(145 days)
Not Found
No
The description focuses on the mechanical and functional aspects of a surgical drill system and its tools, with no mention of AI or ML capabilities. Performance studies are related to mechanical and thermal properties, not algorithmic performance.
No.
The device is described as a surgical drill system used for cutting, removal, drilling, and sawing of tissue and bone during various surgical procedures, which are considered invasive interventions rather than therapeutic treatments offered by the device itself.
No
The Medtronic MR8 Drill System is used for incision, cutting, removal, drilling, and sawing of tissue and bone during various surgical procedures. It is a surgical tool, not a diagnostic device.
No
The device description explicitly states that the system is comprised of both Electric and Pneumatic powered, rotary cutting handpieces, attachments, surgical dissecting tools, and accessories, which are all hardware components.
Based on the provided information, the Medtronic MR8 Drill System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for cutting, drilling, and removing tissue and bone during surgical procedures on a patient. This is an in vivo application (within a living organism).
- Device Description: The description details a system of powered handpieces, attachments, and tools designed for physical manipulation of tissue and bone during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information. The device's function is purely surgical and therapeutic/procedural.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MR8 Drill System does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
HBC, HBB, HBE, ERL, HSZ
Device 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 RexTM MR8TM ClearViewTM Tools are designed to interface with Midas RexTM MR8 Drill System motor to support bone and tissue removal during surgical procedures. The Midas RexTM MR8TM ClearViewTM Tools are part of a larger portfolio of tools and accessories designed to be used with the Midas RexTM MR8 System/Platform.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy. Lumbar spine for 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).
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)
Performance Testing:
- Test: Tool Chatter and Hand Vibration
- Description: Compared the vibration characteristics between the subject devices and their equivalent predicates
- Results: Tool Chatter and Hand Vibration for subject devices scored similar and/or better than the equivalent Predicates
- Test: Irrigation Rate vs IPC Setting
- Description: Compared Irrigation Rate on the IPC against the actual occurrence
- Results: Irrigation Rate delivered by the subject devices was found to be the same or more than the one displayed on the IPC
- Test: Thermal Performance
- Description: Evaluated the integrity of the subject devices through respective duty cycles and the corresponding thermal performance
- Results: The subject devices completed their respective duty cycles intact. The maximum temperature reached by the subject devices was below the burn threshold.
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.
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
§ 882.4360 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).
0
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
1
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
2
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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3
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
4
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
5
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM 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 of
soft and hard tissue, bone,
and biomaterials. | Incision/ cutting,
removal, drilling, and
sawing of soft and hard
tissue, bone, and
biomaterials. | Incision/ cutting, removal,
drilling, and sawing of soft
and hard tissue, bone, and
biomaterials. | Incision/ cutting, removal,
drilling, and sawing of soft
and hard tissue, bone, and
biomaterials. | Identical. |
| 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 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. | The Medtronic Electric Drill
System is indicated for the
incision/cutting, removal,
drilling, and sawing of soft
and hard tissue, bone, and
biomaterials in Neurosurgical
(Cranial, Craniofacial)
including craniotomy; as well
as Ear, Nose and Throat
(ENT), Orthopedic,
Arthroscopic, Spinal, and
General Surgical Procedures
including Maxillofacial,
Craniofacial and
Sternotomy Surgeries.
Additionally, the Electric
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: | The Medtronic Pneumatic
Drill System is indicated for
the incision/cutting, removal,
drilling, and sawing of soft
and hard tissue, bone, and
biomaterials in Neurosurgical
(Cranial, Craniofacial)
including craniotomy; as well
as Ear, Nose and Throat
(ENT), Orthopedic,
Arthroscopic, Spinal, and
General Surgical Procedures
including Maxillofacial,
Craniofacial and
Sternotomy Surgeries.
Additionally, the Pneumatic
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: | Similar.
The Indications of
Use for the MR8
Drill System are
consolidated as
shown.
The subject devices
of Midas RexTM
MR8TM
ClearViewTM Tools
are used with the
MR8TM Drill
system.
The proposed
indications do not
present
any new issues of
safety or
effectiveness, given
the minor
differences between
MR8 Drill System
and Electric and
Pneumatic Drill
Systems that were |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM Tools) | MR8 Drill System
(K163565) | Electric Drill Expanded
(K170312) | Pneumatic Drill Expanded
(K163182) | Selection Rationale |
| | 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. | | • 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) | • 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) | previously cleared
under K163565. |
| General
System
Components
for the Drill
System | Electric Handpiece,
Pneumatic Handpiece
Attachments, Surgical
Dissecting Tools, System
Accessories | Electric Handpiece,
Pneumatic Handpiece,
Attachments, Surgical
Dissecting Tools,
System Accessories | Electric Handpiece,
Attachments, Surgical
Dissecting Tools, System
Accessories | Pneumatic Handpiece,
Attachments, Surgical
Dissecting Tools, System
Accessories | Similar.
The subject devices
Midas RexTM
MR8TM
ClearViewTM Tools
are used with the
MR8 Drill System
but replace
"Attachments" and |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM Tools) | MR8 Drill System
(K163565) | Electric Drill Expanded
(K170312) | Pneumatic Drill Expanded
(K163182) | Selection Rationale |
| | | | | | "Surgical Dissecting
Tools" as one single
Curved Bur with the
key subassemblies.
Similar. |
| Patient
Contacting
Components | Attachments and Surgical
Dissecting Tools
Midas RexTM MR8TM
ClearViewTM Tools | Attachments and
Surgical Dissecting
Tools | Attachments and Surgical
Dissecting Tools
Surgical Curved Burs | Attachments and Surgical
Dissecting Tools
Curved Burs | The subject devices
Midas RexTM
MR8TM
ClearViewTM Tools
are used with the
MR8 Drill System
but replace
"Attachments" and
"Surgical Dissecting
Tools" as one single
Curved Bur with the
key subassemblies. |
| Materials of
Patient
Contacting
Components | Attachments - Stainless
Steel,
Aluminum, Ceramic,
Phenolic, Epoxy, Chrome
Coated Brass, Polymeric
Surgical Dissecting Tools
- Stainless Steel, Tool
Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in
Nickel Substrate,
Titanium Nitride
Midas RexTM MR8TM
ClearViewTM Tools: | Attachments - Stainless
Steel,
Aluminum, Ceramic,
Phenolic, Epoxy,
Chrome Coated
Brass, Polymeric
Surgical Dissecting
Tools - Stainless Steel,
Tool Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in
Nickel Substrate,
Titanium Nitride | Attachments - Stainless Steel,
Aluminum, Ceramic,
Phenolic, Epoxy, Chrome
Coated Brass, Torlon 4301
Dissecting Tools: Stainless
Steel, Tool Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in Nickel
Substrate, Titanium Nitride
Surgical Curved Burs:
Stainless Steel, Tool Steel,
Alloy Steel, Carbide, TDC
Coating, Diamond Coating in
Nickel Substrate, Titanium
Nitride Coating: | Attachments - Stainless Steel,
Aluminum, Ceramic,
Phenolic, Epoxy, Chrome
Coated Brass, Polymeric
Dissecting Tools: Stainless
Steel, Tool Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in Nickel
Substrate, Titanium Nitride
Surgical Curved Burs:
Stainless Steel, Tool Steel,
Alloy Steel, Carbide, TDC
Coating, Diamond Coating in
Nickel Substrate, Titanium
Nitride Coating: | Similar
The materials of
patient contacting
components between
the subject devices
and Predicate
devices
remain similar. |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM Tools) | MR8 Drill System
(K163565) | Electric Drill Expanded
(K170312) | Pneumatic Drill Expanded
(K163182) | Selection Rationale |
| | Stainless Steel, Tool Steel,
Alloy Steel, Carbide, TDC
Coating, Diamond
Coating in Nickel
Substrate, Titanium
Nitride Coating;
Curved Tube: Stainless Steel;
Bushing/Bearing
Retainers: Stainless Steel;
Hub: Polymeric;
Bushing Insert, Cooling
Sleeve: Polymeric;
Lubricant: Nyogel; | | Curved Tube: Stainless Steel;
Bushing/ Bearing
Retainers: Stainless Steel;
Hub: Polymeric;
Bushing Insert Cooling
Sleeve: Polymeric;
Lubricant: Nyogel;
and Adhesive: Cyanoacrylate | Curved Tube: Stainless Steel;
Bushing/Bearing Retainers:
Stainless Steel; Hub:
Polymeric;
Bushing Insert Cooling
Sleeve: Polymeric;
Lubricant: Nyogel;
and Adhesive: Cyanoacrylate | |
| Surgical
Dissecting
Tools – Tip
Style | Round/Acorn, Match
Head, Ball, Cylinder,
Oval, Tapered/Side
Cutting, Metal
Cutting, Twist Drill,
Hole Maker/Saw,
Reverse Taper | Round/Acorn, Match
Head, Ball, Cylinder,
Oval, Tapered/Side
Cutting, Metal Cutting,
Twist Drill, Hole
Maker/Saw, Reverse
Tapered | Round/Acorn, Match Head,
Ball, Cylinder, Oval,
Tapered/Side Cutting, Metal
Cutting, Twist Drill, Hole
Maker/Saw, Reverse Tapered | Round/Acorn, Match Head,
Ball, Cylinder, Oval,
Tapered/Side Cutting, Metal
Cutting, Twist Drill, Hole
Maker/Saw, Reverse Tapered | Similar.
The subject device
Tip designs
remains similar to
the predicate device
Tip designs. Any
new addition of
Tools to the product
family are designed
and manufactured
within the
predicate range of
tip designs.
Similar. |
| Surgical | Surgical Dissecting Tool: | Surgical Dissecting | Surgical Dissecting Tool: | Surgical Dissecting Tool: | Similar. |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM Tools) | MR8 Drill System
(K163565) | Electric Drill Expanded
(K170312) | Pneumatic Drill Expanded
(K163182) | Selection Rationale |
| Dissecting
Tool - Overall
Length | 3-42 cm
Midas RexTM MR8TM
ClearViewTM Tools:
5-14 cm | Tool:
3-42 cm | 3-42 cm
Surgical Curved Bur:
9-14 cm | 3-42 cm
Surgical Curved Bur:
9-11 cm | The overall length of
the subject devices
remains within the
range of length
previously cleared
for the predicate
devices. |
| Surgical
Dissecting
Tool - Head
Diameter | Surgical Dissecting Tool:
0.5 mm - 25 mm
Midas RexTM MR8TM
ClearViewTM Tools:
0.5 mm - 4.5 mm | Surgical Dissecting
Tool: 0.5 mm - 25 mm | Surgical Dissecting Tool:
0.5-25 mm
Surgical Curved Bur:
1-4 mm | Surgical Dissecting Tool:
0.5-25 mm
Surgical Curved Bur:
1-4 mm | Similar.
The head diameter
of the subject
devices remains
within the range of
diameter previously
cleared for the
predicate devices. |
| Attachment
Configuration | Straight, Angled,
Variable, Double-Lock,
Footed, Telescoping,
Perforator, Jacobs Chuck,
J-Latch,
Metal Cutting
Not Applicable to Midas
RexTM MR8TM
ClearViewTM Tools | Straight, Angled,
Variable, Double-Lock,
Footed, Telescoping,
Perforator, Jacobs
Chuck, J-Latch, Metal
Cutting | Straight, Angled, Footed,
Contra Angled, Right Angled,
Metal Cutting, Depth limiting
Drill
Guides, Perforator, Jacob
Chuck Attachments, Wire/Pin
Collet Attachments | Straight, Angled, Footed,
Contra Angled, Right
Angled, Metal Cutting, Depth
limiting Drill
Guides, Perforator, Jacob
Chuck Attachments, Wire/Pin
Collet Attachments | Similar.
The subject devices
Midas RexTM
MR8TM
ClearViewTM Tools
are used with the
MR8 Drill System
but replace
"Attachments" and
"Surgical Dissecting
Tools" as one single
Curved Bur with the
key subassemblies. |
| Attachment
Length | 2-40 cm
Not Applicable to Midas
RexTM MR8TM
ClearViewTM Tools | 2-40 cm | 2-40 cm | 2-40 cm | Similar.
The subject devices
Midas RexTM
MR8TM
ClearViewTM Tools
are used with the
MR8 Drill System |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM Tools) | MR8 Drill System
(K163565) | Electric Drill Expanded
(K170312) | Pneumatic Drill Expanded
(K163182) | Selection Rationale |
| | | | | | but replace
"Attachments" and
"Surgical Dissecting
Tools" as one single
Curved Bur with the
key subassemblies. |
| Drill System
Operating
Principle | Electric powered by IPC
and Pneumatic powered
by Pneumatic Pressure | Electric powered by
IPC and Pneumatic
powered by Pneumatic
Pressure | Electric powered by IPC | Pneumatic powered by
Pneumatic Pressure | Similar.
The drill system
operating principle
is similar to the
predicate devices. |
| Packaging -
Single Use
Dissecting
Tools | The Surgical Dissecting
Tools are individually
packaged in a clear plastic
capped tube
placed within a poly-poly
pouch.
Midas RexTM MR8TM
ClearViewTM Tools:
Sterile Tools are
individually packaged into
a Tyvek Envelope and
sealed. The sealed pouch
is individually packaged
into a shipping carton. | The Surgical Dissecting
Tools are individually
packaged in a clear
plastic capped
tube placed within a
poly-poly pouch. | The Surgical Dissecting Tools
are individually packaged in a
Propionate
cellulosic plastic capped tube
and sealed within a
4 mil PET-Nylon-HDPE Co-
Ex (Peel Seal)/4 mil
PET-Nylon-EVA Pouch.
Curved Burs: Sterile Curved
Burs are individually
packaged into a Tyvek
Envelope and sealed. The
sealed pouch is individually
packaged into a shipping
carton. | The Surgical Dissecting Tools
are individually packaged in a
Propionate cellulosic plastic
capped tube and sealed within
a 4 mil PET-Nylon-HDPE
Co-Ex (Peel Seal)/4 mil
PET-Nylon-EVA Pouch.
Curved Burs: Sterile Curved
Burs are individually
packaged into a Tyvek
Envelope and sealed. The
sealed pouch is individually
packaged into a shipping
carton. | Similar.
The Packaging of
the subject devices
remains similar as
compared to the
Predicate devices. |
| Sterilization | Surgical Dissecting Tools
and Midas RexTM MR8TM
ClearViewTM Tools are
supplied Gamma
Sterilized,
Non-sterile (Handpieces,
Attachments, System | Sterile (Surgical
Dissecting Tools)
Non-sterile
(Handpieces,
Attachments,
System Accessories) | Surgical Dissecting Tools &
Curved Burs are supplied
Gamma Sterilized;
- Electric Handpieces, and
Attachments are
supplied Non-Sterile and
require cleaning and
sterilization prior to each | Surgical Dissecting Tools &
Curved Burs are supplied
Gamma Sterilized; - Pneumatic Handpieces, and
Attachments are supplied
Non-Sterile and require
cleaning and sterilization
prior to each surgical use; | Similar.
The Sterilization of
the subject devices
remains similar as
compared to the
Predicate devices. |
| Feature/
Attribute | Subject Devices (MR8TM
Drill System and Midas
RexTM MR8TM
ClearViewTM 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 are
supplied Non-Sterile. | - Pneumatic Foot Control
Unit, and System Accessories
are supplied Non-Sterile. | |
| Shelf Life | 5 years for Surgical
Dissecting Tools
4 years for Midas RexTM
MR8TM ClearViewTM
Tools | 5 years for Surgical
Dissecting Tools | 5 years for Surgical
Dissecting Tools
4 years for Curved Burs | 5 years for Surgical
Dissecting Tools
4 years for Curved Burs | Similar.
The shelf life of the
subject device is
similar to the
predicate devices. |
6
7
8
9
10
11
12
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 Chatter | ||
| and Hand | ||
| Vibration | Compared the vibration | |
| characteristics between the | ||
| subject devices and their | ||
| equivalent predicates | Tool Chatter and Hand | |
| Vibration for subject | ||
| devices scored similar and/ | ||
| or better than the | ||
| equivalent Predicates | ||
| Irrigation Rate | ||
| vs IPC Setting | Compared Irrigation Rate on the | |
| IPC against the actual | ||
| occurrence | Irrigation Rate delivered by | |
| the subject devices was | ||
| found to be the same or | ||
| more than the one | ||
| displayed on the IPC | ||
| Thermal | ||
| Performance | Evaluated the integrity of the | |
| subject devices through | ||
| respective duty cycles and the | ||
| corresponding thermal | ||
| performance | The subject devices | |
| completed their respective | ||
| duty cycles intact. The | ||
| maximum temperature | ||
| reached by the subject | ||
| devices was below the burn | ||
| threshold. |
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.