(62 days)
The Medline UNITE® REFLEX™ Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as : LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The system includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 27mm. The Medline UNITE® REFLEX™ Nitinol Staples are offered in three different bridge widths. The MNI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples. The system includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drill bits, pins and an inserter.
The provided document describes the Medline UNITE® REFLEX™ Nitinol Staple System (K210482), a metallic bone fixation device, and its substantial equivalence determination by the FDA. The information focuses on non-clinical (bench) testing, as no animal or clinical testing was performed for this 510(k) submission.
Since the submission is for a traditional 510(k) for a metallic bone fixation device, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily related to bench testing for mechanical and material properties, rather than AI/software performance as would be typical for an AI-powered medical device.
Therefore, the response will interpret the request within the context of the provided document, focusing on the mechanical and material performance testing rather than AI-specific criteria.
Here's a breakdown based on the provided text:
Preamble: This 510(k) submission is for a physical medical device (bone staples), not an AI/software device. Consequently, the "acceptance criteria" and "study proving the device meets the acceptance criteria" pertain to benchtop performance testing (mechanical and material properties) to demonstrate substantial equivalence to a predicate device, rather than AI model performance (e.g., sensitivity, specificity, AUC). Therefore, many of the requested points (e.g., number of experts for ground truth, MRMC study, training/test set sample sizes, data provenance for AI) are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
The document details performance testing conducted to show substantial equivalence. The specific numerical acceptance criteria and exact reported performance values are not explicitly stated in the summary, but rather implied by the statement that testing was "conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples are equivalent to the predicate FuseForce Implant System." For 510(k) submissions of this type, the acceptance criterion is typically that the subject device's performance is demonstrably equivalent or superior to the predicate device within a specified statistical margin, or meets established ASTM standards.
| Acceptance Criteria Category | Basis of Acceptance Criterion | Reported Device Performance (Summary) |
|---|---|---|
| Elastic Static Bend Testing (per ASTM F564.A4) | Proposed device's bending stiffness is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Constant Amplitude Bending Fatigue Testing (per ASTM F564.A1) | Proposed device's bending fatigue performance is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Pull-Out Strength Testing (per ASTM F564.A2) | Proposed device's pull-out strength is equivalent to the predicate FuseForce Implant System. | Testing was conducted to ensure equivalence. (Specific numerical results are not provided in this summary, but the conclusion is that they are equivalent). |
| Corrosion Susceptibility Testing (per ASTM F2129) | All samples achieve electrostatic breakdown potential (Eb) equal to or greater than +400mV, as per FDA guidance (Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol) and Corrosion Testing of Medical Implants. | Testing was conducted to ensure the proposed device meets the outlined criteria. (Specific numerical results are not provided in this summary, but the conclusion implies this criterion was met). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the summary for each specific test (e.g., how many staples were bend tested, how many for corrosion). For bench testing, sample sizes are typically determined by statistical power requirements to demonstrate equivalence to the predicate or adherence to a standard, and can vary by test type.
- Data Provenance: The studies were non-clinical bench tests performed by Medline Industries, Inc. (location: Northfield, Illinois, USA). This is retrospective in the sense that the testing was performed to support the 510(k) submission for the device already designed and manufactured. There is no patient or image data involved.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a bench test for a physical device, not an AI/software device requiring "ground truth" established by human experts on clinical data. The "ground truth" for these tests is the quantitative measurement of mechanical and material properties against established ASTM standards and the performance of the predicate device.
4. Adjudication Method for the Test Set
- Not Applicable. As this is bench testing of physical properties, there is no human adjudication process involved. Measurements are objective and quantitative.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- Not Applicable. MRMC studies are used for assessing the performance of medical imaging interpretation systems, particularly AI-assisted reading, by comparing human readers with and without AI assistance across multiple cases. This submission is for a physical orthopedic implant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Not Applicable. This point refers to AI algorithm performance. The Medline UNITE® REFLEX™ Nitinol Staple System is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- Bench Test Results Against Predicate & Standards: The "ground truth" for this device's performance evaluation comes from:
- Quantitative measurements of mechanical and material properties (e.g., bending stiffness, fatigue life, pull-out strength, corrosion potential).
- Comparison of these measurements against the performance of the legally marketed predicate device (FuseForce Implant System).
- Adherence to specified ASTM international standards (ASTM F564, ASTM F2129).
8. The Sample Size for the Training Set
- Not Applicable. This question relates to AI/machine learning models. The device is a physical product, and no training set (in the ML sense) was used. The device design and manufacturing processes are based on established engineering principles and material science.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no "training set" for an AI model, this question is not relevant to this submission. The "ground truth" in physical device development is often internal R&D, design specifications, and the historical performance of similar devices and materials.
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April 22. 2021
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Medline Industries, Inc. Jennifer Mason Regulatory Affairs Senior Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K210482
Trade/Device Name: Medline UNITE REFLEX Nitinol Staple System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: JDR Dated: February 5, 2021 Received: February 19, 2021
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.
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
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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 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.
Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty 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)
K210482
Device Name Medline UNITE® REFLEX™ Nitinol Staple System
Indications for Use (Describe)
The Medline UNITE REFLEX Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as : LisFranc arthrodesis, Akin Osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K210482 Page 1 of 5
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
Registration Number: 1417592
Contact Person
Jennifer Mason Senior Regulatory Affairs Specialist Phone: 847-643-3652 Email: jamason@medline.com
Summary Preparation Date March 2, 2021
Type of 510(k) Submission Traditional
Device Name / Classification
Trade Name: Medline UNITE® REFLEX™ Nitinol Staple System Common Name: Staple, Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories Product Code: JDR Classification Panel: Orthopedics Regulatory Class: Class II Regulation Number: 21 CFR 888.3030
Predicate Device
FuseForce Implant System K124045
Device Description
The Medline UNITE® REFLEX™ Nitinol Staples are manufactured from nickel titanium alloy (Nitinol). The staples utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The system includes staples offered in a range of sizes from 8mm x 8mm to 25mm x
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edline Industries. Inc Three Lakes Drive Northfield, IL 60093
27mm. The Medline UNITE® REFLEX™ Nitinol Staples are offered in three different bridge widths. The MNI features a 1.5mm bridge width, the MAX has a 4.0mm bridge width and the ULTRA has a 5.0mm bridge width. Table 1 below has a description of the staple sizes.
TABLE 1: Staple Descriptions
| Staple | Bridge Widths | Bridge Lengths |
|---|---|---|
| Medline UNITE®REFLEX™ MINI Staples | 1.5mm | 8 x 8mm |
| 10 x 10mm | ||
| 12 x 12mm | ||
| Medline UNITE®REFLEX™ MAX Staples | 4.0mm | 15 x 15mm |
| 15 x 18mm | ||
| 18 x 18mm | ||
| 18 x 20mm | ||
| 20 x 20mm | ||
| Medline UNITE®REFLEX™ ULTRAStaples | 5.0mm | 20 x 20mm |
| 25 x 20mm | ||
| 25 x 25mm | ||
| 25 x 27mm |
The MAX and ULTRA staples have a chamfer on the bridge that is not present on the MINI version of the staples. A comparison of the proposed and predicate staples is included below in Tables 2 and 3. The system includes reusable instrumentation necessary to implant the staples, e.g. drill guides, drill bits, pins and an inserter.
Indications for Use
The Medline UNITE® REFLEX™ Nitinol Staples are intended to provide fixation for fractures, fusions or osteotomies of the bones of the hand and foot such as LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
Summary of Technological Characteristics
| Device Characteristic | Medline UNITE® REFLEX™Nitinol Staples (Proposed) | FuseForce Implant System(Predicate) |
|---|---|---|
| 510(k) | TBD | K124045 |
| Product Owner | Medline Industries, Inc. | Wright Medical Technology |
TABLE 2: Comparison of Proposed and Predicate Devices
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Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093
| (previously Solana Surgical, LLC) | ||
|---|---|---|
| Product Code | JDR | JDR |
| Regulation Number | 21 CFR 880.3030 | 21 CFR 880.3030 |
| Indications for Use | The Medline UNITE® REFLEX™Nitinol Staples are intended toprovide fixation for fractures, fusionsor osteotomies of the bones of thehand and foot such as LisFrancarthrodesis, Akin osteotomy, Scarfand Chevron osteotomies. Staplesare intended for single use only. | The Solana Surgical, LLC FuseForceImplant System is intended toprovide fixation for fractures, fusionsor osteotomies of the bones of thehand and foot such as LisFrancarthrodesis, Akin osteotomy, Scarfand Chevron osteotomies |
TABLE 3: Comparison of Proposed and Predicate Staples
| Device Characteristic | Medline UNITE® REFLEX™ Nitinol Staples (Proposed) | FuseForce Implant System (Predicate) | Comparison |
|---|---|---|---|
| Materials | Nickel Titanium Alloy (Nitinol) | Nickel Titanium Alloy (Nitinol) | Identical |
| Design Feature | Straight top configuration | Straight top configurations | Identical |
| Leg Lengths | 8mm10mm12mm15mm18mm20mm25mm27mm | 8mm10mm12mm13mm and 15mm (offset)15mm16mm20mm22mm | Similar |
| Bridge Lengths | 8mm10mm12mm15mm18mm20mm25mm | 8mm10mm12mm15mm18mm20mm25mm | Identical |
| Sterile vs. Non-Sterile | Non-sterile | Sterile - gamma | Different |
- Indications for Use identical. The indications for use for the Medline UNITE® REFLEX™ . Nitinol Staples are identical to the predicate device. Both staple systems are intended to provide
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Medline Industries, Inc. Three Lakes Drive Northfield. IL 60093
fixation for fractures, fusions or osteotomies of the hand and foot such as LisFranc arthrodesis. Akin osteotomy, Scarf and Chevron osteotomies.
- Materials identical. Both the subject device and the predicate device are made from nickel ● titanium alloy (Nitinol) per ASTM F2063.
- Design Features identical. Both the Medline UNITE® REFLEX™ Nitinol Staples and the . FuseForce staples feature a straight top design.
- . Leg Lengths - similar. The subject device will be offered in sizes ranging from 8mm to 27mm. The predicate device leg lengths range from 8mm to 22mm.
- Bridge Lengths identical. Both the Medline UNITE® REFLEX™ Nitinol Staples and the . FuseForce staples are offered in the exact same lengths and range from 8mm to 25mm.
- . Sterility - the subject device will be offered non-sterile intended to be sterilized by steam sterilization. The predicate FuseForce staples are provided sterile.
Summary of Non-Clinical Testing
The following tests were performed in accordance with ASTM F564 to demonstrate substantial equivalence between the proposed Medline UNITE® REFLEX™ Nitinol Staples and the predicate FuseForce Implant System.
Performance Testing (Bench)
The following tests were performed in accordance with ASTM F2129 to demonstrate substantial equivalence between the proposed Medline UNITE® REFLEX™ Nitinol Staples and the predicate FuseForce Implant System.
Elastic Static Bend Testing
Elastic static bend testing was conducted per ASTM F564.A4. Testing was conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples are equivalent to the predicate FuseForce Implant System in bending stiffness.
Constant Amplitude Bending Fatigue Testing
Constant amplitude bend fatigue testing was conducted per ASTM F564.A1. Testing was conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples are equivalent to the predicate Fuseforce Implant System in bending fatigue.
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edline Industries. Inc. Three Lakes Drive Northfield. IL 60093
Pull-Out Strength Testing
Pull-out strength testing was conducted per ASTM F564.A2. Testing was conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples are equivalent to the predicate Fuseforce Implant System in pull-out strength.
Corrosion Susceptibility Testing
Corrosion susceptibility testing was conducted per ASTM F2129 and the FDA guidance document Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Testing was conducted to ensure that the proposed Medline UNITE® REFLEX™ Nitinol Staples meet criteria outlined in Corrosion Testing of Medical Implants . The risk based acceptance criteria used to determine acceptable corrosion susceptibility for the proposed device, were that all samples achieved electrostatic breakdown potential(Eb) equal to or greater than +400mV.
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 Medline UNITE® REFLEX Nitinol Staple System is substantially equivalent to the predicate device, FuseForce Implant 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.