(113 days)
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) patients.
The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits
This document is a 510(k) premarket notification for the Medline UNITE® Calcaneal Fracture Plating System. It focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria through a study involving AI. Therefore, the requested information elements related to AI/algorithm performance and clinical study outcomes cannot be extracted from this document.
The document primarily describes a medical device, its indications for use, and a comparison of its technological characteristics to a predicate device. The performance testing outlined is largely bench testing to demonstrate mechanical equivalence, not clinical effectiveness studies.
Here's what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide explicit acceptance criteria in a quantitative sense for performance metrics like sensitivity, specificity, or image quality, as it's not and AI device undergoing such validation. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must perform equivalently to a legally marketed predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bending stiffness equivalent to predicate device (ASTM F382) | The Medline Unite® Calcaneal Plates and the predicate Wright Medical ORTHOLOC® Calcaneal Plates are substantially equivalent in 4-point single cycle bend testing. |
| Bending fatigue equivalent to predicate device (ASTM F382) | Results from this testing demonstrate that the Medline UNITE® Calcaneal Plates are substantially equivalent to the Wright Medical ORTHOLOC® CALC Fracture Plates in bending fatigue. |
2. Sample sized used for the test set and the data provenance
Not applicable. The "test set" in this context refers to physical devices undergoing mechanical testing, not a dataset for an AI algorithm. The document mentions "Single Cycle 4-Point Bend Testing" and "Bending Fatigue Testing," which involve physical samples of the plates. The document does not specify the exact number of plates tested in these bench tests, nor does it specify data provenance as it would for a clinical study with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for AI algorithms is not relevant here as this is a physical medical device. The "ground truth" for the performance tests is derived from standardized mechanical testing protocols (ASTM F382).
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically for clinical studies where expert consensus is needed. For mechanical testing, the results are objectively measured per established ASTM standards.
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. This is not an AI device, and therefore, an MRMC study involving human readers and AI assistance was not performed. The document explicitly states: "Performance Testing (Clinical) This section does not apply. No clinical testing was performed." and "Summary of Clinical Testing Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI device.
7. The type of ground truth used
For the bench testing, the "ground truth" or reference for comparison is the performance of the legally marketed predicate device as measured by the specified ASTM standards.
8. The sample size for the training set
Not applicable. There is no AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI algorithm.
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Medline Industries, LP Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K213567
Trade/Device Name: Medline UNITE® Calcaneal Fracture 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 Dated: January 6, 2022 Received: January 10, 2022
Dear Jennifer Mason:
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.
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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) 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 531-542 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 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
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Indications for Use
510(k) Number (if known) K213567
Device Name
Medline UNITE® Calcaneal Fracture Plating System
Indications for Use (Describe)
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used both in adult and pediatric (adolescent and child) 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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K213567 - Page 1 of 3
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ledline Industries, LP Three Lakes Drive Northfield, IL 60093
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, LP Three Lakes Drive Northfield, IL 60093 Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Medline Industries, LP Phone: 847-643-3652 Email: jamason(@medline.com
Summary Preparation Date February 22, 2022
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline UNITE® Calcaneal Fracture Plating System Common Name: Plate, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: HRS Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030
Predicate Device Wright Medical ORTHOLOC® Calcaneal Plating System K142121
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Medline Industries, LP Three Lakes Drive Northfield. IL 60093
Reference Devices
Tornier Calcaneal Fracture Plate System K090582
Medline Foot Plates and Screws K151235
Device Description
The Medline UNITE® Calcaneal Fracture Plating System consists of 3 styles of Sinus Tarsi plates (Sinus Tarsi, Sinus Tarsi Offset, and Sinus Tarsi Extension) made from Titanium Alloy (Ti-6Al-4V ELI) and Perimeter plates made from Commercially Pure Titanium. The Sinus Tarsi Offset, and Sinus Tarsi Extension, and Perimeter plates are each offered in small, medium, and large sizes in left and right configurations. The plates can accommodate 2.7mm, 3.5mm and 4.0mm screws. Previously cleared 3.5mm locking and non-locking screws (K151235) that range from 10-60mm in length will be included in the tray with the Medline UNITE® Calcaneal Fracture Plates. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. targeting guide, drill bits
Indications for Use
Medline UNITE® Calcaneal Fracture Plating System are intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of bones in the feet and ankles including extra-articular, intra-articular, joint depression, tongue-type, and severely comminuted fracture of the calcaneus. The system can be used in both adult and pediatric (adolescent and child) patients.
Summary of Technological Characteristics
The proposed device is substantially equivalent to the predicate, Wright Medical ORTHOLOC® Calcaneal Plating System. A discussion of similarities and differences is listed below.
- Intended Use - identical. The subject device and the predicate device have the same intended use.
- Indications for Use similar. The indications for use for the Medline UNITE® Calcaneal Fracture ● Plating System are more specific than the predicate, but still fall under the same intended use.
- Materials similar. The proposed device and the predicate device are both made from CP4 ● titanium. The proposed device is also available in Ti-6Al-4V.
- . Design Features - identical. Both the proposed plates and the predicate feature polvaxial locking to 15 degrees. Both plates can be used with 3.5mm locking and non-locking screws.
- Design Configurations similar. The proposed plates and the predicate plates are both offered in ● left and right configurations. The predicate plates are reversible, whereas, the Medline plates are not.
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edline Industries. L ree Lakes Drive Northfield II 60093
Summary of Non-Clinical Testing
Performance Testing (Bench)
The following tests were performed in accordance with ASTM F382 to demonstrate substantial equivalence between the proposed Medline UNITE® Calcaneal Fracture Plates and the predicate ORTHOLOC® Calcaneal Plates.
Single Cycle 4-Point Bend Testing
Single cycle 4-point bend testing was conducted per ASTM F382. The purpose of this test was to ensure that the bending stiffness of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending stiffness of the predicate Wright Medical Plates. The Medline Unite® Calcaneal Plates and the predicate Wright Medical ORTHOLOC® Calcaneal Plates are substantially equivalent in 4-point single cycle bend testing.
Bending Fatigue Testing
Bending fatigue testing was conducted per ASTM F382. The purpose of this test was to ensure that the bending fatigue of the proposed Medline Unite® Calcaneal Plates were equivalent to the bending fatigue of the predicate Wright Medical Plates. Results from this testing demonstrate that the Medline UNITE® Calcaneal Plates are substantially equivalent to the Wright Medical ORTHOLOC® CALC Fracture Plates in bending fatigue.
Performance Testing (Animal)
This section does not apply. No animal testing was performed.
Performance Testing (Clinical)
This section does not apply. No clinical testing was performed.
Summary of Clinical Testing
Not applicable.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification. Medline Industries. Inc. concludes that the proposed Medline UNITE® Calcaneal Fracture Plating System is substantially equivalent to the predicate device, K142121 ORTHOLOC® Calcaneal Plating System.
§ 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.