(111 days)
The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.
The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm. The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a. The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies.
It is important to note that the provided document is a 510(k) premarket notification for a medical device (MEDICON IMF-Orion Screws). For such devices, particularly those claiming substantial equivalence, the focus is often on demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, rather than establishing new acceptance criteria through novel clinical studies with specific performance metrics akin to diagnostic AI.
The document primarily relies on comparisons to predicate devices and literature references rather than reporting specific performance metrics from a dedicated study against pre-defined acceptance criteria.
Acceptance Criteria and Study Details for MEDICON IMF-Orion Screws
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, the "acceptance criteria" are implied by the substantial equivalence criteria to predicate devices and the favorable safety and effectiveness profile reported in the cited literature. The device performance is primarily described in terms of its characteristics and consistency with known safe and effective practices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Serve as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures. | Yes. The MEDICON IMF-Orion Screws have the same intended use as predicate devices. (Page 2, 2.7 & Page 3, 2.13) |
| Material Composition: Manufactured from biocompatible and strong material suitable for bone implantation. | Ti6Al4V according to ASTM F 136-02a. This is identical to several predicate devices, with one predicate using 316-L, though the document emphasizes the primary material. (Page 1, 2.6 & Page 3, 2.13) |
| Design Characteristics: Functional screw design (e.g., self-tapping/self-drilling, appropriate thread lengths, head shape for gripping). | Various lengths (10, 12, 14, 16 mm). Diameter of shafts: 2.0 mm. Head diameter: 4.0 mm, grooved for wires/rubber bands, tapered inner hexagonal. Self-retaining fit to the blade. Self-tapping & self-drilling function. These characteristics are described as very similar to SE (Substantially Equivalent) devices, with slight differences in size and specific thread functions not adversely affecting safety/effectiveness. (Page 1, 2.6 & Page 2, 2.9 & Page 3, 2.13) |
| Sterilization Method: Effective sterilization validated to appropriate standards. | Steam Sterilization to SAL of 10^-6. Specific cycle: 3 times pre-vacuum, 132° C, holding time 4 minutes (full cycle), drying time 10 minutes. Validated according to ISO 14937:2000. This is consistent with predicate devices. (Page 3, 2.13) |
| Safety and Effectiveness: Demonstrate comparable safety and effectiveness to predicate devices. | Clinical results of the MEDICON IMF-Orion Screws made out of Titanium Alloy (Ti6Al4V) and manufactured after ASTM F136-02a have shown their safety and effectiveness. This is supported by three cited literary references. "The results of design validation and clinical testing raise no new issues of safety and effectiveness." (Page 2, 2.10 & 2.12) The differences in design and size do not adversely affect safety and effectiveness. (Page 2, 2.12) |
| Compliance with Industry Standards: Adherence to relevant manufacturing, packaging, and sterilization standards. | Certifies compliance with required ISO/EN/ASTM and other device-related standards. (Page 2, 2.11) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of a prospective clinical trial with a defined number of subjects. The document refers to "clinical results of the MEDICON IMF-Orion Screws" but does not quantify the number of patients or cases.
- Data Provenance: The device is German (Medicon eG, Tuttlingen, GERMANY D-78532). The clinical evidence cited is from "German Literature" (OP-Journal 2003, Die FAMI-Schraube...) and "Literature Addenbrooke's NHS" (UK). This suggests data originating from Germany and the UK. The studies appear to be retrospective literature reviews rather than new prospective trials for this specific submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document relies on published clinical literature.
- Qualifications of Experts: The literature cited would have been authored by medical professionals (surgeons, oral and maxillofacial surgeons, etc.) based on their clinical experience and observations. However, their specific qualifications (e.g., years of experience, subspecialty) are not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
- No explicit adjudication method is mentioned, as this is not a study involving expert consensus on cases. The evidence is derived from existing clinical literature, where the "ground truth" would be established by the standard clinical diagnostic and outcome assessment practices described within those publications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is a surgical implant, not an AI-powered diagnostic tool. Therefore, a study of "human readers improving with AI" is not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone performance study (algorithm only) was not done. This device is a physical surgical screw, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" is based on clinical outcomes reported in medical literature concerning the safety and effectiveness of similar IMF screws, specifically those made of Ti6Al4V according to ASTM F136-02a. This implies successful temporary fixation, bone stabilization, and absence of adverse events as assessed by clinical professionals in real-world settings over time.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve an AI algorithm with a distinct "training set." The assessment is based on existing predicate device performance and published clinical experience with similar materials and designs.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, there is no ground truth established for one.
{0}------------------------------------------------
Traditional 510(k) - DZL
Medicon eG
.
Image /page/0/Picture/2 description: The image shows a handwritten string of characters. The string appears to be "K050478". The characters are written in a casual, slightly slanted style, with varying stroke thicknesses. The image is in black and white.
JUN 1 5 2005
2.3 Device Names: [807.92(a)(2)]
| Device Names: [807.92(a)(2)] | |
|---|---|
| Proprietary | MEDICON IMF-Orion Screws |
| Common | Small Bone Screw |
| Classification | Screw, Fixation, Intraosseous |
- 2.4. Reason for Submission: [807.81(2)] New Device
2.5 Predicate Device [807.92(a)(3)]
| Manufacturer | Synthes (USA); Paoli.K010527 |
|---|---|
| Proprietary Name | Synthes (USA) IMF Screws |
| Catalogue #'s | "IMF Screw Set" GP1852-Bsee exhibit 4a |
| Manufacturer | Walter Lorenz Surgical, Inc.K983728 |
| Proprietary Name | Lorenz IMF Screws |
| Catalogue #'s | « 2.0/2.4 MANDIBULAR FRACTURE SYSTEM »00-2117, p. 4see exhibit 4b |
| Manufacturer | KLS-Martin L.P.K980760 |
| Proprietary Name | KLS-Martin MMF Screw |
| Catalogue #'s | « FAST-FIX IMF-SYSTEM » 90-848-02see exhibit 4c |
| Manufacturer | Howmedica Leibinger, Inc.K963030 |
| Proprietary Name | Leibinger IMF Screws |
| Catalogue #'s | « IMF Screw System for Intermaxillary Fixation »90-01590see exhibit 4d |
{1}------------------------------------------------
2.6 Device Description [807.92(a)(4)]
The MEDICON IMF-Orion Screws are available in different lengths. Threadlengths within the range of 10.0, 12.0, 14.0 mm and 16.0 mm. The diameter of the shafts is 2.0 mm.
The head shape is in a diameter of 4.0 mm. It is grooved for fastening of wires and rubber bands. For a self-retaining fit to the blade the top is tapered inner hexagonal. The screws are manufactured of Ti6Al-4V according to ASTM F 136-02a.
The MEDICON IMF-Orion Screws provide temporary occlusal and fracture stabilization which can be achieved within a matter of minutes. These screws may be applied prior to or after exposure of the fracture.
The shapes, sizes and materials used are substantially equivalent to those of SE devices
2.7 Intended Use: [807.92 (a)(5)]
The Medicon IMF Orion Screws are intended for use as a bone screw in temporary fixation of the maxilla and mandible, providing indirect stabilization of fractures of the maxilla, mandible or both.
2.8 Environment of Use
The MEDICON IMF-Orion Screws are intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers.
Within these facilities the MEDICON IMF-Orion Screws may be located in areas where sterile surgical/dental instruments are used such as operating rooms for surgery.
2.9 Difference in Design and Technological Characteristics when Compared to SE Devices [807.92(a)(6)]
- Material: Like the SE devices, the MEDICON IMF-Orion Screws are manufactured from nonmagnetic, high quality Titanium Alloy (Ti6Al4V) acc. to ASTM F136-02a (DIN ISO 5832-3).
- The design is very similar. Both MEDICON and SE devices Design: consist of various sizes regarding length, measurement and fitting of the screw head.
{2}------------------------------------------------
Discussion of Safety and Effectiveness [807.92(b)] 2.10
Clinical results of the MEDICON IMF-Orion Screws made out of Titanium Alloy (Ti6Al4V) and manufactured after ASTM F136-02a have shown their safety and effectiveness:
-
- see exhibit 5a: German Literature OP-Journal 2003 "Verwendung von IMF-Schrauben zur mandibulo-maxillären Fixation"
-
- see exhibit 5b: German Literature with English abstract p. 361 "Die FAMI-Schraube für die temporäre intermaxillare Fixation"
- 5c: Literature Addenbrooke's NHS "THE exhibit 3. see INTERMAXILLARY SCREW -- A DEDICATED BICORTICAL BONE SCREW FOR TEMPORARY INTERMAXILLARY FIXATION"
Industry Standards: [807.92 (d)] 2.11
MEDICON certifies compliance with required ISO/EN/ASTM and other device-related standards that apply to the manufacure, packaging, labeling, sterilization, and reprocessing of subject devices including the validation of these processes.
Substantially Equivalent
Information Bearing on the Safety and Effectiveness: 2.12
[807.92 (b)(3)]
The MEDICON IMF-Orion Screws have the same intended use as predicate devices. They are made of identical material according to ASTM F136-02a.
The slight differences in design and size do not adversely affect the safety and effectiveness of this device.
The results of design validation and clinical testing raise no new issues of safety and effectiveness.
2-4
{3}------------------------------------------------
| 2.13 Comparison with predicate devices (table) | ||||||
|---|---|---|---|---|---|---|
| -- | ------------------------------------------------ | -- | -- | -- | -- | -- |
| MEDICON | WalterLorenz | KLS-Martin | Synthes | HowmedicaLeibinger | |
|---|---|---|---|---|---|
| INTENDED USE:The Medicon IMF Orion Screws areintended for use as a bone screw intemporary fixation of the maxilla andmandible, providing indirect stabilization offractures of the maxilla, mandible or both. | Yes | Yes | Yes | Yes | Yes |
| METHODS OF STERILIZATION:Steam Sterilization to SAL of 10-6(For Medicon IMF Orion Screws:3 times pre-vacuum, 132° C, holding time 4minutes [full cycle], drying time 10 minutes.Validated according to ISO 14937:2000) | Yes | Yes | Yes | Yes | Yes |
| MATERIAL: | Ti6Al4V ASTMF136-02a | Ti6Al4V ASTMF136-02a | Ti6Al4V ASTMF136-02a | 316-L | Ti6Al4V ASTMF136-02a |
| DESIGN:Color, Coding: | Natural silver | Gold,Blue (5.0mm) | Gold | Natural silver | Gold |
| Thread length (mm) | 10, 12, 14, 16 | 5, 7, 9, 11 | 9, 11, 13, 15 | 8, 12 | 8, 14 |
| Thread function | self-tapping &selfdrilling | selfdrilling (bluecolored 5.0mm)self-tapping (7,9, 11) | self-tapping | self-tapping &selfdrilling | Self-tapping |
| Headshape secures fast and safe gripping | Yes | Yes | Yes | Yes | Yes |
| Labeling (Packaging shows indications forscrew identification) | Assumed | Assumed | Assumed | Assumed | Assumed |
| manufactured after ASTM F 136-02asee Exhibit 3 | Yes | Yes | Yes | Assumed | Yes |
2-5
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 5 2005
Mr. Joachim Schmid General Manager Medicon, E.G. Gaensaecker 15 Tuttlingen, GERMANY D-78532
Re: K050478
Trade/Device Name: Medicon IMF Orion Screws Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 1, 2005 Received: June 2, 2005
Dear Mr. Schmid:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becases and his 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinone, or to active act (Act) that do not require approval of a premarket the Federal I vou, Drag, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providens of a 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 (1 Nr.), It hay of be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Eederal Register.
{5}------------------------------------------------
Page 2 - Mr. Schmid
Please be advised that FDA's issuance of a substantial equivalence determination does not I least that FDA has made a determination that your device complies with other requirements Incall that I DA mas made a aves and regulations administered by other Federal agencies. of the Act of ally I oderal business requirements, including, but not limited to: registration 1 out must comply with and are labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 877), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadiation 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) I mis letter wifi are in you The FDA finding of substantial equivalence of your device to a premarket notification - 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 desire specific at 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 may obtain 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,
Querie Y. Michaid DMD
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
{6}------------------------------------------------
INDICATIONS FOR USE
510(k) Number (if known): K050478
.
Device Name: Medicon IMF Orion Screws
Indications for Use: The Medicon IMF Orion Screws are intended for use as a Indications for USC. The Mediconf inn. Onxilla and mandible, providing indirect bono of fractures of the maxilla, mandible or both.
Prescription Use __ X (Part 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 Runoe
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K050478
Page 1 of _ 1
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.