(198 days)
No
The summary describes a physical implantable device made of nitinol. There is no mention of software, algorithms, image processing, or any other indicators of AI/ML technology. The performance studies focus on material properties and corrosion, not algorithmic performance.
Yes.
The device is used for bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation, all of which are therapeutic interventions.
No
Explanation: The device is indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are therapeutic and surgical interventions, not diagnostic processes.
No
The device description clearly states the device is manufactured from nickel titanium alloy (nitinol) and is a physical disc, indicating it is a hardware device, not software.
Based on the provided information, the Medline UNITE® REFLEX™ Dynamic Discs are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation. These are all procedures performed in vivo (within the body).
- Device Description: The description details a physical implant made of nickel titanium alloy.
- 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 to perform tests on samples taken from the body, not implanted into the body for therapeutic or structural purposes.
N/A
Intended Use / Indications for Use
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Medline UNITE® REFLEX™ Dynamic Discs are manufactured from nickel titanium alloy (nitinol). The discs utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The discs are offered in various diameters and thicknesses to be used in conjunction with screws of various diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones appropriate for the size of the device
Indicated Patient Age Range
Not Found
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)
- Transformation Temperature: Transformation testing was performed on the subject Medline UNITE® REFLEX™ Dynamic Discs using the DSC method per ASTM F2004 "Standard Test Method for Transformation Temperature of Nickel-Titanium Allovs by Thermal Analysis".
- Galvanic Corrosion: The Medline UNITE® REFLEX™ Dynamic Discs were tested for galvanic corrosion per ASTM F3044 "Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants". The discs and screws representing the largest surface area ratio of the expected cathode material (titanium allov) to the expected anode material (nitinol) were chosen for testing. Microscopic examination of all 3 test samples revealed no pitting or indications of corrosion. The average calculated material release from mass loss, which includes both titanium alloy and nitinol materials, was significantly less than the CDRH recommended parenteral nickel limit value of 35µg/day for a 70kg adult.
- Corrosion Susceptibility: Corrosion susceptibility testing was conducted per ASTM F2129 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices". The discs, representing the worst-case in surface area, were tested as a construct with the screws implanted into Sawbones® to simulate in-vivo anatomic conditions. All samples achieved electrostatic breakdown potentials in excess of the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility.
- Clinical Testing: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- For galvanic corrosion, microscopic examination of all 3 test samples revealed no pitting or indications of corrosion. The average calculated material release from mass loss was significantly less than the CDRH recommended parenteral nickel limit value of 35µg/day for a 70kg adult.
- For corrosion susceptibility, all samples achieved electrostatic breakdown potentials in excess of the minimum acceptance criteria.
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.
Medline Cannulated Screws K130319
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.
Medline UNITE® REFLEX™ Nitinol Staple System K210482
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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December 10, 2021
Medline Industries, Inc. Jennifer Mason Senior Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K211612
Trade/Device Name: Medline UNITE® REFLEX™ Dynamic Discs Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: September 1, 2021 Received: September 3, 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.
1
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, MPH 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)
Device Name Medline UNITE® REFLEX™ Dynamic Discs
Indications for Use (Describe)
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.
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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4-001
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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 November 22, 2021
Type of 510(k) Submission
Traditional
Device Name / Classification
Trade Name: Medline UNITE® REFLEX™ Dynamic Discs Common Name: Washer, Bolt Nut Classification Name: Washer, Bolt Nut Product Code: HTN Classification Panel: Orthopedic Regulatory Class: Class II Regulation Number: 21 CFR 888.3030
Primary Predicate Device
Medline Cannulated Screws K130319
Reference Device Medline UNITE® REFLEX™ Nitinol Staple System K210482
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Image /page/4/Picture/0 description: The image is the logo for Medline. The logo is white text on a blue background. The text "MEDLINE" is in bold, sans-serif font. To the right of the text is a white starburst symbol.
Device Description
The Medline UNITE® REFLEX™ Dynamic Discs are manufactured from nickel titanium alloy (nitinol). The discs utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The discs are offered in various diameters and thicknesses to be used in conjunction with screws of various diameters.
Indications for Use
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion and fracture repair and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.
Summary of Technological Characteristics
| Device
Characteristic | Proposed Device | Predicate (Primary)
Device | Reference Device | Comparison
Analysis |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Product Name | Medline UNITE®
REFLEX™ Dynamic
Discs | Medline Cannulated
Screws | Medline UNITE®
REFLEX™ Nitinol
Staple System | Different |
| Photos of the
Devices | Image: Proposed Device | Image: Predicate Device | Image: Reference Device | N/A |
| 510(k)
Reference | K211612 | K130319 | K210482 | Different |
| Product Owner | Medline Industries, Inc. | Medline Industries, Inc. | Medline Industries, Inc. | Same |
| Product Code | HTN | HWC | JDR | Different |
| Intended Use | The Medline UNITE®
REFLEX™ Dynamic
Discs are indicated for use
in bone reconstruction,
osteotomies, arthrodesis,
joint fusion and fracture
repair and fracture fixation
of bones appropriate for
the size of the device.
Discs are intended for
single use only. | The Medline Cannulated
Screws are indicated for
use in bone reconstruction,
osteotomies, arthrodesis,
joint fusion, fracture
repair, and fracture
fixation of bones
appropriate for the size of
the device. Screws are
intended for single use
only. | 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 | Primary Predicate
- Same
Secondary
Predicate –
Similar |
TABLE 1: COMPARISON OF PROPOSED, PREDICATE AND REFERENCE DEVICES
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| | | | Staples are single use
only. | |
|-----------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Regulation
Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Design Features | Increases surface area of
screw head | Increases surface area of
screw head | N/A | Same |
| Design
Configurations | Ø3.0 or 5.75mm
Ø3.5 or 6.61mm
Ø4.0 or 7.65mm
Ø4.5 or 8.50mm
Ø5.5 or 10.20mm
Ø7.0 or 12.75mm | Ø2.0/Ø2.5 or 6.00mm
Ø3.0/Ø3.5 or 8.00mm
Ø4.0/Ø4.5 or 10.00mm
Ø6.5 or 14.00mm
Ø7.5 or 16.00mm | 8 x 8mm
10 x 10mm
12 x 12mm
15 x 15mm
15 x 18mm
18 x 20mm
20 x 20mm
25 x 20mm
25 x 25mm
25 x 27mm | Different |
| Materials | Nickel Titanium Alloy | Titanium Alloy or
Stainless Steel | Nickel Titanium Alloy | Primary Predicate
– Different
Secondary
Predicate – Same |
| Prescription vs.
OTC | Prescription | Prescription | Prescription | Same |
| Sterile vs. Non-
Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single Use vs.
Reusable | Single Use Only | Single Use Only | Single Use Only | Same |
The proposed modified device. Medline UNITE® REFLEX™ Dynamic Discs is substantially equivalent to the primary predicate, the Medline Cannulated Screws. A discussion of similarities and differences is listed below.
- Indications for use same. The subject device, the Medline UNITE® REFLEX™ Dynamic Discs . have the exact same indications for use as the Medline Cannulated Screws.
- Design Features same. Both the subject device and the predicate device are intended to increase the . surface area of the screw head.
- Design Configurations – similar. The Medline UNITE® REFLEX™ Dynamic Discs will be offered in sizes ranging from Ø3.0 to Ø7.0 whereas, the predicate device is offered in sizes Ø2.0 to Ø7.5. The subject device falls within the size range of the current Medline Cannulated Screws.
- Materials different. The Medline UNITE® REFLEX™ Dynamic Discs are made from nitinol. The . predicate device, is made from either stainless steel or titanium. To address this difference, a reference device has been provided, the Medline UNITE® RELEX™ Nitinol Staples, which are
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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in a bold, sans-serif font, with the letters arranged horizontally. To the right of the word, there is a stylized star-like symbol with four points. The background of the logo is a solid dark blue color, which provides a strong contrast to the white text and symbol.
made from the exact same nitinol material as the proposed Dynamic Discs. Testing was performed on the Dynamic Discs to ensure the nitinol meets the FDA guidance Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. The testing included determining the austenite finish (Af) temperature on final finished devices per ASTM F2004 and performing corrosion susceptibility testing per ASTM F2129.
Summary of Non-Clinical Testing
Transformation Temperature
Transformation testing was performed on the subject Medline UNITE® REFLEX™ Dynamic Discs using the DSC method per ASTM F2004 "Standard Test Method for Transformation Temperature of Nickel-Titanium Allovs by Thermal Analysis".
Galvanic Corrosion
The Medline UNITE® REFLEX™ Dynamic Discs were tested for galvanic corrosion per ASTM F3044 "Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants". The discs and screws representing the largest surface area ratio of the expected cathode material (titanium allov) to the expected anode material (nitinol) were chosen for testing. Microscopic examination of all 3 test samples revealed no pitting or indications of corrosion. The average calculated material release from mass loss, which includes both titanium alloy and nitinol materials, was significantly less than the CDRH recommended parenteral nickel limit value of 35µg/day for a 70kg adult.
Corrosion Susceptibility
Corrosion susceptibility testing was conducted per ASTM F2129 "Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices". The discs, representing the worst-case in surface area, were tested as a construct with the screws implanted into Sawbones® to simulate in-vivo anatomic conditions. All samples achieved electrostatic breakdown potentials in excess of the minimum acceptance criteria, demonstrating acceptable corrosion susceptibility.
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™ Dynamic Discs are substantially equivalent to the predicate device, the Medline Cannulated Screws.