(120 days)
Not Found
Not Found
No
The provided text describes a mechanical power adapter with a gear ratio reduction. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies described are mechanical tests.
No
The device is described as an adapter that provides power to surgical tools, not as a device that directly treats a condition or restores function.
No
The device is described as an adapter for surgical cutting tools, providing power and gear reduction, not for diagnosing medical conditions.
No
The device description explicitly states the LEGEND® Power Adapter is a "stainless steel adapter" and describes its mechanical function (gear ratio reduction), indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a power adapter for a surgical system used for cutting tools in various surgical procedures. This is a surgical device used on the patient, not a device used to examine specimens from the patient in vitro (outside the body).
- Device Description: The description confirms it's a mechanical adapter for providing power to surgical tools.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is a surgical tool accessory.
N/A
Intended Use / Indications for Use
The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
Product codes (comma separated list FDA assigned to the subject device)
HBC, HBB, GET
Device Description
The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Dynamometer testing was performed to confirm that the LEGEND® Power Adapter would function appropriately when attached to the MIDAS REX® LEGEND® Power Systems. The subject adapter successfully met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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
§ 882.4370 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).
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LEGEND® Power Adapter 510(k) Summary
August 2010
Regulatory Affairs Specialist
AUG 2 4 2010
Medtronic Sofamor Danek USA Company: 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: (901) 396-3133 Fax: (901) 346-9738 Contact: Jennifer Hackney
II. Proposed Proprietary Trade Name: Common Name: Classification Name(s):
Classfication: Product Code(s): Regulation No .: Predicate Device:
LEGEND® Power Adapter Power Adapter Surgical instrument motors and accessories/attachments; Class II HBC 882.4360 MIDAS REX® LEGEND® System Perforator Attachment
III. Description:
I.
The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. The LEGEND® Power Adapter provides a 20:1 gear ratio reduction when used with the MIDAS REX® LEGEND® System.
IV. Indications for Use:
The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
Technological Characteristics: V.
The LEGEND® Power Adapter is a stainless steel adapter that can be used with the MIDAS REX® LEGEND® System to provide power to MEDTRONIC rotating surgical cutting tools. Both products are manufactured from stainless steel, utilize gears to reduce the output of the MIDAS REX® LEGEND® System, and are provided non-sterile for end user steam sterilization.
VI. Substantial Equivalence:
Documentation was provided demonstrating that the LEGEND® Power Adapter is substantially equivalent to other commercially available accessories, including those included in the MIDAS REX® LEGEND® System.
Dynamometer testing was performed to confirm that the LEGEND® Power Adapter would function appropriately when attached to the MIDAS REX® LEGEND® Power Systems. The subject adapter successfully met the acceptance criteria.
C2010 Medtronic Sofamor Danek
. '
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or other bird in flight, represented by three stylized, curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA % Ms. Theresa Leister Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
AUG 2 4 2010
Re: K101168
Trade/Device Name: LEGEND® Power Adapter Regulation Number: 21 CFR 882.4370 Regulation Name: Pneumatic cranial drill motor Regulatory Class: Class II Product Code: HBB. GET Dated: August 18, 2010 Received: August 20, 2010
Dear Ms. Leister:
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. 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
2
Page 2 - Ms. Theresa Leister
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
sincerely, yours,
Mark A. Mulkersen
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
3
K10116.8
510(k) Number (if known): K101168
Device Name: LEGEND® Power Adapter
Indications for Use:
ﺴﻴﺴ
..
The LEGEND® Power Adapter is intended to be used with the MIDAS REX® LEGEND® System. When the LEGEND® Power Adapter is attached to the MIDAS REX® LEGEND® System, the MIDAS REX® LEGEND® System motors provide power to operate removable rotating surgical cutting tools and their accessories intended for neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, and sternotomy surgeries.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use _ X Per 21 CFR 801.109
Over-The-Counter Use ------
Neil H. Oyler for mxm
ivision Sign-Off) (Division Sign of Surgical, Orthopedic, Ivision of Restorative Devices
510(k) Number K101168