(170 days)
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No
The summary describes a mechanical external fixation system with no mention of software, algorithms, or any AI/ML related terms.
Yes
The device is indicated for the treatment and temporary stabilization of various fractures, which directly addresses a medical condition.
No
The Dolphix® External Fixation System is described as a system for building a fixator construct used in the treatment and temporary stabilization of fractures. Its intended use is therapeutic (stabilization), not diagnostic (identifying or characterizing a condition).
No
The device description explicitly states that the system includes physical components such as "fixation bone screws, clamps and rods," which are hardware.
Based on the provided information, the Dolphix® External Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This system is a physical device used to stabilize bone fractures.
- The intended use clearly describes a surgical device for external fixation of bones. It does not mention any analysis of biological samples.
- The device description focuses on the physical components (screws, clamps, rods). There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
Therefore, the Dolphix® External Fixation System falls under the category of a surgical or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
- Temporary stabilization of fractures in the context of polytrauma: -
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
- Temporary stabilization of non-unions; -
- Intra-operative temporary stabilization tool to assist with indirect reduction. -
Dolphix® External Fixation System is intended for use in a non-weight bearing patient.
Product codes
KTT, JDW
Device Description
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Long bone and pelvic fractures
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, bold font. The text is arranged on a single line. The words are clearly legible and appear to be the primary focus of the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
CITIEFFE s.r.l % Mr. Claude Berthoin Thema USA 110 East Granada Boulevard, Suite 209 Ormond Beach, Florida 32176
Re: KI32363
Trade/Device Name: Dolphix® External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDW Dated: December 17, 2013 Received: December 19, 2013
Dear Mr. Berthoin:
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. 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 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 803); good manufacturing practice requirements as set
1
Page 2 - Mr. Claude Berthoin
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable. the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincercly yours.
Ronald#sJean -S for
Mark N. Melkerson Director . Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Applicant: CITIEFFE SRL
510(k) Number (if known): _ K132363
Device Name: Dolphix® External Fixation System
Indication For Use:
Dolphix® External Fixation System includes various elements designed to build a fixator construct. The system includes fixation bone screws. clamps and rods. Dolphix® External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the system is intended for:
- Temporary stabilization of open or closed acute fractures with soft tissue injuries; -
- Temporary stabilization of fractures in the context of polytrauma: -
- Temporary stabilization of certain pelvic fractures or pelvic ring injuries; ...
- Temporary stabilization of limbs after removal of total joint (knee, and ankle) arthroplasty for ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ infection or other failure;
- Temporary stabilization of non-unions; -
- Intra-operative temporary stabilization tool to assist with indirect reduction. -
Dolphix® External Fixation System is intended for use in a non-weight bearing patient.
| Prescription Use X | And/Or | Over the Counter Use |
|---|---|---|
| (21 CFR Part 801 Subpart D) | (21 CFR Part 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
Concurrence of CDRH, Office of Device Evaluation (ODE).
Casey L. Hanley, Ph.D. Division Sign-Off Office of Device Evaluation
510(k)_K132363
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
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