HiCut™ Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone, and biomaterials in Orthopedic Surgery, Neurological and Spinal Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery.

Device Description

The HiCut™ Highspeed Instrument is a sterile packed, single-use cutting device with numerous tip designs and various lengths. The rear end is designed to fit in various commonly marketed surgical motor drill systems. The tip designs are similar to the commonly used tip designs.

The HiCut™ Highspeed Instrument is classified Class II (USA) (Class IIa in EU) per CFR, Part 882.4310. The HiCut™ Highspeed Instruments are simple powered burs to be inserted in pneumatic or electric powered motor drill devices.

AI/ML Overview

The provided document is a 510(k) summary for a surgical bur, the HiCut™ Highspeed Instrument. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving novel effectiveness through clinical studies with specific performance criteria. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

This device is a surgical bur, a mechanical device. The "acceptance criteria" and "reported device performance" in this context refer to the successful completion of non-clinical performance testing confirming that the device is safe and performs as intended, demonstrating substantial equivalence to legally marketed predicate devices.

Acceptance Criteria (Non-clinical Performance Testing)	Reported Device Performance (Conclusion)
Biocompatibility: Evaluated in compliance with ISO 10993.	Based on the selected materials and the provided evaluation, sufficient biocompatibility can be assumed.
Sterility: Method of radiation complies with ISO 11137-1, 2, and 3.	The sterilization process is validated and ensures the sterility of the device throughout the shelf life and transport.
Sterility Assurance Level (SAL): Specific to radiation sterilization.	The sterilization process is validated and ensures the sterility of the device throughout the shelf life and transport. (Implicitly met as part of overall sterility validation).
Packaging Integrity: Testing to ensure packaging maintains device sterility (integrity of sealed seam according to ISO 11607) and is not adversely affected by aging (10-year artificial aging test in accordance with ASTM F 1980) or transport (drop and vibration test based on ISO13355 and ASTM D 5276-98).	The compliance with these criteria is ensured for at least the duration of shelf life.
Parameter Comparison (Substantial Equivalence): Comparison of geometrical conditions and critical values of the subject device and predicate devices. Materials, design, and mechanical constitution.	It can be stated that the subject devices have an equivalent rear end design, which ensures a secure fit into the corresponding drill chucks. Further qualification criteria of the subject device such as materials, design, and mechanical constitution exceed the same results as the predicate devices. Thus, the substantial equivalence and therefore, the safety and effectiveness of the subject device can be established.
Overall Safety and Effectiveness: Based on non-clinical tests and comparison to predicates.	The subject device is as safe, as effective, and performs as well as the predicate devices. The Highspeed Instruments proved to be substantially equivalent. The subject device described in this submission performs as intended and raises no new safety or effectiveness issues.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document mentions "Samples for each system of both the subject and predicate devices were compared" for parameter comparison. It does not specify an exact number of samples. For biocompatibility, sterility, and packaging tests, standard industrial testing protocols would have been followed, likely using a sufficient number of samples as required by the relevant ISO and ASTM standards.
Data Provenance: The studies are non-clinical (laboratory/bench testing) and were conducted by the manufacturer, adeor Medical AG, a German company ("Kirchplatz 1, 82049 Pullach, Germany"). The document indicates the device is marketed in the European Union, suggesting testing would adhere to international standards commonly accepted in both the EU and USA. This is prospective testing related to device manufacturing.

3. 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. The product is a surgical bur, a mechanical instrument. "Ground truth" in this context is established through objective performance metrics derived from laboratory testing, adherence to international standards (ISO, ASTM), and comparison to the physical and material characteristics of predicate devices, rather than through subjective expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no subjective assessment requiring adjudication. The tests (biocompatibility, sterility, mechanical parameter comparison) are objective, laboratory-based analyses against defined standards.

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

This is not applicable. This device is a mechanical surgical instrument, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI performance metrics are irrelevant.

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

This is not applicable. This device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for demonstrating substantial equivalence for this type of device is:

Objective Test Results: Data from standardized laboratory tests (e.g., biocompatibility according to ISO 10993, sterility according to ISO 11137, packaging integrity according to ISO 11607 and ASTM F 1980).
Engineering and Material Specifications: Directly comparing the materials, design specifications, and mechanical performance characteristics of the subject device to those of the predicate devices.
Adherence to Standards: Compliance with recognized international standards indicates that the device meets established safety and performance benchmarks.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established

This is not applicable. There is no "training set."

Summary

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JUN 2 7 2014

Page 1 of 3

K130755

Traditional 510(k) Summary

Submitter:	adeor Medical AGKirchplatz 182049 PullachGermany
Contact Person:	Fabio von ZeppelinCOO
	Phone: +49 (0)89-744 42 398Fax: +49 (0)89-744 24 809
PreparationDate:	May 9th, 2014
Trade Name:	HiCut™ Highspeed Instrument
Common Name:	Bur
ClassificationName:	Neurological surgical devices

Device Description:

Indications for Use:

HiCut™ Highspeed Instruments are surgical burs indicated for trephination, incision, cutting, removal, shaping, sawing of soft and hard tissue, bone and biomaterials in Orthopedic Surgery, Neurological and Spinal Surgery, ENT Surgery, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery,

Intended Use:

The HiCut® Highspeed Instruments are intended to be single-used with a compatible surgical drill system for surgical bone work.

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Predicate Devices:

K113476	Drills, Burrs, Trephines &Accessories (Simple, Powered)(HBE)	The AnspachEffort, Inc.
K922299 K013091	Drills, Burrs, Trephines &Accessories (Simple, Powered)(HBE)	Von ZeppelinChirurgischeInstrumenteGmbH
K081475	Drills, Burrs, Trephines &Accessories (Simple, Powered)(HBE)	MedtronicXomed, Inc.

Substantial Equivalence:

The HiCut™ Highspeed Instrument is substantially equivalent to the predicate devices. The equivalence is based on the device similarity to the predicate devices in indications of use, functionality and technological characteristics. The predicate devices K113476 and K081475 and the subject device are marketed in the European Union as substantially equivalent.

Technological Characteristics Comparison:

The technological characteristics of the subject device are based on the same HiCut™ Highspeed Instrument technology as the predicate devices. The material of both the HiCut™ Highspeed Instruments and of the predicate devices is surgical steel and some have a layer of diamonds. Similar to the other legally marketed burs used for surgical bone trephination (predicate devices) the Hicut™ devices are sterilized, individually packed devices and are used in conjunction with a surgical motor drive either pneumatic or electric.

Performance data testing:

This submissions includes the following non-clinical performance testing:

1. Biocompatibility: evaluated in compliance with ISO 10993.
  Conclusion: Based on the selected materials and the provided evaluation, sufficient biocompatibility can be assumed.
1. Sterility: The method of radiation complies with the norms ISO 11137-1. 2 and 3. Conclusion: The sterilization process is validated and ensures the sterility of the device throughout the shelf life and transport.

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K130755 3 Page 3 of

The following sterility and shelf life testing is included in the submission:

Procedure/Criteria

Validation and Revalidation of the Radiation Sterilization Method

Establishment of the sterilization dose

Sterility assurance level (SAL)

Testing to ensure that packaging maintains device sterility (tested: integrity of the sealed seam according to ISO 11607) and is not adversely affected by aging (10-year of artificial aging test in accordance with ASTM F 1980) or transport (drop and vibration test based on ISO13355 and ASTM D 5276-98). The compliance with these criteria is ensured for at least the duration of shelf life.

1. Parameter comparison: Substantial equivalence to the predicate devices is based on the comparison of geometrical conditions and their critical values. Samples for each system of both the subject and predicate devices were compared. As a result, it can be stated that the subject devices have an equivalent rear end design, which ensures a secure fit into the corresponding drill chucks. Further qualification criteria of the subject device such as materials, design and mechanical constitution exceed the same results as the predicate devices. Thus, the substantial equivalence and therefore, the safety and effectiveness of the subject device can be established.
  Considering the conclusions of the non-clinical tests, it can be stated that the subject device is as safe, as effective, and performs as well as the predicate devices.

Conclusions

Based upon the comparison of their functionality, intended use and technological characteristics to the predicate devices and the conclusions drawn from the non-clinical performance testing, the Highspeed Instruments proved to be substantially equivalent. The subject device described in this submission performs as intended and raises no new safety or effectiveness issues.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services, featuring three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 27, 2014

Adeor Medical AG Mr. Fabio von Zeppelin Chief Operating Officer Kirchplatz 1 Pullach, 82049 Germany

Re: K130755

Trade/Device Name: HiCut™ Highspeed Instrument Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: Class II Product Code: HBE Dated: May 9, 2014 Received: May 27, 2014

Dear Mr. Zeppelin:

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

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Page 2 - Mr. Fabio von Zeppelin

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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Binita S. Ashar -S. 2014.06.27 10:50:49 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K130755

Device Name HiCutTM Highspeed Instrument

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED,

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Joshua C. N lipper -S

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FORM FDA 3881 (1/14)

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).