(111 days)
GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.
The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use. GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion. The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary. The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.
The provided text is a 510(k) Summary for the GEOMED Vascular Clamps, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through extensive clinical trials or performance studies with acceptance criteria in the way a new drug or novel medical software would.
Therefore, the information you've requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, and AI-related studies is not present in this document. The document primarily focuses on demonstrating that the GEOMED Vascular Clamps are substantially equivalent to existing, legally marketed vascular clamps.
Here's a breakdown of why this information isn't available in the provided text, and what is discussed:
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A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the vascular clamps in the way that would be done for a diagnostic device or AI algorithm. The "performance" assessment is based on the device's physical properties and intended use mirroring existing devices.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, in the context of performance metrics for an AI or diagnostic device, is mentioned or used. The "testing" referred to is for cleaning and sterilization procedures, not for clinical performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable. There is no "ground truth" to establish for this type of mechanical device in the same way there would be for an AI diagnostic.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 device is a mechanical surgical instrument, not an AI-powered diagnostic or assistive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
What the document does state regarding "Design Verification Performance":
- Design Verification Performance: "Tests for Cleaning and Sterilization are provided." This indicates that the device underwent testing to ensure it can be properly cleaned and sterilized for reuse, which is a critical safety and functionality aspect for reusable surgical instruments. However, the details of these tests (e.g., number of cycles, specific protocols, acceptance criteria for sterility/cleanliness) are not included in this summary.
In summary, the provided document is a 510(k) summary for a mechanical surgical device (Vascular Clamps) and, as such, does not contain the detailed performance study information typically required for devices involving complex algorithms, diagnostics, or AI. The substantial equivalence claim is based on similar design, materials, and intended use compared to predicate devices.
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510(k) Summary of Safety and Effectiveness
GEOMED Medizin-Technik GmbH & Co. KG Ludwigstaler Straße 27 D-78532 Tuttlingen / Germany
Titel: GEOMED Vascular Clamps
June 1, 2010 ·
NOV - 9 2010
Submitter
ubmitter
pplication correspondent
Application correspondent (consultant)
Trade Name
Common Name
Product Code and Classification Name
Product Classification
GEOMED
Medizin-Technik GmbH & Co. KG Ludwigstaler Strasse 27 D-78532 Tuttlingen Germany Thomas Haug President Telefon: ++49 7461 / 93 55 0 FAX: ++49 7461 / 93 55 93 E-mail: info@ggeomed.de
Harald Jung. General Manager JUNG Consulting Unterer Winkel 3 D-78573 Wurmlingen Germany Telefon +49 7461-96 92 36 FAX +49 7461-96 92 37 E-mail: hjung@harald-jung.de
GEOMED Vascular Clamps
Vascular Clamp
DXC, Clamp, Vascular
21 CFR § 870.4450
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510(k) Summary of Safety and Effectiveness
GEOMED Medizin-Technik GmbH & Co. KG Ludwigstaler Straße 27 D-78532 Tuttlingen / Germany
Predicate:
GEOMED Vascular Clamps are substantially equivalent to other legally marketed Vascular Clamps from different manufacturers, e.g. Aesculap Inc ..
Device Description:
The GEOMED Vascular Clamps are reusable devices and provided non sterile. They must be thoroughly cleaned and sterilized before use.
GEOMED Vascular Clamps are made of Stainless Steel (following ASTM F 899-07). They are provided with ring handles and ratchet closures to adjust the amount of tension applied to the vessel for occlusion or partial occlusion.
The GEOMED Vascular Clamps are available in a wide variety of shapes, sizes and lengths to accomodate to the individual needs of the surgeon. Based on the anatomy of the site, the surgical technique chosen, the size and type of blood vessel and occlusion desired, the surgeon decides which clamp to use. During surgery the handles and shanks need to be out of the field of vision of the operative site and therefore a wide variety of instrument figures and sizes is necessary.
The Vascular Clamps occlude the arteries or veins with a tension that intends to produce minimal trauma to the vessels. They cover the vessel and stop the blood flow.
Indications for Use:
GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.
Substantial Equivalence:
The GEOMED Vascular Clamps are substantial equivalent to the predicate device. since the basic features, design and intended uses are the same. The minor differences between the GEOMED Vascular Clamps and the predicate device have no effect on the performance, function or intended use of the device.
Design Verification Performance:
Tests for Cleaning and Sterilization are provided.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus. The logo is simple and recognizable, representing the department's role in promoting the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, M1) 20993-0002
GEOMED Medizin-Technik GmbH & Co. KG c/o Mr. Harald Jung JUNG Consulting Unterer Winkel 3 D-78573 Wurmlingen Germany
NOV - 9 2010
Re: K102048
Trade Name: Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: October 6, 2010 Received: October 8, 2010
Dear Mr. Jung:
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. Iisting 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.
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Page 2 - Ms. Harald Jung
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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
una R. V. hmer
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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Indications for Use
510(k) Number (if known): K102048
Device Name: GEOMED Vascular Clamps
NOV -- 9 2010
Indications for Use:
GEOMED Vascular Clamps are intended for use for temporary occlusion of blood vessels during surgical procedures.
Prescription Use YES AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dunk R. Vc
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K1020 48
Page REV 01. A 3
§ 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).