(76 days)
Not Found
No
The device description focuses on mechanical and magnetic mechanisms for rod distraction, with no mention of AI/ML for decision-making, image analysis, or automated control.
Yes
The device is intended to treat severe progressive spinal deformities, such as scoliosis, by bracing the spine and allowing for non-invasive distraction to minimize progression, thus providing a therapeutic effect.
No.
The device is described as a spinal rod system used to brace the spine during growth and minimize scoliosis progression, which is a treatment, not a diagnostic, function.
No
The device description clearly outlines multiple hardware components including a spinal rod, fixation components, an External Remote Controller (ERC), a Manual Distractor, a Rod Template, and a Wand Magnet Locator.
Based on the provided information, the MAGEC® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- MAGEC System Function: The MAGEC System is a surgically implanted device used to mechanically brace and distract the spine. It directly interacts with the patient's body to treat a physical condition (spinal deformity). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for treating severe progressive spinal deformities in skeletally immature patients. This is a therapeutic intervention, not a diagnostic one based on analyzing samples.
- Device Description: The description details a mechanical system with a rod, fixation components, and an external controller for physical manipulation of the implant. There is no mention of analyzing biological samples.
Therefore, the MAGEC System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
Product codes (comma separated list FDA assigned to the subject device)
PGN
Device Description
The MAGEC System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline® 4.5-5.0 (Reline Small Stature) or Armada® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC Rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC) 1 or 2 that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC Rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either distract or retract the rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor, MAGEC Rod Template, and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC Rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel and contains a rare-earth magnet. The MAGEC Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC Rod previously implanted in a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
Indicated Patient Age Range
less than 10 years of age
Intended User / Care Setting
Physician / Operating room
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)
Nonclinical testing was performed to demonstrate that the subject MAGEC System is substantially equivalent to the predicate device. Pyrogen testing was performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices. The following testing was performed: Static Compression Bending, Static Torsion, Dynamic Compression Bending, Pyrogenicity - LAL (Kinetic Turbidimetric Assay Pyrogen Test). The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K150885, K161751, K160352, K140178
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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July 29, 2022
NuVasive Specialized Orthopedics, Incorporated Manthan J. Damani Senior Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K171791
Trade/Device Name: MAGEC® System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGN
Dear Manthan J. Damani:
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 August 31, 2017. 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
1
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NuVasive Specialized Orthopedics, Incorporated Mr. Manthan J. Damani Senior Regulatory Affairs Specialist 101 Enterprise. Suite 100 Aliso Viejo, California 92656
August 31, 2017
Re: K171791
Trade/Device Name: MAGEC® System Regulatory Class: Unclassified Product Code: PGN Dated: August 15, 2017 Received: August 16, 2017
Dear Mr. Damani:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
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 (DICE) 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 (DICE) 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,
Katherine D. Kavlock -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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Indications for Use
510(k) Number (if known) K171791
Device Name MAGEC® System
Indications for Use (Describe)
The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Submission MAGEC® System
510(k) Summarv
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Manthan J. Damani Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (858) 909-1800
Date Prepared: August 29, 2017
B. Device Name
| Trade or Proprietary Name: | MAGEC® System |
|---|---|
| Common or Usual Name: | Non Fusion Growing Rod System |
| Classification Name: | Unclassified |
| Regulation Number: | N/A (Unclassified) |
| Product Code: | PGN: Growing Rod System- Magnetic Actuation |
C. Predicate Devices
The subject device is substantially equivalent to the primary predicate device MAGEC 2 Spinal Bracing and Distraction System (K150885) and additional predicate devices MAGEC Spinal Bracing and Distraction System (K161751, K160352, and K140178).
D. Device Description
The MAGEC System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline® 4.5-5.0 (Reline Small Stature) or Armada® fixation components (i.e. pedicle screws, hooks and/or connectors). The implanted MAGEC Rod is used to brace the spine during growth to minimize the progression of scoliosis. The system includes a non-sterile hand held External Remote Controller (ERC) 1 or 2 that is used periodically after implantation to non-invasively distract the implanted spinal rod. The titanium MAGEC Rod includes an actuator portion that holds a small internal magnet. The magnet in the actuator can be turned non-invasively by use of the ERC, which is electrically powered. The hand held non-invasive ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either distract or retract the rod. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted. Additional accessories for the MAGEC System include the MAGEC Manual Distractor, MAGEC Rod Template, and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterile, single use device, which is used in the operating room to test the MAGEC Rod prior to implantation. The MAGEC Manual Distractor used with the MAGEC System is made of Radel and contains a rare-earth magnet. The MAGEC Rod Template is a sterile, single-use accessory used for intraoperative planning of the surgical procedure. The MAGEC Wand Magnet Locator is a non-sterile device which is used during the distraction procedure to locate the magnet within the MAGEC Rod previously implanted in a patient.
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Traditional 510(k) Submission MAGEC® System
The purpose of this premarket notification is to implement design changes to the MAGEC 2 Rod and to allow for use of MAGEC System with the NuVasive Reline 4.5-5.0 System.
E. Indications for Use
The MAGEC® System is intended for skeletally immature patients less than 10 years of age with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth.
F. Comparison of Technological Characteristics with Predicate Device
As was established in this submission, the subject MAGEC System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent to its predicate device through comparison in areas including design, materials, labeling/intended use, and function.
G. Performance Data
Nonclinical testing was performed to demonstrate that the subject MAGEC System is substantially equivalent to the predicate device. Pyrogen testing was performed on the subject device to ensure it meets the pyrogen limit specifications for sterile implant devices.
The following testing was performed:
| Test Description | Applicable Test Standard |
|---|---|
| Static Compression Bending | ASTM F1717-15: Standard Test Methods for Spinal |
| Implant Constructs in a Vertebrectomy Model | |
| Static Torsion | |
| Dynamic Compression Bending | |
| Pyrogenicity - LAL (Kinetic Turbidimetric | |
| Assay Pyrogen Test) | ANSI/ AAMI ST72:2011 – Bacterial Endotoxins – |
| Test Methods, Routine Monitoring, and Alternatives to | |
| Batch Testing |
The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate.
H. Conclusions
The subject MAGEC System has been shown to be substantially equivalent to legally marketed predicate devices for their intended use.