(484 days)
No
The device description focuses on the mechanical properties and materials of the implants, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are limited to mechanical testing and biocompatibility, further supporting the conclusion that it is a purely mechanical device.
No.
The device is described as a "fixation system" used to stabilize fractures to promote fusion, rather than actively treating a disease or condition in a therapeutic manner.
No
The device is a fixation system used to stabilize fractures of the anterior chest wall and promote fusion, which is a treatment function, not a diagnostic one.
No
The device description explicitly details physical implants made of stainless steel (plates, links, and screws) intended for surgical fixation. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "stabilization of fractures of the anterior chest wall... to promote fusion." This describes a surgical implant used to physically support and fix bone fractures.
- Device Description: The device is described as "implants composed of 316 LVM implant quality stainless steel plates, links, and screws." These are physical components designed for surgical implantation.
- Lack of Diagnostic Function: There is no mention of this device being used to test samples (like blood, urine, or tissue) or to provide information about a patient's health status based on such testing. IVDs are used in vitro (outside the body) to diagnose diseases or conditions.
This device is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SternaFuse® Fixation System is indicated for use in the stabilization of fractures of the anterior chest wall, including stemal fixation following sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The SternaFuse® Fixation System implants are composed of 316 LVM implant quality stainless steel plates, links, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in two diameters, 3.0mm and 3.3mm, and lengths of 10mm, 13mm, and 16mm. Multiple plates may be used in one anterior chest wall repair. Variable Assemblies can be configured, and the Links angled for optimum fixation. Implants are designed with centralized saddles to aid in intra-operative contouring, to facilitate cutting during postoperative emergent re-entry, and to provide a location for stainless steel wire.
The implants are individually packaged and sterilized, allowing the surgeon to customize the desired implants for the specific needs of the patient. All implants are provided sterile with a five-year shelf-life. The implants should never be reused under any circumstance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
Biocompatibility assessed according to ISO 10993-1. Implants made of 316LVM Stainless Steel conforming to ASTM standard F138. Results show high demonstrable biological safety.
Pyrogenicity / Endotoxin Testing: Bacterial endotoxin test performed utilizing worst case subject implants. Meet acceptance criteria of ≤ 20 EU/device according to USP. General Chapter , Bacterial Endotoxins Test, and EP Ch 2.6.14 Bacterial Endotoxins as recommended in ISO 10993-11:2009.
Packaging/Sterility: Implants supplied sterile, packaged in a container within a pouch. Pouch validated according to ISO 11607-1 after gamma irradiation and after claimed shelf-life. Transport simulation performed according to ASTM D4169. Sterilization performed according to ISO 11137.
Mechanical Testing:
- Static Tension Testing
- Dynamic Tension Testing
- Screw Pullout Testing per ASTM F543
- Driving Torque Testing per ASTM F543
- Torsion Testing per ASTM F543
MR Safety Testing: Implants manufactured using non-ferromagnetic 316 Stainless Steel. Not evaluated for safety, heating, migration, or compatibility in the MR environment. Safety in MR environment unknown.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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.
0
January 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health and Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION".
Fusion Innovations, LLC % Katelyn Jessup Regulatory & Quality Specialist Kapstone Medical, LLC 520 Elliot Street Charlotte, North Carolina 28202
Re: K202914
Trade/Device Name: SternaFuse Fixation System Regulation Number: 21 CFR 888.3030, 888.3040 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: January 20, 2022 Received: January 21, 2022
Dear Katelyn Jessup:
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, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202914
Device Name SternaFuse® Fixation System
Indications for Use (Describe)
The SternaFuse® Fixation System is indicated for use in the stabilization of fractures of the anterior chest wall, including stemal fixation following sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription 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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510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR 807.92, the following summary of information is provided.
1. Date of Preparation:
January 26, 2022
2. Applicant
Fusion Innovations, LLC 341 N. Maitland Ave. Ste. 270 Maitland, FL 32751 USA
3. Submitter/Contact Person
Katelyn Jessup Regulatory and Quality Specialist Kapstone Medical LLC 520 Elliot St. Charlotte, NC 28202 (856) 577-3432
4. Device Name
Trade Name: SternaFuse® Fixation System Common Name: Plate, Fixation, Bone (primary), and Screw Fixation, Bone Classification Name: Single/multiple component metallic bone fixation appliances and accessories (primary), Smooth or Threaded Metallic Bone Fixation Fastener Regulation Number: 888.3030 (primary), 888.3040 Product Code: HRS (primary), HWC Classification: Class II Panel: Orthopedic
5. Predicate Devices
Biomet Microfixation Sternal Closure System (K111908) - Primary Ethi-pack Surgical Stainless Steel Suture (K931271) - Reference
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6. Indications for Use (Intended Purpose and Conditions of Use):
The SternaFuse® Fixation System is indicated for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy, sternal fractures, and sternal reconstructive surgical procedures, to promote fusion. The device is for prescription use only.
7. Device Description
The SternaFuse® Fixation System implants are composed of 316 LVM implant quality stainless steel plates, links, and screws intended to stabilize and fixate fractures of the anterior chest wall. The components include various sizes to facilitate customization according to the requirements of the anterior chest wall repair. Self-drilling locking screws come in two diameters, 3.0mm and 3.3mm, and lengths of 10mm, 13mm, and 16mm. Multiple plates may be used in one anterior chest wall repair. Variable Assemblies can be configured, and the Links angled for optimum fixation. Implants are designed with centralized saddles to aid in intra-operative contouring, to facilitate cutting during postoperative emergent re-entry, and to provide a location for stainless steel wire.
The implants are individually packaged and sterilized, allowing the surgeon to customize the desired implants for the specific needs of the patient. All implants are provided sterile with a five-year shelf-life. The implants should never be reused under any circumstance.
8. Comparison of Technological Characteristics with the Predicate Devices
As was established in this submission, the subject device SternaFuse® Fixation System is substantially equivalent to the predicate device, cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas including design, intended use, material composition, function, and sterility.
9. Performance Data
There are no clinical data generated and held by the manufacturer, i.e., no premarketing or post-market clinical studies or animal studies have been performed. The following information is provided in support of substantial equivalence.
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Biocompatibility 9.1
The SternaFuse® Fixation System implants are classified as an implant device with tissue/bone contact and permanent contact. Therefore, according to ISO 10993-1, the biological evaluation was assessed for potential effects. The SternaFuse® Fixation System devices are manufactured from 316LVM Stainless Steel conforming to ASTM standard F138. The evaluation was based on a risk assessment of the device considering materials, manufacturing process, and finished device testing. The results show that implants made of 316LVM Stainless Steel have a high demonstratable biological safety. No concerns arose that would preclude clinical use of the SternaFuse® Fixation System. The requirements of the ISO 10993 standard are fulfilled.
9.2 Pyrogenicity / Endotoxin Testing
The bacterial endotoxin test was performed utilizing worst case subject implants to verify that the subject implants meet the acceptance criteria of ≤ 20 EU/device. Testing was successfully performed, and it was confirmed that the SternaFuse® Fixation System meets the acceptance criteria of ≤ 20 EU/device according to USP. General Chapter , Bacterial Endotoxins Test, and EP Ch 2.6.14 Bacterial Endotoxins as recommended in ISO 10993-11:2009 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity. Endotoxin testing will be conducted on every lot.
9.3 Packaging/Sterility
The SternaFuse® Fixation System implants are supplied sterile to the end user, packaged in a container within a pouch. The pouch serves as the sterile barrier and is intended to maintain sterility of the packaged medical device. The pouch has undergone validation, in accordance with ISO 11607-1, to demonstrate the sterile barrier ability after gamma irradiation and after the claimed shelf-life. A transport simulation was performed according to ASTM D4169. Sterilization was performed according to ISO 11137.
The SternaFuse® Fixation System also includes single-use, disposable surgical instrumentation to assist with implantation. Driver bits are provided sterile, packaged in the same container and pouch described above.
9.4 Mechanical Testing
The following testing was performed to demonstrate equivalence:
- Static Tension Testing ●
- Dynamic Tension Testing ●
6
- Screw Pullout Testing per ASTM F543 ●
- Driving Torque Testing per ASTM F543 ●
- Torsion Testing per ASTM F543 ●
MR Safety Testing 9.5
The SternaFuse® Fixation System implants are manufactured using non-ferromagnetic 316 Stainless Steel. The implants have not been evaluated for safety, heating, migration, or compatibility in the MR environment. The SternaFuse® Fixation System has not been tested for heating, migration, or image artefact in the MR environment. The safety of the SternaFuse® Fixation System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.
10. Conclusion
The SternaFuse® Fixation System and the predicate device Biomet Microfixation Sternal Closure System (K111908) have the same "Indications for Use," and are available by prescription only. Compared to the reference device, the SternaFuse® Fixation System is manufactured from the same material and biocompatible. Any technical differences, which were identified, do not result in new questions of safety or effectiveness.
Through assessment of technological characteristics, indications for use and performance data, it can be concluded that SternaFuse® Fixation System is both a safe and effective device and is substantially equivalent to the Biomet Microfixation Sternal Closure System and Ethi-pack Surgical Stainless Steel Suture.