(202 days)
Not Found
Not Found
No
The summary describes a mechanical device (cannulated screw) for fracture fixation and contains no mention of AI, ML, image processing, or data analysis.
No
The device is described as "intended for fracture fixation," which implies a role in treatment or repair of an injury. However, the term "therapeutic device" generally refers to devices used to treat diseases, relieve symptoms, or restore function through active intervention or therapy. Fracture fixation is a surgical intervention, but the device itself is a mechanical component used to stabilize a repair rather than actively providing therapy.
No
The Citieffe Rondò Cannulated Screw is described as being "intended for fracture fixation," which indicates a therapeutic or treatment purpose, not a diagnostic one.
No
The 510(k) summary describes a "Cannulated Screw," which is a physical implantable device used for fracture fixation. There is no mention of software as the primary or sole component of the device.
Based on the provided information, the Citieffe Rondò Cannulated Screw is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fracture fixation of small and long bones and pelvis." This describes a surgical implant used in vivo (within the body) to stabilize fractures.
- Device Description (though not found): While the description is missing, the intended use clearly points to a physical device implanted in the body.
- Lack of IVD characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Citieffe Rondò Cannulated Screw does not fit this description.
N/A
Intended Use / Indications for Use
Citieffe Rondò Cannulated Screw is intended for fracture fixation of small and long bones and pelvis. The system is not intended for spinal use.
Product codes
HWC, HTN, HTY
Device Description
Citieffe Cannulated Screw (Pin) RONDO'
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small and long bones and pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is all capitalized and evenly spaced. The background is plain white.
Image /page/0/Picture/1 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Mail Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and uses a serif font.
Citieffe S.p.A. % Mr. Claude Berthoin, President, Thema USA 110 E. Granada Blvd., Suite 209 Ormond Beach, FL 32176
JUN - 5 2012
Re: K113388
Trade/Device Name: Rondò Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN, HTY Dated: May 29, 2012 Received: June 1, 2012
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.
Sincerely yours,
for Peter
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Applicant: Citieffe S.p.a.
KII 3 3 510(k) Number (if known):
Device Name: Citieffe Cannulated Screw (Pin) RONDO'
Indication For Use:
Citieffe Rondò Cannulated Screw is intended for fracture fixation of small and long bones and pelvis. The system is not intended for spinal use.
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).
b
B.B. Price Jr.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113388
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