(148 days)
Not Found
No
The document describes a passive, physical implant device made of PEEK with tantalum markers. There is no mention of software, algorithms, data processing, or any other components that would suggest the use of AI or ML.
Yes.
The device is indicated for use in the thoracolumbar spine to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. These are therapeutic actions.
No
The device is a vertebral body replacement system used in surgical procedures, not for diagnostic purposes.
No
The device description clearly states the device consists of polyetheretherketone (peek) implants with physical features like holes, tantalum markers, and machined barbs, indicating it is a physical medical device, not software-only.
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 and Intended Use: The Innovasis Box™ peek VBR System is a physical implant designed to replace a vertebral body in the spine. It is surgically implanted into the patient's body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic testing, or any function related to providing diagnostic information based on in vitro analysis.
The device is a surgical implant used for structural support and restoration of spinal anatomy, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella™ Pedicle Screw System. The interior of the Box™ system can be packed with allograft or autograft. Box™ implants are intended to be used in pairs.
Product codes
MQP
Device Description
The Innovasis Box™ Peek VBR System consists of polyetheretherketone(peek) implants meant to be used only in pairs and with supplemental fixation. The devices are offered in a variety of different shapes (i.e. curved, rectangular) and sizes, in order to better accommodate a patient's anatomy. The implants also feature holes located throughout their geometry in order to accommodate bone graft and maximize bone ingrowth.
Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043316, K032064, K050553, K031757, K050449
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
KOO 2151 1 Ok
614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573
| DEC | 2 |
|---|---|
| 2 | 2006 |
| Box™ Peek VBR System | |
|---|---|
| 510(k) Summary | |
| June 5, 2006 | |
| Company: | Innovasis Inc. |
| 614 East 390 |
| Salt Lake City, UT 84107 | |
|---|---|
| Contact: | Warren M. Dansie |
| Phone: (801)261-2236 | |
| Fax: (801) 261-0573 |
- Box™ Peek VBR System Trade Name:
- Vertebral Body Replacement Common Name:
Classification: Product Code: MQP Regulation Number: 21 CRF 888.3060 Classification Name: Spinal intervertebral body fixation orthosis. Panel code: 87
3900 South
| Substantially |
|---|
| Equivalent Devices: |
| Equivalent Devices: | - K043316 – RabeaTM - Signus |
|---|---|
| - K032064 – CPOD/LPODTM VBR System – Theken | |
| - K050553 – NovelTM VBR Spinal System - Alphatec | |
| - K031757 – Peek TetrisTM - Signus | |
| - K050449 – Quantum Vertebral Body Replacement – Quantum Orthopedics |
Device Description:
The Innovasis Box™ Peek VBR System consists of polyetheretherketone(peek) implants meant to be used only in pairs and with supplemental fixation. The devices are offered in a variety of different shapes (i.e. curved, rectangular) and sizes, in order to better accommodate a patient's anatomy. The implants also feature holes located throughout their geometry in order to accommodate bone graft and maximize bone ingrowth.
Tantalum markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The ends of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
| Performance Data:
| Annual program de collection and collection of the collection of the contribution of the contribution of the contribution of the commend | Non-clinical (Bench): |
|---|---|
| Borformanno tacting indicator that the Roy TM Dagk VB |
Performance testing indicates that the Box™ Peek VBR System is capable of performing in accordance with its intended use.
Materials: The implants are machined from Medical Grade peek (Polyetheretherketone) OPTIMA (Invibio™) per ASTM F2026. Marker beads machined from Tantalum per ASTM F560.
1
INNOVASIS. Inc. 614 East 3900 South Salt Lake City, UT 84107 801-261-2236 Fax 801-261-0573
2 af 2
KOG 2151
Intended Use:
Indications for use are as follows:
The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella™ Pedicle Screw System. The interior of the Box™ system can be packed with allograft or autograft. Box™ implants are intended to be used in pairs.
Basis for Substantial Equivalence:
The Box™ Peek VBR System has been subjected to risk analysis and engineering analysis and has been shown to be substantially equivalent to the predicates:
-
K043316 Rabea™ Signus
-
K032064 - CPOD/LPOD™ VBR System -- Theken
-
K050553 Novel™ VBR Spinal System Alphatec
-
K031757 Peek Tetris™ Signus
-
K050449 - Quantum Vertebral Body Replacement - Quantum Orthopedics
with regards to indications for use, technology and performance.
Summary of Safety and Effectiveness:
The Innovasis Box™ Peek VBR System is shown to be safe and effective for use as a vertebral body replacement and in the indications associated with device product code MQP.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of four curved lines that resemble a human figure or a flame, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 2006
Innovasis Inc. c/o Mr. Warren Dansie 614 East 3900 South Salt Lake City, UT 84107
Re: K062151
Trade Name: Box™ PEEK VBR System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MOP Dated: December 18, 2006 Received: December 19, 2006
Dear Mr. Dansie:
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 such 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.
3
Page 2 - Mr. Warren Dansie
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buchund
for
Mark N. Melkers Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications of Use Statement
510(k) Number: K062151
Device Name: Box™ Peek VBR System
Indications for use:
The Innovasis Box™ peek VBR System is a vertebral body replacement indicated for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised during partial and total vertebrectomy procedures due to tumor or trauma, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella™ Pedicle Screw System. The interior of the Box™ system can be packed with allograft or autograft. Box™ implants are intended to be used in pairs.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (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)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buchemi
Division ' General Restorative. and New ological Devices
510(k) Number K062151