(148 days)
Not Found
No
The document describes a mechanical spinal revision system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is intended to immobilize spinal segments and treat various spinal instabilities and deformities, which are therapeutic functions.
No
Explanation: The device is described as a "thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware." It is composed of implants and instruments designed for surgical use, not for diagnostic purposes.
No
The device description explicitly states that the system includes "a variety of non-sterile implants manufactured from titanium alloy or cobalt chrome alloy" and "instruments included in the system facilitate the placement, removal, adjustment, and final locking of the system implants." This indicates the device is a physical medical device with hardware components, 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 device is a spinal system intended to provide immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body.
- Device Description: The device is described as a thoracolumbar revision system including implants (connectors, rods) and instruments for placement and adjustment. These are physical devices used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, not implanted within the body for structural support and fusion.
N/A
Intended Use / Indications for Use
When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:
The Mariner Outrigger Revision System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion system (T1-S2/ilum) in the treatment of the following acute and chronic instabilities or deformities:
· degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- · tumor,
- · pseudarthrosis (i.e., failed previous fusion)
When used with Daytona Small Stature Spinal System for posterior non-cervical pediativ patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. and congental scoliosis. Pedicle screw fixation is limited to a posterior approach.
The Mariner Outrigger Revision System is intended to be used with autograft or allograft.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware.
The Mariner Outrigger Revision System includes a variety of non-sterile implants manufactured from titanium alloy or cobalt chrome alloy and is comprised of various axial and parallel connectors of different shapes, rod slots, and also of various rods. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g. Mariner, Davtona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes of 04.5mm to Ø6.35mm.
The Mariner Outrigger Revision implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), or cobalt chrome alloy (per ASTM F562). The instruments included in the 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1-S2/ilium
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for specific indications)
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 Mariner Outrigger Revision System demonstrated similar performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717 and 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.
K173882, K163604, K180686, K170647, K172194
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
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 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.
May 23, 2019
SeaSpine Orthopedics Corporation Martin Yahiro, M.D. Director, Medical Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K183639
Trade/Device Name: Mariner Outrigger Revision System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: December 20, 2018 Received: December 26, 2018
Dear Dr. Yahiro:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
for CAPT Raquel Peat, PhD, MPH, USPHS OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183639
Device Name Mariner Outrigger Revision System
Indications for Use (Describe)
When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:
The Mariner Outrigger Revision System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion system (T1-S2/ilum) in the treatment of the following acute and chronic instabilities or deformities:
· degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- · spondylolisthesis,
- · trauma (i.e., fracture or dislocation),
- · spinal stenosis,
- · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- · tumor,
- · pseudarthrosis (i.e., failed previous fusion)
When used with Daytona Small Stature Spinal System for posterior non-cervical pediativ patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis. and congental scoliosis. Pedicle screw fixation is limited to a posterior approach.
The Mariner Outrigger Revision System is intended to be used with autograft or allograft.
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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3
510(k) Summary
Contact Details
Applicant Name: | SeaSpine Orthopedics Corporation |
---|---|
Address: | 5770 Armada Drive, Carlsbad CA |
Phone number: | (760) 216-5610 |
Fax number: | (760) 683-6874 |
Contact person: | Martin Yahiro, M.D., Director, Medical Affairs |
Email address: | martin.yahiro@seaspine.com |
Date Prepared: | April 23, 2019 |
Device Name | |
Trade Name: | Mariner Outrigger Revision System |
Common Name: | Pedicle Screw Spinal System |
Classification Name: | 21 CFR 888.3070- Thoracolumbosacral Pedicle Screw |
21 CFR 888.3050- Spinal Interlaminal Fixation Orthosis | |
21 CFR 888.3060- Spinal Intervertebral Body Fixation Orthosis | |
Class: | II |
Product Code: | NKB |
Legally Marketed Predicate Devices
510(k) Number | Product Code | Trade Name | Manufacturer |
---|---|---|---|
PRIMARY PREDICATE Device | |||
K173882 | NKB | Mariner Pedicle | |
Screw System | SeaSpine Orthopedics | ||
Corporation | |||
ADDITIONAL PREDICATE Device | |||
K163604, | |||
K180686 | NKB, OSH, | ||
KWP, KWQ | Daytona Small | ||
Stature System | SeaSpine Orthopedics | ||
Corporation | |||
K170647, | |||
K172194 | NKG, KWP, | ||
NKB, KWQ | Connector System | Orthofix Inc. |
4
Device Description
The Mariner Outrigger Revision System is a thoracolumbar revision system designed to help reduce the trauma associated with revision surgeries by allowing the user the option to leave the existing hardware in and extend the construct or remove and replace with new SeaSpine hardware.
The Mariner Outrigger Revision System includes a variety of non-sterile implants manufactured from titanium alloy or cobalt chrome alloy and is comprised of various axial and parallel connectors of different shapes, rod slots, and also of various rods. The Mariner Outrigger Revision System is compatible with other SeaSpine posterior spinal fixation systems (e.g. Mariner, Davtona Small Stature, Malibu, Newport, and Coral Spinal Systems) which offer titanium and/or cobalt chrome alloy rods ranging in sizes of 04.5mm to Ø6.35mm.
The Mariner Outrigger Revision implants are manufactured from titanium alloy Ti-6Al-4V ELI (per ASTM F136), or cobalt chrome alloy (per ASTM F562). The instruments included in the 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.
Intended Use/Indications for use
When used with the Mariner, Daytona Small Stature, Malibu, Newport, and Coral Spinal Systems:
The Mariner Outrigger Revision System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/ilium) in the treatment of the following acute and chronic instabilities or deformities:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis, ●
- trauma (i.e., fracture or dislocation), ●
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor. ●
- pseudarthrosis (i.e., failed previous fusion) ●
When used with Daytona Small Stature Spinal System for posterior non-cervical pedicle screw fixation in pediatric patients, the Mariner Outrigger Revision System is also indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis, and congenital scoliosis. Pediatric pedicle screw fixation is limited to a posterior approach.
The Mariner Outrigger Revision System is intended to be used with autograft or allograft.
5
Summary of Technological Characteristics
The Mariner Outrigger Revision 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).
The 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 design details and not functionality.
- Utilize similar rods ●
- o Utilize similar connectors
- Have similar locking caps o
- Same implant materials; titanium alloy (ASTM F136) and cobalt chrome alloy (ASTM F562)
Non-Clinical Testing
The Mariner Outrigger Revision System demonstrated similar performance to the predicate systems through static and dynamic mechanical testing with reference to ASTM F1717 and 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 Mariner Outrigger Revision System is substantially equivalent to the cited legally marketed predicate.