(140 days)
No
The summary describes a mechanical screw system and associated instruments for bone fixation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The "Intended Use" states that the device is for "temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments," which is a structural or mechanical support function, not a therapeutic one (e.g., to treat or cure a disease).
No
This device is intended for the temporary fixation and stabilization of bone segments, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly details physical components made of titanium alloy, stainless steel, anodized aluminum, and medical-grade polymer, including screws, ligature wire, drill bits, wire cutters, pliers, drill guides, and screwdrivers. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices." This describes a surgical implant and associated instruments used directly on the patient's body for mechanical support.
- Device Description: The description details screws, ligature wire, and instruments made from materials like titanium alloy and stainless steel. These are typical components of surgical fixation systems.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and structural.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical fixation.
N/A
Intended Use / Indications for Use
The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.
Product codes (comma separated list FDA assigned to the subject device)
DZL
Device Description
The OsteoMed ICON IMF (Intermaxillary Fixation) Screw System is offered in 2.4mm and 2.0mm standard IMF screws in lengths from 10mm (thread lengths from 5mm to 15mm) and 2.0mm ICON AutoDrive IMF Screws in lengths from 12mm to 18mm (thread lengths of 8mm).
The implants of the OsteoMed ICON IMF Screw System are made from Titanium alloy (ASTM F-136) and the ligature wire is made from Stainless Steel.
The system instruments include drill bits, wire cutters, pliers, drill guides and screwdrivers to facilitate the placement of screws and ligature wires. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
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)
The OsteoMed ICON IMF Screws (2.0mm Standard IMF screws and the 2.0mm AutoDrive IMF screws) were compared to the OsteoMed QuickFix 2.4mm standard MMF Screws (K962774-primary predicate) and the 2.0mm AutoDrive Screws (K974785-reference predicate). The 2.0mm AutoDrive IMF screws and the 2.0mm standard IMF screws underwent verification testing to ensure that the design features meet the required mechanical strength criteria for their intended use compared to the predicate device. The intended use of the OsteoMed ICON IMF Screw System is the same as OsteoMed 2.4mm QuickFix screw system (K962774).
The performance testing included failure torque testing of the new devices and the predicate devices in accordance with ASTM F543. All devices met the minimum failure torque requirement based on screw diameter according to the standard. Also, insertion torque testing in accordance with ASTM F543 was performed for all devices met the required failure torque to insertion torque (FT/IT) ratio of FT/IT > 1.0 according to the standard. Lastly, pull-out force and bending force testing was performed on the new devices using equivalent methods to those shown in the primary predicate 510k K962774 and compared against the predicate device results in K962774. The performance testing showed that the new devices were equivalent to the predicate device. Simulated use was performed as part of validation for the new screws and were found to be equivalent to the predicate device.
Biocompatibility and Sterilization testing was justified to the already tested predicate device. No changes to materials, packaging, or sterilization were made, therefore the new devices are equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics include compliance with minimum failure torque requirement based on screw diameter (ASTM F543) and required failure torque to insertion torque (FT/IT) ratio of FT/IT > 1.0 (ASTM F543).
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.
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).
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21,2015
Osteomed Piedad Pena Regulatory Affairs Manager 3885 Arapaho Rd Addison, Texas 75001
Re: K151195
Trade/Device Name: Osteomed Imf Screw Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: September 4, 2015 Received: September 10, 2015
Dear Piedad Pena:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runno DDS, MA
Erin Keith Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known): K151195
Device Name: OsteoMed ICON IMF Screw System
Indications for Use:
The OsteoMed ICON IMF Screw System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fracture bone segments in the oral cavity in conjunction with primary fixation devices.
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)
3
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510(k) SUMMARY
OsteoMed ICON IMF Screw System
| Name of Submitter: | OsteoMed
3885 Arapaho Road
Addison, TX 75001
972 677 4600
972 677 4601 (fax) |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mrs. Piedad Pena, M.S. |
| Date Prepared: | September 4, 2015 |
| Device Proprietary Name:
Device Common Name:
Classification Name:
Product Code: | OsteoMed ICON IMF Screw System
IMF Fixation Screw and wire
21CFR 872.4880: Intraosseous fixation screw or wire
DZL |
Primary Predicate: OsteoMed QUICK-FIX, K962774 Classification Name: 21CFR 872.4880: Intraosseous fixation screw or wire; Product Code: DZL; Class: II
Reference Predicate: Auto-Drive Bone Screw System, K974785 Classification Name: 21CFR 888.3040, Smooth or threaded metallic fixation fastener, Product Code HWC, Device Class: II
Summary:
Device Description:
The OsteoMed ICON IMF (Intermaxillary Fixation) Screw System is offered in 2.4mm and 2.0mm standard IMF screws in lengths from 10mm (thread lengths from 5mm to 15mm) and 2.0mm ICON AutoDrive IMF Screws in lengths from 12mm to 18mm (thread lengths of 8mm).
The implants of the OsteoMed ICON IMF Screw System are made from Titanium alloy (ASTM F-136) and the ligature wire is made from Stainless Steel.
The system instruments include drill bits, wire cutters, pliers, drill guides and screwdrivers to facilitate the placement of screws and ligature wires. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
Intended Use/Indications for Use:
The OsteoMed ICON IMF Screws System is intended and indicated for the temporary ligature and wire lock fixation for temporary constriction and stabilization of fractured bone segments in the oral cavity in conjunction with primary fixation devices.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (973) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
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4
Summary of Technological Characteristics:
| System / Device
Name/510(k)/
Purpose | OSTEOMED ICON IMF Screw
System (New) | OSTEOMED Quick-fix System
K962774
Primary Predicate | OsteoMed Auto-Drive
Bone Screw K974785
(Reference Predicate)
self-driving tip features |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II
21 CFR 872.4880
DZL | Class II
21 CFR 872.4880
DZL | Class II
21 CFR 888.3040
HWC |
| Device Name
Classification: | Intraosseous fixation screw or
wire. | Intraosseous fixation screw or
wire. | Smooth or threaded
metallic bone fixation
fastener. |
| | a) Identification. An
intraosseous fixation screw or
wire is a metal device intended
to be inserted into fractured
jaw bone segments to prevent
their movement. | a) Identification. An
intraosseous fixation screw or
wire is a metal device intended
to be inserted into fractured jaw
bone segments to prevent their
movement. | |
| Indication for
Use/Intended
Use | The device is intended and
indicated for the temporary
ligature and wire lock fixation
for temporary constriction and
stabilization of fracture bone
segments in the oral cavity in
conjunction with primary
fixation devices. | The device is intended and
indicated for the temporary
ligature and wire lock fixation
for temporary constriction and
stabilization of fracture bone
segments in the oral cavity in
conjunction with primary
fixation devices. | Fixation secondary to
trauma or
reconstruction of the
craniofacial and
maxillofacial skeleton and
bones of the
hand |
| Technology | The screws fixate on bone in
conjunction with ligature wire
to allow fixation and
stabilization of the fracture. | The screws fixate on bone in
conjunction with ligature wire to
allow fixation and stabilization
of the fracture. | The screws fixate on bone
in conjunction with plates
for rigid fixation.
(N/A, this device does not
used plates) |
| Screw Driving
technology for
implantation | The standard screws are
implanted after a pilot hole has
been created in the desired
location.
AutoDrive screws do not
require pilot hole for
implantation, they are self-
drilling screws. | The standard screws are
implanted after a pilot hole has
been created in the desired
location. | AutoDrive screws do not
require pilot hole for
implantation, they are self-
drilling screws. |
| Screw Material | Ti6Al4V per ASTM F136 | Ti6Al4V per ASTM F136 | Ti6Al4V per ASTM F136 |
| Principles of
Operation | Rigid Fixation and Wire Lock
stabilization | Rigid Fixation and Wire Lock
stabilization | Rigid Fixation |
| Table 1: Technology Comparison to the Primary Predicate and Reference Device | |
|---|---|
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| System / Device
Name/510(k)/
Purpose | OSTEOMED ICON IMF Screw
System (New) | OSTEOMED Quick-fix System
K962774
Primary Predicate | OsteoMed Auto-Drive
Bone Screw K974785
(Reference Predicate)
self-driving tip features |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Screw
(type and length
range according
to screw
diameter) | 2.4mm IMF Screw (standard)
Length range: 10mm-20mm
Thread range: 5mm to 15mm
(Same as Primary Predicate;
cleared K962774)
2.0mm IMF Screw (standard)
Length range: 10mm-20mm
Thread range: 5mm to 15mm
2.0mm IMF AutoDrive Screw
Length range: 12mm-18mm
Thread range: 8mm-14mm | 2.4mm IMF Standard Screw
Length range: 10mm-20mm
Thread range: 5mm to 15mm
(Cleared) | 2.0mm AutoDrive Screw
Length range: 4mm-8mm
Thread range: 3mm-7mm
(Cleared) |
| Instrumentation
(Materials) | • Stainless Steel
• Anodized aluminum
• Medical grade polymer | • Stainless Steel
• Anodized aluminum
• Medical grade polymer | • Stainless Steel
• Anodized aluminum
• Medical grade polymer |
| Instrumentation | drill bits, wire cutters, pliers,
drill guides and screwdrivers to
facilitate the placement of
screws and ligature wire | drill bits, wire cutters, pliers,
drill guides and screwdrivers to
facilitate the placement of
screws and ligature wire | screwdrivers to facilitate
the placement of screws |
| Sterilization | Packaged and sold Non-sterile,
requires sterilization prior to
use | Packaged and sold Non-sterile,
requires sterilization prior to use | Packaged and sold Non-
sterile, requires
sterilization prior to use |
| Biocompatibility | Ti alloy per ASTM F136 is a
biocompatible material | Ti alloy per ASTM F136 is a
biocompatible material | Ti alloy per ASTM F136 is a
biocompatible material |
Substantial Equivalence Discussion:
The OSTEOMED 2.0mm ICON Standard IMF Screw and the 2.0mm ICON AutoDrive IMF Screw are the same as the predicate device (2.4mm QuickFix MMF Screw, K962774) in the following ways:
- The screws have the same Regulatory Classification (21 CFR 872.4880 DZL)
- The screws have the same indication for use.
- The technology and features of the screws are the same (screws to fixate and allow ligature with wire)
- The range of the screw length is the same as, or encompassed by, that of the predicate:
- o Overall Length = 10mm 20mm
- o Thread Length = 5mm 15mm
- . The length of the screw head, the head diameter, and cross-sectional areas through the wire holes are the same as the predicate device.
- . The 2.0mm ICON Standard IMF Screw has the same number of wire fixation holes (1) as the predicate
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- The screws are manufactured from the same materials (Titanium alloy per ASTM F136) as the predicate and therefore have the same biocompatibility.
- The instrumentation and materials used in conjunction with these screws are the same
- The screws are packaged and sterilized in the same manner and same parameters as the predicate device.
Differences between the new devices and the predicate, do not affect safety and effectiveness
- The 2.0mm ICON AutoDrive IMF Screw has more wire fixation holes (2) than the predicate (1) ●
- The 2.0mm ICON Standard IMF Screw has a smaller cross-sectional area through the wire fixation holes (1.43 mm²) than the predicate (2.04 mm²)
- The 2.0mm ICON AutoDrive IMF Screw has a different tip (sharp, pointed, single threadcutting flute) than the predicate (blunt, rounded) but was equivalent to the reference predicate.
The performance testing comparison listed below showed the new devices were equivalent and did not raise new safety and effectiveness issues.
Performance/Clinical Data:
The OsteoMed ICON IMF Screws (2.0mm Standard IMF screws and the 2.0mm AutoDrive IMF screws) were compared to the OsteoMed QuickFix 2.4mm standard MMF Screws (K962774-primary predicate) and the 2.0mm AutoDrive Screws (K974785-reference predicate). The 2.0mm AutoDrive IMF screws and the 2.0mm standard IMF screws underwent verification testing to ensure that the design features meet the required mechanical strength criteria for their intended use compared to the predicate device. The intended use of the OsteoMed ICON IMF Screw System is the same as OsteoMed 2.4mm QuickFix screw system (K962774).
The performance testing included failure torque testing of the new devices and the predicate devices in accordance with ASTM F543. All devices met the minimum failure torque requirement based on screw diameter according to the standard. Also, insertion torque testing in accordance with ASTM F543 was performed for all devices met the required failure torque to insertion torque (FT/IT) ratio of FT/IT > 1.0 according to the standard. Lastly, pull-out force and bending force testing was performed on the new devices using equivalent methods to those shown in the primary predicate 510k K962774 and compared against the predicate device results in K962774. The performance testing showed that the new devices were equivalent to the predicate device. Simulated use was performed as part of validation for the new screws and were found to be equivalent to the predicate device.
Biocompatibility and Sterilization testing was justified to the already tested predicate device. No changes to materials, packaging, or sterilization were made, therefore the new devices are equivalent to the predicate device.
OsteoMed believes that these non-clinical tests have demonstrated that these devices are safe and effective as the predicate device; therefore, clinical testing is not required to support substantial equivalence.
Substantial Equivalence:
The substantial equivalence of the OsteoMed ICON IMF Screw System is based on similarities in intended use, indications for use, material, function, technology, performance, design, sterilization, and operational principles to the OsteoMed QuickFix (K962774, primary predicate) and design, material and operating principles as the AutoDrive self-drilling features for the OsteoMed AutoDrive Bone Screw (K974785) reference predicate.
7
Conclusion:
Substantial equivalence was shown through failure torque testing, insertion torque testing, pull-out force testing, and bending testing when compared to known standards and to the predicate devices. The indications, design, technology and operational principles are similar between the subject devices and primary predicate OsteoMed 2.4mm QuickFix MMF Screw (K962774), and reference predicate OsteoMed 2.0mm AutoDrive Screw (K974785), therefore OsteoMed believes that the OSTEOMED 2.0mm ICON Standard IMF Screw and OSTEOMED 2.0mm ICON AutoDrive IMF Screw do not raise any new safety or effectiveness issues.
The assessment of the non-clinical data demonstrated the devices were as safe and effective as the predicate devices OsteoMed QuickFix (K962774) and AutoDrive Bone Screw (K974785). In conclusion, the OsteoMed IMF Screw System have been evaluated and proven to be substantially equivalent to the predicate device.
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