(39 days)
The RingFIXTM System is intended for:
- fracture fixation (open and closed)
- pseudarthrosis or nonunions of long bones
- limb lengthening by epiphyseal or metaphyseal distraction
- correction of bony or soft tissue deformities
- correction of segmental bony or soft tissue defects
This Special 510(k) Submission is intended to add additional components to the RingFIX™ System
The provided text is a 510(k) Summary and an FDA clearance letter for the SBi RingFIX™ System. It focuses on establishing substantial equivalence to a predicate device and adding new components to an existing system.
Therefore, it does not contain the detailed information requested regarding acceptance criteria, specific device performance studies with sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies typically associated with AI/software medical devices.
Medical devices like the SBi RingFIX™ System (a bone fixation appliance) are typically evaluated through different types of studies, such as:
- Mechanical Testing: To assess strength, fatigue, and other physical properties.
- Biocompatibility Testing: To ensure the materials are safe for use in the body.
- Sterilization Validation: To confirm the device can be effectively sterilized.
- Pre-clinical (animal) studies: In some cases, to assess performance in a living system.
- Clinical studies (human trials): For new or high-risk devices, to demonstrate safety and effectiveness in patients.
The 510(k) Summary states: "The Design Control Activities Summary demonstrates that the modified device met all of the pre-determined acceptance criteria. The modified RingFIX™ System will achieve the same stability as afforded by the currently available RingFIX™ System." This indicates that performance data exists, but the specifics are not included in this summary document.
Based on the provided text, I cannot complete the requested tables and sections as the information is not present. The document describes a "Special 510(k) Submission" intended to add additional components to an existing system, rather than a clinical trial for a novel device or an AI-powered one.
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JUN 2 9 2007
510(k) Summary
| Manufacturer: | Small Bone Innovations1711 South Pennsylvania AvenueMorrisville, PA 19067215-428-1791215-428-1795 |
|---|---|
| Submitted By: | Small Bone Innovations1711 South Pennsylvania AvenueMorrisville, PA 19067 |
| Proprietary Name: | SBi RingFIX™ System |
| Classification name: | Class II, 888.3030 - Single/multiple component metallicbone fixation appliances and accessories |
| Product Code: | KTT - Appliance, Fixation, Nail/Blade/Plate Combination,Multiple Component |
| Common/Usual Name: | Single/multiple component metallic bone fixationappliances and accessories |
| Substantial Equivalence: | The modified SBi RingFIX™ System shares the sameintended use and fundamental scientific technology as thatof the currently available RingFIX™ System (originallycleared as the Danek Ring Fixator in K890814). TheDesign Control Activities Summary demonstrates that thethe modified device met all of the pre-determinedacceptance criteria. The modified RingFIX™ System willachieve the same stability as afforded by the currentlyavailable RingFIX™ System. |
| Description: | This Special 510(k) Submission is intended to addadditional components to the RingFIX™ System |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Senior Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022
JUN 2 9 2007
Re: K071394
Trade/Device Name: SBi RingFIX™ 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: June 11, 2007 Received: June 14, 2007
Dear Mr. Hoehn:
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 such 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
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Page 2 - Mr. Robert Hoehn
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely your
fur Raths
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K071394 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: RingFIXTM System
Indications For Use:
The RingFIXTM System is intended for:
-
- fracture fixation (open and closed)
-
- pseudarthrosis or nonunions of long bones
-
- Iimb lengthening by epiphyseal or metaphyseal distraction
-
- correction of bony or soft tissue deformities
-
- correction of segmental bony or soft tissue defects
Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 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) (Division Sign-On)
Division of General, Restorative,
Division of General, Devices Division of Overological Devices 510(k) Number_
§ 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.