(30 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the staples, with no mention of AI or ML.
Yes
The device is described as staples intended to provide fixation for fractures of the bones of the hand and foot, which is a direct treatment for a medical condition.
No
Explanation: The device, Medline UNITE® REFLEX® Nitinol Staples, is a surgical implant designed for fixation of bone fractures. Its intended use is therapeutic (providing structural support), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly states the device is manufactured from nickel titanium alloy (Nitinol) and describes physical characteristics like size and bridge width, indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description and Intended Use: The provided information clearly describes a surgical implant (staples made of Nitinol) intended for fixing bone fractures within the body. It is a physical device used in a surgical procedure, not for analyzing biological samples.
The description focuses on the material, dimensions, and mechanical properties of the staples, along with performance testing related to their structural integrity and biocompatibility as an implant. This is consistent with a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
Product codes
JDR
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. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand and foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Performance Testing (Bench)
The following testing and engineering analyses were performed to demonstrate substantial equivalence between the proposed Medline UNITE® REFLEX® Nitinol Staple Kit and the predicate Medline UNITE® REFLEX® Nitinol Staples (non-sterile) cleared in K231885.
- Elastic Static Bend and Constant Amplitude Bending Fatigue Testing per ASTM F564 ●
- Pullout Strength Testing per ASTM F564 ●
- Corrosion Susceptibility Testing per ASTM F2129 ●
- Bacterial endotoxin was evaluated using the Limulus Amebocyte Lysate (LAL) kinetic chromogenic assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device.
Results of the testing and engineering analyses demonstrate that the Medline UNITE® REFLEX® Nitinol Staples are substantially equivalent to the predicate devices.
The proposed Medline UNITE® REFLEX® Nitinol Staples were tested per ASTM F2129 and were found to be acceptable in corrosion susceptibility.
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.
Key Metrics
Bacterial endotoxin: meets the recommended maximum endotoxin level of 20 EU per device.
Predicate Device(s)
Medline UNITE® REFLEX® Nitinol Staple System K231885, Medline UNITE® REFLEX® Nitinol Staple System K210482, Sniper Staple System K162354
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
October 19, 2023
Medline Industries, LP Jennifer Mason Regulatory Affairs Principal Three Lakes Drive Northfield, Illinois 60093
Re: K232905
Trade/Device Name: Medline UNITE® REFLEX® Nitinol Staple Kit 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: September 18, 2023 Received: September 19, 2023
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-reporting-mdr-how-reportmedical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE(@;fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher Ferreira -S
for
Limin Sun, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K232905
Device Name Medline UNITE® REFLEX® Nitinol Staple Kit
Indications for Use (Describe)
The Medline UNITE® REFLEX® Nitinol Staples are intended to provide fixation for fractures of the bones of the hand and foot such as: First metatarsalcunerform arthrodesis, First metatarsophalangeal arthrodesis, Talo-Navicular Fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples 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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3
Image /page/3/Picture/0 description: The image is a logo for Medline. The logo features the word "MEDLINE" in bold, sans-serif font, placed on the left side of the image. To the right of the word is a white, stylized starburst symbol. The background of the logo is a solid dark blue color.
edline Industries, LP ree Lakes Drive Northfield, II 60093
K232905
Page 1 of 6
K232905 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
Contact Person: Jennifer Mason, Regulatory Affairs Principal Phone: 847-643-3652 Email: jamason(@medline.com
Summary Preparation Date September 18, 2023
Type of 510(k) Submission Special
Device Name / Classification
Trade Name: Medline UNITE® REFLEX® Nitinol Staple Kit 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
Primary Predicate Device
Medline UNITE® REFLEX® Nitinol Staple System K231885
Predicate Device
Medline UNITE® REFLEX® Nitinol Staple System K210482
4
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
K232905
Page 2 of 6
Predicate Device
Sniper Staple System K162354
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. Chemical etching and passivation are common processes to create a uniform oxidation layer on the surface of the implant. The kits includes staples offered in a range of sizes from 8mm x 8mm to 25mm x 25mm. The Medline UNITE® REFLEX® Nitinol Staples are offered in three different bridge widths. The MINI 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. Table 1 below has a description of the staple sizes.
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: First metatarsalcuneiform arthrodesis, First metatarasophalangeal arthrodesis, Talo-Navicular fusion, LisFranc arthrodesis, Akin osteotomy, Scarf and Chevron osteotomies. Staples are intended for single use only.
Summary of Technological Characteristics
| Device
Characteristic | Proposed
Device | Primary
Predicate
Device | Predicate
Device | Predicate
Device | Comparison
Analysis |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Product Name | Medline UNITE®
REFLEX® Nitinol
Staple Kit | Medline UNITE®
REFLEX® Nitinol
Staple System | Medline UNITE®
REFLEX® Nitinol
Staple System | Trilliant Sniper
Staple System | Same and
Different |
| 510(k) Reference | TBD | K231885 | K210482 | K162354 | N/A |
| Product Owner | Medline Industries,
LP | Medline Industries,
LP | Medline Industries,
LP | Trilliant Surgical,
LTD | Same and
Different |
| Product Code | JDR | JDR | JDR | JDR | Same |
| Intended Use | The Medline
UNITE®
REFLEX® Nitinol
Staples are
intended to provide
fixation for
fractures, fusions | The Medline
UNITE®
REFLEX® Nitinol
Staples are
intended to provide
fixation for
fractures, fusions | The Medline
UNITE®
REFLEX® Nitinol
Staples are
intended to provide
fixation for
fractures, fusions | The Trilliant
Surgical Sniper
Staple System is
indicated for
fixation of
fractures and
osteotomies of the | Primary Predicate
- same
Predicates -
similar |
| | or osteotomies of
the bones of the
hand and foot such
as: First
metatarsalcuneifor
m arthrodesis, First
metatarasophalang
eal arthrodesis,
Talo-Navicular
fusion, LisFranc
arthrodesis, Akin
osteotomy, Scarf
and Chevron
osteotomies.
Staples are
intended for single
use only. | or osteotomies of
the bones of the
hand and foot such
as: First
metatarsalcuneifor
m arthrodesis, First
metatarasophalang
eal arthrodesis,
Talo-Navicular
fusion, LisFranc
arthrodesis, Akin
osteotomy, Scarf
and Chevron
osteotomies.
Staples are
intended for single
use only. | 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. | hand, foot, and
bones appropriate
for the size of the
device. | Primary Predicate
– same
Predicates – same |
| Regulation
Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | |
| Design Features | Straight top
configurations | Straight top
configurations | Straight top
configurations | Straight top
configurations | |
| Leg Lengths | 8mm | 8mm | 8mm | 8mm | Primary Predicate
– similar
Predicates –
similar |
| | 10mm | 10mm | 10mm | 10mm | |
| | 12mm | 12mm | 12mm | | |
| | 15mm | 14mm | 15mm | | |
| | 18mm | 15mm | 18mm | | |
| | 20mm | 16mm | 20mm | | |
| | 25mm | 18mm | 25mm | | |
| | | 20mm | 27mm | | |
| | | 25mm | | | |
| Legs | 2-leg | 2-leg and 4-leg | 2-leg | 2-leg | Primary Predicate
– similar
Predicates - same |
| | | | | | |
| | | | | | |
| Bridge Lengths | 8mm | 8mm | 8mm | 8mm | Primary Predicate
– similar
Predicates - same
and similar |
| | 10mm | 10mm | 10mm | 10mm | |
| | 12mm | 12mm | 12mm | | |
| | 15mm | 15mm | 15mm | | |
| | 18mm | 18mm | 18mm | | |
| | 20mm | 20mm | 20mm | | |
| | 25mm | 23mm | 25mm | | |
| | | 25mm | | | |
| | | 26mm | | | |
| | | 30mm | | | |
| Materials | Nickel Titanium
Alloy | Nickel Titanium
Alloy | Nickel Titanium
Alloy | Nickel Titanium
Alloy | |
| | | | | | |
| | | | | | |
| Surface Finish | Chemical etch and
passivation | Chemical etch and
passivation | Chemical etch and
passivation | Unknown | Primary Predicate - same
Predicate - same |
| Manufacturing
Process | Wire EDM and
tumbling | Wire EDM and
tumbling | Wire EDM and
tumbling | Unknown | Primary Predicate
– same
Predicate - same |
| Instrumentation | Drill Bit
Drill Guide
Inserter
Pin
Tamp (class I)
Akin Blade (class I) | Drill Bit
Drill Guide
Targeting Guide
Inserter
Sleeve
Pin | Drill Bit
Drill Guide
Inserter
Pin | Drill Bit / Post
Drill Guide
Inserter | Primary Predicate
— similar
Predicates - same
and similar |
| Prescription vs.
OTC | Prescription Use | Prescription Use | Prescription Use | Prescription Use | Primary Predicate - same
Predicate - same |
| Sterile vs. Non-
Sterile | Sterile | Non-sterile | Non-sterile | Sterile | Primary Predicate
— different
Predicate -
different and
same |
TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
6
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Medline Industries. LP Three Lakes Drive Northfield, IL 60093
K232905
Page 4 of 6
- Intended Use same. Both the subject device and the predicate devices are intended to provide . fixation for fractures, fusions or osteotomies of the bones of the hand and foot.
- Indications for Use - same. The indications for use for the new proposed Medline UNITE® REFLEX® Nitinol Staple Kit are identical to the indications for use for the primary predicate device cleared in K231885.
- Design Features same. Both the subject device and both the predicate staples are offered in ● straight top configurations.
- . Leg Lengths - similar. The primary predicate and subject devices are both offered in identical leg lengths of 8mm, 10mm, 12mm, 18mm, 20mm and 25mm. The K162354 staples are only offered in leg lengths of 8mm and 10mm.
- Staple Legs similar. The staples in the Medline UNITE® REFLEX® Nitinol Staple Kit will be ● available in a 2-leg design only.
- Bridge Lengths similar. The predicate and subject 2-leg staples are both offered in identical ● bridge lengths of 8mm, 10mm, 15mm, 18mm, 20mm and 25mm. The K162354 staples are only offered in bridge lengths of 8mm and 10mm.
7
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Medline Industries, LP Three Lakes Drive Northfield, IL 60093
Page 5 of 6
- Materials same. Both the Medline UNITE® REFLEX® Nitinol Staple Kit and the predicate ● staples are manufactured from nickel titanium alloy (Nitinol) per ASTM F2063.
- Surface Finish same. The Medline UNITE® REFLEX® Nitinol Staple Kit and ● the Medline UNITE® predicate staples have the same surface finish. The nitinol staples are chemical etched and passivated. The surface finish of the K162354 is unknown.
- Manufacturing Process same. Both the subject device and the Medline UNITE® predicate ● devices are manufactured using the exact same process. The manufacturing process of the K162354 is unknown.
- Instrumentation similar. Both the subject device and predicate devices have similar ● instrumentation for use with 2-leg staples, but does not include the 4-leg specific instrumentation in the primary predicate.
- Sterility - different and same. The predicate staples are provided non-sterile and intended to be cleaned and steam sterilized prior to use. The subject devices are sterile packed and sterilized via gamma sterilization. A sterilization validation was performed on the Medline UNITE® REFLEX® Nitinol Staple Kit to ensure the devices can be sterilized to a 106 sterility assurance level. In addition, a stability study was conducted to support a 5-year shelf life.
The subject device and the K162354 predicate are both Nitinol bone staples sterilized using gamma radiation.
Summary of Non-Clinical Testing
The subject Medline UNITE® REFLEX® Nitinol Staple Kit do not represent a new worst-case when compared to the previously cleared predicate devices.
Performance Testing (Bench)
The following testing and engineering analyses were performed to demonstrate substantial equivalence between the proposed Medline UNITE® REFLEX® Nitinol Staple Kit and the predicate Medline UNITE® REFLEX® Nitinol Staples (non-sterile) cleared in K231885.
- Elastic Static Bend and Constant Amplitude Bending Fatigue Testing per ASTM F564 ●
- Pullout Strength Testing per ASTM F564 ●
- Corrosion Susceptibility Testing per ASTM F2129 ●
8
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edline Industries, LR Three Lakes Drive Northfield, IL 60093
K232905
Page 6 of 6
- Bacterial endotoxin was evaluated using the Limulus Amebocyte Lysate (LAL) kinetic chromogenic assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device.
Results of the testing and engineering analyses demonstrate that the Medline UNITE® REFLEX® Nitinol Staples are substantially equivalent to the predicate devices.
The proposed Medline UNITE® REFLEX® Nitinol Staples were tested per ASTM F2129 and were found to be acceptable in corrosion susceptibility.
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.
Other Testing
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, LP concludes that the Medline UNITE® REFLEX® Nitinol Staple Kit is as safe and as effective for their intended use as the predicate devices.