(402 days)
Not Found
No
The summary describes a physical implant and its components, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for temporary reconstruction of the mandibular condyle after resective procedures, not for treating existing conditions or diseases.
No
Explanation: The device is indicated for temporary reconstruction of the mandibular condyle, which is a treatment or surgical intervention, not a diagnostic procedure.
No
The device description clearly states it is a "solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate," indicating it is a physical implant and associated hardware, not software.
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 and Intended Use: The provided information clearly describes a physical implantable device used for the temporary reconstruction of the mandibular condyle. It is surgically placed within the body.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, based on the provided information, this device falls under the category of a surgical implant or medical device used for reconstruction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Indicated for temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Implants are intended for single patient use.
Product codes
NEI
Device Description
The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular condyle
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 (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
§ 872.4770 Temporary mandibular condyle reconstruction plate.
(a)
Identification. A temporary mandibular condyle reconstruction plate is a device that is intended to stabilize mandibular bone and provide for temporary reconstruction of the mandibular condyle until permanent reconstruction is completed in patients who have undergone resective surgical procedures requiring removal of the mandibular condyle and mandibular bone. This device is not intended for treatment of temporomandibular joint disorders.(b)
Classification. Class II (special controls). The special controls for this device is FDA's guideline entitled “Temporary Mandibular Condyle Reconstruction Plate Class II Special Controls Guideline.” See § 872.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image shows the word "OSTEOMED" in bold, sans-serif font. The word is slightly curved and is surrounded by a black, curved line above and below it. The black lines give the impression of an oval shape around the word. The font is black and the background is white.
510(k) Summary
JUL 0 8 2004
| Device Proprietary Name: | OsteoMed Temporary Condylar
Attachment System |
|--------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Common Name: | Temporary Condylar Implant |
| Classification Name: | Prosthesis, Condylar,
Mandibular, Temporary |
| Name of Submitter: | OsteoMed L. P.
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 |
| Contact Person: | Dawn T. Holdeman |
| Date Prepared: | May 25, 2004 |
Summary:
This submission describes the OsteoMed Temporary Condylar Attachment System indicated temporary reconstruction of the mandibular condyle in patients who have undergone resective procedures to remove malignant or benign tumors requiring the removal of the mandibular condyle. This device is intended for implantation for no more than one (1) year. This device is not intended for permanent implantation, for patients with TMJ or traumatic injuries, or for treatment of temporomandibular joint disease (TMD). Temporary Condylar Attachment implants are intended for single patient use only.
The OsteoMed Temporary Condylar Attachment system is a solid condylar head which attaches with fastening screws to an OsteoMed Fracture Reconstruction Plate. The OsteoMed Temporary Condylar Attachment is available for right and left placement. System instruments include drivers.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the KLS-Martin Temporary Condylar Implant (K990667), the W. Lorenz Add-On Condyle (K002790), and the Stryker Leibinger Locking Screw Mandibular Reconstruction Plate (K000594).
Due to the similarity of materials and design to predicate devices, OsteoMed believes that the OsteoMed Temporary Condylar Attachment System does not raise any new safety or effectiveness issues.
Image /page/0/Picture/11 description: The image shows the logo for Colson Associates. The logo consists of the word "Colson" in a stylized font inside of a circle. To the right of the circle is the text "A Colson Associate" in a smaller, sans-serif font.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
UUL 0 8 2004
Ms. Dawn T. Holdeman Regulatory Affairs OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K031701
Trade/Device Name: OsteoMed Temporary Condylar Attachment System Regulation Number: 872.3960 Regulation Name: Mandibular Condyle Prosthesis Regulatory Class: III Product Code: NEI Dated: May 25, 2004 Received: May 26, 2004
Dear Ms. Holdeman:
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.
2
Page 2 -- Ms. Holdeman
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 mean that I Drimb mas and regulations administered by other Federal agencies. or the rece of any - with all the Act's requirements, including, but not limited to: registration r od listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (27 es result in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as lectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), 11 you donto the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 vours,
Chin-Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
OsteoMed "Indications for Use" Submission
ҚОЗІ701 510(k) Number:
| Device Name: | OsteoMed Temporary Condylar Attachment System |
|---|---|
| Indication for Use: | Indicated for temporary reconstruction of the |
| mandibular condyle in patients who have undergone | |
| resective procedures to remove malignant or benign | |
| tumors requiring the removal of the mandibular | |
| condyle. This device is not intended for permanent | |
| implantation, for patients with TMJ or traumatic | |
| injuries, or for treatment of temporomandibular joint | |
| disease (TMD). Implants are intended for single | |
| patient use. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
(Per 21 CFR 810.109)
Over-The Counter-Use (Optical Format 1-)
Suver Ruaney
(Division Sign-Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K081170