(322 days)
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Not Found
No
The provided text describes a surgical nailing system for fracture treatment and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the treatment of various fractures and non-unions, which falls under the definition of a therapeutic device as it directly addresses and aims to remediate a medical condition.
No
Explanation: The device, the "EBA One Nailing System," is indicated for the treatment of fractures (e.g., intertrochanteric, pertrochanteric, pathological fractures, non-unions, mal-unions). This describes a therapeutic or surgical intervention, not a process of identifying or diagnosing a disease or condition.
No
The provided text only describes the intended use and indications for a "Nailing System," which is a hardware implant used for fracture treatment. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant (a nailing system) used to treat bone fractures. This is a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Information: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," "Description of the training set," "Description of the test set," "Summary of Performance Studies," and "Key Metrics" further supports that this is not a diagnostic device, as these are often relevant for IVDs, especially those involving image analysis or AI.
In summary, the EBA One Nailing System is a medical device used for surgical treatment of bone fractures, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.
EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
Product codes
HSB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (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
Not Found
§ 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 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 square are the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" below it.
November 14, 2019
CITIEFFE S.r.l. Stefano Pullega Quality and Regulatory Manager Via Armaroli, 21 CALDERARA di RENO, 40012 ITALY
Re: K183666
Trade/Device Name: EBA One Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 14, 2019 Received: October 17, 2019
Dear Stefano Pullega:
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.
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
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
for
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) K183666
Device Name EBA One Nailing System
Indications for Use (Describe)
EBA One Nailing System standard trochanteric nail is indicated for the treatment of stable intertrochanteric fractures, pertrochanteric fractures, non-unions, mal-unions.
EBA One Nailing System long trochanteric nail is indicated for the treatment of pertrochanteric fractures with extension of the fracture line to the diaphysis,pertrochanteric fractures associated with diaphyseal fractures (bifocal fractures), pathological fractures, non-unions, mal-unions.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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