(217 days)
The Guided Growth System plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular 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), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).
The Guided Growth System is designed for the gradual correction of pediatric deformities in both the upper and lower extremities. The device can be used for correction of congenital deformities as well as correction of acquired deformities, provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather 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. Immediately after implantation, the patient is allowed mobility and weight bearing.
The provided document describes the Orthofix Guided Growth System Quad-Plate, a medical device designed for correcting angular deformities in growing children. The submission focuses on demonstrating substantial equivalence to a predicate device through biomechanical testing, rather than a clinical study evaluating the device's diagnostic or predictive capabilities.
Therefore, many of the requested points, particularly those related to a study proving diagnostic performance, ground truth establishment, expert review, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are related to mechanical performance and substantial equivalence to a predicate, rather than diagnostic accuracy.
| Acceptance Criteria (related to substantial equivalence) | Reported Device Performance |
|---|---|
| Mechanical properties necessary to perform intended use. | Biomechanical testing according to ASTM F564-02 "Standard Specification and Test Method for Metallic Bone Staples" was successfully completed, demonstrating the Quad-Plate performs as well as the Guided Growth System Eight-Plate (predicate device). |
| Substantial equivalence in design. | The Guided Growth System Quad-Plate is substantially equivalent in design and function to the Guided Growth System Eight-Plate. (The Quad-Plate has four fixation points vs. two for the Eight-Plate, and slightly different size ranges, but core features like contoured waist, low profile, and material are identical). |
| Substantial equivalence in material. | Material (Ti6AL-4V ELI conforming to ASTM F136) is identical to the predicate device. |
| Substantial equivalence in intended use. | Indications for Use are identical to the predicate device: "redirecting the angle of growth of long bone(s) for gradually correcting angular 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), radial or ulnar deviation, flexion or extension deformities of the wrist (radius)." |
2. Sample size used for the test set and the data provenance
Not applicable for a biomechanical testing submission. The "test set" here refers to the actual physical devices tested, not a dataset of patient information. The testing was conducted in a laboratory setting. No patient data (e.g., country of origin, retrospective/prospective) was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context would refer to the true mechanical properties. These were established by standardized testing protocols (ASTM) rather than expert consensus on patient data.
4. Adjudication method for the test set
Not applicable. This concept applies to human review of data, not to standardized mechanical testing.
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
No. This is a hardware device (bone plate) submission, not an AI/software device. Therefore, no MRMC study or AI-related effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a hardware device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's mechanical performance was established using standardized biomechanical testing methods (ASTM F564-02). For the purpose of substantial equivalence, the "ground truth" for its clinical purpose is its similarity in function and indications to the legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, this question is irrelevant.
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1/2 K093442
SUMMARY OF SAFETY AND EFFECTIVENESS
•
| Summary PreparationDate: | June 10, 2010 | |
|---|---|---|
| 510(k) Submitter: | Mary E. Biggers, RACOrthofix Inc. 1720 Bray Central DriveMcKinney, TX 75609469-742-2500 | JUN 10 2010 |
| Primary Contact: | Darla ChewDirectory, Regulatory AffairsOrthofix Inc.Phone: 469-742-8824Fax: 469-742-2556darlachew@orthofix.com | |
| Device Trade Name: | Guided Growth System™ | |
| Device CommonName: | bone plate | |
| Regulation Name: | Single/multiple component metallic bone fixation appliances and accessories. | |
| Classification Name: | plate, bone, growth control, pediatric, epiphysiodesis(21 CFR Parts 888.3030) | |
| Product Code: | OBT | |
| Indications for Use: | The Guided Growth System plates are designed for the express and solepurpose of redirecting the angle of growth of long bone(s). This is useful forgradually correcting angular deformities in growing children. Specificconditions/diseases for which the device will be indicated include: valgus, varusor flexion, extension deformities of the knee (femur and/or tibia), valgus, varusor plantar flexion deformities of the ankle, valgus or varus deformities of theelbow (humerus), radial or ulnar deviation, flexion or extension deformities ofthe wrist (radius). | |
| Predicate Device: | The Orthofix Inc. Guided Growth System Quad-Plate is substantially equivalentin design, function, and intended use to the Orthofix Guided Growth Systemeight-Plate®. The Orthofix Guided Growth System eight-Plate, manufactured byOrthofix Inc. of McKinney, Texas, was originally cleared by FDA under K031493on November 20, 2003. |
1
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The Guided Growth System is designed for the gradual correction of pediatric Device Description: deformities in both the upper and lower extremities. The device can be used for correction of congenital deformities as well as correction of acquired deformities, provided that the physis (growth plates) are not fused. The plates feature a contoured waist and low profile for pediatric usage. There is a center hole in the plate for a temporary guide pin to be implanted to ensure accurate application of the plate. The plates are attached to the external surface of the bone over the growth plate by two or four screws. These screws are not locked to the plate, but rather 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. Immediately after implantation, the patient is allowed mobility and weight bearing.
| BiomechanicalTesting: | In order to demonstrate that the Guided Growth System Quad-Plate has themechanical properties necessary to perform its intended use, and that the QuadPlate performs as well as or better than the predicate device, Orthofix hasconducted mechanical and functional testing of the Quad-Plate in accordancewith ASTM F564-02 Standard Specification and Test Method for Metallic BoneStaples. The testing was successfully completed demonstrating the Quad Plateperforms as well as the Guided Growth System eight-Plate. |
|---|---|
| Material: | The Guided Growth System eight-Plate, Quad Plate and screws are made fromtitanium alloy, Ti6AL-4V ELI conforming to ASTM F136. |
| Sterilization: | The Guided Growth eight-Plate, Quad-Plate and Bone Screws are suppliedNON-STERILE and require sterilization prior to use. |
| SubstantialEquivalence: | The Guided Growth System Quad Plate is substantially equivalent in design |
and function to the Guided Growth System eight-Plate. The Guided Growth System eight-Plate received 510(k) clearance under K031493 on 11-20-03.
| Features | eight-Plate® | Quad-Plate |
|---|---|---|
| Indications forUse | "The Guided Growth Plate is designed for the express and solepurpose of redirecting the angle of growth of long bone(s). This isuseful for gradually correcting angular deformities in growingchildren. Specific conditions/diseases for which the device will beindicated include: valgus, varus or flexion, extension deformities ofthe knee (femur and/or tibia), valgus, varus or plantar flexiondeformities of the ankle, valgus or varus deformities of the elbow(humerus), radial or ulnar deviation, flexion or extension deformitiesof the wrist (radius)" | Identical |
| Material | Ti6A14V ELI | Identical |
| Features | eight-Plate® | Quad-Plate |
| Fixation Method | Bone Screws | Identical |
| Number ofFixation Points | Two | Four |
| Design Features | a contoured waist and low profile for pediatric usage | Identical |
| Size Ranges(lengths) | 12mm and 16 mm | 16 mm and 22mm |
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K09 3442 3/3
- Based upon the results of biomechanical testing the Guided Growth System Quad-Conclusion: Plate has the mechanical properties to perform its indications for use and is considered to be substantially equivalent to the predicate device in design, material and intended use.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Orthofix, Inc. % Ms. Mary Biggers 1720 Bray Central Drive McKinney, Texas 75069
JUN 1 0 2010
Re: K093442
Trade/Device Name: Guided Growth System Quad-Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: OBT Dated: May 10, 2010 Received: May 12, 2010
Dear Ms. Biggers:
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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Dr w 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 misbrandi, nound adulteration. Please note: CDRH does not evaluate information related to contractly, and warranties. We remind you, however, that device labeling must be truthful and not mucleading.
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 not the Act or any Federal statutes and regulations administered by other Federal agencies. Your 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 (reporting of medical
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Page 2 - Ms. Mary Biggers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Dallard Melker
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE STATEMENT
| Page | |
|---|---|
| of |
510(k) Number (if known):
Device Name:
"Guided Growth System Quad-Plate" (bone plate)
Indications for Use:
The Guided Growth Plates are designed for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting annyllar deformities in growing children. Specific conditions/diseases for which the device will be indicated include: valgus, varus or flexion, extension deformities of the knee (fiem wr and/or tibia), valgus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow (humerus), radial or ulnar deviation, flexion or extension deformitus of the wrist (radius)
Prescription Use: X (Per 21 CFR 801.109)
Or
Over-The-Counter (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Santur for mxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093442
§ 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.