(182 days)
Not Found
No
The provided text describes a mechanical spinal fixation system made of titanium alloy components. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The description focuses solely on the physical components and their intended use for stabilization and fusion.
Yes
The device is described as promoting fusion and providing stabilization, which are therapeutic actions to address various spinal conditions.
No
The device is described as a "multi-component system" used to create a "rigid structure providing stabilization and promote spinal fusion" for conditions like Degenerative Disc Disease, spondylolisthesis, and fracture/dislocation. Its intended use is to promote fusion and provide stabilization, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "multiple component system comprised of a variety of non-sterile, single use implantable components" made of titanium alloy, including plates, screws, hooks, rods, and locking caps. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SENTINEL Spinal System is described as a "temporary, titanium alloy... multiple component system comprised of a variety of non-sterile, single use implantable components." These components are assembled to create a "rigid structure providing stabilization and promote spinal fusion."
- Intended Use: The intended use is to "promote fusion of the cervical spine and occipito-cervico-thoracic junction" and to provide "stabilization to promote fusion following reduction of fracture/dislocation or trauma."
This description clearly indicates that the device is an implantable surgical device used to provide structural support and promote healing within the body. It does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Product codes
KWP
Device Description
The SENTINELTM Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, and locking caps.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine and occipito-cervico-thoracic junction (Occiput - T3), T1-T3, cervical/upper thoracic (C1-T3) spine.
Indicated Patient Age Range
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthese Synapse System (K070573), Biomet Altius OCT System (K043229), Stryker Spine OASYSTM System (K032394), and Depuy SUMMITTM OCT Spinal System (K010681)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The text "Life Spine" is written in a bold, sans-serif font. A curved line appears below the text, adding a visual element to the logo. The logo is simple and professional, conveying a sense of reliability and expertise.
K090343 plof2
2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169 n 847 884 6117 847.884.6118 ww.lifespine.com
510(k) Summary
SENTINELTM Spinal System
Life Spine Submitted By: 2401 W. Hassell Road, Suite 1535 AUG 11 2009 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 510(k) Contact: Murali Audipudy RA/QA Manager Life Spine 2401 W. Hassell Road, Suite 1535 Hoffman Estates, IL 60169 Telephone: 847-884-6117 Fax: 847-884-6118 April 03, 2009 Date Prepared: Trade Name: SENTINELTM Spinal System Classification: KWP, 21 CFR 888.3050, Class II, Spinal Interlaminal Fixation Orthosis. Predicate Devices: Synthese Synapse System (K070573), Biomet Altius OCT System (K043229), Stryker Spine OASYSTM System (K032394), and Depuy SUMMITTM OCT Spinal System (K010681)
Device Description:
The SENTINELTM Spinal System is a temporary, titanium alloy (6AL-4V-ELI per ASTM F 136), multiple component system comprised of a variety of non-sterile, single use implantable components. When assembled, the components create a rigid structure providing stabilization and promote spinal fusion. The system consists of an assortment of occipital plates, occipital bone screws, polyaxial screws, hooks, rods, and locking caps.
Intended Use of the Device:
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation: Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
Google Search Central
1
Image /page/1/Picture/0 description: The image shows the logo for Life Spine. The logo is in black and has a textured appearance. The word "Life" is on the left, followed by "Spine" on the right, with a registered trademark symbol next to it.
2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169 p 847.884.6117 f 847.884.6118 www.lifespine.com
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Material:
Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6A1-4V-ELI) implant grade titanium alloy.
Substantial Equivalence:
The SENTINEL Spinal System was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.
2
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms reaching upwards, positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Life Spine % Mr. Daniel Predick Project Engineer 2401 W. Hassell Road, Suite 1535 Hoffman Estates, Illinois 60169
AUG 11 2009
Re: K090343
Trade Name: SENTINELTM Spinal System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: July 23, 2009 Received: July 28, 2009
Dear Mr. Predick:
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 Mav 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.
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 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 (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.
3
Page 2 -- Mr. Daniel Predick
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FoR Peter D. Rummer
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Life Spine. The logo is in black and has a distressed or textured appearance. Below the text is a curved line that is also distressed.
2401 W. Hassell Road Suite 1535 Hoffman Estates, IL 60169 0847 884 6117 847 884 6118 vww.lifespine.com
Indications for Use
510(k) number (if known): K090343
Device Name: SENTINEL™ Spinal System
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the SENTINEL Spinal System, when properly used, is intended for: Degenerative Disc Discase (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; Atlanto/axial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors.
When used with the occipital plate, the bone screws are limited to occipital fixation only. The bone screws are not intended to be used in the cervical spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in the cervical spine.
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Prescription Use x_ (Part 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)
$\xi$ (ExT for MKM)
(D:: : : 0.03
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K04342 510(k) Number_