(28 days)
No
The summary describes a mechanical depth stop attachment and tools for cranial surgery, with no mention of AI, ML, image processing, or data-driven algorithms. The performance studies focus on mechanical and biocompatibility testing.
No
The device is described as an attachment and tools for creating a cranial access hole, which is a surgical tool used to facilitate access or insertion of other devices, not directly to treat a disease or condition.
No
The device is described as a surgical tool for creating holes in the cranium (incising, cutting, removing, drilling tissue), not for diagnosing conditions. Its purpose is to facilitate surgical access, not to provide diagnostic information about a patient's health status.
No
The device description explicitly refers to "attachment and tools," which are physical components used in surgical procedures, not software. The performance studies also mention "Product Life Verification" and "Biocompatibility Testing," which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "incision, cutting, removing, and drilling of soft and hard tissue during cranial surgical procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description reinforces this by stating its purpose is to "create a cranial access hole."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVDs are used to perform tests on samples taken from the body, not to perform surgical procedures directly on the body.
N/A
Intended Use / Indications for Use
The Midas Rex MR8 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.
Product codes (comma separated list FDA assigned to the subject device)
HBE, HBB, HBC
Device Description
The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known diameter and depth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Risk management was conducted in accordance with ISO 14971:2019 and did not identify any new risks when compared to the predicate. The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate:
- Product Life Verification
- Summative Validation
- Biocompatibility Testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use, indications for use and support a determination of substantial equivalence.
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.
K181535, K183515, K163182, K170312
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 23, 2021
Medtronic Powered Surgical Solutions Carrie Eddings Principal Regulatory Affairs Specialist 4620 North Beach Street Fort Worth, Texas 76137
Re: K213454
Trade/Device Name: Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE, HBB, HBC Dated: October 22, 2021 Received: October 26, 2021
Dear Carrie Eddings:
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.
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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 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.
Adam D. Pierce, Ph.D. 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
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Indications for Use
510(k) Number (if known) K213454
Device Name
Midas Rex MR8 Depth Stop Attachment (MR8-ASDS01 ); Midas Rex MR8 Depth Stop Tool 2. 4mm (MR8-DS1TD24); Midas Rex MR8 Depth Stop Tool 3.2mm (MR8-DS1TD32);Midas Rex MR8 Depth Stop Tool 3.2mm Long (MR8-DS1TD32L); Midas Rex MR8 Depth Stop Tool 7.5mm (MR8-DS1TD75)
Indications for Use (Describe)
The Midas Rex MR8 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.
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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510(k) Summary
November 23, 2021
- Company: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, Texas 76137 Telephone Number: (817) 788-6400
- Carrie Eddings (Primary) Contact: Principal Regulatory Affairs Specialist Telephone Number: (214) 384-0606 Email: carrie eddings(@medtronic.com
Kyle Hoefling (Alternate) Senior Regulatory Affairs Manager Telephone: (760) 207-2432 Email: kyle.d.hoefling(@medtronic.com
Proprietary Trade Name: Midas Rex MR8 Depth Stop Attachment and Tools Common Name: MR8 Depth Stop System Classification Name: Powered cranial drills, burrs, trephines, and their accessories (21 CFR 882.4310) Classification: Class II Product Code: HBE Primary Predicate: Midas Rex Legend Depth Stop Attachment and Tools, K191597
Product Description:
The Midas Rex MR8 Depth Stop attachment and tools are intended to create a cranial access hole of a known diameter and depth.
Indications for Use:
The Midas Rex MR8 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.
Comparison of the Technological Characteristics:
There have been no significant changes to the Midas Rex™ Legend Depth Stop Attachment and Tools since prior clearance in K191597.
The subject device, Midas Rex™ MR8™ Depth Stop Attachment and Tools, are to be used with the MR8TM High-Speed Drill Systems and the Stealth Autoguide™ System to create
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cranial access holes of specific diameter and depth as previously cleared through K191597 for the Midas Rex™ Legend Depth Stop Attachment and Tools.
Changes from the predicate include:
- Compatibility with the predicate MR8 Drill Systems included within K181535 .
- . Extended depth setting to 20mm
- Minor modifications to tool head geometry ●
- Adding a new task in the user workflow .
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| Feature | Subject Device (Midas Rex™
MR8™ Depth Stop System) | Predicate Device (Midas Rex™ Legend™
Depth Stop System, K191597) | Equivalence Discussion |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Medtronic Powered Surgical
Solutions | Medtronic Powered Surgical Solutions | Identical |
| Product Code | HBE | HBE, HBC, HBB | Identical |
| Drill System | • Pneumatic
• Electric | • Pneumatic
• Electric | Identical |
| Operating Principle | | | Identical |
| Intended Use | The Midas Rex MR8 Depth Stop
system is intended to create a
cranial access hole of a known
diameter and depth. | The Midas Rex Legend Depth Stop system is
intended to create a cranial access hole of a
known diameter and depth. | Identical |
| Indications for Use | The Medtronic Midas Rex MR8
Drill System is 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. | The Medtronic Midas Rex Legend Drill System
is 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. | Identical |
| System
components | • Electric Handpieces
• Pneumatic Handpieces
• Attachments
• Surgical Dissecting Tools | • Electric Handpieces
• Pneumatic Handpieces
• Attachments
• Surgical Dissecting Tools | Identical |
| Patient Contacting
Components | • Attachments
• Surgical Dissecting Tools | • Attachments
• Surgical Dissecting Tools | Identical |
| Attachment
Materials | Stainless Steel, Aluminum,
Ceramic, Phenolic, Epoxy,
Chrome Coated Brass, Polymeric | Stainless Steel, Aluminum, Ceramic, Phenolic,
Epoxy, Chrome Coated Brass, Polymeric | Identical |
| Attachment
Configuration | Straight, Variable | Straight, Variable | Identical |
| Feature | Subject Device (Midas Rex™
MR8™ Depth Stop System) | Predicate Device (Midas Rex™ Legend™
Depth Stop System, K191597) | Equivalence Discussion |
| Attachment Tube
Length | 12.8cm (tube retracted)
14.5cm (tube exposed) | 13.7cm (tube retracted)
14.8cm (tube exposed) | Equivalent
The attachment tube length is
inherent due to the overall design of
MR8 attachments and does not
impact the performance or safety of
the device. |
| Sterilization
Method – Reusable
Attachment | Steam | Steam | Identical |
| Surgical Dissecting
Tool Materials | Tool Steel | Tool Steel | Identical |
| Dissecting Tool
Tip Style | Twist Drill | Twist Drill | Equivalent
Minor tool tip modifications which
do not impact safety or performance. |
| Dissecting Tool
Overall Length | 17-22cm | 17-22cm | Identical |
| Dissecting Tool
Head Diameter | 2.1 – 7.5 mm | 2.1 – 7.5 mm | Identical |
| Packaging – Sterile
Dissecting Tools | Individually packaged in a clear
plastic capped tube placed within
a polypoly pouch | Individually packaged in a clear plastic capped
tube placed within a polypoly pouch | Equivalent
The packaging is identical except for
the tube cap. On the predicate device
it is yellow, and on the subject
device, the tube cap is blue. |
| Sterilization
Method – Single
Use Tools | Gamma with minimum radiation
dose of 25 kGy | Gamma with minimum radiation dose of 25 kGy | Identical |
| Shelf Life –
Dissecting Tools | 5 Years | 5 Years | Identical |
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Discussion of the Performance Testing:
The intended use of the subject devices, Midas Rex™ MR8™ Depth Stop Attachments and Tools and predicate are identical, and their technological characteristics are similar. The subject devices are a line extension to the MR8 Drill System (K183515) in the same way that the predicate device was a line extension to the Legend Drill Systems (K163182 and K170312). The changes from the predicate, do not raise any new issues of safety and effectiveness.
Risk management was conducted in accordance with ISO 14971:2019 and did not identify any new risks when compared to the predicate. The following testing was conducted to demonstrate that the modifications to the subject devices are as safe and effective as the predicate.
- . Product Life Verification
- Summative Validation .
- . Biocompatibility Testing
Results of these tests demonstrate that the functionality, integrity, and safety and effectiveness of the subject devices are sufficient for their intended use, indications for use and support a determination of substantial equivalence.
Conclusions
The Midas Rex™ MR8™ Depth Stop Attachment and Tools have shown through comparison to be substantially equivalent to the identified predicate devices.