(219 days)
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No
The provided text describes a mechanical nailing system for fracture fixation and arthrodesis. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for fixation of various types of fractures and for arthrodesis, which are therapeutic interventions.
No
Explanation: The device is a nailing system used for fracture fixation and arthrodesis, which are surgical treatments, not diagnostic procedures. Its intended use focuses on treatment, not on the identification or analysis of medical conditions.
No
The intended use describes a "Nailing System" for fracture fixation, which inherently involves physical implants and surgical tools, not just software.
Based on the provided information, the Estremo Citieffe Nailing System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for femoral and tibial fracture fixation and tibiotalocalcaneal arthrodesis. These are surgical procedures performed directly on the patient's body to treat bone fractures and fuse joints.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used outside the body (in vitro).
The Estremo Citieffe Nailing System is an implantable medical device used within the body for structural support and fixation. This falls under the category of surgical or orthopedic devices, not IVDs.
No.
Explanation: The provided text does not contain any information or mention of a Predetermined Change Control Plan (PCCP) in relation to the device. PCCP status is explicitly stated in a clearance letter.
Intended Use / Indications for Use
The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:
- · diaphyseal femoral fractures;
- · supra-condylar femoral fractures:
- · corrective osteotomies;
- · pseudoarthrosis:
- non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:
- · diaphyseal tibial fractures;
- · corrective osteotomies;
- · pseudoarthrosis;
- · non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal arthrodesis.
Product codes
HSB
Device Description
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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
Femoral, Tibial, Tibiotalocalcaneal
Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.
CITIEFFE S.r.L. Stefano Pullega Quality and Regulatory Manager Via Armaroli, 21 Calderara di Reno, Bologna 40012 - Italy
Re: K181540
Trade/Device Name: Estremo Citieffe Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 14, 2018 Received: December 17, 2018
Dear Stefano Pullega:
We have reviewed vour 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 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
1
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,
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) K181540
Device Name Estremo Citieffe Nailing System
Indications for Use (Describe)
The Estremo Citieffe Nailing System is indicated for femoral fracture fixation, which may include the following:
- · diaphyseal femoral fractures;
- · supra-condylar femoral fractures:
- · corrective osteotomies;
- · pseudoarthrosis:
- non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibial fracture fixation, which may include the following:
- · diaphyseal tibial fractures;
- · corrective osteotomies;
- · pseudoarthrosis;
- · non-unions and mal-unions.
The Estremo Citieffe Nailing System is indicated for tibiotalocalcaneal 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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