(60 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is an implantable spinal fixation system used as an adjunct to fusion for stabilization, not a therapeutic device in itself.
No
This device is a spinal fixation system, intended for surgical implantation to stabilize spinal segments as an adjunct to fusion. Its purpose is therapeutic (fixation and stabilization), not diagnostic (identifying or characterizing a disease or condition).
No
The device description explicitly states it is a "non-cervical spinal fixation device and instrumentation system" consisting of "single-use implants including polyaxial and monoaxial pedicle screws as well as connecting spinal rods and a separate locking element." These are physical hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation to provide immobilization and stabilization of spinal segments. This is a therapeutic and structural function within the body.
- Device Description: The device is described as a spinal fixation system consisting of implants like screws and rods made from metal alloys. This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support and stabilization.
N/A
Intended Use / Indications for Use
The SeaSpine Daytona Small System is intended for posterior, non-cervical 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 SeaSpine 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 pedictic patients, the Daytona Small Stature Spinal System is 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 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. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to SeaSpine's Atoll OCT Spinal System, or Malibu Spinal System using the rod connectors. Refer to the Atoll, Sierra, or Mallou System's Package Insert for the indications for use for those systems.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OSH, KWP, KWO
Device Description
The SeaSpine 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, a posterior non-pedicle fixation system, or as an anterolateral fixation system. The system consists of single-use implants including polyaxial and monoaxial pedicle screws as well as connecting spinal rods and a separate locking element. 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 SeaSpine Daytona Small Stature Spinal System demonstrated similar performance to the predicate systems through the following mechanical testing:
- Dynamic Compression Bending, Static Torsion, and Static Compression Bend per ASTM F1717, and
- Axial Slip, Static A-P, and Static Flexion-Extension per ASTM F1798
Clinical Testing:
Not applicable; 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): 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.
K163206, K122571, K072605, K061342, K051942, K051663, K140276
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.
0
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May 14, 2018
SeaSpine Orthopedics Corporation Ms. Gina Flores Senior Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K180686
Trade/Device Name: SeaSpine Daytona Small Stature Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, OSH, KWP, KWO Dated: March 14, 2018 Received: March 15, 2018
Dear Ms. Flores:
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 (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S for MNM
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180686
Device Name SeaSpine Daytona Small Stature Spinal System
Indications for Use (Describe)
The SeaSpine Daytona Small System is intended for posterior, non-cervical 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 SeaSpine 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 pedictic patients, the Daytona Small Stature Spinal System is 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 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. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to SeaSpine's Atoll OCT Spinal System, or Malibu Spinal System using the rod connectors. Refer to the Atoll, Sierra, or Mallou System's Package Insert 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) 216-5136 | ||
| (760) 683-6874 | ||
| Contact person: | ||
| Email address: | Gina Flores, Regulatory Specialist | |
| gina.flores@seaspine.com | ||
| Date Prepared: | May 10, 2018 | |
| Device Name | ||
| Trade Name: | SeaSpine Daytona Small Stature Spinal System | |
| Common Name: | Pedicle Screw Spinal System | |
| Classification Name: | 21 CFR 888.3070- Thoracolumbosacral pedicle screw system | |
| 21 CFR 888.3050- Spinal interlaminal fixation orthosis | ||
| 21 CFR 888.3060- Spinal intervertebral body fixation orthosis. | ||
| Class: | II | |
| Product Code: | NKB, OSH, KWP, KWO |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K163206 | NKB, OSH | SeaSpine Daytona | |
| Small Stature Spinal | |||
| System | SeaSpine Orthopedics | ||
| Corporation | |||
| ADDITIONAL PREDICATE Devices | |||
| K122571, K072605, | |||
| K061342, K051942, | |||
| K051663 | NKB | SeaSpine Malibu Spinal | |
| System | SeaSpine Orthopedics | ||
| Corporation | |||
| K140276 | NKB, OSH | CD Horizon Spinal | |
| System | Medtronic Sofamor | ||
| Danek |
4
Device Description
The SeaSpine 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, a posterior non-pedicle fixation system, or as an anterolateral fixation system. The system consists of single-use implants including polyaxial and monoaxial pedicle screws as well as connecting spinal rods and a separate locking element. 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 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, kyphosis, and/or lordosis); Spinal tumor; Pseudoarthrosis; and/or Failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the SeaSpine 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 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 Stature Spinal 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. Pediatric pedicle screw fixation is limited to a posterior approach.
The Daytona Small Stature Spinal System can be attached to SeaSpine's Atoll OCT Spinal System, Sierra Spinal System, or Malibu Spinal System using the rod connectors. Refer to the Atoll, Sierra, or Malibu System's Package Insert for the indications for use for those systems.
Summary of Technological Characteristics
The SeaSpine Davtona Small Stature Spinal System and predicate devices have the same operational principle; they are spinal fixation devices designed to aid in the surgical correction and stabilization of the spine during the development of a solid
filiar teaspine Daytona Small Stature Spinal System is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical).
5
The subject and predicate devices are based on the following similar technological elements:
- Utilize similar polyaxial and monoaxial cannulated screws
- Utilize the similar straight and precontoured rods ●
- Utilize similar hooks (laminar, pedicle, angled, and offset)
- Have similar locking caps
- Same implant materials; Titanium alloy (Ti-6AL-4V ELI per ASTM F136) and . Cobalt Chrome alloy (Co-28Cr-6Mo per ASTM F1537)
Non-Clinical Testing
The SeaSpine Daytona Small Stature Spinal System demonstrated similar performance to the predicate systems through the following mechanical testing:
- Dynamic Compression Bending, Static Torsion, and Static Compression Bend per ASTM F1717, and
- Axial Slip, Static A-P, and Static Flexion-Extension per ASTM F1798 ●
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the SeaSpine Daytona Small Stature Spinal System is substantially equivalent to the cited legally marketed predicates.