(63 days)
Not Found
No
The device description focuses on the material, design, and mechanical properties of a bone plating system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a plating system intended for fixation of intra-articular fractures and reconstruction of the distal radius, which are surgical interventions rather than therapeutic treatments that involve healing or treating a disease/condition.
No
Explanation: The NEOVIEW® Plating System is intended for fixation of intra-articular fractures and reconstruction of the distal radius. It is a surgical implant used to stabilize bone fragments, not to diagnose a condition.
No
The device description clearly outlines physical components made of PEEK and Titanium alloy (plates and screws), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the NEOVIEW® Plating System is for the fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a plating system made of PEEK and titanium, designed to be implanted into bone.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
The NEOVIEW® Plating System is an implantable surgical device, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.
Product codes
HRS
Device Description
The NEOVIEW® Plating System is composed of the NEOVIEW® plates and the associated NEO screws. The NEOVIEW® plate is design to adequately maintain the bone fragments of distal radius and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The fixation of NEOVIEW® plate to the bone is performed by the associated NEO screws that are available on locking or not locking versions.
Sizes: The NEOVIEW® plates include 4 different designs. The associated NEO screws are available in one diameter and a large range of lengths packaged individually of in a kit.
Material: The NEOVIEW® plates are made of PEEK according to standard ASTM F2026 and include a marker made of tantalum according to ASTM F560. The NEO screws are made of Titanium alloy Ti-6Al-4V according to ISO 5832-3 and ASTM F136.
Single use: The NEOVIEW® Plating System is designed for single use only.
Sterilization: The NEOVIEW® Plating System is supplied sterile, using gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Place of use: The NEOVIEW® Plating System is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
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)
Performance testing of the NEOVIEW® Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic bending tests on NEOVIEW® Plating System. The results of the testing performed by the independent test laboratory indicate that the NEOVIEW® Plating System met the acceptance criteria.
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
§ 888.3030 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.
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Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol. The symbol is a stylized representation of a human figure, possibly suggesting care and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2016
In2bones SAS % Norman Estrin, Ph.D. Managing Partner Estrin Consulting Group LLC 9109 Copenhaver Drive Potomac, Maryland 20854
Re: K160995
Trade/Device Name: NEOVIEW® Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: April 7, 2016 Received: April 11, 2016
Dear Dr. Estrin:
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 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name NEOVIEW® Plating System
Indications for Use (Describe)
The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.
| 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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510(k) SUMMARY For In2Bones NEOVIEW® Plating System
| Sponsor identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | March 21st, 2016 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in
the United States
NEOVIEW® Plating
System | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
9109 Copenhaver Drive
Potomac, MD 20854
Phone: (301) 279-2899
Cell: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | NEOVIEW® Plating System |
| Common name | NEOVIEW® Distal Radius Plate |
| Device classification
regulation | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Device Product
Code and Panel | HRS: plate, fixation, bone
87 orthopedics |
4
| Device Description | The NEOVIEW® Plating System is composed of the
NEOVIEW® plates and the associated NEO screws.
The NEOVIEW® plate is design to adequately maintain the
bone fragments of distal radius and is made of PEEK, a
material recognized for its mechanical and radiolucent
properties.
The fixation of NEOVIEW® plate to the bone is performed
by the associated NEO screws that are available on locking
or not locking versions. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sizes: The NEOVIEW® plates include 4 different designs.
The associated NEO screws are available in one diameter
and a large range of lengths packaged individually of in a
kit.
Material: The NEOVIEW® plates are made of PEEK
according to standard ASTM F2026 and include a marker
made of tantalum according to ASTM F560. The NEO
screws are made of Titanium alloy Ti-6Al-4V according to
ISO 5832-3 and ASTM F136. |
| | Single use: The NEOVIEW® Plating System is designed for
single use only.
Sterilization: The NEOVIEW® Plating System is supplied
sterile, using gamma irradiation.
Place of use: The NEOVIEW® Plating System is indicated
for use in a hospital, or outpatient surgery center where |
| Predicate Devices | sterile field may be created and maintained.
Piccolo Composite™ Distal Volar Radius Plate (K102597) |
| Indications for use: | The NEOVIEW® Plating System is intended for fixation of
intra-articular and extra-articular fractures of the distal
radius and reconstruction of the distal radius. |
5
| Comparison of the
indications for use
with the predicate
devices: | The indications for use for the NEOVIEW® Plating System are
similar to the predicate device Piccolo Composite™ Distal Volar
Radius Plate (K102597) in intended use, design, material,
technological characteristics and principles of operation. |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
characteristics and
Substantial
Equivalence
Summary: | The NEOVIEW® Plating System is similar to the predicate device
Piccolo Composite™ Distal Volar Radius Plate (K102597) in
intended use, design, size ranges, principle of operation and
materials. |
| Summary
Performance Data | Performance testing of the NEOVIEW® Plating System was
assessed through mechanical bench testing performed by an
independent test laboratory, animal and clinical testing being
considered not applicable.
Testing performed included static and dynamic bending tests on
NEOVIEW® Plating System. The results of the testing performed
by the independent test laboratory indicate that the NEOVIEW®
Plating System met the acceptance criteria. |
| CONCLUSION | Based on the comparison of indications for use and
technological characteristics and the results of the testing
performed, the NEOVIEW® Plating System is substantially
equivalent to the predicate device identified in the 510(k)
submission. |