(68 days)
The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
The Medtronic Midas Rex Legend System is a modular, pneumatic, highspeed instrument system consisting of a motor (handpiece) and accessories/attachments, including but not limited to adapters, spindles, burrs, drills, cutters, and other dissecting tools.
The provided 510(k) summary for the Medtronic Midas Rex Legend System does not contain the detailed information required to describe acceptance criteria and a study proving the device meets those criteria in the way typically expected for AI/ML-driven medical devices.
Instead, this document is a summary for a traditional medical device (a surgical drill system) and focuses on demonstrating substantial equivalence to existing predicate devices, rather than a performance study against specific acceptance criteria for diagnostic or AI-driven tasks.
Therefore, many of your requested points cannot be answered from the provided text. I will address the points as best as possible based on the information given, highlighting where information is missing due to the nature of the device and the document.
Acceptance Criteria and Study for Medtronic Midas Rex Legend System (Surgical Drill System)
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Operate as intended (e.g., provide power, cut effectively) | "Confirms that the device operates as intended" |
| Substantially equivalent to predicate devices (Midas Rex Classic, Midas Rex III, Mednext 1000 Instrumentation Systems) | "Is substantially equivalent to the Midas Rex Classic, Midas Rex III, and Mednext 1000 Instrumentation Systems" |
| No new safety or effectiveness issues | "Raises no new safety or effectiveness issues" |
| Same technological characteristics as predicates | "Have the same technological characteristics" |
| Same operating principles as predicates | "Use the same operating principles" |
| Use same patient contacting materials as predicates | "Use the same patient contacting materials" |
| Similar performance characteristics as predicates | "Have similar performance characteristics" |
Explanation: In a 510(k) submission for a non-AI/ML device, the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance data is therefore framed around "substantial equivalence." Specific quantitative performance metrics (like sensitivity, specificity, accuracy for an AI system) are not typically presented in this type of submission for a surgical drill system.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document states "Performance testing on the Medtronic Midas Rex Legend System confirms that the device operates as intended." This likely refers to engineering and bench testing, rather than a "test set" in the context of data for an AI/ML device. There is no mention of patient data.
- Data Provenance: Not applicable in the context of data for AI/ML. The testing would be performed on the physical device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a surgical instrument, not a diagnostic tool requiring expert interpretation of results to establish ground truth.
4. Adjudication method for the test set
- Not applicable. There is no "test set" in the AI/ML sense, nor a need for expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a surgical tool, not an AI-assisted diagnostic or interpretive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a human-operated surgical tool, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device would be its functional performance (e.g., speed, torque, cutting ability, durability, temperature generation) validated against engineering specifications and comparison to the predicate devices. It would likely involve bench testing, mechanical stress tests, and potentially animal or cadaver studies, though these details are not provided in the summary.
8. The sample size for the training set
- Not applicable. There is no "training set" for an AI/ML algorithm for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for an AI/ML algorithm for this type of device.
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Premarket Notification [510(K)] Summary
MAR 1 8 2002
1/2
KO20069
(per 21 CFR 807.92)
Submitted by: 1.
Medtronic Midas Rex
4620 North Beach Street
Fort Worth, TX 76137
| Contact Person: | Greg CannedyDirector of Regulatory Affairs |
|---|---|
| Telephone: | 817-788-6400 |
| Facsimile: | 817-788-6222 |
January 7, 2002 Date Prepared:
Device Name 2.
Trade/Proprietary Name: Common/Usual Name: Classification Name:
Midas Rex Legend System Surqical drill motors with accessories Pneumatic cranial drill motors for neurosurgery (HBB) Surgical drill for Ear, Nose & Throat (ERL) Surgical Ear. Nose & Throat bur (EQJ) Pneumatic motor for orthopedic surgery (HSZ) Pneumatic motor for general surgery (GET) Pneumatically powered saw (KFK) Powered simple cranial drills, burrs, and accessories (HBE) Blades, saw, surqical cardiovascular (DWH)
3. Predicate Device:
The Medtronic Midas Rex Legend System is substantially equivalent to the Midas Rex Classic and Midas Rex III Instrumentation Systems, and the Mednext 1000 Bone Dissecting System.
4. Intended use of the device
The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
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K02 0069 2/2
Description of the Device 5.
The Medtronic Midas Rex Legend System is a modular, pneumatic, highspeed instrument system consisting of a motor (handpiece) and accessories/attachments, including but not limited to adapters, spindles, burrs, drills, cutters, and other dissecting tools.
Summary of the technological characteristics of the device 6. compared to the predicate device.
The intended use of the Medtronic Midas Rex Legend System have not changed to the intended uses of the Midas Rex Classic, Midas Rex III, and Mednext 1000 systems. The modified device and the predicate devices have the same technological characteristics, the same operating principles, use the same patient contacting materials, and have similar performance characteristics. These systems utilize a high-pressure gas source (either air or nitrogen) to power the motors and drive the cutting tools for use during surgical applications.
7. Testing
Performance testing on the Medtronic Midas Rex Legend System confirms that the device operates as intended, and is substantially equivalent to the Midas Rex Classic, Midas Rex III, and Mednext 1000 Instrumentation Systems.
8. Conclusions
Based upon the testing and comparison to the predicate devices, the Medtronic Midas Rex Legend System performs as intended and raises no new safety or effectiveness issues.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2002
Medtronic Midas Rex Mr. Greg Cannedy Director of Regulatory Affairs 4620 North Beach Street Fort Worth, Texas 76137
Re: K020069
Trade Name: Midas Rex Legend System Regulation Number: 882.4370 Regulation Name: Pneumatic Cranial Drill Motor Regulatory Class: II Product Code: HBB Dated: January 8, 2002 Received: January 9, 2002
Dear Mr. Cannedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, controls provisions or actice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Greg Cannedy
This letter will allow you to begin marketing your device as described in your Section 510(k) This icter will anow your to ocgin mading of substantial equivalence of your device to a legally premaired predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF F Far 659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1097 Compliance at (301) 594-4639. Also, please note the your devices, preads offically by reference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
iriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
Page 1 of 1
KO20069 510(k) Number (if known):
Medtronic Midas Rex® Legend™ Instrumentation System Device Name:
Indications For Use:
The Medtronic Midas Rex Legend System is a pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; ins well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (per 21 CFR 801.109) OR
Over the Counter Use: (Optional Format 1-2-96)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K020069
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).