(272 days)
The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.
The ATLAS™ Plating System is a metallic plate and screw system for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist of children (2-12 years), adolescents (12-21 years), and adults. The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13). The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17).
The provided text is a 510(k) summary for the ATLAS™ Plating System. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, primarily through mechanical testing of the device itself rather than studies involving human or animal subjects or complex algorithms. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic device performance is not present in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantified acceptance criteria (e.g., specific tensile strength values, fatigue limits with minimum requirement numbers) or explicit reported device performance in a table format. Instead, it states that "Mechanical testing for screws (ASTM F543-17)" and "Mechanical testing for plates (ASTM F382-17)" were performed. The conclusion is that "Performance data demonstrate that the ATLAS™ Plating System is substantially equivalent legally marketed predicate devices." This implies that the device met the performance characteristics demonstrated by the predicate devices through these standard tests, which is the basis for substantial equivalence.
If this were an AI/ML device, this section would typically include metrics like Sensitivity, Specificity, AUC, F1-score, accuracy, etc., with associated thresholds.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable to this type of device submission. The "test set" in this context refers to the physical devices (screws and plates) subjected to mechanical testing, not a dataset of patient information. No patient data provenance is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The "ground truth" for mechanical testing is established by engineering standards (ASTM F543-17 and ASTM F382-17) and the physical properties of the materials and device design, not by expert human interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to mechanical testing.
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
This is not applicable. This is a medical device (plating system) submission, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is implicitly the established performance characteristics dictated by the referenced ASTM standards (ASTM F543-17 for screws and ASTM F382-17 for plates), which define the methods and expected results for mechanical properties. The device's performance is compared against the performance of predicate devices tested under similar standards to establish substantial equivalence.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of mechanical device testing for a 510(k) submission of this nature.
9. How the ground truth for the training set was established
This is not applicable.
Summary regarding the provided document:
The provided 510(k) summary for the ATLAS™ Plating System represents a traditional medical device submission focused on mechanical performance and material compatibility. The "study" proving acceptance criteria is a series of mechanical tests conducted according to recognized ASTM standards (ASTM F543-17 and ASTM F382-17). The "acceptance criteria" are not explicitly quantified in the document but are understood to be the successful demonstration of mechanical properties comparable to predicate devices, thus establishing substantial equivalence.
This type of submission does not involve clinical studies with patient data, AI/ML algorithms, or human reader performance evaluations, which are typically found in submissions for diagnostic software or AI-enabled devices.
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April 9, 2020
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MiRus, LLC Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway, Suite 108 Marietta, Georgia 30067
Re: K191867
Trade/Device Name: ATLAS Plating System 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: March 9, 2020 Received: March 10, 2020
Dear Jordan Bauman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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 531-542 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)
Device Name
ATLAS™ Plating System
Indications for Use (Describe)
The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bones and bone fragments in adult and pediatric patients.
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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FORM FDA 3881 (7/17) Page 1 of 1
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510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| I. SUBMITTER | MiRus, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607 |
|---|---|
| II. OFFICIAL CORRESPONDENT | Jordan BaumanVice President, Regulatory AffairsMiRus, LLC1755 West Oak ParkwaySuite 100Marietta, Georgia 30062Tel: (678) 324-6272Fax: (678) 401-5607 |
| III. DATE PREPARED | April 9, 2020 |
| IV. DEVICEName of DeviceCommon NameClassification NameRegulatory ClassProduct CodesSubmission Type | ATLAS™ Plating SystemFixation Bone Screw System21 CFR §888.3030 Single/multiple componentmetallic bone fixation appliances and accessories21 CFR §888.3040 Smooth or threaded metallic bonefixation fastenerClass IIHRS, HWCTraditional 510(k) |
| V. PREDICATE DEVICE | Primary PredicateMINI MAXLOCK Extreme Plating System (K121437)Additional PredicateATLAS™ Plating System (K190415)ORTHOLOC® 3Di Small Bones Plating System(K163039) |
| Reference DeviceEUROPA™ Pedicle Screw System (K130337) |
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VI. DEVICE DESCRIPTION
The ATLAS™ Plating System is a metallic plate and screw system for treatment and fixation of fractures, fusions and osteotomies of bones in the Foot, Ankle, Hand, and Wrist of children (2-12 years), adolescents (12-21 years), and adults. The screws are available in different diameters from Ø2.7mm to Ø5.5mm, non-locking configurations with lengths ranging from 8mm to 60mm. All screws are manufactured from Titanium alloy (Ti-6Al-4V ELI per ASTM F136-13). The plates are available in different geometries to accommodate different patient and bone anatomies. The plates are manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17).
VII. INDICATIONS FOR USE
The ATLAS™ Plating System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies of small bone fragments in adult and pediatric patients.
VIII. PREDICATE DEVICE COMPARISON
The intended use and technological characteristics of the ATLAS™ Plating System are the same as the predicate devices except for the plate material which is manufactured from MoRe® alloy (Molybdenum-47.5Rhenium Alloy per ASTM F3273-17) for enhanced strength.
IX. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Mechanical testing for screws (ASTM F543-17) ●
- Mechanical testing for plates (ASTM F382-17) .
X. CONCLUSIONS
Performance data demonstrate that the ATLAS™ Plating System is substantially equivalent legally marketed predicate devices.
§ 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.