(465 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a simple surgical bur, with no mention of AI/ML capabilities or data processing.
No.
The device is a surgical cutting instrument used for tasks like trephination, incision, and shaping of tissue and bone, not for treating a disease or condition.
No
Explanation: The device is described as a "surgical bur" and a "cutting device" used for trephination, incision, cutting, removal, shaping, and sawing of tissue, bone, and biomaterials. Its intended use is for surgical procedures, not for diagnosing conditions or diseases.
No
The device description clearly states it is a "sterile packed, single-use cutting device with numerous tip designs and various lengths" and a "simple powered bur," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the HiCut™ Highspeed Instruments are surgical burs used for cutting, shaping, and removing tissue and bone during surgical procedures. This is an in vivo (within a living organism) application.
- Device Description: The description details a sterile, single-use cutting device designed to be inserted into surgical motor drill systems. This aligns with a surgical tool, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (like blood, urine, tissue biopsies) or to provide diagnostic information about a patient's condition. IVDs are typically used to detect, measure, or identify substances or characteristics in biological samples.
Therefore, the HiCut™ Highspeed Instrument is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, Plastic and Maxillofacial Surgery, Arthroscopy, Sternotomy and General Surgery.
Product codes
HBE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and hard tissue, bone
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)
This submission includes the following non-clinical performance testing:
-
Biocompatibility: evaluated in compliance with ISO 10993.
Conclusion: Based on the selected materials and the provided evaluation, sufficient biocompatibility can be assumed. -
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.
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. -
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K113476, K922299, K013091, K081475
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUN 2 7 2014
Page 1 of 3
Traditional 510(k) Summary
| Submitter: | adeor Medical AG
Kirchplatz 1
82049 Pullach
Germany |
|-------------------------|--------------------------------------------------------------|
| Contact Person: | Fabio von Zeppelin
COO |
| | Phone: +49 (0)89-744 42 398
Fax: +49 (0)89-744 24 809 |
| Preparation
Date: | May 9th, 2014 |
| Trade Name: | HiCut™ Highspeed Instrument |
| Common Name: | Bur |
| Classification
Name: | Neurological surgical devices |
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.
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.
1
Predicate Devices:
| K113476 | Drills, Burrs, Trephines &
Accessories (Simple, Powered)
(HBE) | The Anspach
Effort, Inc. |
|--------------------|----------------------------------------------------------------------|-----------------------------------------------------|
| K922299
K013091 | Drills, Burrs, Trephines &
Accessories (Simple, Powered)
(HBE) | Von Zeppelin
Chirurgische
Instrumente
GmbH |
| K081475 | Drills, Burrs, Trephines &
Accessories (Simple, Powered)
(HBE) | Medtronic
Xomed, 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:
-
- Biocompatibility: evaluated in compliance with ISO 10993.
Conclusion: Based on the selected materials and the provided evaluation, sufficient biocompatibility can be assumed.
- Biocompatibility: evaluated in compliance with ISO 10993.
-
- 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.
2
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.
-
- 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.
- 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.
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.
3
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
4
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
5
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)
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.
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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"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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FORM FDA 3881 (1/14)