(254 days)
No
The device description details a mechanical surgical clamp with no mention of software, algorithms, or data processing.
No.
The device is a surgical clamp used for temporary occlusion of blood vessels during procedures, not to treat or cure a disease.
No
Explanation: The device is a surgical clamp used for temporary occlusion of blood vessels, not for diagnosing medical conditions.
No
The device description clearly states it is a reusable stainless steel vascular clamp, which is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential recipients, or to monitor therapeutic measures.
- Device Function: The Cardio Vision® MICS Aortic Clamps are surgical instruments used during a surgical procedure to temporarily occlude blood vessels. They are used on the patient's body, not for examining specimens outside the body.
- Intended Use: The intended use clearly states "for temporary or partial occlusion of blood vessels during surgical procedures." This is a surgical function, not a diagnostic one.
The device description and intended use clearly indicate that this is a surgical tool used directly on the patient during a procedure, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
Product codes
DXC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench and animal testing was performed to assess clamp force and aortic tissue damage. Comparison testing included Wexler Vascular Clamp Series (K110148), Transthoracic Aortic Clamp (K982365), and Cygnet Clamp (K010727).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Laboratories
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.
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
4
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