(42 days)
No
The summary describes a mechanical screw system and its intended use, with no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a compression screw system used for fixation in bone fractures, osteotomies, arthrodeses, osteochondritis, and tendon reattachment, which are surgical interventions rather than therapeutic treatments in the medical device context.
No
The device is a compression screw system used for treating bone fractures, osteotomies, arthrodeses, osteochondritis, and tendon reattachment, which are therapeutic interventions, not diagnostic processes.
No
The device description explicitly states that the system consists of physical components (screws and instrumentation) made of titanium alloy, indicating it is a hardware-based medical device.
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 and Intended Use: The description clearly states the HEALIX Compression Screw System is a system of screws and instrumentation used for surgical procedures like fixing bone fractures, osteotomies, and tendon reattachment. This is a surgical implant and associated tools, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The provided information does not mention any analysis of biological samples, laboratory testing, or diagnostic purposes.
Therefore, based on the provided information, the HEALIX Compression Screw System is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The Healix Compression Screw (HCS) System consists of 2.0mm to 8.5mm cannulated, solid titanium alloy, headless, headed screws and specialized instrumentation. The screw system has multiple lengths depending on diameter of the screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bone (including Hand, Orthopedic, and Podiatric, excluding posterior elements (pedicles) of the spine)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hand Surgery, Orthopedic Surgery, and Podiatric Surgery (implicitly, medical professionals in surgical settings)
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)
The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Torsion, driving torque, and axial pullout (per ASTM F543) ●
- Static and dynamic bending (per ASTM F1264)
The results of these tests, as well as engineering analysis of device characteristics, indicate that the HEALIX Compression Screw System is substantially equivalent to the predicate devices.
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.
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
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Nvision Biomedical Technologies, LLC % Jeffrey Brittan Consultant Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, California 92008
December 4, 2018
Re: K182949
Trade/Device Name: Healix™ Compression Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 2, 2018 Received: October 23, 2018
Dear Jeffrey Brittan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The name "Jesse Muir -S" is displayed on the left side of the image. On the right side, it says "Digitally signed by Jesse Muir -S" followed by the date "2018.12.04" and the time "17:14:17 -05'00'".
For: Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Healix™ Compression Screw System
Indications for Use (Describe)
The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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3
K182949 Page 1 of 2
510(k) Summary
DATE PREPARED
October 2, 2018
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, LLC 4754 Shavano Oak, Suite 101 San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Jeffrey Brittan Watershed Ideas Foundry Telephone: (714) 287-6780 jeffbrittan@watershedideas.com Email:
PROPRIETARY NAME OF SUBJECT DEVICE
HEALIX™ Compression Screw System
COMMON NAME Bone Fixation Screw System
DEVICE CLASSIFICATION
Smooth or threaded metallic bone fixation fastener (Classification Regulations: 21 CFR 888.3040, Product Codes: HWC, Class: II)
PREMARKET REVIEW
ODE/DOD/Joint and Fixation Devices (JFDB2) Orthopedic Panel
INDICATIONS FOR USE
The HEALIX Compression Screw (HCS) System is indicated for Bone Fractures, Osteotomies, Arthrodeses, Osteochondritis, and Tendon Reattachment. It is intended for, but not limited to, Hand Surgery, Orthopedic Surgery, and Podiatric Surgery but is not intended for attachment or fixation to the posterior elements (pedicles) of the spine.
DEVICE DESCRIPTION
The Healix Compression Screw (HCS) System consists of 2.0mm to 8.5mm cannulated, solid titanium alloy, headless, headed screws and specialized instrumentation. The screw system has multiple lengths depending on diameter of the screws.
4
Page 2 of 2
PREDICATE DEVICE IDENTIFICATION
The HEALIX Compression Screw System is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary
Predicate |
|---------------|--------------------------------------|----------------------|
| K014154 | Vilex Cannulated Bone Screw System* | ✓ |
| K081149 | BioPro GO-EZ Screw System | |
*Prior Vilex Cannulated Bone Screw System submissions also include K991151, K991197, and K973309
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the HEALIX Compression Screw System. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Torsion, driving torque, and axial pullout (per ASTM F543) ●
- Static and dynamic bending (per ASTM F1264)
The results of these tests, as well as engineering analysis of device characteristics, indicate that the HEALIX Compression Screw System is substantially equivalent to the predicate devices.
EQUIVALENCE TO PREDICATE DEVICES
Nvision believes that the HEALIX Compression Screw System is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K014154 and K081149. The subject device also has the same intended use, as well as similar technological characteristics (self-tapping, cannulated, headed and headless screws) as these predicates. The Indications for Use are equivalent and any minor differences in wording choices are insignificant. The solid versions of the subject screws are the same as the cannulated versions except they do not have a central cannulation; they function equivalently and do not raise additional questions of substantial equivalence. These technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the testing performed, including static bending, dynamic bending, torsion, driving torque, and axial pullout, as well as engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed HEALIX Compression Screw System are assessed to be substantially equivalent to the predicate devices.