(174 days)
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Guided Growth Plate System Plus is designed for the gradual correction of pediatric congenital as well as acquired deformities in both the upper and lower extremities, provided that the physis (growth plates) are not fused. It consists of different sizes of eight-Plate and quad-Plate plus with different cannulated and solid screw options. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plates for a temporary guide pin to be implanted, in order to aid application and removal of the plate. The plates are attached to the external surface of the bone by screws, which are not locked to the plate but rather they are allowed to swivel and diverge in their position as bone growth occurs. The implant acts like a flexible hinge, permitting growth at the growth plate to gradually straighten the limb.
This document describes a medical device, the Guided Growth Plate System Plus, and its clearance through the FDA 510(k) pathway. This pathway establishes substantial equivalence to a predicate device rather than necessarily proving new efficacy. Therefore, the information provided focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving performance against them in the traditional sense of a clinical study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to the predicate device and meeting applicable performance standards. There aren't specific quantitative accuracy metrics for a diagnostic device given here, but rather engineering and biocompatibility criteria.
| Acceptance Criterion (Category) | Reported Device Performance / Assessment |
|---|---|
| Mechanical Performance | - The device was tested according to ASTM F564 – 10 "Standard Specification and Test Methods for Metallic Bone Staples."- "All testing met or exceeded the requirements, as established by the test protocols and applicable standard."- "A review of the mechanical data indicates that the components of the Subject device continues to be capable of withstanding expected loads without failure."- "The Subject device was therefore found to be substantially equivalent to the Predicate device and has the mechanical properties to perform its indications safely." |
| Biocompatibility | - Tests performed on equivalent system devices according to USP 38:2014 <85> "Bacterial endotoxin test (LAL)", USP 38:2014 <161> "Medical devices – bacterial endotoxin and pyrogen tests", ANSI/AAMI ST72:2011 "Bacterial endotoxins - Test methodologies, routine monitoring and alternative batch testing", and FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing: Question and Answers."- "to establish the Subject device non-pyrogenicity" |
| Substantial Equivalence | - Demonstrated similarity to the predicate device (Guided Growth System Quad-Plate, K093442) in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances, and implantable components. |
| Design Improvements | - The subject device provides "design improvements and additional dimensions for implantable components, new sterile components and new related packaging configuration" while maintaining substantial equivalence. |
| Risk Management | - "The potential hazards have been evaluated and controlled through a Risk Management Plan." |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (surgical implant) and its review for substantial equivalence, not an AI/software as a medical device (SaMD) or diagnostic study with a "test set" of patient data in the typical sense.
- Test Set Sample Size: Not applicable in the context of a clinical performance test set for an AI device. The "test set" for this device consists of the physical devices themselves and materials for mechanical and biocompatibility testing. No specific number of devices/materials tested is provided, but it's stated that "All testing met or exceeded the requirements."
- Data Provenance: Not applicable for patient data. The provenance of the performance data (mechanical and biocompatibility) would be from in-vitro laboratory testing conducted by or for Orthofix Srl in Italy. The document mentions "test reports and rationale references list."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. This is not a study that requires expert adjudication for ground truth on clinical images or patient data. The "ground truth" for mechanical testing is defined by the standards (e.g., ASTM F564-10) and for biocompatibility by the international standards listed (e.g., USP 38, ANSI/AAMI ST72). These standards themselves are developed by expert consensus in their respective fields.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (guided growth plate) for surgical implantation, not an AI or imaging diagnostic device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Engineering Standards: For mechanical performance (e.g., ASTM F564-10).
- Biocompatibility Standards: For non-pyrogenicity (e.g., USP 38, ANSI/AAMI ST72).
- Regulatory Substantial Equivalence Criteria: Comparing the device's characteristics to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to establish for one.
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January 9, 2018
Orthofix Srl Gianluca Ricadona Sr. Quality & Regulatory Affairs Manager Via delle Nazioni. 9 97012 Bussolengo (VR) – Italy
Re: K172183
Trade/Device Name: Guided Growth Plate System Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: OBT Dated: November 27, 2017 Received: November 29, 2017
Dear Gianluca Ricadona:
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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Guided Growth Plate System Plus
Indications for Use (Describe)
The Guided Growth Plate System Plus is intended for redirecting the growth of long bones.
It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (femur and/or tibia); valgus, varus, or plantar flexion deformities of the ankle; valgus or varus deformities of the elbow (humerus), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------ |
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Type of Use (Select one or both, as applicable)
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510(k) Summary
(as required by 21 CFR 807.92)
| Submitter | Orthofix Srl |
|---|---|
| Via delle Nazioni, 9 | |
| 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| Contact Person | Gianluca Ricadona |
|---|---|
| Sr. Quality & Regulatory Affairs Manager | |
| Address | Via delle Nazioni, 9 |
| 37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 |
| Fax | + 39 045 6719.380 |
| GianlucaRicadona@orthofix.it |
07/14/2017 Date Prepared
| Trade Name | Guided Growth Plate System Plus |
|---|---|
| Common Name | Bone plate |
| Panel Code | 87 / Orthopaedic |
| Classification Name | plate, bone, growth control, pediatric, epiphysiodesis |
| Class | Class II |
| Regulation Number | 21 CFR 888.3030 |
| Product Code | OBT |
| Name of Predicate Device | 510(k) # | Manufacturer |
|---|---|---|
| Guided Growth System Quad-Plate | K093442 | Orthofix Srl |
| Description | The Guided Growth Plate System Plus is designed for the gradualcorrection of pediatric congenital as well as acquired deformities in boththe upper and lower extremities, provided that the physis (growth plates)are not fused.It consists of different sizes of eight-Plate and quad-Plate plus withdifferent cannulated and solid screw options.The plates feature a contoured waist and low profile for pediatric usage.There is a center hole in the plates for a temporary guide pin to beimplanted, in order to aid application and removal of the plate.The plates are attached to the external surface of the bone by screws,which are not locked to the plate but rather they are allowed to swivel anddiverge in their position as bone growth occurs. The implant acts like aflexible hinge, permitting growth at the growth plate to gradually straightenthe limb. |
|---|---|
| Indications for | The Guided Growth Plate System Plus is intended for redirecting the |
| Indications forUse | The Guided Growth Plate System Plus is intended for redirecting thegrowth of long bones. It is indicated for gradually correcting angulargrowth deformities in growing children.Specific conditions/diseases for which the device will be indicated include:valgus, varus or flexion, extension deformities of the knee (femur and/ortibia); valgus, varus, or plantarflexion deformities of the ankle; valgus or varus deformities of the elbow(humerus), and radial or ulnar deviation, flexion or extension deformitiesof the wrist (radius). |
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| TechnologicalCharacteristicsand SubstantialEquivalence | Documentation was provided to demonstrate that the Subject device issubstantially equivalent to the predicate Guided Growth System Quad-Plate (K093442) in the following fundamental aspects:intended use, indications for use, site of application, patient population,condition of use, technological characteristics, materials, mechanicalperformances and implantable components.Respect to the predicate, the Subject device provides designimprovements and additional dimensions for implantable components,new sterile components and new related packaging configuration. |
|---|---|
| -------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Performance Data | The potential hazards have been evaluated and controlled through a RiskManagement Plan. |
|---|---|
| All testing met or exceeded the requirements, as established by the testprotocols and applicable standard. | |
| A review of the mechanical data indicates that the components of theSubject device continues to be capable of withstanding expected loadswithout failure. | |
| The Subject device was therefore found to be substantially equivalent tothe Predicate device and has the mechanical properties to perform itsindications safely. | |
| Clinical data was not needed to support the safety and effectiveness ofthe Subject Device. | |
| The following standard has been followed to perform mechanical test onthe System configuration:• ASTM F564 – 10 "Standard Specification and Test Methods forMetallic Bone Staples". | |
| Biocompatibilitydata | In order to establish the Subject device non-pyrogenicity, some tests wereperformed on an equivalent System devices, according to the followinginternational standard:• USP 38: 2014 < 85 > "Bacterial endotoxin test (LAL)".• USP 38: 2014 < 161 > "Medical devices – bacterial endotoxin andpyrogen tests".• ANSI / AAMI ST72: 2011 "Bacterial endotoxins - Test methodologies,routine monitoring and alternative batch testing".• FDA 2012 Q&A "Guidance for Industry Pyrogen and Endotoxins Testing:Question and Answers". |
| Here below the tests reports and rationale references list:• 8 Plate Plus_QE_RA01_r1, test rationale• Orthofix Biological Evaluation report, dated 2015/05/11• 16VA00534 validation report, dated 2015/05/11 | |
| Conclusion | Based upon similarities in: intended use, indications for use, site of |
| Conclusion | Based upon similarities in: intended use, indications for use, site of application, patient population, condition of use, technological characteristics, materials, mechanical performances, technology, materials and implantable components, Guided Growth Plate System Plus has been shown to be substantially equivalent to the legally marketed predicate device and to be safe and effective for its intended use. |
|---|---|
| ------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
§ 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.