(160 days)
No
The document describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "intended for fusion procedures" and "comprised of a variety of screws, rods, and staples" used for attachment to the spine to treat various medical conditions like degenerative disc disease, spondylolisthesis, and spinal stenosis. This directly indicates a therapeutic purpose.
No
The device description indicates that the Mercury Spinal System is comprised of screws, rods, and staples used for fusion procedures, which are interventional treatments. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly states that the Mercury Spinal System is comprised of physical components (screws, rods, and staples) made from titanium alloy, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The Mercury Spinal System is described as a system of screws, rods, and staples made from titanium alloy. These are physical implants used in surgical procedures.
- Intended Use: The intended use is for fusion procedures of the spine to treat various conditions. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i e , fracture or dislocation), spinal stenosis, curvatures (1 e , scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion
Product codes
MNI, MNH, KWP, KWQ, NKB
Device Description
Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1) A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone
Screws, rods, and staples are made from titanium alloy (Tr-6A1-4V) conforming to ASTM F 136 or ISO 5832-3
The devices of this submission are new screw designs and sizes that are being added to the existing system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine (T1-S1), non-cervical spine (T1-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071914, K063670, K030383, K061854, K031354, K000450
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
510(k) Summary Mercury™ Spinal System
JAN 2 2 2009
510(k) Number 1082
| Manufacturer Identification | |
|---|---|
| Submitted by: | Spinal Elements, Inc |
| 2744 Loker Ave W, Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-0121 | |
| Contact Information: | Kerri DiMartino |
| Regulatory Affairs Specialist | |
| Spinal Elements, Inc | |
| 2744 Loker Ave W, Suite 100 | |
| Carlsbad, CA 92010 | |
| 760-607-1816 | |
| 760-607-0125 (fax) | |
| kdimartino@spinalelements.com | |
| Date Prepared: | August 13, 2008 |
| Device Identification | |
| Proprietary Name | Mercury™ Spinal System |
| Device Classification | Spinal Interlaminal Fixation and Spinal |
| Intervertebral Fixation Orthosis and/or Pedicle Screw | |
| System (per 21 CFR Section 888 3050, 888 3060 and/or | |
| 888 3070) | |
| Regulatory Class | Class III |
| Device Product Code | MNI, MNH, KWP, KWQ, NKB |
Device Description
Spinal Elements' Mercury Spinal System is comprised of a variety of screws, rods, and staples that are used for attachment to the non-cervical spine (T1-S1) A variety of constructs may be assembled to suit the individual pathology and anatomy of the patient Rods span the distance between screws and achieve fixation by the mechanical joining of the rods with the screws Staples (when used) are placed under the head of the polyaxial or monoaxial screws to help distribute loads placed against the bone
Screws, rods, and staples are made from titanium alloy (Tr-6A1-4V) conforming to ASTM F 136 or ISO 5832-3
The devices of this submission are new screw designs and sizes that are being added to the existing system
1
Intended Use of the Device
The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients This system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i e , fracture or dislocation), spinal stenosis, curvatures (1 e , scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion
Substantial Equivalence
The Mercury Spinal System was shown to be substantially equivalent through comparison to the following predicate spinal systems Mercury Spinal System by Spinal Elements (K071914), CD Horizon® Spinal System by Medttronic Sofamor Danek (K063670), Moss Miami Spinal System by DePuy Acromed (K030383), XIA®/XIA® 4 5 Spinal Systems by Stryker Spine (K061854), Omega21™ Degenerative Spine System by EBI Spine (K031354), and USS by Synthes (K000450)
Performance Data
Mechanical testing indicates that Mercury Spinal System devices are capable of performing in accordance with their intended use
2
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other.
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol on the right side. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
JAN 22 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Spinal Elements, Inc c/o Ms Kerri DıMartıno Regulatory Affaırs Specialist 2744 Loker Ave W , Suite 100 Carlsbad, CA 92010
Re K082353 Trade Name Mercury™ Spinal System Regulation Number 21 CFR 888 3050, 888 3060, and 888 3070 Regulation Name spinal interlaminal fixation, spinal intervertebral fixation orthosis and/or pedicle screw system Regulatory Class III Product Code NKB, MNI, MNH, KWP, and KWQ Dated January 16, 2009 Received January 21, 2009
Dear Ms DiMartino
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 pror 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 molude requirements for annual registration, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbianding and adulteratıon
If your device 1s classified (see above) into enther class II (Special Controls) or class III (PMA), it may be subject to such additional controls Existing major regulations affecting your device can be found in the Code of Feceral 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 comples with other requrements of the Act or any Federal statutes and regulations administered by other Federal agencies You must CER Part 807), lobaling (21 OED D . Including, but not limited to registration and Islands (21 CFR Part 807), labeling (21 CFR Part 801), good manufacturing practice requirements as set
3
Page 2 - Ms Kerrı DıMartıno
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 This letter will allow you to begin marketing your device as described in your Section 510(k) premarket nottfication The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device on a legally
to proceed to the market to proceed to the market
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Development of Curredo out our labeling regulation (21 CFR Part 801), please at (240) 276-0120 Also, please note the regulation entitled, "Misbranding by reference to premarket notifications of Sun 807 97) For questions regarding postmarket surveillance, please contact CDRH's ( 1 ) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR), please contact the reporting of device adverse events
276-3464. You may obtain other consultant the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on Surveillance Systems at 240the Division of Small Manufacturers, Internation on your responsibilites under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http //www fda gov/cdrh/ındustry/support/ındex html
Sincerely yours.
Mark M. Mulhearn
Mark N Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): 认分分 2353
Mercury™ Spinal System Device Name•
Indications for Use.
The Mercury Spinal System is intended for fusion procedures of the thoracic, lumbar, and sacral spine (T1-S1) of skeletally mature patients Thus system is intended for anterior/anterolateral non-pedicle fixation, posterior non-pedicle fixation, and posterior pedicle fixation for the following indications degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i e, fracture or dislocation), spinal stenosis, curvatures (i e , scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
| Gencuriance of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | mkm |
| Division of General, Restorative, and Neurological Devices | Page 1 of 1 |
| 510(k) Number | K082353 |