(98 days)
Not Found
No
The document describes a physical implant and its mechanical testing, with no mention of AI/ML in its function or intended use. The "AI Temperature Test" appears to be a typo or unrelated to artificial intelligence.
Yes.
The device is an implant designed to fix fractures, osteotomies, and arthrodeses, which are therapeutic interventions.
No
The DynaBridge is an implantable device used for fracture and osteotomy fixation and joint arthrodesis. Its purpose is to physically stabilize bones, not to diagnose a condition.
No
The device description clearly states it is a "Superelastic Nitinol Implant," which is a physical hardware device made of a Nickel-Titanium alloy. The performance studies also describe physical tests like bend and pull-out tests, further indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical fixation of bones (fractures, osteotomies, arthrodesis). This is a therapeutic and structural function within the body.
- Device Description: The description confirms it's a bone implant made of Nitinol, designed to be placed within the body to stabilize bone structures.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information for diagnosis. IVDs are used in vitro (outside the body) to examine specimens and provide diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties (bend, pull-out) and biocompatibility (corrosion, pyrogenicity), which are relevant for implantable devices, not diagnostic tests.
Therefore, the DynaBridge is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
DynaBridge is indicated for:
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy.
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
The DynaBridge is indicated for:
· Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
· Fixation of proximal tibial metaphysis osteotomy.
· Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. small fragments of bone which are
not comminuted to the extent to preclude staple placement). These
fragments may be located in long bones such as the femur, fibula, and tibia
in the lower extremities; the humerus, ulna, or radius in the upper
extremities; the clavicle and ribs; and in flat bones such as the pelvis,
scapula, and sternum.
Product codes
JDR
Device Description
The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy
(Nitinol) bone implant intended primarily for fixation of fractured, osteotomy,
and arthrodesis of the hand, foot, and bone appropriate for the size of the
device. The implant is offered in a range of sizes to address a variety of
indications and patient anatomy with bridge sizes from 9mm to 25mm. The
system is offered sterile and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
hand and foot, proximal tibial metaphysis, femur, fibula, tibia, humerus, ulna, radius, clavicle, ribs, pelvis, scapula, sternum
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)
Non-clinical Test Summary: The following analyses were conducted: • Static Four-Point Bend Test. • Dynamic Four-Point BendTest. • Pull-out Test. • Corrosion Test. • AI Temperature Test. • Pyrogenicity was evaluated using the Limulus amebocyte lysate (LAL) assay. The testing demonstrated that the subject device meets the recommended maximum endotoxin level of 20 EU per device. The results of these evaluations indicate that the DynaBridge Staple is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fusion Orthopedics, LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 1001 Oakwood Blvd Round Rock, Texas 78681
Re: K181815
Trade/Device Name: DynaBridge 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 14, 2018 Received: September 17, 2018
Dear Mr. Webb:
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
October 15, 2018
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel S. Ramsey -S 2018.10.15 14:54:22 -04'00'
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
DynaBridge
Indications for Use (Describe)
DynaBridge is indicated for:
- · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
- · Fixation of proximal tibial metaphysis osteotomy.
- · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
· Fixation of small bone fragments (i.e. Small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremittes; the clavicle and ribs; and in flat bones such as the pelvis, scapula and sternum.
| Type of Use (Select one or both, as applicable) |
|---|
| For activities identified in 321 CMR 3.02(2): Shooting Preserves |
| For Field Carries identified in 321 CMR 3.02(3) |
Y Prescription Use (Part 21 CFR 801 Subpart D)
[ ] Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: DynaBridge
| Date Prepared | September 25, 2018 | |
|---|---|---|
| Submitted By: | Fusion Orthopedics, LLC | |
| 4135 S. Power Rd., Suite 110 | ||
| Mesa, AZ 85212 | ||
| 800-403-8876 | ||
| Primary Contact: | J.D. Webb | |
| 1001 Oakwood Blvd. | ||
| Round Rock, TX 78681 | ||
| 512-388-0199 Tele | ||
| email: jdwebb@orthomedix.net | ||
| Trade Name: | DynaBridge | |
| Common Name: | Bone Staple | |
| Classification Name: | Staple, Fixation, Bone | |
| Class: | II | |
| Product Code: | JDR | |
| CFR Section: | 21CFR section 888.3030 | |
| Device Panel: | Orthopedic | |
| Primary Predicate | ||
| Devices: | Speed Staple, BioMedical Enterprises, Inc. (K142292) | |
| Secondary Predicate | ||
| Devices: | Sniper Staple System, Trilliant Surgical (K1623545/ K172405) | |
| Device Description: | The DynaBridge Superelastic Nitinol Implant is a Nickel-Titanium alloy | |
| (Nitinol) bone implant intended primarily for fixation of fractured, osteotomy, | ||
| and arthrodesis of the hand, foot, and bone appropriate for the size of the | ||
| device. The implant is offered in a range of sizes to address a variety of | ||
| indications and patient anatomy with bridge sizes from 9mm to 25mm. The | ||
| system is offered sterile and non-sterile. | ||
| Indications for Use: | The DynaBridge is indicated for: | |
| · Fracture and osteotomy fixation and joint arthrodesis of the hand and foot. | ||
| · Fixation of proximal tibial metaphysis osteotomy. | ||
| · Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. | ||
| · Fixation of small bone fragments (i.e. small fragments of bone which are | ||
| not comminuted to the extent to preclude staple placement). These | ||
| fragments may be located in long bones such as the femur, fibula, and tibia | ||
| in the lower extremities; the humerus, ulna, or radius in the upper | ||
| extremities; the clavicle and ribs; and in flat bones such as the pelvis, | ||
| scapula, and sternum. | ||
| K181815 | ||
| PAGE | ||
| 2 OF 2 | ||
| Materials: | Nitinol (ASTM F-2063) | |
| Stainless steel (ASTM F899) | ||
| 6061 Aluminum (ASTM B209) | ||
| Substantial | ||
| Equivalence Claimed | ||
| to Predicate Devices: | The DynaBridge is substantially equivalent to the predicate devices in terms | |
| of intended use, design, materials used, mechanical safety and performances. | ||
| Non-clinical Test | ||
| Summary: | The following analyses were conducted: | |
| • Static Four-Point Bend Test. | ||
| • Dynamic Four-Point BendTest. | ||
| • Pull-out Test. | ||
| • Corrosion Test. | ||
| • AI Temperature Test. | ||
| • Pyrogenicity was evaluated using the Limulus amebocyte lysate | ||
| (LAL) assay. The testing demonstrated that the subject device meets | ||
| the recommended maximum endotoxin level of 20 EU per device. | ||
| The results of these evaluations indicate that the DynaBridge Staple is | ||
| equivalent to predicate devices. | ||
| Clinical Test | ||
| Summary: | No clinical studies were performed. | |
| Conclusions: Non- | ||
| clinical and Clinical | Fusion Orthopedics, LLC considers the DynaBridge to be equivalent to the | |
| predicate devices listed above. This conclusion is based upon the devices' | ||
| similarities in principals of operation, technology, materials, and indications | ||
| for use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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