(69 days)
Not Found
No
The device description and intended use are purely mechanical components for spinal fixation, with no mention of software, image processing, or AI/ML terms.
Yes
The device is designed to provide immobilization and stabilization of spinal segments for the treatment of various spinal conditions, directly addressing a medical problem.
No
The Diamondback™ Spinal System is described as a spinal implant designed for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. Its intended use is for treatment of various spinal conditions, not for diagnosing them.
No
The device description explicitly lists hardware components (rods, screws, caps, cross connectors, lock screws) and describes mechanical performance testing, indicating it is a physical implant system, not software.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text describes a surgical implant (rods, screws, and connectors) used to stabilize the spine during fusion surgery. This is a medical device used in vivo (within the body) for structural support and immobilization, not for analyzing biological samples.
The information provided clearly indicates a device used for surgical intervention and stabilization of the spine, which falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
Intended Use / Indications for Use
The Diamondback™ Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (T1 to S2) the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Product codes
MNI, MNH
Device Description
The Diamondback™ Spinal System consists of rods, monoaxial and polyaxial screws with caps, and cross connectors with lock screws. Rods are available either straight or pre-contoured in a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spinal segments; L5-S1 vertebra; non-cervical posterior spine (T1 to S2)
Indicated Patient Age Range
skeletally mature patients.
Intended User / Care Setting
Prescription Use
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)
Static compression bending and torsion and dynamic compression bending of the worst case Diamondback™ Spinal System construct was performed according to ASTM F1717. The mechanical results demonstrated that the Diamondback™ Spinal System performs as well as or better than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CD HORIZON® (K031655/K041460), Moss Miami (K992168/K022623), Synergy VLS (K950099/K974749)
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.
0
Image /page/0/Picture/1 description: The image shows a circular emblem with the words "EMINENT SPINE" at the top and "BAD TO THE BONE" at the bottom. In the center of the emblem, there is an illustration of a skeleton riding a worm-like creature. The emblem has a vintage or retro style, with a slightly distressed appearance.
16 April 2010
Eminent Spine, LLC
7200 N IH 35 Bļdg. 1 Georgetown, TX 78626 Phone: (512) 868-5980 Fax: (512) 864-1462
APR 2 2 2010
510(k) Summary
Date: Sponsor:
| Sponsor: | Eminent Spine LLC
7200 N I-35 Building #1
Georgetown, TX 46037
Phone 512-868-5980
Fax 512-864-1462 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dave Freehill, President |
| Proposed Trade
Name: | Diamondback™ Spinal System |
| Device Classification | Class II |
| Classification Name: | Pedicle screw spinal system |
| Regulation: | 888.3070 |
| Device Product
Code: | MNI, MNH |
| Device Description: | The Diamondback™ Spinal System consists of rods, monoaxial and
polyaxial screws with caps, and cross connectors with lock screws.
Rods are available either straight or pre-contoured in a variety of
lengths. Monoaxial and polyaxial screws are available in a variety of
diameter-length combinations. |
| Intended Use: | The Diamondback™ Spinal System is designed to provide
immobilization and stabilization of thoracic, lumbar, and sacral spinal
segments as an adjunct to fusion in skeletally mature patients. The
system is intended for posterior, pedicle fixation for the treatment of
severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra. In
addition, when used as a pedicle screw fixation system of the non-
cervical posterior spine (T1 to S2) the system is intended for the
treatment of the following acute and chronic instabilities or
deformities: degenerative spondylolisthesis with objective evidence
of neurologic impairment, fracture, dislocation, spinal stenosis,
scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed
previous fusion. |
| Materials: | The Diamondback™ Spinal System components are manufactured
from titanium alloy (Ti-6Al-4V) as described by ASTM F136. |
| Predicate Devices: | CD HORIZON® (K031655/K041460)
Moss Miami (K992168/K022623)
Synergy VLS (K950099/K974749) |
1
Diamondback™ Spinal System possesses the same The Technological technological characteristics as the predicate devices. These include Characteristics: basic design (rod-based pedicle screw system having monoaxial and polyaxial screws), material (titanium alloy), sizes (rod and screw sizes are encompassed by those offered by the predicate systems) and intended use (as described above). The fundamental scientific technology of the Diamondback™ Spinal System is the same as previously cleared devices.
Static compression bending and torsion and dynamic compression Performance Data: bending of the worst case Diamondback™ Spinal System construct was performed according to ASTM F1717. The mechanical results demonstrated that the Diamondback™ Spinal System performs as well as or better than the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Eminent Spine LLC % BackRoads Consulting Inc. Karen E. Warden, Ph.D. President 8202 Sherman Road Chesterland, Ohio 44026-2141
Re: K100377
Trade/Device Name: Diamondback "Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: February 04, 2010 Received: February 12, 2010
Dear Dr. Warden:
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
APR 2 2 2010
3
Page 2 - Karen E. Warden, Ph.D.
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Barbara Inehms
Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation -Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: KI00377
Device Name: Diamondback™ Spinal System
Indications for Use:
The Diamondback™ Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion in skeletally mature patients. The system is intended for posterior, pedicle fixation for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra. In addition, when used as a pedicle screw fixation system of the non-cervical posterior spine (T1 to S2) the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
| Prescription Use | X |
|---|---|
| (21 CFR 801 Subpart D) |
AND/OR
| Over-the-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K100377 510(k) Number_