(142 days)
No
The device description focuses on mechanical properties and materials (nitinol, titanium alloy) for compression and stability, with no mention of AI/ML in the intended use, device description, or performance studies.
Yes
The device is indicated for stabilization and fixation of fractures, revisions, arthrodeses, and reconstruction of small bones of the foot, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that this is a system for stabilizing and fixing fractures, revisions, arthrodeses, and reconstruction of small bones, which are all treatment-oriented actions, not diagnostic ones. It performs a physical function (compression and stabilization) rather than detecting or identifying a medical condition.
No
The device description clearly details physical components made of titanium alloy and nitinol, including plates, screws, and instrumentation, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the stabilization and fixation of fractures, revisions, arthrodeses, and reconstruction of bones in the foot. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a plate system with screws and nitinol wires, made from titanium alloy and nitinol. These are materials and components typical of orthopedic implants, not diagnostic reagents or instruments used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used to physically stabilize and fix bones.
N/A
Intended Use / Indications for Use
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:
- Midfoot and hindfoot arthrodeses or osteotomies ●
- Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus) ●
- Intercuneiform arthrodeses
- Naviculocuneiform arthrodeses ●
- Talonavicular arthrodeses
- Calcaneocuboid arthrodeses
- Linsfranc arthrodeses ●
- Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot ●
- First metatarsophalangeal arthrodeses .
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the foot
Indicated Patient Age Range
skeletally mature patients
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 following non-clinical evidence was submitted and relied upon for a determination of substantial equivalence:
- Mechanical performance:
- ASTM F382-17: Standard Specification and Test Method for Metallic Bone . Plates: static and dynamic 4-point bend tests
- . ASTM F543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws: axial pull-out. insertion-removal torque and torsional strength tests
- ASTM F564-17: Standard Specification and Test Methods for Metallic Bone . Staples: static and dynamic tension tests
- Engineering analysis of compression forces .
MR Safety evaluation determined the devices are MR Conditional via the following standard methods:
o ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
o ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment ASTM F2182-11a. Standard Test Method for Measurement of Radio Frequency o Induced Heating Near Passive Implants During Magnetic Resonance Imaging ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of o MR Image Artifacts from Passive Implants
- Cleaning and sterilization validations and evaluations .
- . ISO 10993-1 Biological safety evaluation
- ASTM F2129 Cyclic Potentiodynamic Polarization study for corrosion susceptibility ●
There are no clinical tests relied on in this premarket notification submission for a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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July 22, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font, while "U.S. FOOD & DRUG" and "ADMINISTRATION" are in a smaller font size.
Pioneer Surgical Technology, Inc., DBA RTI Surgical Sarah Pleaugh Regulatory Affairs Manager 375 River Park Circle Marquette, Michigan 49855
Re: K200513
Trade/Device Name: DAC Dynamic Active Compression Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: June 19, 2020 Received: June 22, 2020
Dear Sarah Pleaugh:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
542 of the Act); 21 CFR 1000-1050.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200513
Device Name DAC Dynamic Active Compression Plate
Indications for Use (Describe)
The DAC plate system with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, arthrodeses and reconstruction of small bones of the foot such as:
- Midfoot and hindfoot arthrodeses or osteotomies ●
- Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus) ●
- Intercuneiform arthrodeses
- Naviculocuneiform arthrodeses ●
- Talonavicular arthrodeses
- Calcaneocuboid arthrodeses
- Linsfranc arthrodeses ●
- Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot ●
- First metatarsophalangeal arthrodeses .
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary per 21 CFR 807.92
| Device Trade Name: | DAC Dynamic Active Compression Plate System |
|---|---|
| Manufacturer: | Pioneer Surgical Technology, Inc. DBA RTI Surgical, Inc. |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Registration no: 1833824 | |
| Telephone: (906) 226-9909 | |
| Contact: | Sarah Pleaugh, Manager, Regulatory Affairs |
| Telephone: (906)226-9909 x 5861 | |
| Date Prepared: | June 19, 2020 |
| Submission Type: | Traditional 510(k) |
| Common Name: | Bone Fixation Plate |
| Bone Fixation Screw | |
| Classification | 888.3030 – Single/multiple component metallic bone fixation |
| Regulation: | appliances and accessories |
| 888.3040 - Smooth or threaded metallic bone fixation fastener | |
| Classification Panel: | Orthopedic |
| Class | II |
| Product Codes: | HRS, HWC |
Predicate Device:
Primary Predicate: Claw® II Polyaxial Compression Plating System and Ortholoc™ 3DSi Locking Screws, K113014
Reference Device: Wright Medical FuseForce™ Staple, K124045
Purpose of Submission:
The purpose of this Traditional 510(k) is to seek clearance of a new dynamic active compression plate system for use in skeletally mature patients for stabilization of fractures, revisions, osteotomies, arthrodesis and reconstruction of small bones of the foot.
Device Description and Technological Characteristics:
The DAC Dynamic Active Compression Plate (DAC plate) System is a zero-step locking plate that provides stability and active compression. The system includes screws and plates of varying sizes and configurations to accommodate various patient anatomies. The plates contain nitinol wires housed under tension in sliders kept in place with release pins. When the built-in release pins are removed, the nitinol wires return to their straight condition, creating compression. The implant components of the system are manufactured from titanium alloy (ASTM F136) and nitinol (ASTM F2063). The components of this system should not be used with components of any other system. The implants are provided non-sterile and are supplied with instrumentation to facilitate use of the device components.
4
Indications for Use:
The DAC Plate System with proprietary compression technology is indicated for use in skeletally mature patients for stabilization and fixation of fractures, revisions, osteotomies, arthrodeses and reconstruction of small bones of the foot such as:
- Midfoot and hindfoot arthrodeses or osteotomies ●
- . Tarsometatarsal arthrodeses (metatarsocuneiform, metatarsocuboid, Lapidus)
- . Intercuneiform arthrodeses
- . Naviculocuneiform arthrodeses
- . Talonavicular arthrodeses
- Calcaneocuboid arthrodeses
- Linsfranc arthrodeses
- . Mono-or-bi-cortical osteotomies in the forefoot, midfoot and hindfoot
- First metatarsophalangeal arthrodeses .
Summary of Technological Characteristics
The subject system has the same intended use and technological characteristics as the predicates and the following similarities:
- · Intended use: stabilization and fixation of fractures, revisions, osteotomies, arthrodesis and reconstruction of small bones of the foot
- Fundamental technology: bone plate and screw system for bone fixation .
- · Similar plate sizes with various configurations
- · Bone Screw sizes: 2.7mm and 3.5mm diameter in 12-40mm lengths
- · Packaging and sterility: sold non-sterile; steam sterilized by user
- · Materials: metallic devices with well-established biological safety as orthopedic implants
- · Substantially equivalent mechanical performance sufficient for the intended uses
- · Instrumentation provided to aid in implantation
There are minor differences in the design characteristics of the DAC Plate System, including the nitinol wires which create compression across the fracture as the release pins are removed during surgery. This difference is design was evaluated through mechanical testing which showed equivalent performance with no new failure modes. The differences do not raise different issues of safety or effectiveness, further evidenced by all non-clinical evidence provided in this submission.
Another difference is that the subject system will be labeled as magnetic resonance (MR) conditional; performance testing has been submitted for support of this claim.
Discussion of Supporting Clinical Evidence and Non-Clinical Evidence
The following non-clinical evidence was submitted and relied upon for a determination of substantial equivalence:
- · Mechanical performance:
- ASTM F382-17: Standard Specification and Test Method for Metallic Bone . Plates: static and dynamic 4-point bend tests
- . ASTM F543-17: Standard Specification and Test Methods for Metallic Medical Bone Screws: axial pull-out. insertion-removal torque and torsional strength tests
5
- ASTM F564-17: Standard Specification and Test Methods for Metallic Bone . Staples: static and dynamic tension tests
- Engineering analysis of compression forces .
MR Safety evaluation determined the devices are MR Conditional via the following standard methods:
o ASTM F2052-15, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
o ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment ASTM F2182-11a. Standard Test Method for Measurement of Radio Frequency o Induced Heating Near Passive Implants During Magnetic Resonance Imaging ASTM F2119-07 (Reapproved 2013), Standard Test Method for Evaluation of o MR Image Artifacts from Passive Implants
- Cleaning and sterilization validations and evaluations .
- . ISO 10993-1 Biological safety evaluation
- ASTM F2129 Cyclic Potentiodynamic Polarization study for corrosion susceptibility ●
There are no clinical tests relied on in this premarket notification submission for a determination of substantial equivalence.
Conclusion
Based on the information provided above, the DAC Dynamic Active Compression Plate System is substantially equivalent to the predicate devices.