(84 days)
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Not Found
No
The summary describes titanium plates for craniofacial reconstruction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as providing "structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary," indicating its role in treating or restoring a damaged anatomical structure, which aligns with the definition of a therapeutic device.
No
The device description indicates that the plates "provide structure and support" for craniofacial reconstruction, which is a therapeutic rather than a diagnostic function. It is used in surgery to rebuild anatomy, not to identify a disease or condition.
No
The device description clearly states the device is a series of titanium plates, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that the Orbital Reconstruction Plates are made of titanium and are implanted into the patient's internal orbit to provide structural support.
- Intended Use: The intended use is for "craniofacial reconstruction of the internal orbit" in patients. This is a surgical procedure involving implantation, not the analysis of specimens outside the body.
The device is a surgical implant used for structural support during reconstructive surgery. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
Product codes
87HRS
Device Description
The Orbital Reconstruction Plates are a series of plates made from titanium with different configurations and thicknesses. The configurations vary to accommodate the level of reconstruction required or the patient's anatomy. The difference in thickness provides the necessary support for the internal orbit based on the type and extent of reconstruction required. The screws used with plates were previously cleared under various premarket notifications.
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
internal orbit, orbital walls, orbital floor
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)
Not Found
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
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
July 12 1998
| Proprietary Name: | Orbital Reconstruction Plates |
|---|---|
| Common Name: | Bone Plates |
| Classification Name | Single/Multiple Component Metallic Bone Fixation |
| Reference: | Appliances and Accessories (21 CFR 888.3030) |
| Proposed Regulatory Class: | II |
| Device Product Code: | 87HRS |
Vivian Kelly For information contact: Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7830 Fax: (201) 507-6870
The Orbital Reconstruction Plates are a series of plates made from titanium with different configurations and thicknesses. The configurations vary to accommodate the level of reconstruction required or the patient's anatomy. The difference in thickness provides the necessary support for the internal orbit based on the type and extent of reconstruction required. The screws used with plates were previously cleared under various premarket notifications.
The plates are intended for use in patients requiring craniofacial reconstruction of the internal orbit. These plates provide structure and support to the orbital walls and/or floor when anatomical reconstruction of the internal orbit is necessary.
The substantial equivalence of these components is based on an equivalence in intended use, materials, design, and operational principles to other predicate devices used for orbital reconstruction plates such TiMesh's Titanium Mesh Tilghman Orbit Liner and Synthes' Universal Orbital Floor Plate.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, with three abstract shapes that could be interpreted as wings or flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 1998
Ms. Vivian Kelly · Manager, Regulatory Affairs Howmedica Inc. Pfizer Hospital Products Group 359 Veterans Boulevard Rutherford, New Jersey 07070-2584
Re: K973982 Orbital Reconstruction Plates Trade Name: Regulatory Class: II Product Code: HRS Dated: October 16, 1997 Received: October 20, 1997
Dear Ms. Kelly:
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 requlation (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 Please note: concerning your device in the Federal Register. 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 requlations.
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Page 2 - Ms. Vivian Kelly
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 ene rogalacion Chercross, "Mobianany" (2) 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Calvin M. Whittier, Ph.D., M.
-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
3
Indications for Use
| 510(k) Number (if known): | X OR Over-The-Counter Use ______ |
|---|---|
| --------------------------------------- | ----------------------------------------------------------------------------------------------- |
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K973902 |
|---|---|
| --------------- | --------- |