(31 days)
Not Found
No
The summary describes a mechanical external fixation system with no mention of AI or ML capabilities.
Yes
The device is used to treat various conditions like complex fractures, dislocations, contractures, and for joint arthrodesis, which are therapeutic interventions.
No
Explanation: The device is an external fixation system used for treating fractures, dislocations, and contractures. Its stated intended use is therapeutic, involving physical mechanisms to stabilize and support anatomical structures, rather than diagnosing conditions.
No
The device description explicitly lists physical components like brackets, locking pins, set screws, and k-wires, which are hardware elements of an external fixation system.
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, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The DIGIFIXTM External Fixation System is a surgical device used to physically stabilize and treat fractures and contractures in the finger. It is applied externally to the body and does not involve the analysis of biological specimens.
- Intended Use: The intended use clearly describes the treatment of physical conditions (fractures, dislocations, contractures) through mechanical fixation.
- Device Description: The description details the components used to create an external frame for supporting K-wires, which are inserted into bone. This is a mechanical process, not an in vitro diagnostic test.
Therefore, based on the provided information, the DIGIFIXTM External Fixation System is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of:
DYNAMIC MODE:
-
complex fracture-dislocations or fracture-subluxations, and pilon fractures of the interphalangeal (IP) joint;
-
Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;
-
Dupuytren's contracture
STATIC MODE:
-
Fractures of the phalanges and
-
interphalangeal (IP) joint arthrodesis.
Product codes
JEC
Device Description
The DigiFix TM External Fixation System Sterile Kit includes various elements including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided sterile and are intended for single use only.
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
skeletally mature patients
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
A sterilization validation substantiated a minimum 25 kGy gamma radiation dose for sterilizing a single batch of product and demonstrated a Sterility Assurance Level (SAL) of 10° based on Method VDMax 25, as outlined in ISO 11137-1 and ISO 11137-2 for the Virak DigiFix™ External Fixation System.
A cleaning validation challenged the IPA dipping method to clean the Virak DigiFix™ Eixation System utilizing 99% Isopropyl Alcohol. An Operational Qualification (OQ) was performed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
October 10, 2019
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Virak Orthopedics, LLC % Christine Scifert Executive Vice President Mrc-x, LLC 6075 Poplar Ave Suite 500 Memphis, Tennessee 38119
Re: K192465
Trade/Device Name: DigiFix Sterile Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JEC Dated: September 5, 2019 Received: September 9, 2019
Dear Christine Scifert:
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.
Ting Song Acting 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
Enclosure
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Indications for Use
510(k) Number (if known)
K192465
Device Name
DIGIFIX External Fixation System Sterile Kit
Indications for Use (Describe)
The DIGIFIXTM External Fixation System is intended to be used in skeletally mature patients in treatment of:
DYNAMIC MODE:
-
complex fracture-dislocations or fracture-subluxations, and pilon fractures of the interphalangeal (IP) joint;
-
Post-traumatic joint contracture of the proximal interphalangeal (PIP) joint;
-
Dupuytren's contracture
STATIC MODE:
-
Fractures of the phalanges and
-
interphalangeal (IP) joint arthrodesis.
| 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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K192465
510(k) Summary
DIGIFIX™ External Fixation System Sterile Kit September 5, 2019
| Company: | Virak Orthopedics, LLC
620 Essex St
Harrison, NJ 07029
901-260-7931 |
|--------------------|------------------------------------------------------------------------------|
| Primary Contact: | Christine Scifert |
| Company Contact: | Dr. Virak Tan |
| Trade Name: | DIGIFIX TM External Fixation System Sterile Kit |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | II |
| Regulation Number: | 21 CFR 888.3040 |
| Panel: | 87-Orthopedic |
| Product Code(s): | IEC |
The DigiFix TM External Fixation System Sterile Kit includes various elements Device Description: including brackets, locking pins, set screws and k-wires. The elements are used to create an assembled frame which capture and support the k-wires on the medial and lateral aspect of finger. The brackets, locking pins and set screws are assembled intraoperatively. External fixator components are provided sterile and are intended for single use only.
The DigiFix™ External Fixation System Sterile Kit is intended to be used in Indications for Use: skeletally mature patients in treatment of: DYNAMIC MODE: 1) complex fracture-dislocations or fracture-subluxation, unstable dislocations, and pilon fractures of the interphalangeal (IP) joint; 2) Posttraumatic joint contracture of the proximal interphalangeal (PIP) joint; 3) Dupuytren's contracture STATIC MODE: 1) Fractures of the phalanges and 2) interphalangeal (IP) joint arthrodesis
Substantial Equivalence: The subject components were demonstrated to be substantially equivalent to the following systems previously cleared by the FDA:
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Primary Predicate
- K132731 DigiFix™ External Fixation System .
Performance Testing: A sterilization validation substantiated a minimum 25 kGy gamma radiation dose for sterilizing a single batch of product and demonstrated a Sterility Assurance Level (SAL) of 10° based on Method VDMax 25, as outlined in ISO 11137-1 and ISO 11137-2 for the Virak DigiFix™ External Fixation System.
A cleaning validation challenged the IPA dipping method to clean the Virak DigiFix™ Eixation System utilizing 99% Isopropyl Alcohol. An Operational Qualification (OQ) was performed.
Conclusion
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.