(63 days)
Not Found
No
The summary describes a mechanical implant for bone fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as an "Implant System" intended to "provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot," which are medical treatments.
No
The device, a surgical screw implant, is intended for fixation purposes (fracture, fusion, osteotomy, reconstruction) of bones, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation," indicating it is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided information clearly states that the Solana Surgical LLC, Sola Fix Twist Screw Implant System is a surgical implant intended for the fixation of bones in the hand and foot. It is a physical device used within the body, not a test performed on a sample outside the body.
The description focuses on the mechanical properties and surgical application of the device, which is characteristic of a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the hand and foot
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)
Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate substantial equivalence. Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant.
Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate safety and efficacy. The devices were also evaluated to demonstrate they performed as expected.
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
§ 888.3040 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.
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K120390 '/2
APR 1 0 2012
ਵ
510(k) Summary
Summary of 510 (k) safety and effectiveness information upon which the substantial equivalence determination is based:
Prepared: Applicant:
Contact:
February 6, 2012 Solana Surgical, LLC 6363 Poplar Ave, Suite 434 Memphis. TN 38119 Louise Focht 901-818-1860
Common Name: Device Trade Name: Device Classification Name:
Device Classification: Reviewing Panel: Regulation Number: Product Code: Predicate Device:
Screw, fixation, bone Sola Fix Twist Screw Implant System Smooth or threaded metallic bone fixation fastener. Class II Orthopedic 21 CFR 888.3040 HWC K050819 Charlotte Snap-Off Screw
Device Description:
The Solana Surgical Implant is a one-piece device made of Titanium Alloy intended to be used as a screw for bone fixation, fusion, osteotomy or reconstruction of the hand and foot. The implant is available in a range of sizes (6) including 2.0mm diameter and length range of 11-16mm. The screw driving portion of the screw is intended to separate from the screw head once the screw seats to the bone.
Intended Use:
The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.
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Technological Characteristics:
Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate substantial equivalence. Based on the evaluations performed, the design and indications of the Solana Surgical screw are substantially equivalent to the predicates identified in the 510(k) submission. No new materials or processes are used in the development of this implant.
Substantial Equivalence - Non-Clinical Evidence:
Mechanical testing was performed according to ASTM F543 and an engineering/dimensional comparison to the predicate device was performed to demonstrate safety and efficacy. The devices were also evaluated to demonstrate they performed as expected.
Conclusions:
Similarities of the Solana Surgical device to its predicates include these devices being: intended for single use only, intended for surgical implantation longer than 30 days, system consisting of a series of implants, made of industry standard materials, with no new materials being introduced in the product, comparably sized, and indicated for the same uses. The evaluations performed and data provided in this application demonstrate that the Solana Surgical device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
APR 1 0 2012
Solana Surgical, LLC % Ms. Louise Focht 6363 Poplar Avenue Suite 434 Memphis, TN 38119
Re: K120390
Trade/Device Name: Sola Fix Twist Screw Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: February 6, 2012 Received: February 7, 2012
Dear Ms. Focht:
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 i that FDA has made a determination that your device complies with other requirements of the Act that I Drimas intact a and regulations administered by other Federal agencies. You must or any I cacial statures and registments, including, but not limited to: registration and listing (21 comply with an the Fee brequirements 801); medical device reporting (reporting of medical
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Page 2 - Ms. Louise Focht
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CDRH0ffices/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.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K/20390 Device Name: Sola Fix Twist Screw Implant System Indications for Use:
The Solana Surgical LLC, Sola Fix Twist Screw Implant System is intended to provide fixation for fracture, fusion, osteotomy or reconstruction of the bones of the hand and foot.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120390