MR8 Drill System, Midas Rex MR8 ClearView Tools

K183515 · Medtronic Powered Surgical Solutions · HBC · May 12, 2019 · Neurology

Device Facts

• Record ID: K183515
• Device Name: MR8 Drill System, Midas Rex MR8 ClearView Tools
• Applicant: Medtronic Powered Surgical Solutions
• Product Code: HBC · Neurology
• Decision Date: May 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

MR8 Drill System comprises electric and pneumatic rotary cutting handpieces, attachments, and surgical dissecting tools; used for bone/tissue removal in various surgical specialties. Midas Rex MR8 ClearView Tools are specialized dissecting tools designed to interface with the MR8 motor. System operated by surgeons in clinical/OR settings. Inputs include electrical power (via IPC) or pneumatic pressure; mechanical energy transforms into rotary motion at the tool tip for cutting/drilling. Output is physical tissue removal. Healthcare providers use the system to perform precise bone/tissue resection; clinical benefit includes efficient surgical access and bone modification. ClearView tools integrate key subassemblies into a single curved bur design, replacing separate attachments and tools to improve visibility and access.

Clinical Evidence

Bench testing only. Testing compared subject devices to predicates regarding tool chatter, hand vibration, irrigation rate accuracy, and thermal performance. Results showed subject devices performed similarly or better than predicates, with thermal output remaining below burn thresholds.

Technological Characteristics

Powered rotary drill system (electric/pneumatic). Materials: Stainless steel, tool steel, alloy steel, carbide, titanium nitride, diamond coating, polymeric components (hub, bushing insert, cooling sleeve). Sterilization: Gamma (tools), non-sterile (handpieces/accessories). Connectivity: IPC (Integrated Power Console) for electric models. Dimensions: Tools 5-14 cm length, 0.5-4.5 mm diameter.

Indications for Use

Indicated for incision, cutting, removal, drilling, and sawing of soft/hard tissue, bone, and biomaterials in neurosurgical (cranial/craniofacial), ENT, maxillofacial, orthopedic, arthroscopic, spinal, sternotomy, and general surgical procedures. Includes open and minimally invasive lumbar spine procedures (microdiscectomy, stenosis decompression, PLIF, TLIF, ALIF, DLIF).

Regulatory Classification

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.

Predicate 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 (K163182)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone]
- Contact: Jenna Groves Regulatory Affairs Manager Telephone number: [phone] Email: [e-mail]
- 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/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HBC, HBB, HBE, ERL,<br>HSZ | HBC, HBB, HBE,<br>HSZ, ERL | HBE, HBC, HRX, HWE,<br>EQJ, ERL, KFK | KFK, HBB, ERL, EQJ, HSZ,<br>GET, KFK, HBE, DWH | Similar. |
| Intended Use | Incision/ cutting, removal,<br>drilling, and sawing of<br>soft and hard tissue, bone,<br>and biomaterials. | Incision/ cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials. | Incision/ cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials. | Incision/ cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials. | Identical. |
| Indications for<br>use | The Medtronic MR8 Drill<br>System is indicated for the<br>incision/cutting, removal,<br>drilling, and sawing of<br>soft and hard tissue, bone,<br>and biomaterials in<br>Neurosurgical (Cranial<br>and Craniofacial including<br>craniotomy); Ear, Nose<br>and Throat<br>(ENT), Maxillofacial,<br>Orthopedic, Arthroscopic,<br>Spinal, Sternotomy, and<br>General Surgical<br>Procedures.<br>Additionally, the MR8<br>Drill System is indicated<br>for the incision/cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials during open<br>and minimally invasive<br>spine procedures, which<br>may incorporate<br>application of various<br>surgical techniques during | The Medtronic MR8<br>Drill System is<br>indicated for the<br>incision/ cutting,<br>removal, drilling, and<br>sawing of soft and hard<br>tissue, bone, and<br>biomaterials in<br>Neurosurgical (Cranial<br>and Craniofacial<br>including craniotomy);<br>Ear, Nose and Throat<br>(ENT), Maxillofacial,<br>Orthopedic,<br>Arthroscopic, Spinal,<br>Sternotomy, and<br>General Surgical<br>Procedures. | The Medtronic Electric Drill<br>System is indicated for the<br>incision/cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials in Neurosurgical<br>(Cranial, Craniofacial)<br>including craniotomy; as well<br>as Ear, Nose and Throat<br>(ENT), Orthopedic,<br>Arthroscopic, Spinal, and<br>General Surgical Procedures<br>including Maxillofacial,<br>Craniofacial and<br>Sternotomy Surgeries.<br>Additionally, the Electric<br>Drill System is indicated for<br>the incision / cutting,<br>removal, drilling, and sawing<br>of soft and hard tissue, bone,<br>and biomaterials during open<br>and minimally invasive spine<br>procedures, which may<br>incorporate application of<br>various surgical techniques<br>during the following lumbar<br>spinal procedures: | The Medtronic Pneumatic<br>Drill System is indicated for<br>the incision/cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials in Neurosurgical<br>(Cranial, Craniofacial)<br>including craniotomy; as well<br>as Ear, Nose and Throat<br>(ENT), Orthopedic,<br>Arthroscopic, Spinal, and<br>General Surgical Procedures<br>including Maxillofacial,<br>Craniofacial and<br>Sternotomy Surgeries.<br>Additionally, the Pneumatic<br>Drill System is indicated for<br>the incision / cutting, removal,<br>drilling, and sawing of soft<br>and hard tissue, bone, and<br>biomaterials during open and<br>minimally invasive spine<br>procedures, which may<br>incorporate application of<br>various surgical techniques<br>during the following lumbar<br>spinal procedures: | Similar.<br>The Indications of<br>Use for the MR8<br>Drill System are<br>consolidated as<br>shown.<br>The subject devices<br>of Midas RexTM<br>MR8TM<br>ClearViewTM Tools<br>are used with the<br>MR8TM Drill<br>system.<br>The proposed<br>indications do not<br>present<br>any new issues of<br>safety or<br>effectiveness, given<br>the minor<br>differences between<br>MR8 Drill System<br>and Electric and<br>Pneumatic Drill<br>Systems that were |
| Feature/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale |
| | the following lumbar<br>spinal procedures:<br>• Lumbar<br>Microdiscectomy<br>• Lumbar Stenosis<br>Decompression<br>• Posterior Lumbar<br>Interbody Fusion (PLIF)<br>• Transforaminal Lumbar<br>Interbody Fusion (TLIF)<br>• Anterior Lumbar<br>Interbody Fusion (ALIF)<br>• Direct Lateral Interbody<br>Fusion (DLIF)<br>The Midas Rex MR8<br>ClearView Tools are used<br>only in conjunction with<br>the MR8 Drill System to<br>perform as intended.<br>Please refer to the Midas<br>Rex MR8 Drill System<br>and associated User's<br>Guides for the Indications<br>of Use. | | • Lumbar Microdiscectomy<br>• Lumbar Stenosis<br>Decompression<br>• Posterior Lumbar<br>Interbody Fusion (PLIF)<br>• Transforaminal Lumbar<br>Interbody Fusion (TLIF)<br>• Anterior Lumbar<br>Interbody Fusion (ALIF)<br>• Direct Lateral Interbody<br>Fusion (DLIF) | • Lumbar Microdiscectomy<br>• Lumbar Stenosis<br>Decompression<br>• Posterior Lumbar<br>Interbody Fusion (PLIF)<br>• Transforaminal Lumbar<br>Interbody Fusion (TLIF)<br>• Anterior Lumbar<br>Interbody Fusion (ALIF)<br>• Direct Lateral Interbody<br>Fusion (DLIF) | previously cleared<br>under K163565. |
| General<br>System<br>Components<br>for the Drill<br>System | Electric Handpiece,<br>Pneumatic Handpiece<br>Attachments, Surgical<br>Dissecting Tools, System<br>Accessories | Electric Handpiece,<br>Pneumatic Handpiece,<br>Attachments, Surgical<br>Dissecting Tools,<br>System Accessories | Electric Handpiece,<br>Attachments, Surgical<br>Dissecting Tools, System<br>Accessories | Pneumatic Handpiece,<br>Attachments, Surgical<br>Dissecting Tools, System<br>Accessories | Similar.<br>The subject devices<br>Midas RexTM<br>MR8TM<br>ClearViewTM Tools<br>are used with the<br>MR8 Drill System<br>but replace<br>"Attachments" and |
| Feature/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale |
| | | | | | "Surgical Dissecting<br>Tools" as one single<br>Curved Bur with the<br>key subassemblies.<br>Similar. |
| Patient<br>Contacting<br>Components | Attachments and Surgical<br>Dissecting Tools<br>Midas RexTM MR8TM<br>ClearViewTM Tools | Attachments and<br>Surgical Dissecting<br>Tools | Attachments and Surgical<br>Dissecting Tools<br>Surgical Curved Burs | Attachments and Surgical<br>Dissecting Tools<br>Curved Burs | The subject devices<br>Midas RexTM<br>MR8TM<br>ClearViewTM Tools<br>are used with the<br>MR8 Drill System<br>but replace<br>"Attachments" and<br>"Surgical Dissecting<br>Tools" as one single<br>Curved Bur with the<br>key subassemblies. |
| Materials of<br>Patient<br>Contacting<br>Components | Attachments - Stainless<br>Steel,<br>Aluminum, Ceramic,<br>Phenolic, Epoxy, Chrome<br>Coated Brass, Polymeric<br>Surgical Dissecting Tools<br>- Stainless Steel, Tool<br>Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in<br>Nickel Substrate,<br>Titanium Nitride<br>Midas RexTM MR8TM<br>ClearViewTM Tools: | Attachments - Stainless<br>Steel,<br>Aluminum, Ceramic,<br>Phenolic, Epoxy,<br>Chrome Coated<br>Brass, Polymeric<br>Surgical Dissecting<br>Tools - Stainless Steel,<br>Tool Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in<br>Nickel Substrate,<br>Titanium Nitride | Attachments - Stainless Steel,<br>Aluminum, Ceramic,<br>Phenolic, Epoxy, Chrome<br>Coated Brass, Torlon 4301<br>Dissecting Tools: Stainless<br>Steel, Tool Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in Nickel<br>Substrate, Titanium Nitride<br>Surgical Curved Burs:<br>Stainless Steel, Tool Steel,<br>Alloy Steel, Carbide, TDC<br>Coating, Diamond Coating in<br>Nickel Substrate, Titanium<br>Nitride Coating: | Attachments - Stainless Steel,<br>Aluminum, Ceramic,<br>Phenolic, Epoxy, Chrome<br>Coated Brass, Polymeric<br>Dissecting Tools: Stainless<br>Steel, Tool Steel, Alloy Steel,<br>Carbide, TDC Coating,<br>Diamond Coating in Nickel<br>Substrate, Titanium Nitride<br>Surgical Curved Burs:<br>Stainless Steel, Tool Steel,<br>Alloy Steel, Carbide, TDC<br>Coating, Diamond Coating in<br>Nickel Substrate, Titanium<br>Nitride Coating: | Similar<br>The materials of<br>patient contacting<br>components between<br>the subject devices<br>and Predicate<br>devices<br>remain similar. |
| Feature/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale |
| | Stainless Steel, Tool Steel,<br>Alloy Steel, Carbide, TDC<br>Coating, Diamond<br>Coating in Nickel<br>Substrate, Titanium<br>Nitride Coating;<br><br>Curved Tube: Stainless Steel;<br><br>Bushing/Bearing<br>Retainers: Stainless Steel;<br><br>Hub: Polymeric;<br><br>Bushing Insert, Cooling<br>Sleeve: Polymeric;<br><br>Lubricant: Nyogel; | | Curved Tube: Stainless Steel;<br>Bushing/ Bearing<br>Retainers: Stainless Steel;<br>Hub: Polymeric;<br><br>Bushing Insert Cooling<br>Sleeve: Polymeric;<br><br>Lubricant: Nyogel;<br>and Adhesive: Cyanoacrylate | Curved Tube: Stainless Steel;<br>Bushing/Bearing Retainers:<br>Stainless Steel; Hub:<br>Polymeric;<br><br>Bushing Insert Cooling<br>Sleeve: Polymeric;<br><br>Lubricant: Nyogel;<br>and Adhesive: Cyanoacrylate | |
| Surgical<br>Dissecting<br>Tools – Tip<br>Style | Round/Acorn, Match<br>Head, Ball, Cylinder,<br>Oval, Tapered/Side<br>Cutting, Metal<br>Cutting, Twist Drill,<br>Hole Maker/Saw,<br>Reverse Taper | Round/Acorn, Match<br>Head, Ball, Cylinder,<br>Oval, Tapered/Side<br>Cutting, Metal Cutting,<br>Twist Drill, Hole<br>Maker/Saw, Reverse<br>Tapered | Round/Acorn, Match Head,<br>Ball, Cylinder, Oval,<br>Tapered/Side Cutting, Metal<br>Cutting, Twist Drill, Hole<br>Maker/Saw, Reverse Tapered | Round/Acorn, Match Head,<br>Ball, Cylinder, Oval,<br>Tapered/Side Cutting, Metal<br>Cutting, Twist Drill, Hole<br>Maker/Saw, Reverse Tapered | Similar.<br>The subject device<br>Tip designs<br>remains similar to<br>the predicate device<br>Tip designs. Any<br>new addition of<br>Tools to the product<br>family are designed<br>and manufactured<br>within the<br>predicate range of<br>tip designs.<br>Similar. |
| Surgical | Surgical Dissecting Tool: | Surgical Dissecting | Surgical Dissecting Tool: | Surgical Dissecting Tool: | Similar. |
| Feature/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale |
| Dissecting<br>Tool - Overall<br>Length | 3-42 cm<br>Midas RexTM MR8TM<br>ClearViewTM Tools:<br>5-14 cm | Tool:<br>3-42 cm | 3-42 cm<br>Surgical Curved Bur:<br>9-14 cm | 3-42 cm<br>Surgical Curved Bur:<br>9-11 cm | The overall length of<br>the subject devices<br>remains within the<br>range of length<br>previously cleared<br>for the predicate<br>devices. |
| Surgical<br>Dissecting<br>Tool - Head<br>Diameter | Surgical Dissecting Tool:<br>0.5 mm - 25 mm<br>Midas RexTM MR8TM<br>ClearViewTM Tools:<br>0.5 mm - 4.5 mm | Surgical Dissecting<br>Tool: 0.5 mm - 25 mm | Surgical Dissecting Tool:<br>0.5-25 mm<br>Surgical Curved Bur:<br>1-4 mm | Surgical Dissecting Tool:<br>0.5-25 mm<br>Surgical Curved Bur:<br>1-4 mm | Similar.<br>The head diameter<br>of the subject<br>devices remains<br>within the range of<br>diameter previously<br>cleared for the<br>predicate devices. |
| Attachment<br>Configuration | Straight, Angled,<br>Variable, Double-Lock,<br>Footed, Telescoping,<br>Perforator, Jacobs Chuck,<br>J-Latch,<br>Metal Cutting<br>Not Applicable to Midas<br>RexTM MR8TM<br>ClearViewTM Tools | Straight, Angled,<br>Variable, Double-Lock,<br>Footed, Telescoping,<br>Perforator, Jacobs<br>Chuck, J-Latch, Metal<br>Cutting | Straight, Angled, Footed,<br>Contra Angled, Right Angled,<br>Metal Cutting, Depth limiting<br>Drill<br>Guides, Perforator, Jacob<br>Chuck Attachments, Wire/Pin<br>Collet Attachments | Straight, Angled, Footed,<br>Contra Angled, Right<br>Angled, Metal Cutting, Depth<br>limiting Drill<br>Guides, Perforator, Jacob<br>Chuck Attachments, Wire/Pin<br>Collet Attachments | Similar.<br>The subject devices<br>Midas RexTM<br>MR8TM<br>ClearViewTM Tools<br>are used with the<br>MR8 Drill System<br>but replace<br>"Attachments" and<br>"Surgical Dissecting<br>Tools" as one single<br>Curved Bur with the<br>key subassemblies. |
| Attachment<br>Length | 2-40 cm<br>Not Applicable to Midas<br>RexTM MR8TM<br>ClearViewTM Tools | 2-40 cm | 2-40 cm | 2-40 cm | Similar.<br>The subject devices<br>Midas RexTM<br>MR8TM<br>ClearViewTM Tools<br>are used with the<br>MR8 Drill System |
| Feature/<br>Attribute | Subject Devices (MR8TM<br>Drill System and Midas<br>RexTM MR8TM<br>ClearViewTM Tools) | MR8 Drill System<br>(K163565) | Electric Drill Expanded<br>(K170312) | Pneumatic Drill Expanded<br>(K163182) | Selection Rationale…