(29 days)
The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.
Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur wire, bur tang) and the protective tube / cooling sleeve / hub. The hub connects and locks into the existing Legend telescoping attachment base. Legend telescoping attachment base connects to the Legend motor. The motor provides the power to rotate the dissecting tool / bur. The attachment / tube provide support and stability to the dissecting tool. The bur head which may be fluted or diamond coated, is the actual cutting tip on the device.
The provided document is a 510(k) summary for the Medtronic Midas Rex® Curved Burs. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the curved burs themselves. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.
However, I can extract the information that is available and highlight what is missing.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) submission for substantial equivalence generally doesn't include specific performance acceptance criteria for the new device in the same way a clinical trial or a test report would. The "performance" being evaluated here is the claim that the new device (Curved Bur) is as safe and effective as the predicate device, not against specific measurement thresholds.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. There is no mention of a "test set" or data provenance as this 510(k) is based on a technological comparison, not a new performance evaluation study in the traditional sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As there's no "test set" or explicit ground truth establishment described, no experts for this purpose are mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided in the document. This device (a surgical bur) is not an AI-assisted diagnostic or imaging device, so an MRMC study or AI-related effectiveness analysis is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. This is a physical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
This information is not explicitly stated as there is no mention of a formal ground truth used for performance validation. The "ground truth" in a 510(k) context for substantial equivalence is often implicitly the established performance and safety profiles of the predicate device.
8. The Sample Size for the Training Set
This information is not provided in the document. No "training set" is mentioned as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. No "training set" is mentioned.
Summary of Device and 510(k) Filing:
The document describes the Medtronic Midas Rex® Curved Burs, a sterile, single-use surgical dissecting tool. It's intended to cut and/or remove bone and biomaterials in various surgical procedures, including neurosurgical, spine, ENT, orthopedic, and general and plastic surgery.
The 510(k) filing (K072315) seeks to establish substantial equivalence to the predicate device, the Medtronic Midas Rex® Legend® Pneumatic High Speed System (K020069), specifically focusing on the Legend Telescoping System tools.
The core argument for substantial equivalence is that the device modification (Curved Bur) does not affect intended use, indication for use, device safety and effectiveness, and the fundamental scientific technology is the same as the previously cleared Legend Telescoping System. This implies that the safety and effectiveness are "proven" by virtue of being technologically equivalent to an already cleared and marketed product. The FDA's clearance letter confirms this determination of substantial equivalence.
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·Medtronic Powered Surgical Solutions 510(k) for Midas Rex® Curved Burs
4. 510(k) Summary
SEP 1 8 2007
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.
| Establishment Registration Number: | 1625507 |
|---|---|
| Address of Manufacturer: | Medtronic Powered Surgical Solutions4620 North Beach StreetFort Worth, TX 76137(805) 968-1546 ext. 1770Fax: (805) 968-9336 |
| Contact Person: | Jeffrey Henderson |
| Date: | August 16, 2007 |
| Trade or Proprietary Name: | Midas Rex® Curved Bur |
| Common usual or Classification Name: | Dissecting tool - Powered Simple cranial bur(882.4310) |
| Predicate Device Identification: | Medtronic Midas Rex® Legend® PneumaticHigh Speed System (K020069) |
Description: Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur wire, bur tang) and the protective tube / cooling sleeve / hub. The hub connects and locks into the existing Legend telescoping attachment base. Legend telescoping attachment base connects to the Legend motor. The motor provides the power to rotate the dissecting tool / bur. The attachment / tube provide support and stability to the dissecting tool. The bur head which may be fluted or diamond coated, is the actual cutting tip on the device.
Intended Use: Midas Rex Curved Burs are designed to work with all Legend motors through the Legend Telescoping attachment base under the recommended operating range for these motors. Legend motor provides the power to operate the telescoping attachments base, which then transmits the motion to activate the Curved Bur wire intended to cut and/or remove bone and biomaterials in the surgical procedures. Midas Rex Curved Burs are single use, disposable tools that may be used only for one surgical procedure.
Intended Use of predicate device(s): The Legend Telescoping system is intended to be used with Legend Motors. Legend motor provides the power to operate the telescoping attachments base, which then transmits the motion to activate the Legend tools intended to cut and/or remove bone and biomaterials in the surgical procedures. Legend tools are single use, disposable tools that may be used only for
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Medtronic Powered Surgical Solutions 510(k) for Midas Rex® Curved Burs
one surgical procedure. Legend telescoping tubes are disposable following multiple uses. Legend Telescoping system is part of Medtronic Midas Rex Legend Pneumatic High Speed system.
Technological comparison: Medtronic Powered Surgical Solutions submits that the device modification does not affect intended use, indication for use, device safety and effectiveness and fundamental scientific technology of the Curved Burs is the same as the previously reviewed and cleared Legend Telescoping System.
Based upon the summary above, Medtronic Powered Surgical Solutions determines substantial equivalence, safety, and efficacy of the Curved Bur products compared to the predicate and currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
SEP 1 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medtronic Powered Surgical Solutions % Mr. Jeffrey Henderson VP. Quality & Regulatory Affairs 4620 North Beach Street Fort Worth, Texas 76137
Re: K072315
Trade/Device Name: Midas Rex® Curved Burs Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE, EQJ Dated: August 16, 2007 Received: August 20, 2007
Dear Mr. Henderson:
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. 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.
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
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Page 2 - Mr. Jeffrey Henderson
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html (
Sincerely yours,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Medtronic Fower d Surgical Solutions 510(k) for Midas Rex® Curved Burs
II. Statement of Indications for Use
510(k) Number (if known):
K 072315
Device Name: Midas Rex® Curved Burs
Indications for Use:
The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Cohourence of CDRH, Office of Device Evaluation (ODE)
Mark A. Williame
Division of General, Restorative, and Neurological Devices
510(k) Number
Page 13 of 121
§ 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).