(60 days)
Not Found
No
The summary describes surgical tools and attachments used with a computer-assisted surgery system, but there is no mention of AI or ML being used for image processing, decision support, or any other function within the device itself or the associated system. The performance studies focus on functional, reliability, navigational accuracy, and usability aspects, not on AI/ML model performance.
Yes
The device is described as "Midas Rex™ attachments and dissecting tools" used for "incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures," which directly performs a therapeutic function.
No
Explanation: The device description and intended use clearly state that the Midas Rex™ attachments and dissecting tools are for surgical procedures involving the incision, cutting, drilling, burring, and removal of tissue and bone. While it mentions computer-assisted surgery as an aid for locating anatomical structures, the primary function of the attachments is interventional (performing a physical action on the body), not diagnostic (identifying a disease or condition). The performance studies also focus on functional and navigational accuracy for surgical execution, not diagnostic metrics.
No
The device description explicitly states that the device consists of "attachments and dissecting tools" and is part of "electric and pneumatic drill handpieces and system accessories," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the incision/cutting, drilling, burring, and removal of hard tissue and bone in vivo (within the body) during surgical procedures.
- Device Description: The description reinforces this by stating the instruments are used through a cannula for open and minimally invasive spine procedures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is a surgical tool used directly on the patient's anatomy during a procedure.
N/A
Intended Use / Indications for Use
The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.
Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for 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
Device Description
Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures.
The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT- or MR-based model, fluoroscopic images
Anatomical Site
rigid anatomical structure, such as a long bone or vertebra (specifically, spine)
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)
- Functional and Reliability Design Verification: Demonstrates the ability of the Midas Rex™ attachment and dissecting tools to perform throughout a single procedure and throughout expected product life thus, verifying the design robustness.
- Navigational Accuracy Analysis: Provides confirmation that the subject devices satisfy the necessary navigational accuracy requirements.
- CAD Model Analysis: Verifies the correctness of CAD model representations of the subject devices for the Mazor X Stealth Edition™ system.
- Human Factors/Usability Testing: Demonstrates that the usability and human factors considerations were adequately addressed and validated, and the product design performs according to its intended use.
The subject devices met the appropriate requirements and passed all the performance testing activities listed above. Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are noncytotoxic, non-sensitizing, non- irritating, non-toxic, non-pyrogenic, non-hemolytic and pose a negligible risk of adverse biological effects to patients when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
System level Navigation Accuracy Acceptance Criteria:
Mean Positional Error (mm) ≤ 2.0 mm
Mean Trajectory Error (degrees): ≤ 2.0 degrees
System level Navigation Accuracy Values:
Mean Positional Error (mm): 1.12 mm
Mean Trajectory Error (degrees): 0.37 degrees
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
§ 882.4560 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 is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 2, 2020
Medtronic Powered Surgical Solutions (MPSS) Jainam Shah Sr Regulatory Affairs Specialist 4620 North Beach Street Fort Worth, Texas 76137
Re: K202552
Trade/Device Name: Midas Rex Attachments and Dissecting Tools Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 2, 2020 Received: September 3, 2020
Dear Jainam Shah:
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,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202552
Device Name Midas RexTM attachments and dissecting tools
Indications for Use (Describe)
The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/outting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.
Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
September 02, 2020
- I. Company: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 Telephone Number: (720) 890-3200
- Jainam Shah Contact: Sr. Regulatory Affairs Specialist Telephone Number: (720) 890-2595 Fax: (720) 890-3500 Email: jainam.shah@medtronic.com
Jenna Groves (Alternate) Regulatory Affairs Manager Telephone number: (817) 788-6686 Email: jenna.a.groves@medtronic.com
- II. Proprietary Trade Name: Midas Rex™ Attachments and Dissecting tools
- III. Common Name: Orthopedic Stereotaxic Instrument
- IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
- V. Classification: Class II
VI. Product Code: OLO
VII. Predicate Devices
The legally marketed predicate devices are identified below:
| Predicate | 510(k) Clearance |
|---|---|
| Primary Predicate | |
| MR8TM Drill System and Midas | |
| RexTM MR8TM ClearViewTM Tools | K183515 |
| S.E. 12-May-2019 | |
| Additional Predicate: | |
| Stealth Midas MR8TM System | K183644 |
| S.E. 22-May-2019 |
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VIII. Product Description:
Midas Rex™ attachments and surgical dissecting tools for Mazor are intended for the incision/cutting, drilling, burring, and removal of hard tissue and bone. The subject instruments are designed to be utilized through a cannula, for use with the Mazor X Stealth Edition™ system in open and minimally invasive spine procedures.
The subject devices perform the intended function as part of the existing Medtronic Midas Rex TM surgical drill systems which consist of the subject attachments and dissecting tools, electric and pneumatic drill handpieces and system accessories.
IX. Indications for Use:
The Midas Rex™ attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.
Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for 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.
X. Comparison of the Technological Characteristics:
The subject Midas Rex™ attachments and dissecting tools utilize the same fundamental scientific technology and have the same mode of operation and functionality as the predicate attachments and surgical dissecting tools (K183515), i.e. they are powered by the existing electric/pneumatic handpieces for the intended use. The subject devices have equivalent materials and sterilization/reprocessing methods as the primary predicate (K183515). The changes in design features between the subject and the predicates do not raise any new risks or any concerns about the safety and effectiveness. The subject navigated devices have an integrated optical tracker to enable real-time navigation in a manner identical to the additional predicate Stealth Midas™ (K183644). The subject navigated devices also meet the established system-level navigation accuracy requirements.
| Table 1: Comparison of technological characteristics | |||
|---|---|---|---|
| Feature | Subject Devices | ||
| (Midas RexTM | |||
| attachments and | |||
| surgical dissecting tools) | Primary Predicate | ||
| Midas MR8TM Drill System | |||
| and Midas RexTM MR8TM | |||
| ClearViewTM Tools | |||
| (K183515) | Additional Predicate | ||
| Stealth MidasTM | |||
| MR8TM | |||
| (K183644) | |||
| Regulation | 21 CFR 882.4560 | ||
| (Stereotaxic Instrument) | 21 CFR 882.4360 (Motor, | ||
| Drill, Electric) |
21CFR 882.4370 (Motor,
Drill, Pneumatic) | 21 CFR 882.4560
(Stereotaxic Instrument) |
| Feature | Subject Devices (Midas Rex TM attachments and surgical dissecting tools) | Primary Predicate Midas MR8 TM Drill System and Midas Rex TM MR8 TM ClearView TM Tools (K183515) | Additional Predicate Stealth Midas TM MR8 TM (K183644) |
| | | 21 CFR 882.4310 (Drills, Burs, Trephines & Accessories | |
| Product Code | OLO | HBC, HBB, HBE | OLO, HAW |
| Intended Use | Incision/cutting, drilling, burring, and removal of hard tissue and bone. | 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 TM attachments and dissecting tools for Mazor are indicated for the incision/cutting, drilling, burring, and removal of hard tissue and bone in open and minimally invasive spine procedures.
Computer-assisted surgery and its associated applications are intended as an aid for locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition for 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. | 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 | The Stealth-Midas MR8 TM 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. |
| Feature | Subject Devices
(Midas Rex™
attachments and
surgical dissecting tools) | Primary Predicate
Midas MR8™ Drill System
and Midas Rex™ MR8™
ClearView™ Tools
(K183515) | Additional Predicate
Stealth Midas™
MR8™
(K183644) |
| | | Midas Rex MR8 Drill System
and associated User's Guides
for the Indications of Use | |
| General
System
Components | • Attachments - Guided
and Navigated w/
optical tracker
• Surgical Dissecting
Tools
• System Accessories | • Electric Handpieces
• Pneumatic Handpieces
• Attachments
• Surgical Dissecting Tools
• System Accessories | • Electric Handpieces
w/ optical tracker
• Pneumatic Handpieces
w/ optical tracker
• Attachments
• Surgical Dissecting
Tools
• System Accessories |
| Materials | Attachments: Stainless
Steel
Tracker: Aluminum,
Stainless
Steel
Surgical Dissecting
Tools: Tool (M2) Steel | Attachments: Stainless
Steel, Aluminum, Ceramic,
Phenolic, Epoxy, Chrome
Coated Brass, Torlon 4301
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, Polymeric
Surgical Dissecting
Tools - Stainless Steel,
Tool Steel, Alloy Steel,
Carbide, TDC Coating,
Diamond Coating in
Nickel Substrate,
Titanium Nitride
Tracker: Aluminum |
| Surgical
Dissecting
Tool Tip
Style | Twist Drill | 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
Taper |
| Surgical
Dissecting
Tool Overall
Length | 23cm
31cm | 3 - 42 cm | 3-42 cm |
| Surgical
Dissecting
Tool Head
Diameter | 3.0 mm | 0.5 - 25 mm | 0.5 - 25 mm |
| Attachment
Configuration | Straight | Straight, Angled,
Variable, Double-Lock,
Footed, Telescoping,
Perforator, Jacobs Chuck, J-
Latch, Contra Angle, Metal
Cutting | Straight, Angled,
Variable, Double-Lock,
Footed, Telescoping,
Perforator, Jacobs
Chuck, J-Latch, Contra
Angle, Metal Cutting |
| Feature | Subject Devices
(Midas RexTM
attachments
and
surgical dissecting tools) | Primary Predicate
Midas MR8TM Drill System
and Midas RexTM MR8TM
ClearViewTM Tools
(K183515) | Additional Predicate
Stealth MidasTM
MR8TM
(K183644) |
| Attachment
Length | 23 cm
31cm | 2 – 40 cm | 2 – 40 cm |
| Drill System
Operating
Principle | • Pneumatic (powered
by Pneumatic Pressure)
• Electric (powered
by IPC) | • Pneumatic (powered by
Pneumatic Pressure)
• Electric (powered by IPC) | • Pneumatic (powered
by Pneumatic
Pressure)
• Electric (powered by
IPC) |
| Packaging -
Sterile
Surgical
Dissecting
Tools | Individually packaged in
a clear plastic capped
tube placed within a
poly-poly
pouch | Individually packaged in a
clear plastic capped tube
placed within a poly-poly
pouch | The Surgical Dissecting
Tools are individually
packaged in a clear
plastic capped tube
placed within a poly-poly
pouch. |
| Sterilization
Method –
Single Use
Tools | Gamma with minimum
radiation dose of 25 kGy | Gamma with minimum
radiation dose of 25 kGy | Gamma with minimum
radiation dose of 25 kGy |
| Sterilization
Method -
Reusable
Attachment | Steam | Steam | Steam |
| Shelf Life -
Surgical
Dissecting
Tools | 5 Years | 5 Years | 5 Years |
| Navigation
Optical
Tracking
Principle | Optical (Infra-red) | N/A | Optical (Infra-red) |
| System level
Navigation
Accuracy
Acceptance
Criteria | Mean Positional Error
(mm) ≤ 2.0 mm
Mean Trajectory Error
(degrees): ≤ 2.0 degrees | N/A | Mean Positional Error
(mm) ≤ 2.0 mm
Mean Trajectory Error
(degrees): ≤ 2.0 degrees |
| System level
Navigation
Accuracy
Values | Mean Positional Error
(mm):
1.12 mm
Mean Trajectory Error
(degrees):
0.37 degrees | N/A | Mean Positional Error
(mm):
0.94 mm
Mean Trajectory Error
(degrees):
0.85 degrees |
Table 1· Comnarison of technological characteristics
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XI. Discussion of the Performance Testing:
Testing conducted to demonstrate equivalency of the subject device to the predicate devices is summarized as follows:
| Performance Testing
| Activity | Description |
|---|---|
| Functional and | |
| Reliability Design | |
| Verification | Demonstrates the ability of the Midas Rex™ attachment and |
| dissecting tools to perform throughout a single procedure | |
| and throughout expected product life thus, verifying the | |
| design robustness. | |
| Navigational | |
| Accuracy Analysis | Provides confirmation that the subject devices satisfy the |
| necessary navigational accuracy requirements. | |
| CAD Model | |
| Analysis | Verifies the correctness of CAD model representations of |
| the subject devices for the Mazor X Stealth Edition™ | |
| system. | |
| Human Factors/ | |
| Usability Testing | Demonstrates that the usability and human factors |
| considerations were adequately addressed and validated, and | |
| the product design performs according to its intended use. |
The subject devices met the appropriate requirements and passed all the performance testing activities listed above. Additionally, biological endpoint testing, conducted per recommendations from ISO 10993-1:2018, indicates that the subject devices are noncytotoxic, non-sensitizing, non- irritating, non-toxic, non-pyrogenic, non-hemolytic and pose a negligible risk of adverse biological effects to patients when used as intended.
XII. Conclusions
The subject devices have shown through comparison to be substantially equivalent to the identified predicate devices.