(65 days)
The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.
The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.
This looks like a 510(k) summary for a medical device that has achieved substantial equivalence, not a study evaluating whether a device meets specific acceptance criteria through performance.
The provided text, K080694, describes the OsteoMed Modular Locking Fixation System, indicated for fracture fixation in cranio-maxillofacial trauma, mandibular reconstruction, and orthognathic reconstruction. However, it is a document seeking clearance for a medical device by demonstrating substantial equivalence to predicate devices already on the market, rather than a clinical study with acceptance criteria and reported device performance metrics.
Therefore, many of the requested categories for a study that proves a device meets acceptance criteria cannot be extracted because this document is not a performance study in that sense.
Here's a breakdown based on the provided text, Highlighting why certain information is not available from this type of document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. This submission focuses on substantial equivalence, not on pre-defined performance thresholds for the device itself. | Not applicable in this document. Performance metrics (e.g., success rates, accuracy, precision, error rates) are not reported here. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. This document does not describe a performance study with a test set.
- Data Provenance: Not applicable. This document relies on comparisons to predicate devices and their established safety and effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. No test set or ground truth establishment by experts is described in this document.
4. Adjudication Method for the Test Set
- Not applicable. No test set adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. This submission uses a substantial equivalence pathway.
6. If a Standalone (algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device (plates, screws, instrumentation), not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable. No ground truth is established or used in this submission. The basis for clearance is substantial equivalence to legally marketed predicate devices, meaning that the device is shown to be as safe and effective as existing devices.
8. The Sample Size for the Training Set
- Not applicable. There is no concept of a "training set" for this type of physical, non-AI medical device submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See #8)
Summary Explanation:
The document provided (K080694) is a 510(k) premarket notification. The primary goal of a 510(k) submission is to demonstrate that the device is "substantially equivalent" to a legally marketed predicate device (or devices). This means the device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, it does not raise new questions of safety and effectiveness and the information submitted demonstrates that the device is as safe and effective as the legally marketed device.
This clearance pathway typically involves:
- Comparison to Predicate Devices: Identifying existing devices with similar indications for use, materials, and design.
- Performance Testing (Non-Clinical): Often involves bench testing (e.g., mechanical strength, fatigue, biocompatibility) to ensure the device meets specified engineering standards and performs comparably to the predicates. These tests are usually against internal company specifications or recognized standards, not necessarily "acceptance criteria" for a clinical performance study.
- Material Equivalence: Demonstrating that materials used are equivalent to those in predicate devices or have established safe use.
The text explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790, Stryker K022185, KLS K032442, OsteoMed (K911936/Addendum K924138 and K030448), and Lorenz (K063052)." and "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues."
Therefore, this document does not contain the information requested about a clinical study involving acceptance criteria, test sets, expert adjudication, or AI performance metrics because it is a regulatory clearance document based on substantial equivalence, not a clinical trial report.
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510(k) Summary
Device Proprietary Name:
OsteoMed Modular Locking FixationAY 1 5 2008
Suntam System
Device Common Name:
Classification Name:
Name of Submitter:
System
Modular Locking Fixation System
JEY, Bone Plate
OsteoMed L. P. 3885 Arapaho Road Addison, Texas 75001 Phone: (972) 677-4600 Fax: (972) 677-4601
Contact Person:
Piedad Peña
Date Prepared:
March 10, 2008
Summary:
This submission describes the OsteoMed Modular Locking Fixation System indicated for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction. The implants and drills are intended for single use only.
The OSTEOMED Modular Locking Fixation System is comprised of plates, screws and instrumentation utilized in the fixation of craniofacial, maxillofacial and mandibular fractures. The locking screw and plate interface allows up to 20 degrees of angulation within screw placement. The plating system allows for the use of locking standard screws, locking Auto-Drive™ screws, standard nonlocking screws, safety screws and Auto-Drive™ screws, as needed. The screws are made from Titanium Alloy (ASTM F-136). The plates are made from Titanium Alloy (ASTM F-136) or commercially pure Titanium (ASTM F-67). Drill bits, plate bending pliers, plate holding forceps, plate cutters, drill guides, cannulae, taps, countersinks, and screwdrivers to facilitate the placement of screws and modification of plates will also be a part of the system.
Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Synthes K063790. Stryker K022185. KLS K032442. OsteoMed (K911936/Addendum K924138 and K030448 ), and Lorenz (K063052).
OsteoMed also notes, that some sections of this system could have been letter to file based on the OsteoMed previously cleared submissions. The intent of this submission is to present the system as complete modules and include the
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changes to the designs, which would allow up to 20 degrees of angulation within the locking screw and plate interface.
The locking screw and plate interface designs and operational principles addressed in this submission are based on similarities to the predicate devices Synthes (K063790), Stryker (K022185), and KLS (K032442) based on their promotional materials and labeling.
Due to the similarity of materials and design to both pre-enactment and postenactment devices, OsteoMed believes that the OsteoMed Modular Locking Fixation System does not raise any new safety or effectiveness issues.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
Ms. Piedad Peña Regulatory Affairs Specialist OsteoMed L.P. 3885 Arapaho Road Addison, Texas 75001
Re: K080694
Trade/Device Name: OsteoMed Modular Locking Fixation System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: March 10, 2008 Received: March 11, 2008
Dear Ms. Peña:
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. Peña
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.
Clars
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):
Device Name: OsteoMed Modular Locking Fixation System Indications for Use:
The OsteoMed Modular Locking Fixation System is intended for fracture fixation in cranio-maxillofacial trauma reconstruction, mandibular reconstruction and orthognathic reconstruction.
The OsteoMed Modular Locking Fixation System implants and drills are intended for single use only.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runno
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
(Posted November 13, 2003) 510(k) Number:
10850694
§ 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.