(145 days)
The Medtronic MR8 Drill System is 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.
Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- Lumbar Stenosis Decompression
- Posterior Lumbar Interbody Fusion (PLIF)
- Transforaminal Lumbar Interbody Fusion (TLIF)
- Anterior Lumbar Interbody Fusion (ALIF)
- Direct Lateral Interbody Fusion (DLIF)
The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.
The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable.
The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.
This document describes the Medtronic MR8 Drill System and Midas Rex MR8 ClearView Tools. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than independent performance claims against specific acceptance criteria. Therefore, the information provided primarily compares the device to existing predicate devices.
1. Table of Acceptance Criteria & Reported Device Performance:
The document does not explicitly present a table of "acceptance criteria" for the overall device in the typical sense of a clinical trial or performance study with defined thresholds. Instead, it details performance testing conducted for the Midas Rex MR8 ClearView Tools to ensure functionality with the MR8 Drill system and comparability to predicate devices. The "acceptance criteria" for this testing appear to be qualitative (e.g., "similar and/or better," "same or more," "below the burn threshold").
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tool Chatter and Hand Vibration | Similar and/or better than equivalent predicates | Scored similar and/or better than the equivalent Predicates |
| Irrigation Rate vs IPC Setting | Same or more than the rate displayed on the IPC | Delivered the same or more than the one displayed on the IPC |
| Thermal Performance | Completed respective duty cycles intact; Max temperature below burn threshold | Completed duty cycles intact; Maximum temperature below burn threshold |
No additional testing was performed on the MR8 Drill System itself as there were no design changes to it for this submission. The Midas Rex MR8 ClearView Tools are the new elements being evaluated for their compatibility and performance within the existing MR8 Drill System.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the individual performance tests (Tool Chatter and Hand Vibration, Irrigation Rate vs IPC Setting, Thermal Performance)conducted on the Midas Rex MR8 ClearView Tools.
The provenance of the data is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that this is a 510(k) submission for a medical device by Medtronic, a US-based company, it is highly likely that the testing was conducted under standard quality systems and engineering practices, likely within a controlled laboratory environment. The tests appear to be engineering/bench testing rather than clinical studies with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of testing described. The tests are engineering performance tests, not clinical evaluations requiring expert interpretation of ground truth (e.g., diagnosis from medical images).
4. Adjudication Method for the Test Set:
This information is not applicable. The tests are objective, quantitative measurements or qualitative observations during engineering performance testing, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
This information is not applicable. The device described is a surgical drill system and associated tools, not an AI-assisted diagnostic or interpretative system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
This information is not applicable. This is not an AI-driven device or algorithm. The performance evaluation focuses on the mechanical and operational characteristics of the surgical tools.
7. The Type of Ground Truth Used:
The "ground truth" for the performance tests effectively refers to the physical and functional parameters of the device as designed and expected, as well as established safety thresholds (e.g., burn threshold for thermal performance). It's based on engineering specifications and safety standards relevant to surgical instruments.
8. The Sample Size for the Training Set:
This information is not applicable. No "training set" is mentioned as this is not a machine learning or AI-driven device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As there is no training set mentioned, there is no ground truth established for one.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".
May 12, 2019
Medtronic Powered Surgical Solutions Jenna Groves Regulatory Affairs Manager 4620 North Beach Street Fort Worth, Texas 76137
Re: K183515
Trade/Device Name: MR8 Drill System, Midas Rex MR8 ClearView Tools Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBB, HBE, ERL, HSZ Dated: April 11, 2019 Received: April 12, 2019
Dear Jenna Groves:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Matthew Krueger, M.S.E. Assistant Director Neurosurgical Devices DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183515
Device Name MR8 Drill System Midas Rex MR8 ClearView Tools
Indications for Use (Describe)
The Medtronic MR8 Drill System is 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.
Additionally, the MR8 Drill System is indicated for the incision/cutting, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- · Lumbar Stenosis Decompression
- · Posterior Lumbar Interbody Fusion (PLIF)
- · Transforaminal Lumbar Interbody Fusion (TLIF)
- · Anterior Lumbar Interbody Fusion (ALIF)
- · Direct Lateral Interbody Fusion (DLIF)
The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.
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) |
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510(k) Summary
December 13, 2018
- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach St. Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: Jenna Groves Regulatory Affairs Manager Telephone number: (817) 788-6686 Email: jenna.a.groves@medtronic.com
- II. Proprietary Trade Name: MR8™ Drill System Midas Rex™ MR8TM ClearView™ Tools
- III. Common Name: Powered Drill System Dissecting tool - Powered Simple cranial bur
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
- VI. Product Codes: HBC, HBB, HSZ, ERL, HBE
VII. Product Description:
The Medtronic MR8TM Drill System is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories designed to remove soft and hard tissue, bone, and biomaterials during various surgical procedures. The surgical dissecting tools are provided sterile and are single use, while the rest of the system components are provided non-sterile and are reusable.
The Midas Rex™ MR8TM ClearView™ Tools are designed to interface with Midas Rex™ MR8 Drill System motor to support bone and tissue removal during surgical
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procedures. The Midas Rex™ MR8™ ClearView™ Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas Rex™ MR8 System/Platform.
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.
Additionally, the MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:
- Lumbar Microdiscectomy
- · Lumbar Stenosis Decompression
- · Posterior Lumbar Interbody Fusion (PLIF)
- · Transforaminal Lumbar Interbody Fusion (TLIF)
- · Anterior Lumbar Interbody Fusion (ALIF)
- · Direct Lateral Interbody Fusion (DLIF)
The Midas Rex MR8 ClearView Tools are used only in conjunction with the MR8 Drill System to perform as intended. Please refer to the Midas Rex MR8 Drill System and associated User's Guides for the Indications of Use.
IX. Summary of the Technological Characteristics
See Table 3-1: MR8 Drill System and Midas Rex MR8 ClearView Tools as compared to Primary Predicate Devices
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| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
|---|---|---|---|---|---|
| Product Code | HBC, HBB, HBE, ERL,HSZ | HBC, HBB, HBE,HSZ, ERL | HBE, HBC, HRX, HWE,EQJ, ERL, KFK | KFK, HBB, ERL, EQJ, HSZ,GET, KFK, HBE, DWH | Similar. |
| Intended Use | Incision/ cutting, removal,drilling, and sawing ofsoft and hard tissue, bone,and biomaterials. | Incision/ cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials. | Incision/ cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials. | Incision/ cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials. | Identical. |
| Indications foruse | The Medtronic MR8 DrillSystem is indicated for theincision/cutting, removal,drilling, and sawing ofsoft and hard tissue, bone,and biomaterials inNeurosurgical (Cranialand Craniofacial includingcraniotomy); Ear, Noseand Throat(ENT), Maxillofacial,Orthopedic, Arthroscopic,Spinal, Sternotomy, andGeneral SurgicalProcedures.Additionally, the MR8Drill System is indicatedfor the incision/cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials during openand minimally invasivespine procedures, whichmay incorporateapplication of varioussurgical techniques during | The Medtronic MR8Drill System isindicated for theincision/ cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials inNeurosurgical (Cranialand Craniofacialincluding craniotomy);Ear, Nose and Throat(ENT), Maxillofacial,Orthopedic,Arthroscopic, Spinal,Sternotomy, andGeneral SurgicalProcedures. | The Medtronic Electric DrillSystem is indicated for theincision/cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials in Neurosurgical(Cranial, Craniofacial)including craniotomy; as wellas Ear, Nose and Throat(ENT), Orthopedic,Arthroscopic, Spinal, andGeneral Surgical Proceduresincluding Maxillofacial,Craniofacial andSternotomy Surgeries.Additionally, the ElectricDrill System is indicated forthe incision / cutting,removal, drilling, and sawingof soft and hard tissue, bone,and biomaterials during openand minimally invasive spineprocedures, which mayincorporate application ofvarious surgical techniquesduring the following lumbarspinal procedures: | The Medtronic PneumaticDrill System is indicated forthe incision/cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials in Neurosurgical(Cranial, Craniofacial)including craniotomy; as wellas Ear, Nose and Throat(ENT), Orthopedic,Arthroscopic, Spinal, andGeneral Surgical Proceduresincluding Maxillofacial,Craniofacial andSternotomy Surgeries.Additionally, the PneumaticDrill System is indicated forthe incision / cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials during open andminimally invasive spineprocedures, which mayincorporate application ofvarious surgical techniquesduring the following lumbarspinal procedures: | Similar.The Indications ofUse for the MR8Drill System areconsolidated asshown.The subject devicesof Midas RexTMMR8TMClearViewTM Toolsare used with theMR8TM Drillsystem.The proposedindications do notpresentany new issues ofsafety oreffectiveness, giventhe minordifferences betweenMR8 Drill Systemand Electric andPneumatic DrillSystems that were |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| the following lumbarspinal procedures:• LumbarMicrodiscectomy• Lumbar StenosisDecompression• Posterior LumbarInterbody Fusion (PLIF)• Transforaminal LumbarInterbody Fusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct Lateral InterbodyFusion (DLIF)The Midas Rex MR8ClearView Tools are usedonly in conjunction withthe MR8 Drill System toperform as intended.Please refer to the MidasRex MR8 Drill Systemand associated User'sGuides for the Indicationsof Use. | • Lumbar Microdiscectomy• Lumbar StenosisDecompression• Posterior LumbarInterbody Fusion (PLIF)• Transforaminal LumbarInterbody Fusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct Lateral InterbodyFusion (DLIF) | • Lumbar Microdiscectomy• Lumbar StenosisDecompression• Posterior LumbarInterbody Fusion (PLIF)• Transforaminal LumbarInterbody Fusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct Lateral InterbodyFusion (DLIF) | previously clearedunder K163565. | ||
| GeneralSystemComponentsfor the DrillSystem | Electric Handpiece,Pneumatic HandpieceAttachments, SurgicalDissecting Tools, SystemAccessories | Electric Handpiece,Pneumatic Handpiece,Attachments, SurgicalDissecting Tools,System Accessories | Electric Handpiece,Attachments, SurgicalDissecting Tools, SystemAccessories | Pneumatic Handpiece,Attachments, SurgicalDissecting Tools, SystemAccessories | Similar.The subject devicesMidas RexTMMR8TMClearViewTM Toolsare used with theMR8 Drill Systembut replace"Attachments" and |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| "Surgical DissectingTools" as one singleCurved Bur with thekey subassemblies.Similar. | |||||
| PatientContactingComponents | Attachments and SurgicalDissecting ToolsMidas RexTM MR8TMClearViewTM Tools | Attachments andSurgical DissectingTools | Attachments and SurgicalDissecting ToolsSurgical Curved Burs | Attachments and SurgicalDissecting ToolsCurved Burs | The subject devicesMidas RexTMMR8TMClearViewTM Toolsare used with theMR8 Drill Systembut replace"Attachments" and"Surgical DissectingTools" as one singleCurved Bur with thekey subassemblies. |
| Materials ofPatientContactingComponents | Attachments - StainlessSteel,Aluminum, Ceramic,Phenolic, Epoxy, ChromeCoated Brass, PolymericSurgical Dissecting Tools- Stainless Steel, ToolSteel, Alloy Steel,Carbide, TDC Coating,Diamond Coating inNickel Substrate,Titanium NitrideMidas RexTM MR8TMClearViewTM Tools: | Attachments - StainlessSteel,Aluminum, Ceramic,Phenolic, Epoxy,Chrome CoatedBrass, PolymericSurgical DissectingTools - Stainless Steel,Tool Steel, Alloy Steel,Carbide, TDC Coating,Diamond Coating inNickel Substrate,Titanium Nitride | Attachments - Stainless Steel,Aluminum, Ceramic,Phenolic, Epoxy, ChromeCoated Brass, Torlon 4301Dissecting Tools: StainlessSteel, Tool Steel, Alloy Steel,Carbide, TDC Coating,Diamond Coating in NickelSubstrate, Titanium NitrideSurgical Curved Burs:Stainless Steel, Tool Steel,Alloy Steel, Carbide, TDCCoating, Diamond Coating inNickel Substrate, TitaniumNitride Coating: | Attachments - Stainless Steel,Aluminum, Ceramic,Phenolic, Epoxy, ChromeCoated Brass, PolymericDissecting Tools: StainlessSteel, Tool Steel, Alloy Steel,Carbide, TDC Coating,Diamond Coating in NickelSubstrate, Titanium NitrideSurgical Curved Burs:Stainless Steel, Tool Steel,Alloy Steel, Carbide, TDCCoating, Diamond Coating inNickel Substrate, TitaniumNitride Coating: | SimilarThe materials ofpatient contactingcomponents betweenthe subject devicesand Predicatedevicesremain similar. |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| Stainless Steel, Tool Steel,Alloy Steel, Carbide, TDCCoating, DiamondCoating in NickelSubstrate, TitaniumNitride Coating;Curved Tube: Stainless Steel;Bushing/BearingRetainers: Stainless Steel;Hub: Polymeric;Bushing Insert, CoolingSleeve: Polymeric;Lubricant: Nyogel; | Curved Tube: Stainless Steel;Bushing/ BearingRetainers: Stainless Steel;Hub: Polymeric;Bushing Insert CoolingSleeve: Polymeric;Lubricant: Nyogel;and Adhesive: Cyanoacrylate | Curved Tube: Stainless Steel;Bushing/Bearing Retainers:Stainless Steel; Hub:Polymeric;Bushing Insert CoolingSleeve: Polymeric;Lubricant: Nyogel;and Adhesive: Cyanoacrylate | |||
| SurgicalDissectingTools – TipStyle | Round/Acorn, MatchHead, Ball, Cylinder,Oval, Tapered/SideCutting, MetalCutting, Twist Drill,Hole Maker/Saw,Reverse Taper | Round/Acorn, MatchHead, Ball, Cylinder,Oval, Tapered/SideCutting, Metal Cutting,Twist Drill, HoleMaker/Saw, ReverseTapered | Round/Acorn, Match Head,Ball, Cylinder, Oval,Tapered/Side Cutting, MetalCutting, Twist Drill, HoleMaker/Saw, Reverse Tapered | Round/Acorn, Match Head,Ball, Cylinder, Oval,Tapered/Side Cutting, MetalCutting, Twist Drill, HoleMaker/Saw, Reverse Tapered | Similar.The subject deviceTip designsremains similar tothe predicate deviceTip designs. Anynew addition ofTools to the productfamily are designedand manufacturedwithin thepredicate range oftip designs.Similar. |
| Surgical | Surgical Dissecting Tool: | Surgical Dissecting | Surgical Dissecting Tool: | Surgical Dissecting Tool: | Similar. |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| DissectingTool - OverallLength | 3-42 cmMidas RexTM MR8TMClearViewTM Tools:5-14 cm | Tool:3-42 cm | 3-42 cmSurgical Curved Bur:9-14 cm | 3-42 cmSurgical Curved Bur:9-11 cm | The overall length ofthe subject devicesremains within therange of lengthpreviously clearedfor the predicatedevices. |
| SurgicalDissectingTool - HeadDiameter | Surgical Dissecting Tool:0.5 mm - 25 mmMidas RexTM MR8TMClearViewTM Tools:0.5 mm - 4.5 mm | Surgical DissectingTool: 0.5 mm - 25 mm | Surgical Dissecting Tool:0.5-25 mmSurgical Curved Bur:1-4 mm | Surgical Dissecting Tool:0.5-25 mmSurgical Curved Bur:1-4 mm | Similar.The head diameterof the subjectdevices remainswithin the range ofdiameter previouslycleared for thepredicate devices. |
| AttachmentConfiguration | Straight, Angled,Variable, Double-Lock,Footed, Telescoping,Perforator, Jacobs Chuck,J-Latch,Metal CuttingNot Applicable to MidasRexTM MR8TMClearViewTM Tools | Straight, Angled,Variable, Double-Lock,Footed, Telescoping,Perforator, JacobsChuck, J-Latch, MetalCutting | Straight, Angled, Footed,Contra Angled, Right Angled,Metal Cutting, Depth limitingDrillGuides, Perforator, JacobChuck Attachments, Wire/PinCollet Attachments | Straight, Angled, Footed,Contra Angled, RightAngled, Metal Cutting, Depthlimiting DrillGuides, Perforator, JacobChuck Attachments, Wire/PinCollet Attachments | Similar.The subject devicesMidas RexTMMR8TMClearViewTM Toolsare used with theMR8 Drill Systembut replace"Attachments" and"Surgical DissectingTools" as one singleCurved Bur with thekey subassemblies. |
| AttachmentLength | 2-40 cmNot Applicable to MidasRexTM MR8TMClearViewTM Tools | 2-40 cm | 2-40 cm | 2-40 cm | Similar.The subject devicesMidas RexTMMR8TMClearViewTM Toolsare used with theMR8 Drill System |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| but replace"Attachments" and"Surgical DissectingTools" as one singleCurved Bur with thekey subassemblies. | |||||
| Drill SystemOperatingPrinciple | Electric powered by IPCand Pneumatic poweredby Pneumatic Pressure | Electric powered byIPC and Pneumaticpowered by PneumaticPressure | Electric powered by IPC | Pneumatic powered byPneumatic Pressure | Similar.The drill systemoperating principleis similar to thepredicate devices. |
| Packaging -Single UseDissectingTools | The Surgical DissectingTools are individuallypackaged in a clear plasticcapped tubeplaced within a poly-polypouch.Midas RexTM MR8TMClearViewTM Tools:Sterile Tools areindividually packaged intoa Tyvek Envelope andsealed. The sealed pouchis individually packagedinto a shipping carton. | The Surgical DissectingTools are individuallypackaged in a clearplastic cappedtube placed within apoly-poly pouch. | The Surgical Dissecting Toolsare individually packaged in aPropionatecellulosic plastic capped tubeand sealed within a4 mil PET-Nylon-HDPE Co-Ex (Peel Seal)/4 milPET-Nylon-EVA Pouch.Curved Burs: Sterile CurvedBurs are individuallypackaged into a TyvekEnvelope and sealed. Thesealed pouch is individuallypackaged into a shippingcarton. | The Surgical Dissecting Toolsare individually packaged in aPropionate cellulosic plasticcapped tube and sealed withina 4 mil PET-Nylon-HDPECo-Ex (Peel Seal)/4 milPET-Nylon-EVA Pouch.Curved Burs: Sterile CurvedBurs are individuallypackaged into a TyvekEnvelope and sealed. Thesealed pouch is individuallypackaged into a shippingcarton. | Similar.The Packaging ofthe subject devicesremains similar ascompared to thePredicate devices. |
| Sterilization | Surgical Dissecting Toolsand Midas RexTM MR8TMClearViewTM Tools aresupplied GammaSterilized,Non-sterile (Handpieces,Attachments, System | Sterile (SurgicalDissecting Tools)Non-sterile(Handpieces,Attachments,System Accessories) | Surgical Dissecting Tools &Curved Burs are suppliedGamma Sterilized;- Electric Handpieces, andAttachments aresupplied Non-Sterile andrequire cleaning andsterilization prior to each | Surgical Dissecting Tools &Curved Burs are suppliedGamma Sterilized;- Pneumatic Handpieces, andAttachments are suppliedNon-Sterile and requirecleaning and sterilizationprior to each surgical use; | Similar.The Sterilization ofthe subject devicesremains similar ascompared to thePredicate devices. |
| Feature/Attribute | Subject Devices (MR8TMDrill System and MidasRexTM MR8TMClearViewTM Tools) | MR8 Drill System(K163565) | Electric Drill Expanded(K170312) | Pneumatic Drill Expanded(K163182) | Selection Rationale |
| Accessories) | surgical use;- Electric Foot Control Unit,and System Accessories aresupplied Non-Sterile. | - Pneumatic Foot ControlUnit, and System Accessoriesare supplied Non-Sterile. | |||
| Shelf Life | 5 years for SurgicalDissecting Tools4 years for Midas RexTMMR8TM ClearViewTMTools | 5 years for SurgicalDissecting Tools | 5 years for SurgicalDissecting Tools4 years for Curved Burs | 5 years for SurgicalDissecting Tools4 years for Curved Burs | Similar.The shelf life of thesubject device issimilar to thepredicate devices. |
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X. Identification of Legally Marketing Devices
- MR8 Drill System (K163565)
- . IPC Systems, Legend EHS Handpieces And Legend Stylus Touch Handpiece, Microsaw Handpieces, Triton Electric High Torque Handpiece, Attachments And Surgical Dissecting Tools (K170312)
- Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System . Incorporating Various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; And System Accessories (K163182)
XI. Discussion of the Performance Testing
There has been no additional testing performed on the MR8™ Drill System as there are no design changes.
Testing was completed to ensure the functionality of Midas Rex™ ClearView™ Tools with the MR8™ Drill system. The following table summarizes the performance testing completed:
| Test | Description | Results |
|---|---|---|
| Tool Chatterand HandVibration | Compared the vibrationcharacteristics between thesubject devices and theirequivalent predicates | Tool Chatter and HandVibration for subjectdevices scored similar and/or better than theequivalent Predicates |
| Irrigation Ratevs IPC Setting | Compared Irrigation Rate on theIPC against the actualoccurrence | Irrigation Rate delivered bythe subject devices wasfound to be the same ormore than the onedisplayed on the IPC |
| ThermalPerformance | Evaluated the integrity of thesubject devices throughrespective duty cycles and thecorresponding thermalperformance | The subject devicescompleted their respectiveduty cycles intact. Themaximum temperaturereached by the subjectdevices was below the burnthreshold. |
XII. Conclusions
The MR8™ Drill System has been shown through comparison to be substantially equivalent to the identified predicate devices.
The Midas Rex™ MR8™ ClearView™ Tools have the same intended use, and have shown through comparison and testing to be substantially equivalent to the identified predicate devices.
§ 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).