(446 days)
MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.
MARVEL™ Growing Rods are posterior stabilization rods that can be surgically lengthened by manual mechanical actuation on a periodic basis as the patient grows. These rods are used as part of a growing rod construct consisting of MARVEL™ rods and screws, and are limited to a posterior approach. The rods include a tapered distal tip for a minimally invasive surgical approach. MARVEL ™ Growing Rods are manufactured from titanium alloy and PEEK.
The provided text describes a medical device submission (K213196) for MARVEL™ Growing Rods. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the format you requested for an AI/algorithm-based device.
Therefore, the information required to answer your specific questions about acceptance criteria, study data, ground truth, and expert involvement for an AI medical device cannot be found in this document.
This document describes a physical medical device (growing rods for spinal deformities) and primarily relies on mechanical performance testing and material biocompatibility to demonstrate substantial equivalence, not the performance of an AI algorithm.
To explicitly answer your points:
- A table of acceptance criteria and the reported device performance: Not applicable. The document describes mechanical performance tests (static and dynamic compression bending, static component torsion) in accordance with ASTM F1717 and ASTM F543, and bacterial endotoxin testing (BET) per ANSI/AAMI ST-72:2011. It states "Performance data demonstrate substantial equivalence to the predicate devices" but does not provide specific numerical acceptance criteria or reported performance values for these tests.
- Sample size used for the test set and the data provenance: Not applicable. This refers to mechanical testing of physical rods, not a test set for an algorithm.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth and expert review are not relevant for the mechanical testing of a physical device.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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December 19, 2022
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Globus Medical Inc. Kelly Baker Senior Vice President, Regulatory and Clinical Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403
Re: K213196
Trade/Device Name: MARVEL™ Growing Rods Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: PGM Dated: November 16, 2022 Received: November 17, 2022
Dear Kelly Baker:
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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.
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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
Enclosure
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Indications for Use
510(k) Number (if known) K213196
Device Name MARVEL™ Growing Rods
Indications for Use (Describe)
MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.
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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510(k) Summary: MARVEL™ Growing Rods
| Company: | Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800 |
|---|---|
| A 1 1 | Career States of Canadian Career Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Comparis Compar |
- Contact: Kelly J. Baker, Ph.D. Senior Vice President, Requlatory and Clinical Affairs
- December 18, 2022 Date Prepared:
- Device Name: MARVEL™ Growing Rods
- Common Name: Growing Rod System
- Per 21 CFR §888.3070 Classification: Thoracolumbosacral Pedicle Screw System Product Code: PGM Regulatory Class: Class II, Panel Code: 87
Primary Predicate: In-Line Connector Growing Rods (K181068)
Reference Device: SUSTAIN® R Spacers, PATRIOT® Spacers (K152022)
Purpose:
The purpose of this submission is to request clearance for MARVEL™ Growing Rods.
Device Description:
MARVEL™ Growing Rods are posterior stabilization rods that can be surgically lengthened by manual mechanical actuation on a periodic basis as the patient grows. These rods are used as part of a growing rod construct consisting of MARVEL™ rods and screws, and are limited to a posterior approach. The rods include a tapered distal tip for a minimally invasive surgical approach. MARVEL ™ Growing Rods are manufactured from titanium alloy and PEEK.
Indications for Use:
MARVEL™ Growing Rods are indicated in patients under 10 years of age with potential for additional spine growth who require surgical treatment to obtain and maintain correction of severe, progressive, life-threatening, early onset spinal deformities associated with thoracic insufficiency, including early onset scoliosis, as part of a growing rod construct.
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Performance Data:
Mechanical testing (static and dynamic compression bending, static component torsion) was conducted in accordance with ASTM F1717 and ASTM F543. Performance data demonstrate substantial equivalence to the predicate devices.
Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.
Technoloqical Characteristics:
The subject MARVEL™ Growing Rods have similar technological characteristics as the predicate devices including design, intended use, material composition, function, and range of sizes.
Basis of Substantial Equivalence:
The subject MARVEL™ Growing Rods have been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject implants to the predicate device.
N/A