(68 days)
Not Found
No
The document describes a pneumatically operated surgical instrument system with no mention of AI or ML capabilities.
No.
The device is a surgical instrument system used for cutting and dissecting, not for treating or rehabilitating a disease or injury.
No
The description clearly states it is a "pneumatically operated surgical instrument system" used for "surgical cutting tools and their accessories" and "dissecting tools," indicating its function is for treatment/surgery, not diagnosis.
No
The device description explicitly states it is a "pneumatically operated surgical instrument system" consisting of a "motor (handpiece) and accessories/attachments," 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 a surgical instrument system used for cutting and dissecting tissue during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on biological samples).
- Device Description: The device description details a motor, handpiece, and various surgical tools like burrs and cutters. These are instruments used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue samples), reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Medtronic Midas Rex Legend System is a surgical device, not an IVD.
N/A
Intended Use / 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; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.
Product codes
HBB, ERL, EQJ, HSZ, GET, KFK, HBE, DWH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Cannedy
Director 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.
1
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.
2
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.
3
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
4
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