(135 days)
K99014
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on combining existing software for navigation.
No
The device is an aid for precisely locating anatomical structures during surgical procedures, primarily for navigation and fracture repair, rather than directly treating a disease or condition.
No
Explanation: The device is intended as an "aid for precisely locating anatomical structures" and assisting "surgeons with the stabilization and repair of orthopaedic fractures." It does not provide a medical diagnosis.
Unknown
The summary describes the device as "software" but also mentions combining it with "existing FluoroNav (K99014)". FluoroNav is a surgical navigation system, which typically includes hardware components (e.g., cameras, trackers, displays). Without further information about the specific integration and whether the submission covers only the software component or the combined system, it's unclear if this is a software-only device.
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 an "aid for precisely locating anatomical structures in either open or percutaneous procedures." This describes a surgical navigation or guidance system used during a medical procedure on a patient.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside of the body (in vitro).
- Device Description: The description reinforces that the software is used to "assist surgeons with the stabilization and repair of orthopaedic fractures," which is a surgical intervention.
- Input Imaging Modality: The input modalities (CT, MR, fluoroscopy) are used for imaging the patient's anatomy in vivo (within the body) to guide the surgical procedure.
The device's function is to provide guidance and localization during surgery, not to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Orthopaedic Trauma Application is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Orthopaedic Trauma Application is indicated for trauma procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, pelvis or vertebra can be identified relative to a CT or MR based model, digitized landmarks or fluoroscopy images of the anatomy.
- Acetabular, femoral and tibia fractures
- Guide Wire placement
- Implant/Hardware Removal
- Intertrochanteric Fractures
- Intramedullary Nailing
- Long-bone Fracture Fixation
- Long-bone Fracture Reduction
- Pelvic Fracture Fixation
- Pelvic Fracture Reduction
- Screw/Implant Placement
- Tibial, Femoral and Acetabular Osteotomies
Product codes
HAW
Device Description
The Medtronic Orthopaedic Trauma Application software combines existing FluoroNav (K99014) is used to assist surgeons with the stabilization and repair of orthopaedic fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
skull, a long bone, pelvis or vertebra
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
nary of Safety and Effectiveness Medtronic Orthopaedic Trauma Application
Manufacturer l.
Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027 USA Telephone Number: (720) 890-3217 Fax Number: (720) 890-3517
Contact 11.
Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc.
Product Name / Classification lll.
- Stereotaxic instrument Common Name: Instrument, Stereotaxic Classification Name: Medtronic Orthopaedic Trauma Application Trade Name: Stereotaxic instrument - Class II as described in 21 CFR § 882.4560 Product Code: HAW
Date Summary Submitted IV.
March 11, 2005
Description of Device Modification V.
Description of Device Modification software combines existing FluoroNav (K99014) The Meditorile Orthopaedic Tradina Applications used to assist surgeons with the stabilization and repair of orthopaedic fractures.
Substantial Equivalence VI.
Substantial Equivalence
The Medtronic Orthopaedic Trauma Application is substantially equivalent to the substantially The Meditonic Orthopaedic Hip (K021980) applications and is also substantially the Huordvav (K5902 14) and Ofthopacition (K012448). As required by risk equivalent to the Brancab Vooter Helenchvities performed by designated individuals and the results demonstrated substantial equivalence.
Indications for Use VII.
Indications for Use
The Orthopaedic Trauma Application is intended as an aid for precisely locating anatomical The Orthopaeuic Trauma Application is in the Orthopaedic Trauma Application is indicated for trauma procedures in which the use of stereotactic surgery may be appropriate, and indicated to trauma proceduces in which the ass of ever the skull, a long bone, pelvis or vertebra where reletence to a nglo andonifour stransmission of alleritized landmarks or fluoroscopy images of the anatomy
- Acetabular, femoral and tibia 1 fractures
- Guide Wire placement .
- Implant/Hardware Removal 트
- Intertrochanteric Fractures I
- Intramedullary Nailing 동
- Long-bone Fracture Fixation I
- Long-bone Fracture . Reduction
- Pelvic Fracture Fixation I
- Pelvic Fracture Reduction 제
- Screw/Implant Placement .
- Tibial. Femoral and ■ Acetabular Osteotomies
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.
JUL 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina Dreiling Associate Regulatory Affairs Specialist Medtronic Navigation, Inc. 826 Coal Creek Circle Louisville, Colorado 80027
Re: K050651
Trade/Device Name: Medtronic Orthopaedic Trauma Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: July 5, 2005 Received: July 6, 2005
Dear Ms. Dreiling:
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 or any I 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.
2
Page 2 - Ms. Tina Dreiling
This letter will allow you to begin marketing your device as described in your Section 510(k) I his icter with anow you to ocgin maining of substantial equivalence of your device to a legally prematics notineation. The Pro mixessification 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 If you desire specific acriously - J at (240) 276-0115. Also, please note the regulation entitled, Colliact the Office of Compullion in (21 transmit) (21CFR Part 807.97). You may obtain of Small other gelleral information on your response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Stupt Edwards
Mark N. Melkerson, MS Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications For Use
510(k) Number (if known): K050651
Device Name: Medtronic Orthopaedic Trauma Application
Indications For Use: The Orthopaedic Trauma Application is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Orthopaedic Trauma Application is indicated for trauma procedures in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, pelvis or vertebra can be identified relative to a CT or MR based model, digitized landmarks or fluoroscopy images of the anatomy
- Acetabular, femoral and tibia fractures 이
- Guide Wire placement ●
- t Implant/Hardware Removal
- Intertrochanteric Fractures ●
- Intramedullary Nailing 해
- Long-bone Fracture Fixation .
- Long-bone Fracture Reduction .
- Pelvic Fracture Fixation I
- Pelvic Fracture Reduction 체
- Screw/Implant Placement 트
- Tibial, Femoral and Acetabular Osteotomies 1
Prescription Use
(Part 21 CFR 801 Subpart D) X
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(ODE)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
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