(88 days)
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No
The provided text describes a mechanical implant system for fracture stabilization and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as providing temporary stabilization for bone fractures, malunions, and nonunions of the femur and tibia, which falls under structural support rather than directly treating or preventing a disease or condition. While it aids in healing, it is a mechanical support device.
No
The device is described as a "Locking Nail System" intended to stabilize fractures, malunions, and nonunions of the femur and tibia. This indicates a therapeutic or supportive function rather than a diagnostic one. There is no mention of the device being used to detect, identify, or monitor conditions.
No
The device description clearly states it consists of physical components like nails, screws, and end caps made of titanium alloy or stainless steel, which are hardware.
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 for "temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia." This describes a surgical implant used to treat a physical condition within the body.
- Device Description: The description details a system of "round nails used for intramedullary nailing of femoral and tibial fractures," along with screws and end caps. These are physical devices implanted into the bone.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.
Product codes
HSB
Device Description
The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral and tibial fractures. The system includes two styles of femoral nails, tibial nails, reconstruction nails, screws and end caps. The nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.
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
femur and tibia
Indicated Patient Age Range
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Intended User / Care Setting
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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): 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.
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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.
Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System and Gamma Locking Nail System.
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
K98 2958
510(k) Summary
Proprietary Name: Common Name: Classification Name & Reference: Proposed Requiatory Class: II Device Product Code:
Zeta MultiZone Locking Nail System IM Rod Intramedullary Fixation Rod 21 CFR 888.3020
87HSB
For information contact:
Vivian Kelly Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Zeta MultiZone Locking Nail System consists of a family of round nails used for intramedullary nailing of femoral and tibial fractures. The system includes two styles of femoral nails, tibial nails, reconstruction nails, screws and end caps. The nails are available in varying diameters and lengths and have proximal and distal holes for cross-locking. The nails and additional components are fabricated from either titanium alloy or stainless steel.
The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.
The substantial equivalence of this device is based on an equivalence in intended use, materials, designs and operational principles to Howmedica's Alta IM Rod System, Grosse & Kempf Locking Nail System and Gamma Locking Nail System.
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of what appears to be an abstract symbol, possibly representing a human figure or a symbol related to health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1998
Mr. John F. Dichiara Director of Regulatory Affairs and Public Policy Howmedica Inc. Pfizer Medical Technology, Inc. 359 Veterans Boulevard 07070-2584 Rutherford, New Jersey
K982958 Re: Zeta Multizone Locking Nail System Trade Name: Regulatory Class: II Product Code: нав Dated: August 21, 1998 Received: August 24, 1998
Dear Mr. Dichiara:
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 The general controls provisions of the Act 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 Regulation (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.
2
Page 2 - Mr. John F. Dichiara
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 requlation (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
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 982958
Device Name: Zeta MultiZone SCN Locking Nail
Indications for Use:
The Zeta MultiZone Locking Nail System is intended to provide temporary stabilization of various types of fractures, malunions and nonunions of the femur and tibia. The nails are inserted using an opened or closed technique and can be statically or dynamically locked.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number_ K982958