(28 days)
MQN
Not Found
No
The summary describes a mechanical external fixator system with no mention of software, algorithms, or any technology related to AI or ML.
No
The device is intended to stabilize and treat fractures and deformities, which are functions of a therapeutic device. However, per FDA classification, it is considered a surgical tool and not a therapeutic device.
No.
The device is described as an external fixator intended to stabilize and treat fractures, not to diagnose them.
No
The device description explicitly lists hardware components (adjustable parallel pin clamp, Schanz Screws, K-wires, Titanium Rods) that constitute the medical device. It is not solely software.
Based on the provided information, the Synthes Mandible External Fixator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Synthes Mandible External Fixator is a device used to stabilize and treat fractures in the maxillofacial area. It is a physical device implanted or applied externally to the body.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test.
Therefore, the Synthes Mandible External Fixator falls under the category of a surgical or orthopedic device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Synthes Mandible External Fixator is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
Product codes
MQN
Device Description
Synthes Mandible External Fixator consists of the following components: An adjustable parallel pin clamp - MR safe; 4.0/2.5 Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. The components of this system are designed for use in the MR environment. The rods and Schanz Screws are available in various lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial area, mandibular
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)
Synthes Mandible External Fixator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a human figure inside of a circle. There is a horizontal line underneath the word "SYNTHES".
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3.0 510(k) Summary
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| Sponsor: | Synthes (USA)
1302 Wrights Lane East
West Chester, PA 19380
(610) 719-5000 | MAR 1 5 2005 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name: | Synthes Mandible External Fixator | |
| Classification: | Class II, 21 CFR §872.4760
Bone Plate | |
| Predicate Device: | Synthes Mandible External Fixator | |
| Device Description: | Synthes Mandible External Fixator consists of the following
components: An adjustable parallel pin clamp - MR safe; 4.0/2.5
Schanz Screws, 2.0 mm K-wires; and 4.0 mm Titanium Rods. The
components of this system are designed for use in the MR
environment. The rods and Schanz Screws are available in various
lengths. | |
| Intended Use: | Synthes Mandible External Fixator is intended to stabilize and
provide treatment for fractures of the maxillofacial area, including
severe open mandibular fractures, highly comminuted closed
fractures, nonunions and delayed unions (especially associated with
infection), fractures associated with infections, tumor resections,
facial deformity corrections, gunshot wounds, pan facial fractures,
burn maintenance, and bone grafting defects. | |
| Substantial
Equivalence: | Documentation is provided which demonstrates that Synthes
Mandible External Fixator is substantially equivalent to other
legally marketed Synthes devices. | |
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized graphic of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Senior Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
MAR 1 5 2005
Re: K050378
Trade/Device Name: Synthes Mandible External Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: February 14, 2005 Received: February 15, 2005
Dear Ms. Musgnung:
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.
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Page 2 – Ms. Musgnung
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 of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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), please contact the Office of Compliance at (240) 276-0115. 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/industry/support/index.html.
Sincerely vours,
Chiu 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
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Indications for Use
| 510(k) Number (if known): | K050378 |
|---|---|
| Device Name: | Synthes Mandible External Fixator |
| Indications: | Synthes Mandible External Fixator is intended to stabilize and |
| provide treatment for fractures of the maxillofacial area, | |
| including severe open mandibular fractures, highly comminuted | |
| closed fractures, nonunions and delayed unions (especially | |
| associated with infection), fractures associated with infections, | |
| tumor resections, facial deformity corrections, gunshot wounds, | |
| pan facial fractures, burn maintenance, and bone grafting defects. |
Prescription Use _ X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Quann
. , at Anacthesiology, General Hospital onon Control. Dental Devices
Number: L050875
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