(30 days)
The Predicate Device(s) K/DEN number is not found in the provided text.
Not Found
No
The summary describes a physical implantable device and its intended use, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is used for spinal fusion procedures to treat degenerative disc disease, and as a vertebral body replacement due to tumor or trauma, with the goal of restoring stability and function to the spine.
No
This device is an implantable spinal spacer system used for fusion procedures and vertebral body replacement, not for diagnosing medical conditions.
No
The device description explicitly states the device is an "implantable device manufactured from PEEK and titanium alloy," indicating it is a physical hardware device, 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 describes a surgical implant used for spinal fusion and vertebral body replacement. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an implantable device made from PEEK and titanium alloy, designed to be surgically placed in the spine. This is consistent with a medical device for treatment, not an IVD.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
Therefore, the Novel ALIF Spinal Spacer System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.
Product codes
MAX, MQP
Device Description
The Novel® ALIF Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1, T1-L5
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)
The test results demonstrate that the mechanical performance of the Novel ALIF Spinal Spacer System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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510(k) SUMMARY
APR 2 2 2009
Novel® ALIF Spinal Spacer System 510(k) SUMMARY March 2009
| Company: | Alphatec Spine, Inc.
5818 El Camino Real
Carlsbad, CA 92008 USA
Direct: (760) 494-6771
Fax: (760) 431-0289 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Stanners, Regulatory Affairs Specialist II |
| Trade/Proprietary Name: | Novel® ALIF Spinal Spacer System |
| Common Name: | Intervertebral Body Fusion Device
Vertebral Body Replacement Device |
| Classification Name: | Intervertebral Body Fusion Device
Spinal Intervertebral Body Fixation Orthosis |
| Classification Number(s)/Product Code(s): | 21 CFR 888.3080 (MAX)
21 CFR 888.3060 (MQP) |
Product Description:
The Novel® ALIF Spinal Spacer System is an implantable device manufactured from PEEK and titanium alloy that is available in a variety of different shapes and sizes to suit individual pathology and anatomical conditions of the patient.
Indications for Use:
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.
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Substantial Equivalence:
Data was provided which demonstrated the Novel ALIF Spinal Spacer System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, design, material and function.
Performance Data:
The test results demonstrate that the mechanical performance of the Novel ALIF Spinal Spacer System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black. The seal is simple and iconic, representing the department's role in promoting health and well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alphatec Spine, Inc % Ms. Mary Stanners Regulatory Affairs Specialist II 5818 EL Camino Road Carlsbad, California 92008
Re: K090782
Trade/Device Name: Novel® ALIF Spinal Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MOP Dated: March 20, 2009 Received: March 23, 2009
APR 2 2 2009
Dear Ms. Stanners:
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 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.
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Page 2- Ms. Mary Stanners
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
erely yours,
k N. Melkerson
Mark N. Melkerson Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K090782
Device Name: Novel® ALIF Spinal Spacer System
Indications for Use:
Intervertebral Body Fusion
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
Vertebral Body Replacement
When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically-the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.
Prescription Use X (Per 21 CFR 801.109)
OR ·
Over-The Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K090782
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