(192 days)
Not Found
No
The device description focuses on mechanical and magnetic mechanisms for spinal rod lengthening, with no mention of AI or ML for decision-making, image analysis, or control.
Yes
The device is intended to treat and mitigate severe progressive spinal deformities and Thoracic Insufficiency Syndrome (TIS), which are medical conditions, and clinical studies evaluate its effect on relevant health outcomes.
No.
Explanation: The device is an implanted system designed for bracing and distracting the spine in children with severe spinal deformities, and it does not involve diagnosing conditions. Its function is therapeutic rather than diagnostic.
No
The device description clearly outlines multiple hardware components including a surgically implanted spinal rod, an external remote controller (ERC), a manual distractor, and a wand magnet locator.
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.
- Device Function: The Ellipse MAGEC Spinal Bracing and Distraction System is a surgically implanted device used to mechanically brace and lengthen the spine in skeletally immature patients with severe spinal deformities. It directly interacts with the patient's body and does not analyze biological samples.
- Intended Use: The intended use clearly describes a mechanical intervention for spinal deformities, not the analysis of biological specimens for diagnostic purposes.
Therefore, the device falls under the category of a surgical implant and a mechanical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Ellipse MAGEC Spinal Bracing and Distraction 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 Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium 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. Rotation of the magnet causes the MAGEC Rod to be lengthened or shorten.
The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract 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. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to test the device prior to implantation. 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. The ERC is placed over this location on the child's back.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing on the MAGEC System included Static and Dynamic Mechanical testing according to a modified ASTM F1717 test setup and design verification and validation. Results of these tests demonstrate that there are no new risks associated with the device can be expected to perform in a manner substantially equivalent to the predicate.
The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
Static Mechanical Testing, Modified ASTM F1717
Dynamic Mechanical Testing, Modified ASTM F1717
Design Verification and Validation, None
Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the MAGEC System with the MAGEC 70 mm Rod line extension. The performance testing on the predicate device includes design functionality and verification, shelf life testing, validation of the gamma radiation sterilization cycle in accordance with the VDmax 35 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 101, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device.
In vivo animal studies were performed in the porcine model to evaluate the performance of the predicate MAGEC System and verify that the MAGEC Rod is safe and is able to perform per functional specifications. Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred.
The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and maintenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL).
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.
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
Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618
Re: K140613
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
Dear John McIntyre:
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 September 18, 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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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The profiles are stacked slightly on top of each other, creating a sense of depth. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
Ellipse Technologies, Incorporated Mr. John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K140613
Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulatory Class: Unclassified Product Code: PGN Dated: July 24, 2014 Received: July 25, 2014
Dear Mr. McIntyre:
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. Iisting 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 (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.
2
Page 2 - Mr. John McIntyre
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/Resourcesfor You/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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Indications for Use
510(k) Number (if known) K140613
Device Name
MAGEC® Spinal Bracing and Distraction System
Indications for Use (Describe)
The Ellipse MAGEC Spinal Bracing and Distraction 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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Image /page/4/Picture/0 description: The image shows the logo for Ellipse. The logo consists of a graphic on the left and the word "ELLIPSE" on the right. The graphic is made up of three overlapping ellipses in shades of blue and green. The word "ELLIPSE" is written in a bold, sans-serif font in a dark blue color.
510(k) Summary
MAGEC® Spinal Bracing and Distraction System
Premarket Notification Number: K140613
| 1. | Company: | Ellipse Technologies, Incorporated
13900 Alton Parkway, Suite 123
Irvine, CA 92618 |
|----|-------------------------|------------------------------------------------------------------------------------------------|
| | Contact: | John McIntyre
Vice President, RA/QA/CA
Phone: (949) 837-3600 x203
Fax: (949) 837-3664 |
| | Date Prepared: | July 23, 2014 |
| 2. | Proprietary Trade Name: | MAGEC® Spinal Bracing and Distraction System |
| 3. | Common Name: | Non Fusion Growing Rod System |
- Classification Name: Unclassified (Product Code PGN, Growing Rod System Magnetic 4. Actuation)
- Product Description: The MAGEC Spinal Bracing and Distraction System is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia9 fixation components (i.e. Pedicle screws, hooks and/or connectors). The system includes a non-sterile hand held External Remote Controller (ERC) that is used at various times after implant to non-invasively lengthen or shorten the implanted spinal rod. The implanted spinal rod is used to brace the spine during growth to minimize the progression of scoliosis. The titanium 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. Rotation of the magnet causes the MAGEC Rod to be lengthened or shorten.
The hand held non-invasive ERC is electrically powered. The ERC is placed over the patient's spine and then manually activated, which causes the implanted magnet to rotate and either lengthen or shorten the rod. Periodic lengthening of the rod is performed to distract 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. Additional accessories for the MAGEC System include the MAGEC Manual Distractor and the MAGEC Wand Magnet Locator. The MAGEC Manual Distractor is a sterilizable, single use device, which is used in the operating room to
5
test the device prior to implantation. 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. The ERC is placed over this location on the child's back.
Indications for Use: The Ellipse MAGEC Spinal Bracing and Distraction System is intended 6. 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.
- Substantial equivalence: Documentation that includes mechanical test results, design verification and detailed comparison to the predicate device demonstrates that the MAGEC System with the 70 mm Actuator rod is substantially equivalent to the following 510(k) cleared device:
- MAGEC Spinal Bracing and Distraction System (K140178) ●
Substantial equivalence to the predicate device is based on indications for use, principles of operation, technological characteristics, and pre-clinical testing performed.
The MAGEC System subject of this premarket notification and the predicate device have the same indications for use. The MAGEC System subject of this premarket notification and the predicate device are spinal rods that have adjustable length, and are implanted on the posterior spine using hooks or screws. Both systems operate on the same non-invasive distraction technology using the Ellipse External Remote Controller (ERC). The technological characteristics of the subject device and the predicate device are similar. Both systems are manufactured of biocompatible metals and supplied sterile. The difference between the two systems is the addition of a MAGEC Rod with a 70 mm Actuator to the product offering. The MAGEC 70 mm Rod has a shorter stroke length, and some components have dimensional differences.
Non-clinical testing on the MAGEC System included Static and Dynamic Mechanical testing according to a modified ASTM F1717 test setup and design verification and validation. Results of these tests demonstrate that there are no new risks associated with the device can be expected to perform in a manner substantially equivalent to the predicate.
The specific non-clinical tests that have been performed in order to establish equivalence to the predicate device include:
6
| Test Description | Applicable Test Standard |
|---|---|
| Static Mechanical Testing | Modified ASTM F1717 |
| Dynamic Mechanical Testing | Modified ASTM F1717 |
| Design Verification and Validation | None |
Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the MAGEC System with the MAGEC 70 mm Rod line extension. The performance testing on the predicate device includes design functionality and verification, shelf life testing, validation of the gamma radiation sterilization cycle in accordance with the VDmax 35 methodology as given in ISO 11137-2 to verify that the gamma radiation sterilization process provides a sterility assurance level of 101, and biocompatibility in accordance with ISO 10993-1 for the intended use of the device. There are no changes to the ERC being made as a result of this submission, therefore all testing that was performed on the predicate MAGEC System for the ERC are applicable to the MAGEC System subject of this premarket notification.
In vivo animal studies were performed in the porcine model to evaluate the performance of the predicate MAGEC System and verify that the MAGEC Rod is safe and is able to perform per functional specifications. Results of the in vivo porcine study demonstrates that the MAGEC System is safe and provides an efficient means of non-invasive distraction of the spine. No complications from distraction occurred.
8. Clinical Performance Data:
The safety and probable benefit of the predicate MAGEC System was evaluated outside the United States in a retrospective clinical study for children who had either a primary or revision spinal bracing procedure using the MAGEC System. In assessing probable benefit, the endpoints chosen in the study included Cobb angle correction in the coronal plane, thoracic spine height increase, improvement in space available for lung (SAL), coronal and sagittal balance, reduction in the number of subsequent surgical procedures, and weight gain.
The results of the clinical study showed the MAGEC System provides the benefits of spinal deformity correction and continued growth, similar to that for traditional growing rods, without the need for regular surgical lengthening procedures in these children. As with traditional growing rods, the MAGEC System provides direct bracing to the spine. This bracing provides for correction and maintenance of the scoliotic curve as defined by the Cobb Angle. In addition, a return to a more normal symmetry of the thoracic cavity is provided as demonstrated by the space available for lung (SAL). While implantation of the MAGEC System shares many of the same risks and hazards associated with those of traditional growing
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Image /page/7/Picture/0 description: The image shows the logo for Ellipse. The logo consists of a circular design on the left and the word "ELLIPSE" on the right. The circular design is made up of three overlapping circles, each with a different color gradient. The word "ELLIPSE" is written in a bold, sans-serif font and is colored in a dark blue.
rods, the MAGEC System offers the benefit of non-invasive adjustment to lengthen the implanted rod without the need to perform another surgery. The ability of the device to be adjusted non-invasively in length provides the ability of the spine to continue growing in these subjects and for the Thoracic Spine Height to increase with this growth.
9. Conclusion:
Conclusions can be drawn from these tests that the MAGEC System is substantially equivalent to the predicate device.