(328 days)
Not Found
No
The summary describes a mechanical screw system for bone fixation and delivery of bone void fillers. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.
No.
The N-Force Fixation System is described as a screw system for fracture fixation and bone reconstruction, which are mechanical support functions, not directly therapeutic. While it can deliver bone void fillers, the device itself is for fixation.
No
The N-Force Fixation System is a screw system for fracture fixation and bone reconstruction; it is not used to diagnose a condition.
No
The device description explicitly states that the N-Force Fixation System is a screw system made of titanium alloy and includes accompanying instruments, indicating it is a hardware device.
Based on the provided information, the N-Force Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fixation of bone fractures and bone reconstructions." This is a surgical procedure performed in vivo (within the living body), not a test performed in vitro (outside the living body) on biological samples to diagnose a condition.
- Device Description: The device is described as a "screw system for fracture fixation" made of titanium alloy. This is a medical device used for structural support within the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the N-Force Fixation System falls under the category of a surgical implant or fixation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:
- . Beta-bsm (ETEX Corporation)
- CarriGen (ETEX Corporation) .
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.
The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pullout, insertion torque, and extraction torque. Additional testing was performed to demonstrate the substantial equivalence of the N-Force Fixation System to the ETEX recommended instruments with respect to their ability to deliver bone void filler material.
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.
K083912, K993106, K961213, K991889, K101557
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.
0
510(k) Summary
JUL 28 2011
| Contact: | Michelle McDonough
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 21, 2011 |
| Device Trade Name: | N-Force Fixation System |
| Manufacturer: | Innovision, Inc.
1975 Nonconnah Blvd.
Memphis, TN 38132. |
| Common Name: | Smooth or threaded metallic bone fixation fastener |
| Classification: | 21 CFR 888.3040 |
| Class: | II |
| Product Code: | HWC |
Indications For Use:
The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:
- . Beta-bsm (ETEX Corporation)
- CarriGen (ETEX Corporation) .
Device Description:
The N-Force Fixation System is a screw system for fracture fixation. It includes fully and partially cannulated screws in various lengths, and accompanying instruments.
The N-Force Fixation System screws are made of titanium alloy (Ti-6Al-4V) conforming to ASTM F136. The N-Force Fixation System is cannulated and fenestrated which allow it to be used as a delivery system for ETEX Beta-bsm and ETEX CarriGen bone void fillers.
Predicate Devices:
The N-Force Fixation System was shown to be substantially equivalent to previously cleared screw devices including Treu Bone Fixation Screws and Pins (K083912) and S&N 4.0mm Cannulated Screws (K993106); the Haig Nail System (K961213 and K991889) which, like the
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N-Force Screw, is a fracture fixation device that temporarily serves as a surgical instrument; and the delivery systems used with ETEX Beta-bsm and ETEX CarriGen bone void fillers (K101557).
Substantial Equivalence:
Testing performed on the N-Force Screw indicates that it is substantially equivalent to predicate devices. Mechanical testing of the screw included static three-point bending, torsion, axial pullout, insertion torque, and extraction torque. Additional testing was performed to demonstrate the substantial equivalence of the N-Force Fixation System to the ETEX recommended instruments with respect to their ability to deliver bone void filler material.
Conclusion
The N-Force Fixation System is substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials.
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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 stylized depiction of an eagle or bird-like figure, with its wings spread and head turned to the right. The bird is rendered in a thick, black line. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innovision, Inc. % Ms. Michelle McDonough 1331 H Steet Northwest, 12th Floor Washington, District Columbia 20005
JUL 28 2011
Re: K102528
Trade/Device Name: N-Force Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: June 16, 2011 Received: June 20, 2011
Dear Ms. McDonough:
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. Iisting 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
3
Page 2 - Ms. Michelle McDonough
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 vours.
Mark A. Millener,
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): K102528
Device Name: N-Force Fixation System
The N-Force Fixation System is intended for the fixation of bone fractures and bone reconstructions. When used for these indications, the N-Force Fixation System can also be used to deliver the following bone void fillers to a surgical site:
- Beta-bsm (ETEX Corporation) .
- CarriGen (ETEX Corporation) .
Prescription Use ﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ar M. Melkerson
(Division Sign-Oft) (Division Sign-On))
Division of Surgical, Orthopedic, Division of Surge
and Restorative Devices
510(k) Number K102528
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