(75 days)
EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Not Found
I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study proving that a device meets such criteria. The document is a letter from the FDA to Citieffe S.r.l. regarding the 510(k) premarket notification for the EBA2 Femoral Nailing System. It primarily discusses the substantial equivalence determination and regulatory requirements for marketing the device.
The letter does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance for test or training sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- How ground truth for the training set was established.
Therefore, I cannot fulfill your request for this specific information using the provided document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25, 2013
Citieffe S.r.l. % Thema U.S.A Mr. Claude Berthoin Regulatory Consultant 110 East Granada Boulevard, Suite 209 Ormond Beach, Florida 32176
Re: K131005
Trade/Device Name: EBA2 Femoral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 30, 2013 Received: May 31, 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
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Page 2 - Mr. Claude Berthoin
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21CFR 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 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.
Sincerely yours,
rin I.Keith
For
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Applicant: CITIEFFE SRL
K131005 510(k) Number (if known): _
Device Name: EBA2 Femoral Nailing System
Indication For Use:
EBA2 Femoral Nailing System is intended for insertion into the medullary canal of femur for the alignment, stabilization and fixation of various types of fractures or deformities caused by trauma or disease. These include: tractures, re-fractures, non-union, reconstruction, malunion, malalignment, pathological fractures and impending pathological fractures.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (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).
Division Sign-Off Office of Device Evaluation
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices
510(k)
§ 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.