(159 days)
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used to fix fractures and osteotomies, which are medical conditions, thereby providing therapy.
No
This device, the Field Orthopaedics Micro Screw System, is intended for fixation of fractures, osteotomies, and arthrodeses, which are therapeutic interventions, not diagnostic procedures.
No
The device description explicitly details physical components made of titanium alloy, stainless steel, and other materials, including screws, pins, wires, and instrumentation. This indicates it is a hardware-based medical device, not software-only.
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 the "fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm" and "fixation of bone fractures or as guidance at insertion of implants into the skeletal system." These are surgical procedures performed directly on the patient's body.
- Device Description: The device consists of "cannulated compression screws," "K-wires," and "Pins," along with "instrumentation." These are all physical implants and surgical tools used in orthopedic surgery.
- 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 compatibility testing.
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 FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.
The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.
Product codes
HWC, HTY
Device Description
The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.
The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.
The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.
Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).
All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).
The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones in the foot, hand, and forearm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Performance analysis of the FO micro screw was conducted through theoretical engineering analyses and mechanical testing methods. Engineering analyses were performed on the FO Micro screw, Trimed CCS 1.7, and Aptus Hand 1.2. Mechanical testing of the FO Micro Screws was performed per ASTM F543. More specifically, the torsional strength, maximum torque to drive-in and remove the screws, and pull out force were determined for the worst-case size and length of FO Micro Screw, and compared to predicate devices. The results of mechanical testing and engineering analysis showed the subject device to possess greater strength than the predicate devices, and meet the strength requirements for (solid) screws (ASTM F543). Simulated surgeon-user testing per the prescribed surgical technique showed the FO Micro Screw System to perform as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K121425, K143050, K050681, K124027
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Field Orthopaedics Pty. Ltd. % Robert Poggie, Ph.D. President BioVera Inc. 65 Promenade Saint Louis Notre-Dame-del-L'Ile-Perrot, J7V 7P2 Ca July 17, 2018
Re: K180348
Trade/Device Name: Field Orthopaedics Micro Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, HTY Dated: June 1, 2018 Received: June 4, 2018
Dear Dr. Poggie:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Dr. Robert Poggie
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180348
Device Name Field Orthopaedics Micro Screw System
Indications for Use (Describe)
The Field Orthopaedics Micro Screw System consists of the following kits with the following indications:
The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.
The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Field Orthopaedics Micro Screw System
In accordance with 21 CFR 807.92 of the Federal Code of Regulations, the following information is a summary of safety and effectiveness of the Field Orthopaedics Micro Screw System.
A. SUBMITTERS INFORMATION
| Submitter Name: | BioVera, Inc. |
|---|---|
| Submitter Address: | 65 Promenade Saint-Louis, NDIP, Québec, J7V 7P2, CANADA |
| Contact Person: | Robert A Poggie, PhD |
| Phone Number: | (514) 901-0796 |
| Fax Number: | (514) 901-0796 |
| Date of Submission: | July 12, 2018 |
B. DEVICE IDENTIFICATION & MANUFACTURER
| Manufacturer Name: | Field Orthopaedics Pty. Ltd. |
|---|---|
| Manufacturer Address: | 375 Wickham Terrace Spring Hill, 4000 QLD, Australia |
| Registration Number: | |
| Contact Name: | Christopher Jeffery, B.ENG (Hons), GCE, Lead, MBBS |
| Title: | CEO |
| Device Trade Name: | Field Orthopaedics Micro Screw System |
| Device Common Name: | Metallic bone screw; Kirschner wire (K-Wire) |
| Classification Name: | Smooth or threaded metallic bone fixation fastener; |
| Classification Codes: | HWC, HTY – Class II |
| Classification Panel: | Orthopaedic |
| Regulation Number: | 21 CFR section 888.3040 |
C. PREDICATE AND REFERENCE DEVICES
C1: Primary Predicates Devices:
| K051567 | Medartis, Inc | Aptus 1.2 Cortical Screw | APTUS Titanium Fixation System |
|---|---|---|---|
| Aptus 1.2 Hand | |||
| K100736 | SMT Schilling | ||
| Metailtechnik GmbH | 0.6 - 2.0 mm Single and Double | ||
| Trocar Pins and K-Wires | Orthopaedic Fixation Pins and | ||
| Wires / Kirschner / Guide Wires |
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C2: Reference Devices:
| K121425 | Wright Medical
Technology, Inc. | Titanium Alloy (ASTM F136)
Bone Screws | ORTHOLOC 3Di Ankle Fusion
Plating System and ORTHOLOC
Bone Screws |
|---------|------------------------------------|-------------------------------------------|-------------------------------------------------------------------------|
| K143050 | Smith & Nephew,
Inc. | Cobalt-Chromium Alloy K-Wires | VLP FOOT Plating, Screw System
and Accessories |
| K050681 | TriMed Inc. | 1.7mm CCS | Omnitech and Easylock
Osteosystem |
| K124027 | Apogee
OrthoSolutions, LLC | Monster Screw System | Monster Screw System |
D. DEVICE DESCRIPTION
The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.
The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.
The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.
Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).
All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).
The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.
E. INTENDED USE
The Field Orthopaedics Micro Screw System consists of the following indications:
The FO Micro Screw Kit is intended for fixation of fractures, and arthrodeses of small bones in the foot, hand, and forearm.
The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.
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F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.
The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.
The materials, length and diameter options, and indications for use of the FO Micro Screws, Pins and K-Wires were compared to those of the predicate devices and determined to be substantially equivalent.
G. PERFORMANCE DATA
Performance analysis of the FO micro screw was conducted through theoretical engineering analyses and mechanical testing methods. Engineering analyses were performed on the FO Micro screw, Trimed CCS 1.7, and Aptus Hand 1.2. Mechanical testing of the FO Micro Screws was performed per ASTM F543. More specifically, the torsional strength, maximum torque to drive-in and remove the screws, and pull out force were determined for the worst-case size and length of FO Micro Screw, and compared to predicate devices. The results of mechanical testing and engineering analysis showed the subject device to possess greater strength than the predicate devices, and meet the strength requirements for (solid) screws (ASTM F543). Simulated surgeon-user testing per the prescribed surgical technique showed the FO Micro Screw System to perform as intended.
H. CONCLUSION
The Field Orthopaedics Micro Screw System is substantially equivalent to the identified predicate devices based on the indications for use, materials, design, length and diameter options, and performance data presented in this 510(k) application.