CARDIO VISION MICS AORTIC CLAMPS by CARDIOMEDICAL GMBH

Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular 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.

AI/ML Overview

This document describes a 510(k) summary for the Cardio Vision® MICS Aortic Clamps, a vascular clamp. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the manner of an AI/ML powered device. Therefore, many of the requested categories for a comprehensive device study (especially those related to AI/ML performance, human readers, and ground truth establishment) are not applicable or not explicitly detailed in this type of submission for a mechanical device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a mechanical device like a vascular clamp is typically linked to functional requirements and safety, rather than statistical performance metrics like sensitivity/specificity for an AI algorithm. For this 510(k) submission, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety. The reported "performance" is a comparison to these predicates.

Feature	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (Cardio Vision® MICS Aortic Clamps)
Indications for Use	Temporary or partial occlusion of blood vessels during surgical procedures.	Meets: Indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Design	Ring-handled clamps with ratchet mechanism, or handleless clamps with screw mechanism.	Meets/Exceeds: Ring-handled clamps with ratchet; Handleless clamps with screw closure mechanism adjusted manually or by means of an applicator (offering more design variations than some predicates).
Principle of Operation	Clamp jaws apply tension for occlusion/partial occlusion via ratchet or screw.	Meets: Clamp jaws are applied to the vessel. The amount of tension applied is adjusted by means of the ratchet or screw closure mechanism.
Material	Stainless Steel	Meets: Stainless Steel
Sterility	Non-sterile (for user sterilization)	Meets: Non-sterile
Reusable	Yes	Meets: Yes
Safety/Functionality	Safe and effective performance (implied by predicate clearance).	Supported by Bench and Animal Testing: Assessed clamp force and aortic tissue damage. Comparison testing included Wexler Vascular Clamp Series (K110148), Transthoracic Aortic Clamp (K982365), and Cygnet Clamp (K010727).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document states "Bench and animal testing was performed to assess clamp force and aortic tissue damage." However, specific sample sizes for these tests are not provided in this summary.
Data Provenance: The document does not explicitly state the country of origin for the animal testing, but the submitter (Cardiomedical GmbH) is from Germany. The testing itself is described as "bench and animal testing," indicating it was likely conducted in a controlled environment as part of the device development and validation. It is prospective testing for the device's validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable in the context of this device. For a mechanical device like a vascular clamp, "ground truth" is not established by expert consensus on observational data (like medical images). Instead, the performance (e.g., clamp force, tissue damage) is measured directly in controlled laboratory and animal settings, often against established engineering standards or comparative data from predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are relevant for subjective assessments, typically in image interpretation or diagnostic tasks involving multiple human readers. For the objective measurement of clamp force or tissue damage, such a method is not used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a mechanical device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

For this mechanical device, the "ground truth" implicitly refers to objective measurements of physical properties (e.g., clamp force, assessment of aortic tissue damage) obtained through laboratory and animal testing. This is not "expert consensus, pathology, or outcomes data" in the typical sense for diagnostic devices, but rather direct empirical data on the device's mechanical function and biological interaction.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of mechanical device.

Summary

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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: +49.511.7248548 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 LaboratoriesK810162, 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.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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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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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)

Regulation Number and Section

§ 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).