(137 days)
No
The document describes a robotic positioning and guidance system that interprets navigation data and surgical plans. There is no mention of AI, ML, or image processing that would suggest the use of these technologies for tasks like image analysis, decision support, or autonomous planning. The system appears to be based on pre-defined plans and feedback from a standard image-guided navigation system.
No.
The device is a positioning and guidance system that assists surgeons in guiding instruments and creating access holes; it does not directly treat or cure a medical condition.
No
The device is described as a "positioning and guidance system" and a "remotely-operated positioning and guidance system" intended to assist neurosurgeons in guiding standard neurosurgical instruments and creating cranial access holes. Its purpose is to facilitate surgical procedures based on pre-operative plans and image-guided navigation, not to diagnose a condition.
No
The device description explicitly states it is a "robotic positioning and guidance system" and mentions "Hardware Verification testing ensuring the hardware requirements identified for the system are met and hardware performs as intended." This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the Stealth Autoguide™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons during surgical procedures. It is a guidance system for physical instruments used on the patient's body.
- Device Description: The description reinforces this by stating it's a robotic positioning and guidance system to position and orient instrument holders or tool guides.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment. IVDs are typically used in laboratories or at the point of care for analyzing biological samples.
The Stealth Autoguide™ System is a surgical navigation and guidance system, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.
Product codes (comma separated list FDA assigned to the subject device)
HAW, HBC, HBB, HBE
Device Description
Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Neurosurgeons
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 was conducted by establishing substantial equivalence of the system and verifying that the device will perform as intended meeting all the design inputs. Testing included:
- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment Part 1:General . Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General . requirements for safety; Electromagnetic Compatibility - Requirements andTests
- Software Verification and Validation testing verifying the operating system ● software requirements are met and software performs as intended
- Hardware Verification testing ensuring the hardware requirements identified for ● the system are met and hardware performs as intended
- Usability Testing was conducted in accordance to IEC 62366 demonstrating that . the usability and human factors requirements were adequately met.
Under representative worst-case configuration, the Stealth Autoguide™ System when used with the StealthStation™ System utilizing Stealth Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error 1.0, All HI
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
November 1, 2019
Medtronic Navigation, Inc. Jason Woehrle Senior Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027
Re: K191597
Trade/Device Name: Stealth Autoguide System, Midas Rex Legend Depth Stop System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW, HBC, HBB, HBE Dated: September 27, 2019 Received: October 2, 2019
Dear Jason Woehrle:
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Assistant Director 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) K191597
Device Name Stealth Autoguide™ System
Indications for Use (Describe)
The Stealth Autoguide™ System is a positioning and guidance system intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments, based on a pre-operative plan and feedback from an image-guided navigation system with three-dimensional imaging software.
The Stealth Autoguide™ System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (for example, stereotactic EEG, laser tissue ablation, etc.).
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K191597
Device Name Midas Rex™ Legend™ Depth Stop System
Indications for Use (Describe)
The Midas Rex™ Legend™ depth stop attachment and tools are incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary June 14, 2019
-
I. Company: Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: 720-890-3200
Medtronic Powered Surgical Systems 4620 N Beach Street Ft Worth, TX 76137 USA -
Contact: Jason Woehrle (Primary) Senior Regulatory Affairs Specialist Telephone Number: 949-399-1509 Fax Number: 720-890-3500
K. Elizabeth Waite (Alternate) Principal Regulatory Affairs Specialist Telephone: (720)-890-2182 Fax: 720-890-3500 -
II.
Proprietary Trade Name:
Stealth Autoguide™System
Midas Rex " Legend" "Depth Stop System
III. Common Name:
Stealth Autoguide™ System: Stereotaxic Instrument Midas Rex " Legend " Depth Stop System: Motor, Drill, Electric, Motor, Drill, Pneumatic, Powered simple cranial drills, burrs, trephines, and their accessories
IV. Classification Name:
Stealth Autoguide " System: Stereotaxic Instrument (21 CFR 882.4560) Midas Rex™ Legend™ Depth Stop System: Electric cranial drill motor (21 CFR 882.4360) Pneumatic cranial drill motor (21 CFR 882.4370) Powered simple cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310)
- V. Classification: Stealth Autoguide™ System: Class II Midas Rex " Legend " Depth Stop System: Class II
- VI. Product Code: Stealth Autoguide™ System: HAW Midas Rex 1 Legend " Depth Stop System: HBC, HBB, HBE
5
VII. Product Description:
Stealth Autoguide™ System: The Stealth Autoguide System is a robotic positioning and guidance system intended to interpret navigation tracker coordinates and surgical plan coordinates from the StealthStation to robotically position and orient instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments to pre-defined plans.
Midas Rex™ Legend™ Depth Stop System: The Midas Rex™ Legend™ Depth Stop System consists of a Depth Stop Attachment and specific surgical dissecting tools that will be used in conjunction with the Stealth Autoguide System to create cranial access holes for neurosurgical procedures.
Indications for Use: VIII.
Stealth Autoguide "" System: The Stealth Autoguide System is a remotely-operated positioning and guidance system, indicated for any neurological condition in which the use of stereotactic surgery may be appropriate (e.g., stereotactic biopsy, stereotactic EEG, laser tissue ablation, etc.).
Midas Rex "" Legend"" Depth Stop System: The Midas Rex "" Legend" depth stop attachment and tools are indicated for the incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures with the intent to create a hole through the cranium to allow surgeons access to desired surgical locations and/or to facilitate insertion, placement of other surgical devices during such procedures.
IX. Identification of Legally Marketed Devices (Predicate Devices): Stealth Autoguide "System:
Predicate: K151359 – ROSA Brain, manufactured by MEDTECH S.A Reference Devices: K131433 - iSYS1, manufactured by ISYS Reference Devices: K162309 - StealthStation S8 Cranial, manufactured by Medtronic Navigation, Inc. Reference Devices: K162604 - Cranial Reducing Tubes, manufactured by Medtronic Navigation, Inc.
Midas Rex "" Legend "" Depth Stop System:
Predicate: K170312. K163182 – Midas Rex Legend Electric and Pneumatic Drill Systems, manufactured by Medtronic Powered Surgical Systems.
6
X. Summary of the Technological Characteristics:
| Stealth AutoguideTM System | ||
|---|---|---|
| Item | Subject Device | Predicate Devices |
| General Description | Computer controlled | |
| electromechanical multi- | ||
| jointed arm for use as a | ||
| stereotactic instrument | Predicate: ROSA Brain | |
| (K151359) | ||
| Computer controlled | ||
| electromechanical multi- | ||
| jointed arm for use as a | ||
| stereotactic instrument | ||
| Product Code | HAW | Predicate: ROSA Brain |
| (K151359) HAW | ||
| Intended Use/ | ||
| Indications for Use | The Stealth AutoguideTM | |
| System is a positioning and | ||
| guidance system intended for | ||
| the spatial positioning and | ||
| orientation of instrument | ||
| holders or tool guides to be | ||
| used by neurosurgeons to | ||
| guide standard neurosurgical | ||
| instruments, based on a pre- | ||
| operative plan and feedback | ||
| from an image-guided | ||
| navigation system with three- | ||
| dimensional imaging software. | ||
| The Stealth AutoguideTM | ||
| System is a remotely-operated | ||
| positioning and guidance | ||
| system, indicated for any | ||
| neurological condition in | ||
| which the use of stereotactic | ||
| surgery may be appropriate | ||
| (for example, stereotactic | ||
| biopsy, stereotactic EEG, laser | ||
| tissue ablation, etc.). | Predicate: ROSA Brain | |
| (K151359) | ||
| Intended for the spatial | ||
| positioning and orientation of | ||
| instrument holders or tool | ||
| guides to be used by | ||
| neurosurgeons to guide | ||
| standard neurosurgical | ||
| instruments (biopsy needle, | ||
| stimulation or recording | ||
| electrode, endoscope). The | ||
| device is indicated for any | ||
| neurosurgical procedure in | ||
| which the use of stereotactic | ||
| surgery may be appropriate. |
Reference Device: iSYS
1 (K131433)
The iSYS 1 device is intended
to assist the surgeon in the
positioning of a needle or
electrode where both
computed tomography (CT)
and fluoroscopic imaging can |
| Item | Subject Device | Predicate Devices |
| | | be used for target trajectory
planning and intraoperative
tracking. The needle or
electrode is then manually
advanced by the surgeon.
Trajectory planning is made
with software that is not part
of the iSYS device. |
| Operating Principle | Preoperative images
(StealthStation)
Surgical planning
(StealthStation)
Patient registration
Guidance of instruments | Reference Device: iSYS
1 (K131433)
Preoperative images (third
party)
Surgical planning (third party)
Patient registration
Guidance of instruments |
| Localization Means | Optical markers on tool holder | Reference Device:
Stealth S8 Cranial (K162309)
Optical markers on tool holder |
| Image-Guided | Yes (on StealthStation) | Reference Device: iSYS
1 (K131433)
Yes |
| Planning Software | Compatible with:
S8 Cranial v1.1
Synergy Cranial v.3.1 | Reference Device:
Stealth S8 Cranial (K162309)
S8 Cranial v1.2 |
| System Accuracy
Requirement | Under representative worst-
case configuration, the
StealthStation® System with
Cranial Software used with
Stealth AutoguideTM System,
has demonstrated performance
in 3D positional accuracy with
a mean error ≤ 2.0 mm and in
trajectory angle accuracy with
a mean error ≤ 2.0 degrees. | Reference Device:
Stealth S8 Cranial (K162309)
Under representative worst-
case configuration, the
StealthStation® System S8
with StealthStationTM Cranial
v1.0.0 Software, has
demonstrated performance in
3D positional accuracy with a
mean error ≤ 2.0 mm and in
trajectory angle accuracy with
a mean error ≤ 2.0 degrees. |
| Instrumentation | Navigated Trajectory Guide
Tool Holders (Drill Guides,
Reducing Tubes)
Height Guides
Tapping Tube | Reference Device:
Cranial Reducing Tubes
(K162604)
Navigated Trajectory Guide
Tool Holders (Drill Guides,
Reducing Tubes |
| Item | Subject Device | Predicate Devices |
| Instrument Fixation | Special tool holders for different applications mounted to the Stealth Autoguide | Height Guides
Tapping Tube
Reference Device: iSYS
1 (K131433)
Special tool holders for different applications mounted to the device |
| Guide Position
Adjustment | Robotic movement | Predicate: ROSA Brain
(K151359)
Automatic (Robotized) |
| Accessories | Sterile Drapes
Head Frame Adapter
Cable Sets | Reference Device: iSYS
1 (K131433)
Sterile Drapes
Table Adapters
Cable Sets |
| Real-Time Instrument
Position | Yes (on StealthStation) | Reference Device: iSYS
1 (K131433)
Yes |
| Patient Registration | Optical Registration Device
(via StealthStation) | Reference Device:
Stealth S8 Cranial (K162309)
Optical Registration Device
(via StealthStation) |
| Surgeon Performs Final
Instrument Delivery
through Instrument
Guide | Yes | Reference Device: iSYS
1 (K131433)
Yes |
Stealth Autoguide TM System
7
8
9
| Feature/
Attribute | Subject
Devices
Midas
Rex™
Legend™
Depth
Stop | Electric Drill
Expanded Indications
(K170312) | Pneumatic Drill
Expanded Indications
(K163182) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | HBC, HBB,
HBE | HBE, HBC, HRX,
HWE, EQJ, ERL, KFK | KFK, HBB, ERL, EQJ, HSZ,
GET, KFK, HBE, DWH |
| Intended Use | Incision,
cutting,
removing,
and drilling
of soft and
hard tissue | 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. |
| Indications
for use | The Midas
Rex Legend
Depth Stop
attachment
and tools
are
indicated
for the
incision,
cutting,
removing,
and drilling
of soft and
hard tissue
during
cranial
surgical
procedures
with the
intent to
create a hole
through the
cranium to
allow
surgeons
access to
desired
surgical
locations
and/or to | 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 | 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:
• Lumbar Microdiscectomy
• Lumbar
Stenosis |
| Feature/
Attribute | Subject
Devices
Midas
Rex™
Legend™
Depth
Stop | Electric Drill
Expanded Indications
(K170312) | Pneumatic Drill
Expanded Indications
(K163182) |
| | facilitate
insertion,
placement
of other
surgical
devices
during such
procedures. | 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) | • Posterior Lumbar
Interbody Fusion (PLIF)
• Transforaminal
Lumbar Interbody
Fusion (TLIF)
• Anterior Lumbar
Interbody Fusion (ALIF)
• Direct Lateral
Interbody Fusion
(DLIF) |
| General
System
Components | Attachment,
Surgical
Dissecting
Tool | Electric Handpiece,
Attachments, Surgical
Dissecting Tools,
System Accessories | Pneumatic Handpiece,
Attachments, Surgical
Dissecting Tools, System
Accessories |
| Patient
Contacting
Components | Attachment
and Surgical
Dissecting
Tools | Attachments and
Surgical Dissecting
Tools | Attachments and Surgical
Dissecting Tools |
| Materials of
Patient
Contacting
Components | Attachment
- Stainless
Steel,
Phenolic,
Chevron | Attachments - Stainless
Steel, Aluminum,
Ceramic, Phenolic,
Epoxy, Chrome Coated
Brass, Torlon 4301 | Attachments - Stainless Steel,
Aluminum, Ceramic, Phenolic,
Epoxy, Chrome Coated Brass,
Polymeric |
| | SRI Grease
2
Surgical
Dissecting
Tools -Tool
Steel | Dissecting Tools:
Stainless Steel, Tool
Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in | Dissecting Tools: Stainless
Steel, Tool Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in Nickel
Substrate, Titanium Nitride |
| Feature/
Attribute | Subject
Devices
Midas
Rex™
Legend™
Depth
Stop | Electric Drill
Expanded Indications
(K170312) | Pneumatic Drill
Expanded Indications
(K163182) |
| | | Nickel Substrate,
Titanium Nitride | |
| Surgical
Dissecting
Tools - Tip
Style | Twist Drill | Round/Acorn, Match
Head, Ball, Cylinder,
Oval, Tapered/Side
Cutting, Metal
Cutting, Twist Drill,
Hole Maker/Saw, | Round/Acorn, Match Head,
Ball, Cylinder, Oval,
Tapered/Side Cutting, Metal
Cutting, Twist Drill, Hole
Maker/Saw, Reverse Tapered |
| Surgical
Dissecting
Tool -
Overall
Length | Surgical
Dissecting
Tool:
6.7-8.7cm | Surgical Dissecting
Tool:
3-42cm | Surgical Dissecting Tool:
3-42cm |
| Surgical
Dissecting
Tool - Head
Diameter | Surgical
Dissecting
Tool:
2.5 - 7.5mm | Surgical Dissecting
Tool:
0.5-25mm | Surgical Dissecting Tool:
0.5-25mm |
| Attachment
Configuration | Depth Stop | 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 |
| Attachment
Length | ASDS01
13.7cm -
14.8cm in
1mm
increments | 2-40cm | 2-40cm |
| Drill System
Operating
Principle | Electric
powered by
IPC and
Pneumatic
powered by
Pneumatic
Pressure | Electric powered by IPC | Pneumatic powered by
Pneumatic Pressure |
| Feature/
Attribute | Subject
Devices
Midas
RexTM
Legend™
Depth
Stop | Electric Drill
Expanded Indications
(K170312) | Pneumatic Drill
Expanded Indications
(K163182) |
| Packaging -
Single Use
Dissecting
Tools | 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. | 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. | 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. |
| Sterilization | Surgical
Dissecting
Tools are
supplied
Gamma
Sterilized
Non-sterile,
Attachments | Surgical Dissecting
Tools are supplied
Gamma Sterilized; - Electric Handpieces,
and Attachments are
supplied Non-Sterile
and require cleaning and
sterilization prior to
each surgical use: - Electric Foot Control
Unit, and System
Accessories are supplied
Non-Sterile. | Surgical Dissecting Tools are
supplied Gamma Sterilized; - Pneumatic Handpieces, and
Attachments are supplied Non-
Sterile and require cleaning and
sterilization prior to each
surgical use; - Pneumatic Foot Control Unit,
and System Accessories are
supplied Non-Sterile. |
| Shelf Life | 5 years for
Surgical
Dissecting
Tools | 5 years for Surgical
Dissecting Tools | 5 years for Surgical Dissecting
Tool |
Midas Rex™ Legend™ Depth Stop System:
10
11
12
13
XI. Discussion of the Performance Testing:
Testing conducted demonstrates the product will perform as intended according to the outlined design requirements. The following testing was conducted on the Stealth Autoguide TM System and Midas Rex TM Legend TM Depth Stop System to establish substantial equivalence of the system and verify that the device will perform as intended meeting all the design inputs:
- AAMI/ANSI ES 60601-1:2012 Medical Electrical Equipment Part 1:General . Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
- IEC 60601-1-2:2014 Medical Electrical Equipment Part 1-2: General . requirements for safety; Electromagnetic Compatibility - Requirements andTests
- Software Verification and Validation testing verifying the operating system ● software requirements are met and software performs as intended
- Hardware Verification testing ensuring the hardware requirements identified for ● the system are met and hardware performs as intended
- Usability Testing was conducted in accordance to IEC 62366 demonstrating that . the usability and human factors requirements were adequately met.
The following table summarizes the testing conducted on the Stealth Autoguide™ System when used with the StealthStation 100 System and Stealth Cranial Software
Description
Under representative worst-case configuration, the Stealth Autoguide™ System when used with the StealthStation™ System utilizing Stealth Cranial Software, has demonstrated performance in 3D positional accuracy with a mean error ≤ 2.0 mm and in trajectory angle accuracy with a mean error 1.0,
All HI