(29 days)
There are no Reference Devices (K/DEN numbers) listed in the provided text. The text explicitly states "Reference Device(s): Not Found".
No
The document describes a pedicle screw system and navigation instruments, which are mechanical and manual tools. There is no mention of AI or ML in the intended use, device description, or performance studies. The navigation system relies on external imaging modalities and a separate navigation system (Medtronic StealthStation), but the description of the SeaSpine instruments themselves does not indicate AI/ML capabilities.
Yes
The device provides immobilization and stabilization of spinal segments and assists in the placement of spinal implants to treat various spinal conditions, indicating a direct therapeutic effect.
No
The device is a pedicle screw system and navigation system instruments used for spinal immobilization and stabilization, and to assist in precisely locating anatomical structures during surgery. It does not diagnose medical conditions.
No
The device description clearly outlines physical implants (screws, rods, locking elements) and manual surgical instruments, indicating it is a hardware-based medical device system, not software-only. While it mentions a navigation system that uses imaging data, the core device is the physical pedicle screw system.
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 and Intended Use: The description clearly states that the Mariner Pedicle Screw System and the SeaSpine Navigation System are surgical devices used for spinal fixation and navigation during surgery. They are implanted in the body or used to guide surgical procedures.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient. Its function is mechanical and navigational within the surgical setting.
Therefore, the device falls under the category of a surgical implant and a surgical navigation system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is 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.
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
-pseudarthrosis, and/or
-failed previous fusion.
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes
NKB, KWQ, OLO
Device Description
The Mariner Pedicle Screw 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 screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted motion pedicle screws as well as connecting spinal rods and a separate locking element.
The Mariner implants are manufactured from titanium alloy Ti-6A1-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Mo per ASTM F1537). The instruments included in the Mariner Pedicle Screw System facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The SeaSpine Navigation System instruments are manual, surgical instruments that assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The SeaSpine Navigation Instruments will be incorporated into the Mariner Pedicle Screw System.
With an increased demand for less invasive posterior fixation, the Mariner MIS Pedicle Screw System will offer instrumentation to its existing modular implant design to assist surgeons with MIS techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks
Anatomical Site
thoracic, lumbar, and sacral spine; skull, a long bone, or vertebra
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
surgeons; spinal surgery; open or minimally invasive procedures
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 mechanical testing was not performed on the subject devices. The subject devices are the same as the predicate devices in terms of materials, sizes, and intended use. The subject devices do not introduce a new worst case. Engineering analyses of the subject devices determined that no additional mechanical testing is necessary.
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)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
July 19, 2019
SeaSpine Orthopedics Corporation Ms. Aly Alvarez Senior Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K191648
Trade/Device Name: Mariner MIS Pedicle Screw System: SeaSpine Navigation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, KWQ, OLO Dated: June 19, 2019 Received: June 21, 2019
Dear Ms. Alvarez:
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 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,
Ronald P. Jean, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191648
Device Name
Mariner MIS Pedicle Screw System
Indications for Use (Describe)
The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is 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.
The indications for use are as follows:
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
-pseudarthrosis, and/or
-failed previous fusion.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K191648
Device Name SeaSpine Navigation System
Indications for Use (Describe)
The SeaSpine Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine Navigation reusable instruments are specifically designed for use with the Medtronic Stealth Station System, which is indical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | [ ] Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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 | |
| Primary contact: | |
| Email address: | |
| Secondary contact: | |
| Email address: | Alicia McArthur, Regulatory Specialist |
| alicia.mcarthur@seaspine.com | |
| Aly Alvarez, Sr. Regulatory Specialist | |
| alyssa.alvarez@seaspine.com | |
| Date Prepared: | June 18, 2019 |
| Device Name | |
| Trade Name: | 1. Mariner MIS Pedicle Screw System |
- SeaSpine Navigation System |
| Common Name: | 1. Pedicle Screw Spinal System; Spinal Intervertebral Body Fixation
Appliance - Orthopedic Stereotaxic instrument |
| Classification: | 1. 21 CFR 888.3070; 21 CFR 888.3060 - 21 CFR 882.4560 |
| Classification Name: | 1. Thoracolumbosacral Pedicle Screw System, Spinal Intervertebral Body Fixation
Orthosis - Stereotaxic Instrument |
| Class: | 1. II - II |
| Product Code: | 1. NKB, KWQ - QLQ |
5
Legally Marketed Predicate Devices
1.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K160902 | NKB | Mariner Pedicle Screw | |
| System | SeaSpine Orthopedics | ||
| Corporation |
2.
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PRIMARY PREDICATE Device | |||
| K172517 | OLO | SeaSpine Navigation | |
| System | SeaSpine Orthopedics | ||
| Corporation |
Device Description
The Mariner Pedicle Screw 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 screw fixation system, or as an anterolateral fixation system. The system consists of single-use implants including fixed, polyaxial, cephalad/caudal restricted-motion, and medial/lateral restricted motion pedicle screws as well as connecting spinal rods and a separate locking element.
The Mariner implants are manufactured from titanium alloy Ti-6A1-4V ELI (per ASTM F136), and cobalt chrome (Co-35Ni-20Cr-10Mo per ASTM F562 and Co-28Cr-6Mo per ASTM F1537). The instruments included in the Mariner Pedicle Screw System facilitate the placement, removal, adjustment, and final locking of the system implants. Other accessories to the system also include the trays and caddies for storage, protection, and organization prior to and during the steam sterilization process.
The SeaSpine Navigation System instruments are manual, surgical instruments that assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. The SeaSpine Navigation Instruments will be incorporated into the Mariner Pedicle Screw System.
With an increased demand for less invasive posterior fixation, the Mariner MIS Pedicle Screw System will offer instrumentation to its existing modular implant design to assist surgeons with MIS techniques.
Intended Use/Indications for use
-
- The intended use of the Mariner Pedicle Screw System in a posterior or anterolateral approach is to provide immobilization and stabilization of spinal segments in skeletally
6
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.
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 .
- pseudarthrosis, and/or .
- failed previous fusion. .
-
- The SeaSpine® Navigation System reusable instruments are intended to be used during the preparation and placement of SeaSpine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SeaSpine® Navigation System reusable instruments are specifically designed for use with the Medtronic® StealthStation™ System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Summary of Technological Characteristics
The Mariner MIS Pedicle Screw System is 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).
All implants are used to treat the same conditions, have the same precautions and contraindications for use, and they represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
The SeaSpine Navigation System is similar to the cited predicated devices in regard to components, indications for use, technology, and performance specifications.
Non-Clinical Testing
Non-clinical mechanical testing was not performed on the subject devices. The subject devices are the same as the predicate devices in terms of materials, sizes, and intended use. The subject devices do not introduce a new worst case. Engineering analyses of the subject devices determined that no additional mechanical testing is necessary.
7
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 Mariner MIS Pedicle Screw System and the SeaSpine Navigation System is substantially equivalent to the cited legally marketed predicates.