(51 days)
No
The device description and summary of performance studies do not mention any AI or ML components or capabilities. The system relies on a mechanical rod and an external magnetic controller for distraction.
Yes
The device is described as a "spinal rod" that is "surgically implanted" to "brace the spine during growth to minimize the progression of scoliosis" and address Thoracic Insufficiency Syndrome. These actions directly treat a medical condition.
No
The device is described as a spinal rod system used to brace the spine during growth and minimize scoliosis progression. Its function is to distract or retract the rod to achieve this. It does not perform diagnostic functions like detecting, monitoring, or diagnosing a medical condition.
No
The device description clearly outlines multiple hardware components including a spinal rod, fixation components, and an External Remote Controller (ERC). It is a system with both implanted and external hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- MAGEC System Function: The MAGEC System is an implanted medical device used to mechanically brace and distract the spine in skeletally immature patients with severe spinal deformities. It directly interacts with the patient's body and does not analyze biological specimens.
- Intended Use: The intended use clearly describes a surgical implant for spinal bracing and distraction, not for in vitro analysis.
- Device Description: The description details a physical implant, an external controller, and surgical accessories, all of which are used in a surgical or clinical setting for mechanical intervention.
Therefore, the MAGEC System falls under the category of an implanted surgical device, 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 andle of 30 dearees 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
PGN
Device Description
The MAGEC® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, 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 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.
The purpose of this premarket notification is to implement assembly process changes and a design change to the MAGEC Rod cleared in K171791 to address the Field Safety Notice and Product Recall issued on February 13, 2020 for the MAGEC X device (FDA Recall Number Z-1898-2020 and Recall Event ID 85495).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine, Thorax
Indicated Patient Age Range
less than 10 years of age
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
Nonclinical testing was performed to demonstrate that the subject MAGEC® System is substantially equivalent to the predicate devices. The following testing was performed: Static Compression Bending, Dynamic Compression Bending, Static Torsion (Applicable Standard: ASTM F1717: Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model); Distraction and Retraction Verification (Applicable Standard: N/A); Torsional Strength (Applicable Standard: ASTM F1798: Standard Guide For Evaluating The Static And Fatigue Properties Of Interconnection Mechanisms And Subassemblies Used In Spinal Arthrodesis Implants). The results demonstrate that the subject MAGEC® System is substantially equivalent to the predicates.
Key Metrics
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 29, 2022
NuVasive Specialized Orthopedics, Inc. Ivanna Lopez Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K201543
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 Ivanna Lopez:
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 30, 2020. 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
July 30, 2020
Image /page/1/Picture/1 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.
NuVasive Specialized Orthopedics, Inc. Ivanna Lopez Regulatory Affairs Specialist 101 Enterprise, Suite 100 Aliso Viejo, California 92656
Re: K201543
Trade/Device Name: MAGEC® System Regulatory Class: Unclassified Product Code: PGN Dated: June 8, 2020 Received: June 9, 2020
Dear Ms. Lopez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
2
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations. please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'neill -S
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
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 andle of 30 dearees 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): | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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MAGEC® System 510(k) Summary
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:
A. Submitted by:
Ivanna Lopez Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (858) 909-1878
Date Prepared: June 08, 2020
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Classification: Product Code:
MAGEC® System Non Fusion Growing Rod System Growing Rod System- Magnetic Actuation N/A (Unclassified) N/A (Unclassified) PGN
C. Predicate Devices
The subject device is substantially equivalent to the following devices:
Primary Predicate
- K171791 - MAGEC System
Additional Predicates
- K150885 MAGEC 2 Spinal Bracing And Distraction System ●
- K140178 MAGEC Spinal Bracing And Distraction System ●
Device Description D.
The MAGEC® System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate NuVasive® Reline®, 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
5
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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 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.
The purpose of this premarket notification is to implement assembly process changes and a design change to the MAGEC Rod cleared in K171791 to address the Field Safety Notice and Product Recall issued on February 13, 2020 for the MAGEC X device (FDA Recall Number Z-1898-2020 and Recall Event ID 85495).
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 the Predicate Device
As was established in this submission, the subject MAGEC® System is substantially equivalent to the predicates, MAGEC System (K171791), MAGEC 2 Spinal Bracing and Distraction System (K150885) and MAGEC Spinal Bracing And Distraction System (K140178), which were previously cleared by the FDA for commercial distribution in the United States. The subject device has been shown to be substantially equivalent and have equivalent technological characteristics to the predicates through comparison in areas including design, material composition, labeling/intended use, and function.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject MAGEC® System is substantially equivalent to the predicate devices. The following testing was performed:
| Testing Description | Applicable Standard |
|---|---|
| Static Compression Bending | |
| Dynamic Compression Bending | |
| Static Torsion | ASTM F1717: Standard Test Methods for |
| Spinal Implant Constructs in a Vertebrectomy | |
| Model | |
| Distraction and Retraction Verification | N/A |
| Torsional Strength | ASTM F1798: Standard Guide For Evaluating |
| The Static And Fatigue Properties Of | |
| Interconnection Mechanisms And Subassemblies | |
| Used In Spinal Arthrodesis Implants |
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The results demonstrate that the subject MAGEC® System is substantially equivalent to the predicates.
Conclusions H.
The subject device, the MAGEC® System, has been shown to be substantially equivalent to the legally marketed predicate devices for its intended use.