(29 days)
Not Found
No
The 510(k) summary describes a mechanical spinal fixation system and its components. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
Explanation: The device is intended to treat various spinal conditions, such as degenerative disc disease, spondylolisthesis, trauma, and spinal tumors, by providing immobilization and stabilization of spinal segments. This aligns with the definition of a therapeutic device, which is used to prevent, diagnose, or treat diseases or conditions.
No
The device is a spinal implant system intended for fusion and stabilization, not for diagnosing medical conditions.
No
The device description explicitly states it consists of physical components like pedicle screws, locking caps, rods, and instruments, all made of metal alloys. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SeaSpine NewPort Spinal System is for "posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used to treat structural issues in the spine.
- Device Description: The device description details the components (pedicle screws, locking caps, rods) and materials (titanium alloy, cobalt washer) of a physical implant. It also mentions instruments for placement and removal.
- 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 compatibility testing. IVDs are typically used in laboratories or point-of-care settings for analysis of biological samples.
The SeaSpine NewPort Spinal System is a surgical implant used to mechanically stabilize the spine.
N/A
Intended Use / Indications for Use
The SeaSpine NewPort 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 for the following indications:
-
Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
-
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.
Product codes
NKB
Device Description
The SeaSpine NewPort Spinal System consists of pedicle screws, locking caps and rods, and is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The NewPort implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) with a cobalt washer (Co-28Cr/6Mo per ASTM F1537). The NewPort screws are offered in a variety of lengths and diameters and NewPort rods are offered in a variety of lengths to accommodate patient anatomy. The instruments included in the NewPort System facilitate the placement, removal, adjustment, and final locking of the system implants. The instruments also include the trays and caddies for protection during storage and the steam sterilization process. The trays and caddies also provide a means for organization of the instruments during the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine, L5-S1 vertebra
Indicated Patient Age Range
skeletally mature 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
Non-Clinical Testing: SeaSpine conducted mechanical testing to demonstrate substantial equivalence between the NewPort Spinal System (subject) and the predicate systems. The subject NewPort Spinal System demonstrated substantial equivalent performance to the predicate systems through static and dynamic mechanical testing in accordance with ASTM F1717-15.
Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Key Metrics
Not Found
Predicate Device(s)
K161535, K083089, K122571, K072605, K061342, K051942, K051663
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 shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2018
SeaSpine Orthopedics Corporation Ms. Gina Flores Senior Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 90228
Re: K180176
Trade/Device Name: SeaSpine NewPort Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: January 26, 2018 Received: January 29, 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
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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); 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 mediation-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,
Ronald P. Jean -S for
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)
K180176
Device Name SeaSpine NewPort Spinal System
Indications for Use (Describe)
The SeaSpine NewPort 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 for the following indications:
-
Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
-
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion,
-
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Submart D) | Over-The-Counter I lea (21 CER 801 Subnart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic in shades of blue on the left, followed by the word "SeaSpine" in orange. The wave graphic has four curved lines that start thick and gradually become thinner as they curve upwards and to the right. The word "SeaSpine" is written in a sans-serif font, with a small dot after the word.
510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation | ||
|---|---|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA | ||
| Phone number: | (760) 216-5136 | ||
| Fax number: | (760) 683-6874 | ||
| Contact person: | |||
| Email address: | Gina Flores, Sr. Regulatory Affairs Specialist | ||
| gina.flores@seaspine.com | |||
| Date Prepared: | January 17, 2018 | ||
| Device Name | |||
| Trade Name: | SeaSpine NewPort Spinal System | ||
| Common Name: | Pedicle Screw System |
| Common Name: | Pedicle Screw System |
|---|---|
| Classification Name: | Thoracolumbosacral Pedicle Screw System |
| Class: | II |
| Product Code: | NKB |
Legally Marketed Predicate Devices
| 510(k) Number | Product
Code | Trade Name | Manufacturer |
|---------------------------------------------------|-----------------|--------------------------------|----------------------------------------|
| PRIMARY PREDICATE Device | | | |
| K161535 | NKB | SeaSpine NewPort Spinal System | SeaSpine
Orthopedics
Corporation |
| Additional Predicate Devices | | | |
| K083089 | NKB | SeaSpine NewPort Spinal System | SeaSpine
Orthopedics
Corporation |
| K122571, K072605,
K061342, K051942,
K051663 | NKB | SeaSpine Malibu System | SeaSpine
Orthopedics
Corporation |
4
Image /page/4/Picture/0 description: The image shows the logo for SeaSpine. The logo consists of a blue wave-like design on the left and the word "SeaSpine" in orange on the right. The wave design has three curved lines that start thin and become thicker as they move to the right. The word "SeaSpine" is written in a sans-serif font, and there is a period after the word.
Device Description
The SeaSpine NewPort Spinal System consists of pedicle screws, locking caps and rods, and is intended to act as a temporary or permanent posterior, non-cervical pedicle fixation implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The NewPort implants are manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) with a cobalt washer (Co-28Cr/6Mo per ASTM F1537). The NewPort screws are offered in a variety of lengths and diameters and NewPort rods are offered in a variety of lengths to accommodate patient anatomy. The instruments included in the NewPort System facilitate the placement, removal, adjustment, and final locking of the system implants. The instruments also include the trays and caddies for protection during storage and the steam sterilization process. The trays and caddies also provide a means for organization of the instruments during the surgical procedure.
Intended Use/Indications for Use
The SeaSpine NewPort 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 for the following indications:
- -Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- -Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
- 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.
Summary of Technological Characteristics
The NewPort Spinal System and predicate devices have operational principle; the devices are designed to operate as a spinal fixation device designed to aid in the surgical correction and stabilization of the spine during the development of a solid fusion. The SeaSpine NewPort Spinal System is substantially equivalent to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
5
The subject and predicate device are based on the following similar technological elements:
- Screw lengths
- · Screw diameters
- · Same implant materials, titanium alloy (Ti-6Al-4V ELI per ASTM F136) and cobalt chrome (Co-28Cr/6Mo per ASTM F1537)
- · Utilize the same NewPort housing (extended tab), pin, and locking cap, and are used with the NewPort MIS and cap/rod combination rods.
All implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and they represent a basic design concept in terms of safety and effectiveness, and differ only in minor design details and not functionality.
Non-Clinical Testing
SeaSpine conducted mechanical testing to demonstrate substantial equivalence between the NewPort Spinal System (subject) and the predicate systems. The subject NewPort Spinal System demonstrated substantial equivalent performance to the predicate systems through static and dynamic mechanical testing in accordance with ASTM F1717-15.
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 NewPort Spinal System is substantially equivalent to the cited legally marketed predicate.