HEBUmedical Vascular Clamps are reusable stainless steel ring-handled clamps provided in a wide variety of shapes, sizes and lengths to accommodate the individual needs of the surgeon and the procedure. based on the anatomy of the site and type of occlusion. The length and angles are design features that can be important to keep the handles and shanks out of the field of vision of the operative site. The handle is provided with a ratchet closure, which permits the surgeon to adjust the amount of tension applied to the vessel. The device is provided non-sterile for sterilization by the user.

AI/ML Overview

The provided 510(k) summary for HEBUmedical GmbH's Vascular Clamps does not describe a study involving an AI/software device, clinical data analysis, or a comparison with human readers. Instead, it describes a medical device (vascular clamps) that is a physical instrument, and its performance evaluation is based on bench testing.

Therefore, most of the requested information (sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth for training/test sets, effect size of human improvement with AI) is not applicable to this submission.

However, I can extract the information relevant to the provided text regarding the device and its performance relative to acceptance criteria.

Analysis of Acceptance Criteria and Device Performance for HEBUmedical Vascular Clamps

The 510(k) summary for the HEBUmedical Vascular Clamps focuses on demonstrating substantial equivalence to predicate devices through technological and performance characteristics, primarily assessed via bench testing. The "acceptance criteria" here are implicitly defined by the similar performance of the predicate devices in the described characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not quantitative thresholds but rather qualitative comparisons to existing predicates, demonstrating similar characteristics to establish substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (HEBUmedical Vascular Clamps)
Design	Multiple jaw tips and orientation, ratchet lock on handle, ring handle	Multiple jaw tips and orientation, ratchet lock on handle, ring handle
Principle of Operation	Clamp jaw applied to vessel; tension for occlusion/partial occlusion adjusted by ratchet closure	Clamp jaw is 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.
Material	Stainless Steel (one predicate also includes Titanium)	Stainless Steel
Sterility	Non-sterile	Non-sterile
Reusable	Yes	Yes
Functional Performance	Adequate clamp force and occlusion (demonstrated by bench testing)	Bench testing was performed to assess clamp force and occlusion. The device has similar technological and performance characteristics as the predicate devices.

2. Sample Size and Data Provenance

Sample Size for Test Set: Not explicitly stated in terms of a "test set" for data or images. The evaluation was based on bench testing of the physical vascular clamps. The number of clamps tested (sample size for bench testing) is not specified.
Data Provenance: The data provenance is from bench testing performed by the manufacturer, HEBUmedical GmbH, in Germany. This is an engineering/physical performance evaluation, not clinical data from patients. It is implicitly a prospective evaluation in the sense that the new device's performance was tested.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This submission is for a physical medical device (vascular clamp) and relies on bench testing for performance evaluation, not expert-labeled clinical data or images. Ground truth was established through physical measurements of clamp force and occlusion during bench testing.

4. Adjudication Method for the Test Set

Not Applicable. As no clinical image or data review requiring human expert interpretation was performed, there was no need for an adjudication method. Bench test results are typically objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not conducted as this device is a physical surgical instrument, not an AI/software product, and its evaluation did not involve human readers interpreting clinical cases.

6. Standalone Performance (Algorithm Only)

Not Applicable. This is a physical device, not an algorithm or software. Its "standalone performance" refers to its physical characteristics and functionality, which were assessed via bench testing for clamp force and occlusion.

7. Type of Ground Truth Used

Objective Bench Testing Measurements. The ground truth for evaluating the device's performance was derived from objective measurements obtained during bench testing of the physical clamp force and occlusion capabilities, compared against the characteristics of predicate devices.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this physical device's evaluation. The device itself is manufactured, not "trained."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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510(k) SUMMARY

K123077

Date: September 27, 2012 Submitter: Name: HEBUmedical GmbH Address: Badstrasse 5 78532 Tuttlingen Germany Contact Thomas Butsch Person: Telephone: +49.7461.94710 +49.7461.947122 Fax: Product: Trade Name: Vascular Clamps Common Name: Vascular Clamp Classification Name: Vascular Clamp Predicate o K992053 - Aesculap Vascular Instruments Device: o K072834 - Sibel Vascular Clamp Device HEBUmedical Vascular Clamps are reusable stainless Description: steel ring-handled clamps provided in a wide variety of shapes, sizes and lengths to accommodate the individual needs of the surgeon and the procedure. based on the anatomy of the site and type of occlusion. The length and angles are design features that can be important to keep the handles and shanks out of the field of vision of the operative site. The handle is provided with a ratchet closure, which permits the surgeon to adjust the amount of tension applied to the vessel. The device is provided non-sterile for sterilization by the user. Indications for Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical Use: procedures. Technological Bench testing was performed to assess clamp force and Characteristics occlusion. The device has similar technological and performance characteristics as the predicate devices, as shown by the following summary table:

MAY 1 4 2013

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Manufacturer	HEBUmedical	SurgicalInstrumentsBelgium	Aesculap
Design	Multiple jaw tipsand orientation,ratchet lock onhandle, ringhandle	Multiple jaw tipsand orientation,ratchet lock onhandle, ringhandle	Multiple jaw tipsand orientation,ratchet lock onhandle, ringhandle
Principle ofOperation	Clamp jaw isapplied to thevessel. Theamount oftension appliedto the vessel forocclusion orpartial occlusionis adjusted bymeans of theratchet closure	Clamp jaw isapplied to thevessel. Theamount of tensionapplied to thevessel forocclusion orpartial occlusionis adjusted bymeans of theratchet closure	Clamp jaw isapplied to thevessel. Theamount of tensionapplied to thevessel forocclusion orpartial occlusionis adjusted bymeans of theratchet closure
Material	Stainless Steel	Stainless Steel,Titanium	Stainless Steel
Sterility	Non-sterile	Non-sterile	Non-sterile
Reusable	Yes	Yes	Yes

Conclusion:

The information provided in this 510(k) submission provides reasonable assurance that the subject device Vascular Clamps is safe and effective and that it is substantially equivalent to the predicate device with respect to intended use and technological characteristics.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2013

HEBUmedical GmbH Attention: Angelika Scherp Regulatory Affairs Consultant Badstrasse 8 78532 Tuttlingen, Germany

Re: K123077

Trade Name: Vascular Clamps Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: April 24, 2013 Received: May 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 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

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Page 2 - Ms. Angelika Scherp

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" (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.

Bram D. Z@Ckerman -S

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): K123077

Device Name: VASCULAR CLAMPS

Indications for Use: Vascular Clamps are indicated for use for temporary or partial occlusion of blood vessels during open surgical procedures.

Prescription Use __ X__ . (Part 21 CFR 80) 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)

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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).