(114 days)
K/DEN number: K133904
No
The device description focuses on mechanical components and surgical techniques, with no mention of AI/ML terms or functionalities. The performance studies compare the device to traditional growth rod systems based on clinical outcomes and mechanical strength, not AI/ML performance metrics.
Yes
The device is indicated for correcting and maintaining the correction of severe, progressive spinal deformities, which is a therapeutic treatment.
No
The device description indicates it is a system of rods, hooks, and screws used for the surgical correction and maintenance of severe, progressive spinal deformities, not for diagnosing them.
No
The device description explicitly states that the SHILLA™ Growth Guidance System consists of physical components such as steel rods, hooks, screws, plates, and connecting components, all made from medical grade stainless steel. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SHILLA™ Growth Guidance System is a surgical implant used to treat spinal deformities in skeletally immature patients. It is a physical device implanted in the body to provide structural support and guidance for growth.
- Device Description: The description details the components of the system (rods, hooks, screws, plates, etc.) which are all physical, implantable parts.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The information provided describes a surgical implant, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The SHILLA™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLATM Growth Guidance System is intended to be removed after skeletal maturity.
Product codes
PGM
Device Description
The SHILLA™ Growth Guidance System is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. Severe, progressive early-onset scoliosis is defined as a greater than 40° Cobb angle or a rib-vertebral angle difference greater than 20°. The SHILLATM Growth Guidance System consists of a variety of shapes and sizes of steel rods, hooks, screws, CROSSLINK® Plates, and connecting components, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. All SHILLATM components are manufactured from medical grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
Indicated Patient Age Range
skeletally immature patients less than 10 years of age with the potential for additional spinal growth
Intended User / Care Setting
Not Found
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)
Retrospective clinical data for the subject device compared to traditional growth rod devices were provided in support of this application. The clinical outcomes demonstrated the subject SHILLATM Growth Guidance System to be substantially equivalent to traditional growth rod systems when treating the same patient population. Additionally, mechanical testing was provided which demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent with regards to mechanical strength to the CD HORIZON® Growth Rod Conversion Set.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
Medtronic Sofamor Danek USA, Inc. Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K140750
Trade/Device Name: SHILLA™ Growth Guidance System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM
Dear Mr. Grant:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 17, 2014. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under regulation number, 21 CFR 888.3070.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ronald Jean, OHT6: Office of Orthopedic Devices, (301)796-5650, Ronald.Jean@fda.hhs.gov.
Sincerely,
Ronald P. Jean -S
Ronald P. Jean, Ph.D. Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 17, 2014
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis. Tennessee 38132
Re: K140750
Trade/Device Name: SHILLATM Growth Guidance System Regulatory Class: Unclassified Product Code: PGM Dated: June 17, 2014 Received: June 19. 2014
Dear Mr. Grant:
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 10 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 cither class 11 (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 (reporting of medical 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.
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Page 2 - Mr. Lee Grant
- 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" (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.
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,
Ronald P. Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140750
Device Name SHILLATM Growth Guidance System
Indications for Use (Describe)
The SHILLATM Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLA™ Growth Guidance System is intended to be removed after skeletal maturity.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
P. Jean
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."
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JUL 1 7 2014
SHILLATM Growth Guidance System 510(k) Summary K140750
July 2014
| Company: | Medtronic Sofamor Danek USA
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lee Grant
Distinguished Regulatory Affairs Advisor |
| Proprietary Trade Name: | SHILLA TM Growth Guidance System |
| Product Code: | PGM |
| Regulation: | Pre-Amendment Unclassified |
| Classification: | Unclassified |
Description: The SHILLA™ Growth Guidance System is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. Severe, progressive early-onset scoliosis is defined as a greater than 40° Cobb angle or a rib-vertebral angle difference greater than 20°. The SHILLATM Growth Guidance System consists of a variety of shapes and sizes of steel rods, hooks, screws, CROSSLINK® Plates, and connecting components, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. All SHILLATM components are manufactured from medical grade stainless steel.
Indications for Use: The SHILLA™ Growth Guidance System is indicated for skeletally immature patients less than 10 years of age with the potential for additional spinal growth, who require surgical treatment for correction and maintenance of the correction of severe, progressive, life-threatening early-onset deformities, including early-onset scoliosis, which are associated with or at risk of thoracic insufficiency syndrome. The SHILLATM Growth Guidance System is intended to be removed after skeletal maturity.
Summary of the Technological Characteristics: The subject SHILLA™ Growth Guidance System has the same fundamental scientific technology as the predicate CD HORZION® Growth Rod Conversion Set. The subject device utilizes equivalent surgical approaches, implant materials, surgical instruments, and sterilization methods.
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Identification of Legally Marketed Devices: The subject SHILLATM Growth Guidance System is substantially equivalent to the CD HORIZON® Growth Rod Conversion Set K 133904 (1/30/14) and to the pre-amendment Harrington Rod Spinal System.
Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing: Retrospective clinical data for the subject device compared to traditional growth rod devices were provided in support of this application. The clinical outcomes demonstrated the subject SHILLATM Growth Guidance System to be substantially equivalent to traditional growth rod systems when treating the same patient population. Additionally, mechanical testing was provided which demonstrated the SHILLA™ Growth Guidance System to be substantially equivalent with regards to mechanical strength to the CD HORIZON® Growth Rod Conversion Set.
Conclusion: The design features, materials used, manufacturing and sterilization methods are substantially equivalent to the previously cleared CD HORIZON® Growth Rod Conversion Set. The retrospective clinical data supplied in this application identified no new potential risks to patients and demonstrated substantially equivalent outcomes when comparing the SHILLA™ Growth Guidance System to traditional growth rods. Therefore, Medtronic believes the subject SHILLA™ Growth Guidance System implants contained in this application to be substantially equivalent to the legally marketed predicate CD HORIZON® Growth Rod Conversion Set implants cleared in K133904.