(90 days)
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No
The document describes a mechanical bone plate system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is used for stabilization and rigid fixation of fractures and reconstructive procedures, which are reparative rather than therapeutic.
No
Explanation: This device is a bone plate system intended for the stabilization and rigid fixation of mandibular fractures and reconstructive procedures. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it includes bone plates and bone screws made of titanium and titanium alloy, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a "bone plate system" consisting of plates and screws made of titanium. These are implants used to physically stabilize bone.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health.
This device is clearly an implantable surgical device, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.
Product codes (comma separated list FDA assigned to the subject device)
76 JEY
Device Description
Satyrne InterFlex Mandibular Fixation System is a new bone plate system for use in oral and maxillofacial surgery. The design includes plates of different thicknesses that are secured to the mandibular bony tissue using bone screws of varying lengths and designs. The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.
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
mandibular skeleton
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)
Based on mechanical test results, the Satyme InterFlex Mandibular Fixation System is substantially equivalent to the legally marketed Stryker Leibinger Universal CMF System K022185 and the Synthes Mandibular Modular Fixation System K954385. The plates and screws are made of the same material as predicate devices. The system contains various shapes of plates and screws similar to predicate devices.
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.
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 a handwritten string of characters, "K072463". The characters are written in black ink on a white background. The characters are all uppercase and are of varying sizes and thicknesses. The characters are slightly slanted to the right.
3 510(k) Summary
Submitter Contact Information:
Satyrne Medical 1909 Gold Ave. SE #1 Albuquerque, NM 87106 (505) 620-3856
Contact Person: Scott T. Lovald Summary prepared 8/24/2007
NOV 2 9 2007
Trade Name: InterFlex Mandibular Fixation System
Device Classification: Class II Common Name: Bone Plates Regulation Number: 21 CFR 872.4760 Classification Product Code: 76 JEY
Predicate Devices
Stryker Instruments -Universal CMF System (K022185) Synthes - Mandibular Modular Fixation System (K954385)
Device Description
Satyrne InterFlex Mandibular Fixation System is a new bone plate system for use in oral and maxillofacial surgery. The design includes plates of different thicknesses that are secured to the mandibular bony tissue using bone screws of varying lengths and designs. The bone plates and bone screws will be manufactured of commercially pure (CP) titanium or Ti6Al4V alloy in compliance with ASTM F67 and ASTM F136.
Intended Use
Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.
Substantial Equivalence
Based on mechanical test results, the Satyme InterFlex Mandibular Fixation System is substantially equivalent to the legally marketed Stryker Leibinger Universal CMF System
1
K022185 and the Synthes Mandibular Modular Fixation System K954385. The plates and screws are made of the same material as predicate devices. The system contains various shapes of plates and screws similar to predicate devices.
:
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the logo. The seal is black and white.
NOV 2 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Lovald CTO Satyrne Medical 1909 Gold Avenue SE #1 Albuquerque, New Mexico 87106
Re: K072463
Trade/Device Name: InterFlex Mandibular Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 26, 2007 Received: August 31, 2007
Dear Mr. Lovald:
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.
3
Page 2 - Mr. Lovald
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 yours,
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
4
Indications for Use 2
510(k) Number (if known):
Device Name: InterFlex Mandibular Fixation System
Indications for Use:
Satyrne's InterFlex Mandibular Fixation System is intended for the stabilization and rigid fixation of fractures and reconstructive procedures of the mandibular skeleton. Each device is intended for single use only in conjunction with other titanium and titanium alloy implants.
1 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
S
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K022463