(63 days)
The NEOVIEW® Plating System is intended for fixation of intra-articular fractures of the distal radius and reconstruction of the distal radius.
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 sterile field may be created and maintained.
This document is a 510(k) premarket notification for the In2Bones NEOVIEW® Plating System. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study of the device's performance in meeting specific acceptance criteria like those found in AI/ML performance studies.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample sizes for test/training sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be extracted from this document in the typical sense of AI/ML device evaluations.
However, I can extract information related to the performance testing that was done and the overall conclusion regarding acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Met acceptance criteria | The NEOVIEW® Plating System met the acceptance criteria in mechanical bench testing. |
| Similar to predicate device | Similar in intended use, design, material, technological characteristics, and principles of operation to the predicate device. |
| Safe and effective for its intended use | Determined to be substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified. The document only mentions "mechanical bench testing."
- Data Provenance: Not applicable in the context of clinical data for AI/ML. The testing was "performed by an independent test laboratory."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. The ground truth for mechanical bench testing typically relies on engineering specifications and physical measurements, not expert clinical consensus in the way AI/ML studies do.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication as described (e.g., 2+1) is relevant for human interpretation of clinical data, not mechanical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. An MRMC study is not relevant for this type of device (metallic bone fixation system) or the type of performance testing reported. The document explicitly states "animal and clinical testing being considered not applicable."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Was it done?: Not applicable. This device is a physical implant, not an algorithm. The reported testing is for the physical and mechanical properties of the implant.
7. Type of Ground Truth Used:
- The ground truth for the "mechanical bench testing" would be based on engineering specifications and established biomechanical standards for bone fixation plates, which define acceptable strength, fatigue life, and other mechanical properties.
8. Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of Conclusions from the Document:
The document concludes that "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." This substantial equivalence is based on:
- Similarities in intended use, design, material, technological characteristics, and principles of operation to the predicate device (Piccolo Composite™ Distal Volar Radius Plate, K102597).
- Results from mechanical bench testing performed by an independent test laboratory, which indicated that the NEOVIEW® Plating System met its acceptance criteria.
- The absence of a need for animal and clinical testing for this specific type of device and submission.
{0}------------------------------------------------
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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange.
510(k) SUMMARY For In2Bones NEOVIEW® Plating System
| Sponsor identification | In2Bones SAS28 chemin du Petit Bois69130 Ecully – FrancePhone: +33.4.72.29.26.26Fax: +33.4.72.29.26.29 |
|---|---|
| Establishmentregistration number | 3010470577 |
| Date of preparation | March 21st, 2016 |
| Contact person | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Cell: 240-994-9999Email: estrin@yourFDAconsultant.com |
| Authorized Agent inthe United StatesNEOVIEW® PlatingSystem | Norman F. Estrin, Ph.D.Estrin Consulting Group LLC9109 Copenhaver DrivePotomac, MD 20854Phone: (301) 279-2899Cell: 240-994-9999Email: estrin@yourFDAconsultant.com |
| Proprietary Name | NEOVIEW® Plating System |
| Common name | NEOVIEW® Distal Radius Plate |
| Device classificationregulation | 21 CFR 888.3030: Single/multiple component metallic bonefixation appliances and accessoriesClass II |
| Device ProductCode and Panel | HRS: plate, fixation, bone87 orthopedics |
{4}------------------------------------------------
| Device Description | The NEOVIEW® Plating System is composed of theNEOVIEW® plates and the associated NEO screws.The NEOVIEW® plate is design to adequately maintain thebone fragments of distal radius and is made of PEEK, amaterial recognized for its mechanical and radiolucentproperties.The fixation of NEOVIEW® plate to the bone is performedby the associated NEO screws that are available on lockingor not locking versions. |
|---|---|
| Sizes: The NEOVIEW® plates include 4 different designs.The associated NEO screws are available in one diameterand a large range of lengths packaged individually of in akit.Material: The NEOVIEW® plates are made of PEEKaccording to standard ASTM F2026 and include a markermade of tantalum according to ASTM F560. The NEOscrews are made of Titanium alloy Ti-6Al-4V according toISO 5832-3 and ASTM F136. | |
| Single use: The NEOVIEW® Plating System is designed forsingle use only.Sterilization: The NEOVIEW® Plating System is suppliedsterile, using gamma irradiation.Place of use: The NEOVIEW® Plating System is indicatedfor 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 ofintra-articular and extra-articular fractures of the distalradius and reconstruction of the distal radius. |
{5}------------------------------------------------
| Comparison of theindications for usewith the predicatedevices: | The indications for use for the NEOVIEW® Plating System aresimilar to the predicate device Piccolo Composite™ Distal VolarRadius Plate (K102597) in intended use, design, material,technological characteristics and principles of operation. |
|---|---|
| Comparison ofTechnologicalcharacteristics andSubstantialEquivalenceSummary: | The NEOVIEW® Plating System is similar to the predicate devicePiccolo Composite™ Distal Volar Radius Plate (K102597) inintended use, design, size ranges, principle of operation andmaterials. |
| SummaryPerformance Data | Performance testing of the NEOVIEW® Plating System wasassessed through mechanical bench testing performed by anindependent test laboratory, animal and clinical testing beingconsidered not applicable.Testing performed included static and dynamic bending tests onNEOVIEW® Plating System. The results of the testing performedby the independent test laboratory indicate that the NEOVIEW®Plating System met the acceptance criteria. |
| CONCLUSION | Based on the comparison of indications for use andtechnological characteristics and the results of the testingperformed, the NEOVIEW® Plating System is substantiallyequivalent to the predicate device identified in the 510(k)submission. |
§ 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.