(86 days)
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws.
The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended.
Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, cheek retractor with drill guide and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.
This looks like documentation for a medical device (a mandibular reconstruction plating system) and not an AI/ML powered medical device. Therefore, the concepts of "acceptance criteria," "study," "sample size," "ground truth," "expert consensus," "training set," and "MRMC comparative effectiveness study" are not applicable in the context of AI/ML.
The provided document, K043297, is a 510(k) summary for the Medicon 2.4 Mandibular Reconstruction Plating System. It details the device description, intended use, and claims substantial equivalence to a previously cleared device (K951689). The FDA's review confirms this substantial equivalence.
Instead of an AI/ML study, the document focuses on regulatory compliance for a physical medical device. The "acceptance criteria" here would be established by the FDA's regulatory framework for medical devices, specifically demonstrating substantial equivalence to a predicate device.
Key points from the document relevant to its clearance:
- Device Description: The system includes titanium plates, titanium alloy Star*Grip screws, templates, and instruments. Plates are 2.5 mm thick, come in various configurations, and accept 2.4 mm or 2.7 mm screws. The device is supplied non-sterile.
- Intended Use: Used for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts in emergency and non-emergency situations.
- Substantial Equivalence: The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the Medicon Titanium Mandibular Reconstruction System (K951689) with modifications in plate material, thickness, screw holes, and expanded product lines for plates, screws, and instruments.
The FDA's letter (pages 2-3) confirms the substantial equivalence determination, allowing the device to be marketed. This regulatory process does not involve the type of acceptance criteria or studies typically associated with AI/ML device performance.
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Kou3297
FEB 2 3 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM
1. General Information
| Proprietary Name: | Medicon 2.4 Mandibular ReconstructionPlating System |
|---|---|
| Common Name: | Mandibular Fixation System |
| Classification Name: | Bone Plate |
| Classification Code(s): | JEY, 872.4760 |
| Submitter: | Medicon, E.G.Gaensaecker 15Tuttlingen, D-78532GermanyTel.: 011-49-7462-2009-31Fax: 011-49-7462-2009-9931 |
| Est. Reg. No. | 8010099 |
| Contact Person: | Angelika ScherpRequlatory AffairsTel.: 011-31-20-428-9591 |
| Summary Preparation Date: | November 22, 2004 |
2. Device Description
The Medicon 2.4 Mandibular Reconstruction Plating System includes titanium plates, titanium alloy Star*Grip screws, templates and accompanying instruments and accessories. Plates are 2.5 mm thick and include flat and preformed straight, angled, and full mandible configurations in lengths from 6 screw holes to 29 screw holes. Plates can accept 2.4 mm diameter locking screws or standard, non-locking 2.4 mm and 2.7 mm diameter bone screws. All screws are self-tapping. The 2.7 mm diameter screws can also be used as emergency screws.
The device is supplied non-sterile and must be sterilized prior to use. Moist heat sterilization is recommended.
Instruments and accessories available are: screwdrivers, screw holding forceps, twist drills, drill guide, depth gauge, cheek retractor with drill guide
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and trocar, plate bender, plate bending forceps, plate bending pliers, cutting lever, plate holding forceps, plate cutting forceps, tap, templates, storage and sterilization trays for implants and instruments.
3. Intended Use
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
4. Substantial Equivalence
The Medicon 2.4 Mandibular Reconstruction Plating System is substantially equivalent to the previously cleared Medicon Titanium Mandibular Reconstruction System (K951689), with the following modifications:
- a) Plates
- · Change in material from titanium alloy to titanium
- · Thickness increased from 2 mm to 2.5 mm
- · Thread added to holes
- · Product line expanded to include anatomically preformed plates
- b) Screws
- · Product line expanded to include 2.4-mm-diameter screws with and without locking function
- c) Instruments
- · Product line expanded to include cutting lever, plate cutting forceps and tap.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Public Health Service
FEB 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medicon, E.G. C/O Ms. Angelika Scherp Director, Regulatory Affairs Business Support International Amstel 320-I Amsterdam, 1017AP NETHERLANDS
Re: K043297
Trade/Device Name: Medicon 2.4 Mandibular Reconstruction Plating System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: January 4, 2005 Received: January 31, 2005
Dear Ms. Scherp:
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. Scherp
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,
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
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Indications for Use
510(k) Number (if known): _K043297
Device Name: Medicon 2.4 Mandibular Reconstruction Plating System
Indications for Use:
The Medicon 2.4 Mandibular Reconstruction Plating System is intended to be used during emergency and nonemergency situations for replacement of mandibular bone, primary and secondary functionally stable defect bridging of mandibular defects, anatomically-positioned fixation of mandibular bone stumps, and fixation of bone grafts.
× Over-The-Counter Use Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Rundor
Sign-Off
s.on of Anesthesiology, General Hospital, action Control. Dental Devices
Number K093297
§ 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.