(84 days)
No
The summary describes a mechanical fixation device made of titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for "general management of fractures and reconstructive surgery," which are therapeutic interventions.
No
Explanation: The Lagwire is described as a fixation system used in the general management of fractures and reconstructive surgery, indicating it is a therapeutic device rather than a diagnostic one. Its components (wire and cap) and materials (Titanium 6Al-4V alloy) are consistent with a surgical implant for stabilization or repair, not for identifying a condition or disease.
No
The device description clearly states it consists of a wire and a cap made of Titanium alloy, which are physical hardware components.
Based on the provided information, the Lagwire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the general management of fractures and reconstructive surgery." This describes a surgical device used directly on the patient's body to fix bones.
- Device Description: The description details a physical implantable device made of titanium, consisting of a wire and a cap. This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Lagwire does not fit this description.
N/A
Intended Use / Indications for Use
The Lagwire System is intended for use in the general management of fractures and reconstructive surgery.
Product codes
HWC
Device Description
The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.
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)
Bench testing was conducted to support equivalency
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K070393
2/6/2007
510K Summary of Safety and Effectiveness Fx Devices Lagwire System
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- Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
MAY - 4 2007
- Sponsor Name FxDevices One South Ocean Blvd., Suite 324 Boca Raton, FL 33432
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- Device Name Lagwire System Panel Orthopaedic Classification Name CFR Number
Smooth or Threaded Metallic Bone Fixation Fastener Class II (per 21 CFR 888.3040) HWC
- Device Name Lagwire System Panel Orthopaedic Classification Name CFR Number
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ന് Identification of Predicate or Legally Marketed Device The Lagwire is substantially equivalent to the Triage Medical BONE-LOK® MVP Cortical-Cancellous Compression Device cleared under K042244
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- Device Description
Product Code
The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.
- ട്. Intended Use The Lagwire System is intended for use in the general management of fractures and reconstructive surgery.
- റ. Comparison of Technological Characteristics The Lagwire was compared to the predicate with respect to in design, materials, construction, intended use, and performance.
- 7 Performance Testing Bench testing was conducted to support equivalency
-
- Statement of Equivalency The Lagwire System is substantially equivalent in design, materials, construction and intended use as those of the predicate device and therefore does not raise any new safety and efficacy concerns when compared to these similar legally marketed devices.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FxDevices % Mr. Rich Lipschutz Operations Manager One South Ocean Boulevard Suite 324 Boca Raton, Florida 33432
MAY - 4 2007
Re: K070393
Trade/Device Name: Lagwire 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, 2007 Received: February 9, 2007
Dear Mr. Lipschutz:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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); good manufacturing practice requirements as set
2
Page 2 – Mr. Rich Lipschutz
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 devices as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 vours.
Chabaud Buens
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K070393 |
|---|---|
| Device Name: | Lagwire System |
| Indications For Use: |
The Lagwire is indicated for use in the general management of fractures and reconstructive surgery.
Prescription Use _ X _ _ _
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Sarhare Buehum formykn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
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510(k) Number 1620393
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