(64 days)
, Rush Pins
Not Found
No
The description focuses on the mechanical properties and design of a physical implant (intramedullary nail) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the fixation of bone fractures, which is a therapeutic purpose.
No
The device is described as an intramedullary nail used for the fixation of fractures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical intramedullary nail made of pins and a bolt system, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fractures of the humerus." This is a surgical procedure performed in vivo (within the body) to stabilize bone fractures.
- Device Description: The description details a physical implantable device (an intramedullary nail) made of pins and a bolt system. This is a medical device used for structural support, not for analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information contains no mention of analyzing biological samples or providing diagnostic information based on such analysis.
The Marchetti-Vicenzi Humeral Intramedullary Nail is a surgical implant used for orthopedic fixation.
N/A
Intended Use / Indications for Use
The Marchetti-Vicenzi Humeral Intramedullary Nail is a single-use device intended for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 cm proximal to the olecranon fossa.
Product codes
HTY
Device Description
The Marchetti-Vicenzi Humeral Intramedullary Nail is an intramedullary rod made up of several pins that provide elastic fixation of humeral fractures. The cylindrical, rod-like base of the nail is tapered and is preloaded with either four or five pins. A bolt system holds the tips of the pins together until the nail is properly inserted, at which time the bolt is removed back through the canal and the pins diverge and return to their preconditioned position. The cylindrical base that holds the pins contains a screw hole through which a screw can be inserted for distal locking. Distal locking is required for the humeral nail.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The Marchetti-Vicenzi Humeral Nail exhibited statistically higher bending strength and rigidity in both the 4-pin and 5-pin configurations when compared to Rush Pins.
Key Metrics
Not Found
Predicate Device(s)
Rush Pins
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image shows the logo for Zimmer. The logo consists of a large, bold letter "Z" inside of a circle. Below the circle is the word "zimmer" in a smaller, lowercase font.
SEP 1 9 1997
P.O. Box 708 Warsaw, IN 46581-0708 219 267-6131
Summary of Safety and Effectiveness Marchetti-Vicenzi Intramedullary Nail, Humeral
Submitted by:
Zimmer, Inc. P.O. Box 708 Warsaw, IN 46581-0708
-
Prepared by: ●
Ralph H. Larsen Manager Global Regulatory Affairs Telephone: 219-372-4129 Telefax: 219-372-4605 -
. Date:
June 27, 1997 -
Trade Name: .
Marchetti-Vicenzi Intramedullary Nail, Humeral -
Common Name: .
Intramedullary Rod -
Classification Name: .
Intramedullary Fixation Rod -
Predicate Devices: .
Rush Pins, marketed by Zimmer
1
1
Summary of Safety and Effectiveness Marchetti-Vicenzi Intramedullary Nail, Humeral (Continued)
Device Description
The Marchetti-Vicenzi Humeral Intramedullary Nail is an intramedullary rod made up of several pins that provide elastic fixation of humeral fractures. The cylindrical, rod-like base of the nail is tapered and is preloaded with either four or five pins. A bolt system holds the tips of the pins together until the nail is properly inserted, at which time the bolt is removed back through the canal and the pins diverge and return to their preconditioned position. The cylindrical base that holds the pins contains a screw hole through which a screw can be inserted for distal locking. Distal locking is required for the humeral nail.
Intended Use
The Marchetti-Vicenzi Humeral Intramedullary Nail is a single-use device intended for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 cm proximal to the olecranon fossa.
Performance Data
The Marchetti-Vicenzi Humeral Nail exhibited statistically higher bending strength and rigidity in both the 4-pin and 5-pin configurations when compared to Rush Pins.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing to the 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
Ralph H. Larsen, RAC ·Manager Global Requlatory Affairs Zimmer P.O. Box 708 46581-0708 Warsaw, Indiana
SEP 1 9 1997
Re: K972692 Marchetti-Vicenzi™ Intramedullary Nail, Humeral Requlatory Class: II Product Code: HTY Dated: July 16, 1997 Received: July 17, 1997
Dear Mr. Larsen:
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 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 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 (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 requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Ralph H. Larsen, RAC
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) 594-4659. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page _ 1 __ of __ l __
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Marchetti-Vincenzi™ Intramedullary Nail, Humeral
Indications for Use:
:
The Marchetti-Vicenzi Humeral Intramedullary Nail is indicated for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 centimeters proximal to the olecranon fossa.
(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)
RA06701K.510
(Division Sign-Off) Division of General Restorative Devi 510(k) Number