(140 days)
K062151, P960025
Not Found
No
The description focuses on the physical characteristics, materials, and mechanical performance of a PEEK intervertebral body fusion device. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as an "intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain," which clearly indicates a therapeutic purpose.
No
This device is an implantable intervertebral body fusion device used to stabilize a spinal segment, not to diagnose a condition.
No
The device description clearly states it consists of physical implants made of PEEK, Tantalum, and Titanium, along with reusable stainless steel surgical instruments. This is a hardware medical 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 is to stabilize a spinal segment to promote fusion using bone graft, restrict motion, and decrease pain. This is a therapeutic and structural function within the body.
- Device Description: The device is a physical implant made of PEEK, Tantalum, and Titanium, designed to be surgically placed in the spine. It also includes surgical instruments for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on mechanical properties and structural integrity (compression, torsion, expulsion, subsidence), which are relevant to a surgical implant, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used within the body for structural support and fusion.
N/A
Intended Use / Indications for Use
The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
The Innovasis Box PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either an anterior or anterolateral (A-Box) or lateral (L-Box) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Innovasis Box™ Peek IBF System consists of polyetheretherketone (PEEK) implants meant to be used with supplemental fixation and offered in a variety of different sizes, in order to accommodate the patient's anatomy and surgeon's preference for installation. The implants feature holes in the interior geometry in order to accommodate bone graft and maximize bone ingrowth. Tantalum (A-Box) or titanium (L-Box) radiographic markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
The A-Box device is an anatomically shaped IBF with two interior holes to allow for packed autograft. This device is designed to be inserted from an anterior or anterolateral approach.
The L-Box device is similar to the A-Box, but is longer and designed to be inserted from a lateral approach. It has a rounded nose which can be used to aid in placement.
Materials: The implants are machined from Medical Grade PEEK (Polyetheretherketone) Zeniva™ (Solvay) per ASTM F2026. Marker beads (A-Box) machined from implant grade Tantalum per ASTM F560. Marker pins (L-Box) machined from implant grade Titanium per ASTM F-67.
The system comes with reusable stainless steel surgical instruments designed to be cleaned and steam-sterilized between uses. These instruments aid in the preparation of the area and installation of the PEEK implants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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 bench testing has been conducted on sterilized samples of the identified "worst case" sizes from the Box™ PEEK IBF System (A-Box and L-Box). Worst case was determined using Finite Element Analysis. The testing included: Static Axial Compression, Static Torsion (ultimate torque), Offset Yield Torque (all per F2077-11), Expulsion (per in-house method) and Subsidence (per F2267-04).
The Box PEEK IBF implants, the L-Box and A-Box, were substantially equivalent to predicate devices and met the acceptance criteria for each test. The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria. The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062151, P960025
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
$\overline{K}_{12}|S\overline{\delta}|$
510(k) Summary Report Section 5 Box™ PEEK IBF System
September 12, 2012
| September 12, 2012 | OCT 17 2012 | |
|---|---|---|
| Company: | Innovasis Inc. | |
| 614 East 3900 South | ||
| Salt Lake City, UT 84107 | ||
| Contact: | Marshall C. McCarty | |
| Phone: (801)261-2236 | ||
| Fax: (801) 261-0573 | ||
| Trade Name: | Box™ PEEK IBF System | |
| Common Name: | Interbody Fusion Device | |
| Classification: | Product Code: MAX | |
| Regulation Number: 21 CRF 888.3080 | ||
| Classification Name: Intervertebral Body Fusion Device | ||
| Panel code: 87 | ||
| Substantially | ||
| Equivalent Devices: | - K062151 - Box PEEK VBR System—Innovasis, Inc. |
- P960025 - Jaguar Lumbar I/F Cage System—DePuy Spine, Inc. | |
Intended Use: The Innovasis Box PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.
Indications for use are as follows:
The Innovasis Box PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via either an anterior or anterolateral (A-Box) or lateral (L-Box) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the Innovasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.
Device Description:
The Innovasis Box™ Peek IBF System consists of polyetheretherketone (PEEK) implants meant to be used with supplemental fixation and offered in a variety of different sizes, in order to accommodate the patient's anatomy and surgeon's preference for installation. The implants feature holes in the interior geometry in order to accommodate bone graft and maximize bone
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ingrowth. Tantalum (A-Box) or titanium (L-Box) radiographic markers are incorporated into the material to allow for visualization of the implant configuration during and after surgery. The surfaces of the implants have machined barbs meant to engage the vertebral endplates and prevent expulsion.
The A-Box device is an anatomically shaped IBF with two interior holes to allow for packed autograft. This device is designed to be inserted from an anterior or anterolateral approach.
The L-Box device is similar to the A-Box, but is longer and designed to be inserted from a lateral approach. It has a rounded nose which can be used to aid in placement.
Materials: The implants are machined from Medical Grade PEEK (Polyetheretherketone) Zeniva™ (Solvay) per ASTM F2026. Marker beads (A-Box) machined from implant grade Tantalum per ASTM F560. Marker pins (L-Box) machined from implant grade Titanium per ASTM F-67.
The system comes with reusable stainless steel surgical instruments designed to be cleaned and steam-sterilized between uses. These instruments aid in the preparation of the area and installation of the PEEK implants.
Performance Data-Non-clinical (Bench):
The standard ASTM F2077 is recognized by FDA and internationally as a uniform method for testing Intervertebral Body Fusion Devices, and the results can be compared to other devices. Testing to this standard can assess the mechanical behavior of the device.
This method simulates the loads that will be seen in an implant application, i.e. compressive loads are parallel to the axis of the spine and torsional loads rotate around the axis of the spine.
The standard ASTM F2267 is a recognized standard method to determine subsidence of an IVBFD for comparison purposes.
Testing protocols and acceptance criteria were defined prior to testing in various documents filed in the Design History Files for these products.
Performance bench testing has been conducted on sterilized samples of the identified "worst case" sizes from the Box™ PEEK IBF System (A-Box and L-Box). Worst case was determined using Finite Element Analysis. The testing included: Static Axial Compression, Static Torsion (ultimate torque), Offset Yield Torque (all per F2077-11), Expulsion (per in-house method) and Subsidence (per F2267-04).
Biocompatibility
PEEK has a substantial history and laboratory evidence of biocompatibility. In order to verify that the processing at Innovasis does not introduce new biocompatibility issues, Limulus Amebocyte Lysate (LAL) and MEM Elution tests have been performed on representative A-Box and L-Box devices. The devices were manufactured per Innovasis specifications and procedures, then were submitted for testing. All tests passed well below the cutoff limit.
Sterilization Validation
Autoclave (steam) sterilization was performed by an independent contractor on the A-Box IBF and Instruments in the carrying case. This is the worst case configuration for the Box
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IBF products, because all instruments and implants are included in one case, presenting a large mass and heat sink.
Pre-vacuum and gravity steam sterilization per parameters in the Innovasis IFU were validated to a sterility assurance level (SAL) of 10th using the biological indicator overkill method for both the A-Box and L-Box systems.
Conclusion
The Box PEEK IBF implants, the L-Box and A-Box, were substantially equivalent to predicate devices and met the acceptance criteria for each test. The worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria. The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device.
Performance testing indicates that the Box™ Peek IBF System is capable of performing in accordance with its intended use.
Basis for Substantial Equivalence:
The Box™ Peek IBF System has been subjected to risk analysis and engineering analysis including recognized ASTM standard testing and has been shown to be substantially equivalent to the predicates:
- K062151 Box Peek VBR System-Innovasis, Inc.
- P960025 Jaguar Lumbar I/F Cage System (Brantigan Cage)-DePuy Spine, Inc.
Summary of Safety and Effectiveness:
The Innovasis Box™ Peek IBF System is shown to be substantially equivalent for use as a intervertebral body fusion device and in the indications associated with device product code MAX.
For the new additions to the product line, the worst-case implants performed substantially equivalent to the predicates for multiple modes of loading and met all of the acceptance criteria. The Innovasis Inc. A-Box and L-Box IBF will adequately stabilize the lumbar spine for an interbody fusion indication as it demonstrated favorable mechanical performance compared to legally marketed predicate device.
Analysis of the intended use, design, materials and physical characteristics has shown the Box™ PEEK IBF System to be substantially equivalent when compared to the predicate devices. Based on feature comparisons, performance testing, indications for use, and adherence to good laboratory practice, Innovasis believes the Box™ PEEK IBF System to be substantially equivalent to existing legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innovasis, Incorporated % Mr. Marshall C. McCarty Manager, Regulatory Affairs 614 East 3900 South Salt Lake City, Utah 84107
stan 84107
Re: K121581
Trade/Device Name: Box ™ PEEK IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 11, 2012 Received: September 14, 2012
Dear Mr. McCarty:
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 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
CT 17 2012
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Page 2 - Mr. Marshall C. McCarty
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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the word "INNOVASIS" in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance. Below the main word, there is a smaller line of text that reads "INNOVATE / INVOLVE / INVENT" in a simpler font. The overall design is clean and straightforward, with a focus on the company name.
Indications for Use Statement Section 4
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Box™ PEEK IBF System
Indications for use are as follows:
The Innovasis Box PEEK IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-SI). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 monds of non operative a the involved level(s). These implants are used to facilitate spond) in the lumbar spine and are placed via either an anterior or anterolateral (A-Box) or lateral (L-Box) approach.
This device is intended to be used with internal supplemental spinal fixation systems such as the I movasis Excella" Spinal System. The interior of the Box implants is intended to be packed with autograft.
X 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 IE NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cal-Rf
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
. 510(k) Number k/2/58/