(147 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on navigation and power tools, not AI/ML capabilities.
No.
The device is a surgical drill system used for tissue removal during spinal and cranial procedures, which is an interventional function, not a therapeutic one as defined by direct treatment of a disease or condition.
No
The description indicates that the device is a surgical system for drilling, burring, and removing hard tissue and bone, and for locating anatomical structures during surgery. It is used as an aid in surgical procedures, not for identifying a medical condition or disease.
No
The device description explicitly mentions electric and pneumatic drill handpieces, which are hardware components, and the system includes reusable and single-use surgical tools and burs.
Based on the provided information, the Stealth-Midas MR8 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Stealth-Midas MR8 System Function: The description clearly states the system is used for "drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures." It's a surgical tool used during a procedure on the patient's body, not for analyzing samples outside the body.
- Intended Use: The intended use is for surgical procedures, aided by navigation for precise anatomical location. This is a surgical intervention, not a diagnostic test.
The system utilizes imaging modalities (CT, MR, fluoroscopy) and navigation, but these are used to guide the surgical tool, not to analyze biological samples for diagnostic information.
N/A
Intended Use / Indications for Use
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
Product codes (comma separated list FDA assigned to the subject device)
OLO, HAW
Device Description
The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, fluoroscopic images
Anatomical Site
spinal and cranial surgical procedures, long bone, or vertebra
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)
Test: Navigation Accuracy Analysis
Description: Confirmed navigated instrument accuracy
Test: CAD Model Evaluation
Description: Verified that CAD models are accurately reflected in the application software
Test: Formative Usability
Description: Confirmed users can follow the navigated workflow and assemble the device
Test: Summative Testing
Description: Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software.
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.
Stealth-Midas System (K160713), MR8 Drill System (K183515)
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
§ 882.4560 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Medtronic Powered Surgical Solutions Jenna Groves Regulatory Affairs Manager 4620 North Beach Street Fort Worth, Texas 76137
Re: K183644
Trade/Device Name: Stealth-Midas MR8 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: December 21, 2018 Received: December 26, 2018
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
May 22, 2019
1
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 (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 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,
For: CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 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) K183644
Device Name Stealth-Midas MR8 System
Indications for Use (Describe)
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
| 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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K183644
510(k) Summary
December 17, 2018
- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: Jenna Groves Regulatory Affairs Manager Telephone Number: (817) 788-6686 Fax: (817) 788-6222 Email: Jenna.a.groves@medtronic.com
- II. Proprietary Trade Name: Stealth-Midas MR8 System
- III. Common Name: Orthopedic, Neurologic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- Classification: Class II V.
- VI. Product Code(s): OLO, HAW
VII. Product Description:
The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.
VIII. Indications for Use:
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
IX. Identification of Legally Marketed Devices (Predicate Devices):
- Stealth-Midas System (K160713) ●
4
- . MR8 Drill System (K183515)
X. Comparison of the Technological Characteristic:
The only significant difference between the subject navigated handpieces and the currently cleared navigated handpieces are minor changes to the optical tracker geometry.
The passive optical tracking technology is identical to that employed in the use of the predicate navigated instrument. Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate system.
The currently cleared MR8 Drill System consists of pneumatic and electric handpieces, attachments, and surgical dissecting tools that are indicated for various cranial and spinal procedures. There are no changes to any of the attachments or surgical dissecting tools. The only significant difference between the subject handpiece and the currently available MR8 handpiece is the addition of a passive optical tracker to the hind to enable navigation of a selection of dissecting tool. As a drill, the Stealth-Midas MR8 is identical to the MR8 drill system, with the exception, as stated, an optical tracker has been attached to the hind of the handpiece to allow navigation. The addition of the tracker does not impact the ability of the drill system to perform to their intended use as a drill system. See below table for a comparison of qualitative characteristics.
5
| Feature | Stealth-Midas System
MR8 (subject devices) | Stealth Midas System
(primary predicate)
K160713 | MR8 Drill System and MR8
ClearView (secondary predicate)
K183515 | Equivalence Discussion |
|--------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation | 21 CFR 882.4560
(Stereotaxic Instrument) | 21 CFR 882.4560 (Stereotaxic
Instrument) | 21 CFR 882.4360 (Motor, Drill,
Electric)
21CFR 882.4370 (Motor, Drill,
Pneumatic)
21 CFR 882.4310 (Drills, Burs,
Trephines & Accessories | Same
As a navigated drill, the Stealth-Midas
MR8 falls into the same regulation number
as the primary predicate Stealth-Midas and
has the same intended use.
Similar
The Stealth-Midas MR8 operates and
performs the same as the predicate MR8
drill and falls into a similar regulation. |
| Product Code | OLO, HAW | OLO | HBC, HBB, HBE, ERL, HSZ | Equivalent
The Stealth-Midas MR8 System is
indicated for use in navigated cranial and
spinal procedures. As such, it carries the
same OLO product code (orthopedic
stereotaxic instrument) as predicate
Stealth-Midas spine instruments and also
includes product code HAW (neurological
stereotaxic). HAW falls within the same
regulation number 21 CFR 882.4560 and
has the same intended use as OLO. |
| 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. | Equivalent
The Navigated Electric and Pneumatic
Stealth-Midas MR8 motors, with the
tracker on the hind of the motor, allow for
optical tracking of the -tip at the surgical
site. The subject Stealth-Midas MR8 and
the predicate devices have the same
intended use.
As a drill system the subject system
intended use is identical to that of the
predicate drill system. The only difference
between the subject and the predicate MR8 |
6
| Indications for Use | The Stealth-Midas MR8 | The Stealth-Midas System is | The Medtronic MR8 | Handpieces is that the proposed Stealth-
Midas MR8 Handpieces are supplied with
a Tracker on the hind of the Handpieces.
Equivalent |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Stealth-Midas MR8
System is indicated for the
drilling, burring and
removal of hard tissue and
bone in spinal and cranial
surgical procedures.
Computer-assisted surgery
and its associated
applications are intended
as an aid for precisely
locating anatomical
structures in either open or
percutaneous procedures.
Their use is indicated for
any medical condition in
which the use of
stereotactic surgery may be
appropriate, and where
reference to a rigid
anatomical structure, such
as a long bone, or vertebra,
can be identified relative to
a CT- or MR-based model,
fluoroscopic images, or
digitized landmarks of
the anatomy. | indicated for the incision /
cutting, removal, drilling, and
sawing of soft and hard tissue,
bone, and biomaterials in spinal
surgical procedures. Computer-
assisted surgery and its
associated applications are
intended as an aid for precisely
locating anatomical structures
in either open or percutaneous
procedures. Their use is
indicated for any medical
condition
in which the use of stereotactic
surgery may be appropriate,
and where reference to a rigid
anatomical structure, such as a
long bone, or vertebra, can be
identified relative to a CT- or
MR-based model, fluoroscopic
images, or digitized landmarks
of the anatomy. | 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) | The Navigated Electric and Pneumatic
Stealth-Midas MR8 motors, with the
tracker on the hind of the motor, allow for
optical tracking of the tool-tip at the
surgical site. The subject Stealth-Midas
MR8 and the predicate devices have the
same intended use, but the subject device
is indicated for both cranial and spinal
applications and the predicate Stealth-
Midas is indicated for spinal applications.
As a drill system the subject system
intended use is identical to that of the
predicate MR8 drill system. The only
difference between the subject motor and
the predicate motor is the Stealth-Midas
MR8 motors are supplied with a tracker or
the hind of the handpieces/motor. The
subject motor and the predicate motor are
both indicated for spinal and cranial
applications. | |
| | | | | |
| StealthStation
Operating
Principle
(Tracking
Method) | Optical (infra-red) | Optical (infra-red) | • 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. | Identical
The Operating Principle of the subject
Stealth-Midas MR8 device is identical to
the predicate Stealth-Midas |
| StealthStation
System
Accuracy
Requirements | 3D Accuracy Testing: