surgeon to adjust the amount of tension applied to the vessel. The length and design of the clamps can be important to keep the devices out of the field of vision of the operative site. Three basic models are available to accommodate the individual needs of the surgeon and the procedure based on the anatomy of the site. Standard Clamp - Ring-handled clamp with ratchet closure o 2nd Generation Clamp -- Handleless clamp with manual screw 0 mechanism closure Clamp by Glauber - Handleless clamp with screw mechanism closure. o The clamp is positioned and removed by means of an applicator and remains wholly within the thorax throughout the duration of the procedure. The device is provided non-sterile for steam sterilization by the user. Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or Indications for Use: partial occlusion of blood vessels during surgical procedures. Technological The device has similar technological and performance characteristics as the Characteristics predicate devices, as shown by the following summary table:

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| Manufacturer | Cardiomedical | Wexler K110148 | American Edwards Laboratories<br>K810162, K832554 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures. | The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures. | The Fogarty Softjaw Spring Clips and Handleless Clamps and Fogarty-Hydragrip Surgical Clamp Insert Sets are intended for atraumatic vessel occlusion for distinct vessel conditions and procedures. |
| Design | Ring-handled clamps with ratchet.<br>Handleless clamps with screw closure mechanism adjusted manually or by means of an applicator. | Ring-handled clamps with ratchet. | Handleless clips and clamps or ring-handle surgical clamp insert sets with flexible shaft, provided with positioning device. |
| Principle of Operation | Clamp jaws are applied to the vessel. The amount of tension applied to the vessel for occlusion or partial occlusion is adjusted by means of the ratchet or screw closure mechanism. | Clamp jaws are applied to the vessel. The amount of tension applied to the vessel for occlusion or partial occlusion is adjusted by means of the ratchet closure mechanism. | Clamp jaws are applied to vessel. The amount of tension applied to the vessel for occlusion or partial occlusion is determined by the spring or adjusted by means of the ratchet closure. |
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Reusable | Yes | Yes | Yes |

Bench and animal testing was performed to assess clamp force and aortic Testing: tissue damage. Comparison testing included Wexler Vascular Clamp Series (K110148), Transthoracic Aortic Clamp (K982365), and Cygnet Clamp (K010727).

The information provided in this 510(k) submission demonstrates that Conclusion: subject device Cardio Vision® MICS Aortic Clamps is substantially equivalent to the predicate devices with respect to intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

August 1, 2013

Cardiomedical GMBH C/O Business Support International Amstel 320-1 Amsterdam, Noord-Holland Netherlands, 1017AP ATTN: Angelika Scherp

Re: K123571

> Trade/Device Name: Cardio Vision MICS Aortic Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: June 6, 2013 Received: June 7, 2013

Dear Ms. Scherp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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## Page 2 - Ms. Angelika Scherp

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M. A. Hillenbrand

for

Bram D. Zuckerman, Ph.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): K123571

Device Name: CARDIO VISION® MICS AORTIC CLAMPS

Indications for Use: Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

MA