(99 days)
Not Found
No
The summary describes a mechanical drill system and its performance characteristics, with no mention of AI or ML capabilities.
No
The device is a surgical drill system used for cutting and removing tissue, bone, and biomaterials during various surgical procedures; it is an operative tool rather than a therapeutic device that treats a condition.
No
The device is indicated for surgical procedures involving the cutting, removal, drilling, and sawing of tissue, bone, and biomaterials. This describes a surgical tool, not a device used to diagnose a medical condition.
No
The device description explicitly states that the system consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories, which are all hardware components.
No, the Medtronic MR8 Drill System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- MR8 Drill System Function: The description clearly states the MR8 Drill System is used for "incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials" during surgical procedures. This is an in vivo (within the body) function, directly interacting with the patient's tissues.
The intended use and device description focus on surgical manipulation of tissue within the body, not on testing samples taken from the body.
N/A
Intended Use / Indications for Use
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
Product codes
HBC, HBB, HSZ, ERL, HBE
Device Description
The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
| Test | Description | Results |
|---|---|---|
| Motor Speed/Torque Analysis | Analyzed motor speed/torque profile in comparison to predicate devices | Speed/torque profile is similar to that of predicate Legend device |
| Drill System Cutting Performance | Cutting performance was compared to predicate drill system in terms of tool chatter and hand vibration | Cutting performance was equivalent or better to that of predicate device |
| Electrical Safety | Electric powered instruments evaluated for electrical safety | Instruments conform to IEC 60601-1:2005 for electrical safety. |
| Electromagnetic Compatibility | Electric powered instruments evaluated for electromagnetic compatibility | Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility. |
| Cadaveric Simulated Use | Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers | MR8 Drill System acceptable for its intended use in various surgical procedures |
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2017
Medtronic Powered Surgical Solutions % John Connor Senior Regulatory Affairs Specialist Medtronic Navigation 826 Coal Creek Circle Louisville, Colorado 80027
Re: K163565
Trade/Device Name: MR8 Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBB, HSZ, ERL, HBE Dated: December 16, 2016 Received: December 19, 2016
Dear Mr. Connor:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name MR8 Drill System
Indications for Use (Describe)
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
December 19, 2016
- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach St. Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
- II. Proprietary Trade Name: MR8 Drill System
- III. Common Name: Powered Drill System
- IV. Classification Name: Motor, Drill, Electric (21 CFR 882.4360) Motor, Drill, Pneumatic (21 CFR 882.4370) Drill, Surgical, ENT (21 CFR 874.4250) Drills, Burs, Trephines & Accessories (21 CFR 882.4310)
- V. Classification: Class II
- Product Code: HBC, HBB, HSZ, ERL, HBE VI.
VII. Product Description:
The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.
VIII. Indications for Use:
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.
IX. Identification of Legally Marketed Devices (Predicate Devices)
- Midas Rex Legend EHS Electric Drill System (K081475)
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X. Comparison of the Technological Characteristics:
The currently available Midas Rex Drill System consists of pneumatic and electric handpieces, attachments, surgical dissecting tools, and system accessories. The subject drill system remains similar to the predicate drill system in terms of operating principles, where air and/or electric energy is supplied to the handpiece to provide power to operate interchangeable Surgical Dissecting Tools supported by Attachments and intended for use in various surgical procedures to remove soft and hard tissue, bone, and biomaterials. The materials used in design and manufacturing of the drill system remain similar to those of the predicate drill system. Minor design changes were made to the electric/pneumatic handpieces and the attachments to both improve the performance/efficiency of the drill system. None of the changes to the system impact safety and effectiveness or its ability to perform to its intended use as a drill system.
XI. Discussion of the Performance Testing
Testing was completed to ensure the functionality of the new drill system. The following table summarizes the performance testing completed:
| Test | Description | Results |
|---|---|---|
| Motor Speed/Torque | ||
| Analysis | Analyzed motor speed/torque profile in comparison to predicate devices | Speed/torque profile is similar to that of predicate Legend device |
| Drill System Cutting | ||
| Performance | Cutting performance was compared to predicate drill system in terms of tool chatter and hand vibration | Cutting performance was equivalent or better to that of predicate device |
| Electrical Safety | Electric powered instruments evaluated for electrical safety | Instruments conform to IEC 60601-1:2005 for electrical safety. |
| Electromagnetic | ||
| Compatibility | Electric powered instruments evaluated for electromagnetic compatibility | Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility. |
| Cadaveric Simulated | ||
| Use | Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers | MR8 Drill System acceptable for its intended use in various surgical procedures |
XII. Conclusions
The MR8 Drill System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.