(106 days)
No
The document describes a mechanical fixation system and does not mention any AI or ML components or functionalities.
No
The device is used for fixation of bone or soft tissue in orthopedic procedures, which is a structural or supportive function, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as a system for fixation of bone or soft tissue to bone, used in orthopedic procedures requiring repair or reconstruction. This function is therapeutic and structural, not diagnostic.
No
The device description explicitly lists physical components such as titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "fixation of bone or soft tissue to bone" in orthopedic procedures. This is a mechanical function within the body.
- Device Description: The description details components like titanium buttons and sutures, which are used for physical fixation.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVDs are used to diagnose diseases or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Performance Studies: The performance studies focus on mechanical properties like static and dynamic testing, sterilization, and packaging, which are relevant to a surgical implant, not a diagnostic test.
Therefore, the Dunamis Fixation Button System is a surgical implant used for mechanical fixation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction, including providing fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HTN
Device Description
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The Dunamis Fixation System consists of titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 testing performed included static testing, dynamic testing, sterilization, sterile barrier packaging performance and aging of sterile medical device. The non-clinical performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Fixation Button System (with Continuous Loop or Adjustable Loop) are substantially equivalent to the predicate device, Arthrex TightRope (K112990). Additionally, the Dunamis Fixation Button System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.
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.
K043248, K052776, K112990, K160655, K171060, K082095
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows 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".
Dunamis LLC % Hollace Saas Rhodes Vice President, Orthopedic Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001
Re: K191319
Trade/Device Name: Dunamis Fixation Button System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HTN Dated: July 24, 2019 Received: July 24, 2019
Dear Ms. Rhodes:
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
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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 (OS) 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,
Laurence D. Coyne, Ph.D. 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) K191319
Device Name Dunamis Fixation Button System
Indications for Use (Describe)
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distributing suture tension over areas of ligament or tendon repair.
Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.
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)
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510(k) Summary
| Manufacturer: | Dunamis Medical , LLC
509 E. Commerce Street, Suite 3
Greenville, AL 36037
Phone: 731.217.2533 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. PrithviRaj Chavan
President |
| Prepared By: | MCRA, LLC
1050 K Street, NW, Suite 1000
Washington, DC 20001
Phone: 202.552.5800 |
| Date Prepared: | August 28, 2019 |
| Device Trade Name: | Dunamis Fixation Button System |
| Device Common Name: | Fastener, fixation, nondegradable, soft tissue |
| Classification: | 21 CFR 888.3040 – Fastener, fixation, nondegradable, soft tissue
21 CFR 888.3030 – Single/multiple component metallic bone
fixation appliances and accessories |
| | Class II |
| | Product Codes: |
Indications for Use:
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.
Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction, including providing fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.
Device Description:
The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The Dunamis Fixation System consists of titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports.
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Predicate Devices:
The Dunamis Fixation Button System is substantially equivalent to the following predicates with respect to indications, design, material and function: Arthrex TightRope (K043248, K052776, K112990), RiverPoint OrthoButton CL (K160655), RiverPoint OrthoButton AL (K171060) and Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device (K082095). The sutures proposed for use with the subject system are those used with the reference device, Dunamis Force DFX Suture (K150327), with respect to material, design, and function.
Substantial Equivalence:
Non-clinical testing performed included static testing, dynamic testing, sterilization, sterile barrier packaging performance and aging of sterile medical device. The non-clinical performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Fixation Button System (with Continuous Loop or Adjustable Loop) are substantially equivalent to the predicate device, Arthrex TightRope (K112990). Additionally, the Dunamis Fixation Button System is in compliance with LAL testing requirements for orthopedic implants per AAMI ST-72 testing.