(90 days)
Not Found
No
The device description and performance studies focus on mechanical distraction and bracing, with no mention of AI/ML for analysis, prediction, or control.
Yes
The device is described as a "Spinal Bracing and Distraction System" indicated for treating severe progressive spinal deformities in skeletally immature patients with early-onset scoliosis. Its mechanism of action involves surgically implanting rods that are periodically distracted to lengthen the spine, thus providing bracing during growth and minimizing scoliosis progression. This aligns with the definition of a therapeutic device, which is used to treat or alleviate a medical condition.
No
Explanation: The MAGEC Spinal Bracing and Distraction System is described as a treatment device intended to lengthen the spine and provide bracing for patients with severe progressive spinal deformities. It does not perform any diagnostic function.
No
The device description clearly outlines hardware components including sterile single-use rods, a Rod Template, Manual Distractor, Wand Magnet Locator, and an External Remote Controller (ERC). The core function involves the physical manipulation of an implanted rod via an external magnetic field generated by the ERC. This is a hardware-based system with a software component (the ERC's control), not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The MAGEC Spinal Bracing and Distraction System is a surgically implanted device used to treat spinal deformities. It is a physical implant that interacts directly with the patient's anatomy.
- Intended Use: The intended use is to provide bracing and distraction to the spine in skeletally immature patients with severe progressive spinal deformities. This is a therapeutic intervention, not a diagnostic test performed on a sample.
The device's function and application clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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 subject MAGEC Spinal Bracing and Distraction System has an identical design and principle of operation to the predicate design iterations cleared in the predicate Magec System (K201543, K161751, K140613). The subject system includes sterile single use MAGEC rods manufactured from Ti-6Al-4V, conforming to ASTM F136, along with various accessories including a sterile Rod Template and Manual Distractor, a non-sterile Wand Magnet Locator, and is compatible with a hand held External Remote Controller (ERC) 1 or 2. The MAGEC rod can be surgically implanted using appropriate NuVasive Reline 4.5-5.0 (Reline Small Stature or RSS) or Armada fixation components (i.e., pedicle screws, hooks and/or connectors). 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. Periodic distraction of the rod is performed to lengthen the spine and to provide adequate bracing during growth to minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, Thoracic
Indicated Patient Age Range
Skeletally immature patients
Intended User / Care Setting
Physician
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)
A large retrospective registry study of pediatric early-onset scoliosis patients treated with the subject device was performed. The study population consisted of patient groups:
- Group 1: Age at index MAGEC implantation at less than 10 years (N= 1,080 patients)
- Group 2: Age at index MAGEC implantation at 10 years or greater (N= 172 patients)
All patients were diagnosed to have early-onset scoliosis before 10 years of age. All patients were treated with the MAGEC System. In total, there were 1,252 patients treated with the MAGEC System, including 1,080 patients treated before 10 years of age, and 172 patients who were treated with the MAGEC System at 10 years of age or older. The clinical and radiographic data demonstrates that the MAGEC System device, when used in patients 10 years of age or older, is substantially equivalent to the predicate Magec System device indicated for use in patients younger than 10 years of age.
Data Source: Registry Study (Group 1: N=1,080; Group 2: N=172); Literature (Group B: N=57)
Key results:
- Major curve Cobb angle, Δ, mean: Group 1: 26.5%, Group 2: 25.0%, Group B: 36.6%
- Thoracic height (T1-T12), Δ, mean: Group 1: 15.1%, Group 2: 15.5%, Group B: 16.4%
- Spinal height (T1-S1), Δ mean: Group 1: 15.3%, Group 2: 15.3%, Group B: 15.4%
- Device-related adverse events: Group 1: 35.3%, Group 2: 8.1%, Group B: 10.5%
The results demonstrate that the subject MAGEC System is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Major curve Cobb angle, Δ, mean
Thoracic height (T1-T12), Δ, mean
Spinal height (T1-S1), Δ mean
Device-related adverse events
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.
0
February 6, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a sans-serif font.
Nu Vasive Specialized Orthopedics, Incorporated Miriam Cervantes Senior Regulatory Affairs Specialist 101 Enterprise Suite 100 Aliso Viejo, California 92656
Re: K233593
Trade/Device Name: MAGEC Spinal Bracing and Distraction System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: PGN Dated: November 8, 2023 Received: November 8, 2023
Dear Miriam Cervantes:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Advice (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. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K233593
Device Name
MAGEC Spinal Bracing and Distraction System
Indications for Use (Describe)
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to earlyonset scoliosis 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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3
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K233593 Page 1 of 5
MAGEC Spinal Bracing and Distraction 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 bv:
Miriam Cervantes Senior Regulatory Affairs Specialist NuVasive Specialized Orthopedics, Inc. 101 Enterprise, Suite 100 Aliso Viejo, CA 92656 Telephone: (909) 229-7836
Date Prepared: November 7, 2023
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name: Device Class: Regulation Number: Product Code:
MAGEC Spinal Bracing and Distraction System Non Fusion Growing Rod System Growing Rod System- Magnetic Actuation Class II 21 CFR § 888.3070 PGN
C. Predicate Devices
The subject MAGEC Spinal Bracing and Distraction System is substantially equivalent to the primary predicate MAGEC® System (K201543) and additional predicates MAGEC® Spinal Bracing and Distraction System (K161751) and Magec Spinal Bracing And Distraction System (K140613).
D. Device Description
The subject MAGEC Spinal Bracing and Distraction System has an identical design and principle of operation to the predicate design iterations cleared in the predicate Magec System (K201543, K161751, K140613). The subject system includes sterile single use MAGEC rods manufactured from Ti-6Al-4V, conforming to ASTM F136, along with various accessories including a sterile Rod Template and Manual Distractor, a non-sterile Wand Magnet Locator, and is compatible with a hand held External Remote Controller (ERC) 1 or 2. The MAGEC rod can be surgically implanted using appropriate NuVasive Reline 4.5-5.0 (Reline Small Stature or RSS) or Armada fixation components (i.e., pedicle screws, hooks and/or connectors). 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. Periodic distraction of the rod is performed to lengthen the spine and to provide adequate bracing during growth to
4
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minimize the progression of scoliosis. Once the physician determines that the implant has achieved its intended use and is no longer required, the implant is explanted.
The purpose of this premarket notification is to expand the indications for use to include treatment of skeletally immature patients of any age with early onset scoliosis.
E. Indications for Use
The MAGEC Spinal Bracing and Distraction System is indicated for skeletally immature patients with severe progressive spinal deformities (e.g., Cobb angle of 30 degrees or more; thoracic spine height less than 22 cm) secondary to early-onset scoliosis 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.
Technological Characteristics F.
As was established in this submission, the subject MAGEC System is substantially equivalent to its predicate devices 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 predicate through comparison in areas including clinical use, design, material composition, intended use, and function.
The following table describes the summary comparison of technological characteristics of the subject device with the predicate device:
| | Subject Device | Predicate Device
(K201543/K161571/K140613) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The MAGEC Spinal Bracing and
Distraction System is indicated for
skeletally immature patients with
severe progressive spinal deformities
(e.g., Cobb angle of 30 degrees or
more; thoracic spine height less than
22 cm) secondary to early-onset
scoliosis 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. | The Magec System is indicated 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. |
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| Explanation of
differences in
Indications for
Use | The subject device is indicated for
skeletally immature patients of any
age with early-onset scoliosis. The
purpose of specifying early-onset
scoliosis is to explicitly identify the
treated condition for patients,
surgeons, hospitals, and payers. It is
solely to clarify the indications. This
does not change the intended patient
population or treated conditions. | The predicate device is indicated for
use in skeletally immature patients
less than 10 years of age. |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
the technology
similarities to
the predicate
device | • Principle of Operation: Brace the
spine during growth to minimize
the progression of scoliosis
• Material Composition: Titanium
• Design: Magnetic mechanism
• Accessories: Magec Manual
Distractor, Magec Rod Template,
and Magec Wand Magnet Locator | • Principle of Operation: Brace the
spine during growth to minimize
the progression of scoliosis
• Material Composition: Titanium
• Design: Magnetic mechanism
• Accessories: Magec Manual
Distractor, Magec Rod Template,
and Magec Wand Magnet Locator |
| Summary of
the technology
differences to
the predicate
device | Identical to predicate | No change in technology |
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C. Performance Data
MAGEC System The subject to the predicate Magec System (K201543/K161571/K140613). There have been no design changes introduced as part of this submission. The purpose of this submission is to expand the indications for use of the MAGEC System to include treatment of skeletally immature patients of any age with early onset scoliosis.
The following non-clinical testing was previously provided and reviewed by FDA:
- Biocompatibility evaluation per ISO 10993-1, including cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18 and toxicological risk assessment per ISO 10993-17
- Wear Debris Testing and Post-Wear Debris Testing Device Analysis
As the subject MAGEC System device is identical to the predicate Magec System (K201543/K161571/K140613) device in design, material, and manufacturing, there are no new risks related to biocompatibility of the subject device when compared to the predicate.
Additionally, a large retrospective registry study of pediatric early-onset scoliosis patients treated with the subject device was performed. The study population consisted of patient groups:
-
- Group 1: Age at index MAGEC implantation at less than 10 years (N= 1,080 patients)
-
- Group 2: Age at index MAGEC implantation at 10 years or greater (N= 172 patients)
All patients were diagnosed to have early-onset scoliosis before 10 years of age. All patients were treated with the MAGEC System. In total, there were 1,252 patients treated with the MAGEC System, including 1,080 patients treated before 10 years of age, and 172 patients who were treated with the MAGEC System at 10 years of age or older. The clinical and radiographic data demonstrates that the MAGEC System device, when used in patients 10 years of age or older, is substantially equivalent to the predicate Magec System device indicated for use in patients younger than 10 years of age. Any potential hazards of the changes introduced as part of this submission have been evaluated and assessed to have risk mitigators, and any relevant information has been addressed in the subject device labeling, after all control measures have been implemented.
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| Data Source | Registry Study | Literature | |
|---|---|---|---|
| Study Group | Group 1 | Group 2 | Group B |
| (Predicate) | (Subject) | (Subject) | |
| Age at Magec implantation |