(139 days)
Not Found
The text does not contain any Reference Devices with K/DEN numbers.
No
The document describes a mechanical implant for spinal stabilization and does not mention any AI/ML components or capabilities.
Yes
The device is described as "partial vertebral body replacement to aid in surgical correction and stabilization of the spine," and it is indicated for restoring height and decompressing the spinal cord, all of which are therapeutic actions.
No
This device is a vertebral body replacement system, acting as a spacer to restore height and stabilize the spine. It is a treatment device, not a diagnostic one.
No
The device description explicitly states the device is manufactured from Ti6Al4V and stainless steel, indicating it is a physical implant, not software.
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 for "partial vertebral body replacement to aid in surgical correction and stabilization of the spine." This is a surgical implant used in vivo (within the body).
- Device Description: The description confirms it's a "spacer to maintain proper vertebral body spacing and angulation following partial corpectomy," manufactured from materials like Ti6Al4V and stainless steel. This is consistent with a surgical implant.
- Anatomical Site: The device is used in the "thoracolumbar spine (T1 to L5)," which is an anatomical location within the body.
IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Innvotec Surgical SEC VBR does not fit this description.
N/A
Intended Use / Indications for Use
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a The Innvotec Surgical SEC VBR is always to be used with prolonged period. supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.
Product codes
MQP
Device Description
The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing performed on this device indicates that the SEC VBR is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
Innvotec Surgical SEC VBR 510(k)
K091743
=
510(k) Summary 5.
NOV - 2 2009
ﺗﺮ
| Contact: | Justin Eggleton
Musculoskeletal Clinical & Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
202.552.5800 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | SEC VBR |
| Manufacturer: | Innvotec Surgical, Inc.
150 North Hill Drive, Suite 1
Brisbane, CA 94005 |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3060 |
| Class: | II |
| Product Code: | MQP |
Indications For Use:
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a The Innvotec Surgical SEC VBR is always to be used with prolonged period. supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.
Device Description:
The SEC VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial corpectomy. The SEC VBR is manufactured from Ti6Al4V and stainless steel. The SEC VBR is for single level anterior spinal use from T1-L5.
Predicate Device(s):
The SEC VBR was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used.
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长091743
Innvotec Surgical SEC VBR 510(k)
Performance Standards:
Testing performed on this device indicates that the SEC VBR is substantially equivalent to predicate devices. ASTM F2077 performance standards were adhered to and all applicable requirements were met.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.
. Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Innvotec Surgical, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street, NW - 12th Floor Washington, District of Columbia 20005
NOV - 2 2009
Re: K091743
Trade/Device Name: SEC VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: October 27, 2009 Received: October 28, 2009
Dear Mr. Eggleton:
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.
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
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Page 2 - Mr. Justin Eggleton
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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely, Mark,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Innvotec Surgical SEC VBR 510(k)
4. Indications for Use
510(k) Number (if known): K09|743
Device Name: SEC VBR
The Innvotec Surgical SEC VBR is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Innvotec Surgical SEC VBR is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a The Innvotec Surgical SEC VBR is always to be used with prolonged period. supplemental internal spinal fixation. Additionally, the Innvotec Surgical SEC VBR may be used with bone graft.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of GDRH, Office of Device Evaluation (ODE)
Mark H. Milliken
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number .