(199 days)
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Not Found
No
The summary describes a mechanical intramedullary nail system for bone fractures and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is used to stabilize fractures of the humerus, which constitutes treatment for a medical condition.
No
The device, the MAGELLAN™ Intramedullary Humeral Nail System, is indicated for the stabilization of long bone shaft fractures of the humerus, which is a therapeutic rather than a diagnostic function.
No
The device is described as an "Intramedullary Humeral Nail System," which is a physical implant used in surgery. This clearly indicates it is a hardware device, not software-only.
Based on the provided information, the MAGELLAN™ Intramedullary Humeral Nail System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the surgical stabilization of bone fractures within the human body (specifically the humerus). This is an in vivo application, meaning it's used directly on or within a living organism.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This is an in vitro application, meaning it's performed outside of a living organism.
The MAGELLAN™ system is a surgical implant used to treat bone fractures, which falls under the category of medical devices but not specifically IVDs.
N/A
Intended Use / Indications for Use
The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.
Product codes
HSB
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
humerus
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2000
Mr. Ben Shappley President OrthoMatrix, Inc. 711 Chaney Cove Collierville, Tennessee 38017
Re: K992856
Trade Name: Magellan Humeral Intramedullary Nail Regulatory Class: II Product Code: HSB Dated: January 12, 2000 Received: January 13, 2000
Dear Mr. Shappley:
We have reviewed your Section 510(k) 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 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). You may, therefore, market the device, subject to the general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Ben Shappley
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4559. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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.
Henry C. Taylor
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE OF THE DEVICE
Device Name: MAGELLAN Intramedullary Humeral Nail System
Indications for Use:
The MAGELLAN™ Intramedullary Humeral Nail System is indicated for use in long bone shaft fractures of the humerus which require stabilization of the axis of the bone. These include shaft fractures, segmented fractures, fractures with bone loss, comminuted fractures, proximal and distal fractures, non-unions and malunions.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Div
Div of General Restorative Devices
510(k) Number 16992856
Prescription Use
(per 21 CFR 801.109)
+
OR
Over-the-Counter Use