(51 days)
Not Found
No
The device description and intended use focus on mechanical components for external fixation and do not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used for external fixation of fractures and reconstruction of small bones, which are therapeutic interventions rather than diagnostic.
No
The device is described as an external fixation system for treating fractures and reconstructing small bones. Its purpose is mechanical support and stabilization, not to diagnose or identify medical conditions.
No
The device description clearly states it consists of physical components like pins, rails, accessories, instruments, and a tray, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SBi Mini Rail External Fixation System is a surgical device used to physically stabilize and fix bones. It involves implanting pins and assembling external components directly onto the patient's body.
- Intended Use: The intended use is for "fixation, compression, and distraction osteo-genesis of small bones" and "external fixation of fractures and/or reconstruction of small bones." This is a therapeutic and structural intervention, not a diagnostic test performed on a sample.
The description clearly indicates a device used on the patient for structural support and healing, not a device used to analyze a biological sample outside the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.
The pins and external connecting components are intended for single use only. The implants are intended for single use only.
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Product codes (comma separated list FDA assigned to the subject device)
KTT
Device Description
The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones, such as metacarpal and metatarsal
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
.. K093550
: : . ·
'JAN - 7 2010 \
6. 510(k) Premarket Notification Summary of Safety and Effectiveness
Submission Information Manufacturer: Small Bone Innovations, Inc. 1380 South Pennsylvania Avenue Morrisville, PA 19067 Ph: 215-428-1791 Fax: 215-428-1795
Submitted By: Small Bone Innovations, Inc. John Minier 1380 South Pennsylvania Avenue Morrisville, PA 19067
Proprietary Name: SBi Mini Rail External Fixation System
Classification name: Class II, 21 CFR 888.3030 - Single/multiple component metallic bone fixation appliances and accessories
Product Code: KTT
Common/Usual Name and Reference Number: appliance, fixation, nail/blade/plate combination, multiple component, 21 CFR 888.3030
Substantial Equivalence: Documentation is provided which demonstrated the SBi Mini Rail External Fixation System to be substantially equivalent to other legally marketed devices.
Device Description: The SBi Mini Rail External Fixation System consists of pins of various diameters and lengths as well as the rails and accessories with which to connect and stabilize them. The system also includes instruments to implant the pins and connect the external components. A tray is included to store and transport the set. The devices are supplied non-sterile.
Intended Use: The SBi Mini Rail External Fixation System is intended for fixation, compression, and distraction osteo-genesis of small bones, such as metacarpal and metatarsal. The system also includes the instruments with which to place the pins and assemble the construct. A tray is available for conveying and storing the system. The system is not intended for spinal use.
The pins and external connecting components are intended for single use only. The implants are intended for single use only.
Materials: The pins are made from implant grade 316LS stainless steel (ASTM F138). The external components are made from medical grade aluminum and stainless steel.
Predicate Devices: The modified device is equivalent to the cleared SBi (formerly Fixano) MiniFIX External Fixator K964094.
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1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized symbol of a bird or eagle, with its wings spread and head facing left. The symbol is composed of three curved lines that suggest movement and flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Small Bone Innovations, Inc. % Mr. John Minier Regulatory Affairs Director 1380 South Pennsylvania Avenue Morrisville, Pennsylvania 19067
Re: K093550
Trade/Device Name: SBi Mini Rail External Fixator System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories. Regulatory Class: Class II Product Code: KTT Dated: December 10, 2009 Received: December 11, 2009
JAN - 7 2010
Dear Mr. Minier:
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.
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
2
Page 2 - Mr. John Minier
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Oerbeie Buelup
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
6093550 5. Statement of Indications for Use
510(k) Number:
Device Name: SBi Mini Rail External Fixation System
Indications For Use:
The SBi Mini Rail External Fixation System is indicated for use in external fixation of fractures and/or reconstruction of small bones, including metacarpal and metatarsal.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Senatur for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number K093550