(219 days)
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.
Not Found
This document is an FDA 510(k) clearance letter for the Estremo Citieffe Nailing System, which is an intramedullary fixation rod for fracture fixation. It is NOT an AI/ML medical device submission.
As such, the document does not contain the information required to answer the prompt. The prompt asks for details about a study that proves an AI/ML device meets acceptance criteria, including:
- A table of acceptance criteria and reported device performance (for an AI/ML device, this would typically involve metrics like sensitivity, specificity, AUC, etc.)
- Sample size for the test set and data provenance
- Number and qualifications of experts for ground truth
- Adjudication methods
- MRMC study details and effect size
- Standalone AI performance
- Type of ground truth used
- Training set sample size and ground truth establishment
None of this information is present in the provided FDA 510(k) clearance letter for a physical medical implant (nailing system). The letter confirms the device's substantial equivalence to a predicate device based on its indications for use and general controls, but it does not describe an AI/ML algorithm's performance study.
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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
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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
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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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§ 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.