(312 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical components for non-invasive rod lengthening, with no mention of AI or ML algorithms for decision-making, image analysis, or other functions.
Yes
The device is described as a "Spinal Bracing and Distraction System" used to treat severe progressive spinal deformities and Thoracic Insufficiency Syndrome (TIS), indicating its use in managing a medical condition.
No
The device is described as a spinal bracing and distraction system used to surgically implant a rod and subsequently lengthen or shorten it, indicating a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines hardware components including a sterile single use spinal rod, a non-sterile hand held External Remote Controller (ERC), a MAGEC Manual Distractor, and a MAGEC Wand Magnet Locator. While software validation is mentioned, the device is fundamentally a system of physical components.
Based on the provided information, the Ellipse MAGEC® Spinal Bracing and Distraction System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The MAGEC system is a surgically implanted device used to mechanically brace and distract the spine. It works by physically lengthening a rod to support spinal growth and minimize scoliosis progression.
- Lack of Specimen Analysis: The device does not analyze any biological specimens from the patient. Its function is purely mechanical and involves direct interaction with the patient's skeletal structure.
- Intended Use: The intended use is to treat severe progressive spinal deformities and address Thoracic Insufficiency Syndrome, which is a structural and mechanical issue, not a condition diagnosed or monitored through in vitro testing.
Therefore, the MAGEC system falls under the category of a surgical implant and a mechanical device, not an IVD.
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
PGN
Device Description
The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System 6. is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker Xia 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 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 shortened.
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 during a distraction procedure.
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
skeletally immature patients less than 10 years of age
Intended User / Care Setting
Physician, Operating Room, In-clinic for distraction procedures
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 Performance Data: Non-clinical testing on the MAGEC System includes design functionality and verification on the ERC 2 device. The following documentation and testing have been included in order to establish equivalence to the predicate device.
Test/Document Description: Risk Management Report, Applicable test standard: EN ISO 14971
Test/Document Description: Electrical Safety, Applicable test standard: IEC 60601-1 (3rd edition)
Test/Document Description: Electromagnetic Compatibility and Interference, Applicable test standard: IEC 60601-1-2
Test/Document Description: Design Verification Testing, Applicable test standard: N/A
Test/Document Description: Software Validation, Applicable test standard: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Substantial equivalence is based on the intended use and design of the ERC 2 and the predicate ERC. Both the ERC 2 and the predicate ERC have the same intended use, operating principle, scientific technology, mechanism of action and performance specifications. Non-clinical performance data shows there are no new risks identified with the ERC 2 and that the device meets the intended use and performance specifications.
Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the ERC 2 and this submission. These include animal studies, mechanical tests on the implant, biocompatibility tests on the implant, sterility and packaging testing on the implant. These tests were not repeated since the implant component of the MAGEC System are not being changed as part of this premarket notification.
Clinical Performance Data: The retrospective clinical study performed on the MAGEC System and previously submitted is also applicable to the ERC 2 and this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 29, 2022
Ellipse Technologies, Incorporated John McIntyre Vice President, Regulatory, Quality, and Clinical Affairs 13900 Alton Parkway Suite 123 Irvine, California 92618
Re: K141278
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 March 24, 2015. 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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2015
Ellipse Technologies, Incorporated Mr. John McIntyre Vice President, Regulatory, Quality and Clinical Affairs 13900 Alton Parkway, Suite 123 Irvine, California 92618
Re: K141278
Trade/Device Name: MAGEC® Spinal Bracing and Distraction System Regulatory Class: Unclassified Product Code: PGN Dated: February 20, 2015 Received: February 23, 2015
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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K141278
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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K141278 - Page 1 of 3
13900 Alton Parkway, Suite 123 Irvine, California 92618 US Office: 949-837-3600 Fax: 949-837-3664 www.ellipse-tech.com
510(k) Summarv Ellipse MAGEC® Spinal Bracing and Distraction System 510(k) Summary - K141278 September 2014
-
- Company: Ellipse Technologies, Incorporated 13900 Alton Parkway, Suite 123 Irvine, CA 92618
- John McIntyre Contact: Vice President, RA/QA/CA Phone: (949) 837-3600 Fax: (949) 837-3664
Date Prepared: September 26, 2014
FDA Establishment Registration No: 3006179046
-
- Proprietary Trade Name: MAGEC® Spinal Bracing and Distraction System
-
- Common Name: Non-Fusion Growing Rod
-
- Classification Name: Unclassified (Product Code PGN, Growing Rod System - Magnetic Actuation)
-
- Predicate Device: Ellipse Technologies, Inc. MAGEC® Spinal Bracing and Distraction System, K140178
- Product Description: The Ellipse Technologies, Inc. MAGEC Spinal Bracing and Distraction System 6. is comprised of a sterile single use spinal rod that can be surgically implanted using appropriate Stryker® Xia® 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 in the actuator can be
5
Image /page/5/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 circles in shades of blue and green. The word "ELLIPSE" is written in a bold, sans-serif font in a dark blue color.
13900 Alton Parkway, Suite 123 Irvine, California 92618 U Office: 949-837-3600 Fax: 949-837-3664 www.ellipse-tech.com
K141278 - Page 2 of 3
turned non-invasively by use of the ERC. Rotation of the magnet causes the MAGEC rod to be lengthened or shortened.
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 during a distraction procedure.
-
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.
-
Substantial Equivalence: Documentation demonstrates substantial equivalence to the Ellipse MAGEC System cleared under K140178 (cleared on February 27, 2014). The purpose of this premarket notification is to include a second generation External Remote Controller (ERC 2) into the System. Data provided in this submission includes information relevant to the ERC 2. Substantial equivalence is based on similar indications for use, designs, in vitro testing and software validation. The in vitro evaluations included specific tests performed on the ERC 2 to demonstrate the suitability of the device for its intended use, and electrical safety and electromagnetic compatibility tests.
-
Technological Characteristics: The ERC 2 was designed to improve ergonomic handling and user interfaces, and has the same methods and principles of operation as the first generation ERC. The ERC 2 incorporates the controller and hand piece into one unit, to be more ergonomic and user friendly. The ERC 2 contains a colored touchscreen LCD-display screen. The second generation ERC for the Ellipse MAGEC System was developed and evaluated in accordance with recognized standards and with inhouse developed test methodologies. This testing includes risk assessment of the device and testing to applicable IEC standards, which are included in this premarket notification. The results of testing demonstrate that the ERC 2 for the Ellipse MAGEC System that is the subject of this premarket
6
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13900 Alton Parkway, S Irvine, California 9261 Office: 949-837-360 949-837-3664 www.ellinse-tech.com
K141278 - Page 3 of 3
notification is substantially equivalent to the predicate ERC cleared in the original premarket notification, K140178.
- Non-Clinical Performance Data: Non-clinical testing on the MAGEC System includes design functionality and verification on the ERC 2 device. The following documentation and testing have been included in order to establish equivalence to the predicate device.
| Test/Document Description | Applicable test standard |
|---|---|
| Risk Management Report | EN ISO 14971 |
| Electrical Safety | IEC 60601-1 (3rd edition) |
| Electromagnetic Compatibility and Interference | IEC 60601-1-2 |
| Design Verification Testing | N/A |
| Software Validation | FDA Guidance for the Content of Premarket Submissions |
| for Software Contained in Medical Devices |
Substantial equivalence is based on the intended use and design of the ERC 2 and the predicate ERC. Both the ERC 2 and the predicate ERC have the same intended use, operating principle, scientific technology, mechanism of action and performance specifications. Non-clinical performance data shows there are no new risks identified with the ERC 2 and that the device meets the intended use and performance specifications.
Additional non-clinical tests that were performed on the predicate MAGEC System are also applicable to the ERC 2 and this submission. These include animal studies, mechanical tests on the implant, biocompatibility tests on the implant, sterility and packaging testing on the implant. These tests were not repeated since the implant component of the MAGEC System are not being changed as part of this premarket notification.
-
Clinical Performance Data: The retrospective clinical study performed on the MAGEC System and previously submitted is also applicable to the ERC 2 and this submission.
-
Conclusion: Conclusions can be drawn from the tests that the line extension to include the ERC 2 to the MAGEC System is substantially equivalent to the predicate device.