(208 days)
The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiosraphic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.
The Dymaxeon Spine System is a posterior pedicle screw system designed for temporary stabilization of the spine during the development of spinal fusion. The Dymaxeon Spine System is comprised of a variety of pedicle screws, rods, hooks, connectors and fasteners. The implants are sold sterile.
The provided text is a 510(k) summary for the Dymaxeon Spine System. It focuses on the mechanical testing and substantial equivalence of the device, particularly the new eCarbon rods and rod connectors, to predicate devices. It does not describe a study involving an AI component or a device that has acceptance criteria related to performance metrics like sensitivity, specificity, or accuracy in a diagnostic context.
Therefore, I cannot extract the information required by your prompt, as it is designed for a medical device that utilizes AI and has performance-based acceptance criteria, which this document does not contain.
The document describes the device, its indications for use, materials, and mechanical testing results to demonstrate substantial equivalence, but it does not include:
- A table of acceptance criteria and reported device performance related to diagnostic accuracy or AI outputs.
- Sample size used for a test set in the context of diagnostic performance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- MRMC comparative effectiveness study or human reader improvement with AI.
- Standalone (algorithm-only) performance.
- Type of ground truth (expert consensus, pathology, outcomes data) for diagnostic tasks.
- Sample size for a training set.
- How ground truth for a training set was established.
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May 12, 2020
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Back 2 Basics Direct, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting, Inc. 12520 Heath Road Chesterland, Ohio 44026
Re: K192930
Trade/Device Name: Dymaxeon Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: April 10, 2020 Received: April 13, 2020
Dear Dr. Warden:
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 (OS) 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,
Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K192930
Device Name Dymaxeon Spine System
Indications for Use (Describe)
The Dymaxeon Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the non-cervical spine for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiosraphic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, and or lordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/or failed previous fusion. The eCarbon rods can be used in the treatment of the above indications for use with the exception of procedures requiring instrumentation that spans more than 3-levels.
| 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
| Date: | 26 February 2020 |
|---|---|
| Sponsor: | Back 2 Basics Direct, LLC6701 Rockside Road, Suite 200Independence, OH 44131Office: 216.447.5205Fax: 216.447.6071 |
| Sponsor Contact: | Louis Keppler MD, Principal |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed Trade Name: | Dymaxeon Spine System |
| Common Name: | Posterior pedicle screw system |
| Device Classification: | Class II |
| Classification Names,Regulations, ProductCodes: | Thoracolumbosacral pedicle screw system, 888.3070, NKBSpinal interlaminal fixation orthosis, 888.3050, KWP |
| Submission Purpose: | The subject 510(k) adds rod connectors and eCarbon rods to theDymaxeon Spine System. |
| Device Description: | The Dymaxeon Spine System is a posterior pedicle screw system designedfor temporary stabilization of the spine during the development of spinalfusion. The Dymaxeon Spine System is comprised of a variety of pediclescrews, rods, hooks, connectors and fasteners. The implants are soldsterile. |
| Indications for Use: | The Dymaxeon Spine System is intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunctto fusion of the non-cervical spine for the following indications: degenerativedisc disease (defined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies), spinal stenosis,spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/ orlordosis), trauma (i.e., fracture or dislocation), tumor, pseudarthrosis and/orfailed previous fusion. The eCarbon rods can be used in the treatment ofthe above indications for use with the exception of procedures requiringinstrumentation that spans more than 3-levels. |
| Materials: | eCarbon rods are manufactured from PEEK-OPTIMA Ultra Reinforcedpolymer (PEEK-OPTIMA per ASTM F2026 and carbon fibers). eCarbon rodintegral markers are manufactured from gold wire (per ASTM B562). Allother Dymaxeon Spine System components are manufactured from titaniumalloy (Ti-6Al-4V ELI, per ASTM F136). |
| Primary Predicate: | Dymaxeon Spine System (Back 2 Basics Direct LLC – K170989) |
| Additional Predicates: | Dymaxeon Spine System (Back 2 Basics Direct LLC - K150184), Optima™ Spinal System (U&I Corporation - K051971), GII Osta-Pek® Plate (coLigneAG - K051089) |
| Performance Data: | Mechanical testing of the worst case Dymaxeon rod connector and eCarbon rod constructs included static and dynamic compression bending and static torsion according to ASTM F1717. In addition, axial and torsion grip testing was performed under ASTM F1798 on eCarbon rod subconstructs.The test results demonstrated equivalent mechanical performance of the Dymaxeon eCarbon rod and rod connectors compared to the cited predicate devices under the same test conditions. |
| TechnologicalCharacteristics: | The eCarbon rods of the Dymaxeon Spine System possess similar technological characteristics as one or more of the predicate devices. While the eCarbon rod is not identical to the predicate devices, the differences were shown not to raise new questions of safety and effectiveness. Therefore the fundamental scientific technology of the Dymaxeon Spine System is similar to previously cleared devices. |
| Conclusion: | The rod connectors and eCarbon rods of the Dymaxeon Spine System possess an intended use and technological characteristics similar to the predicate devices. Therefore these additional Dymaxeon Spine System components are substantially equivalent for their intended use. |
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§ 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.