(10 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a spinal system intended for fixation, immobilization, and stabilization of spinal segments as an adjunct to fusion for various spinal conditions, which clearly falls under the definition of a therapeutic device.
No
This device is a spinal fixation system intended to provide immobilization and stabilization of spinal segments, not to diagnose medical conditions.
No
The device description explicitly states that the system consists of single-use implants made from titanium alloy and cobalt chrome alloy, which are hardware components.
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 SeaSpine Daytona Small Stature Spinal System is a system of implants (screws, rods, etc.) used for surgical fixation of the spine. It is a physical device implanted in the body.
- Intended Use: The intended use describes the surgical application of the device for stabilizing the spine in various conditions. It does not involve testing biological samples.
Therefore, the description clearly indicates a surgical implant system, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small System may be used for the above indications as an adjunct to fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g. Atoll OCT, Sierra Malibu, Daytona and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.
Product codes
NKB, KWP, KWQ
Device Description
The Daytona® Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants, including monoaxial, polyaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) per ASTM F1537.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients
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: The Daytona® Small Stature Spinal System demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798.
Clinical Testing: Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 28, 2020
SeaSpine® Orthopedics Corporation Ms. Alicia McArthur Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K200381
Trade/Device Name: Daytona® Small Stature Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: February 12, 2020 Received: February 18, 2020
Dear Ms. McArthur:
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
1
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 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 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,
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200381
Device Name Daytona® Small Stature Spinal System
Indications for Use (Describe)
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small System may be used for the above indications as an adjunct to fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small System is intended to treat pediatric patients diagnosed with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g. Atoll OCT, Sierra Malibu, Daytona and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.
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
Contact Details
| Applicant Name: | SeaSpine® Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (760) 216-5117 | |
| (760) 683-6874 | |
| Primary Contact: | Alicia McArthur, Regulatory Affairs Specialist |
| Date Prepared: | February 12, 2020 |
| Device Name | |
| Trade Name: | Daytona® Small Stature Spinal System |
| Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Thoracolumbosacral Pedicle Screw System (21 CFR 888.3070) |
| Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050) | |
| Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) | |
| Class: | II |
| Product Code: | NKB, KWP, KWO |
Legally Marketed Predicate Devices
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|---------------------------------------|-----------------------|-----------------------------------------|--------------------------------------|
| Primary Predicate Device | | | |
| K180686 | NKB, OSH,
KWP, KWQ | Daytona® Small Stature
Spinal System | SeaSpine® Orthopedics
Corporation |
| Additional Predicate Device(s) | | | |
| K163604 | NKB, | Daytona® Small Stature
Spinal System | SeaSpine® Orthopedics
Corporation |
Device Description
The Daytona® Small Stature Spinal System is a non-cervical spinal fixation device and instrumentation system intended for use as a posterior pedicle screw fixation system, as a posterior non-pedicle screw fixation system, or as an anterolateral fixation system. The system consists of
4
single-use implants, including monoaxial, polyaxial, and uniplanar screws, rods, locking caps, crossbars, hooks, and connectors. All implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and cobalt chrome alloy (Co-28Cr-6Mo) per ASTM F1537.
Intended Use/Indications for Use
The SeaSpine Daytona Small Stature Spinal System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The indications for use are as follows: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, and/or lordosis); spinal tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the Daytona Small Stature Spinal System may be used for the above indications as an adjunct to fusion in skeletally mature patients.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Daytona Small Stature Spinal System is also indicated as an adjunct to fusion in the treatment of progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Additionally, the Daytona Small Stature Spinal System with spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to other cleared SeaSpine posterior fixation systems (e.g. Atoll OCT. Sierra Malibu, Daytona and Mariner Spinal Systems) using the rod connectors. Refer to the package inserts for the indications for use for those systems.
Summary of Technological Characteristics
The Daytona® Small Stature Spinal System is identical or similar to the cited predicate device in regard to intended use/indications for use, device description, technological characteristics (i.e., operating principle, design, components, materials, manufacturing, labeling, etc.), and nonclinical performance (i.e., mechanical testing).
All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
Non-Clinical Testing
The Daytona® Small Stature Spinal System demonstrated similar mechanical performance to the predicate system based on mechanical testing per ASTM F1798.
5
Clinical Testing
Not applicable. The determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the Daytona® Small Stature Spinal System is substantially equivalent to the cited legally marketed predicate device for its intended use.