(141 days)
Not Found
No
The summary describes a passive implant (interbody fusion device) and its mechanical properties, with no mention of AI/ML in the device description, intended use, or performance studies.
Yes
The device is indicated for treating degenerative disc disease by facilitating interbody fusion, which directly addresses a disease state.
No
This device is an implantable interbody fusion device used in spinal surgery, not a device for diagnosing medical conditions. It is used after a diagnosis of degenerative disc disease has been made.
No
The device description clearly indicates it is a physical implant made of PEEK material with tantalum markers, designed for surgical implantation. It also mentions custom positioning instruments. This is a hardware device, not software.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Innovasis C-Box PEEK Cervical IBF device is an implantable medical device used inside the body during surgery to facilitate bone fusion in the cervical spine.
- Intended Use: The intended use clearly describes a surgical procedure and the device's role in that procedure, not a diagnostic test performed on a sample.
- Device Description: The description details the physical characteristics and materials of an implant, not the components of a diagnostic test kit or instrument.
Therefore, the Innovasis C-Box PEEK Cervical IBF device falls under the category of a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The C-Box PEEK Cervical IBF device is intended for use in Anterior Cervical Discectorny and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.
Product codes
ODP
Device Description
The single use devices are rectangular in shape with rounded corners and are offered in a variety of different heights to accommodate patient anatomy. The design features include: · Proportional sizing for the cervical spine · 6º lordosis · Manufactured with Invibio PEEK OPTIMA® polyetheretherketone · Large central window for bone autograft material • Radiolucent · Tantalum markers to facilitate and verify device placement · Custom position instruments to facilitate proper implant placement · Proud tooth design on superior and inferior surfaces to resist migration
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Physicians trained in orthopedic surgery; hospitals and surgery sites equipped to perform spinal surgery.
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 Data: (Non-clinical)-Performance testing per ASTM F2077-11 and F2267-04 for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, Subsidence and Expulsion, indicates that the C-Box PEEK Cervical IBF is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082801 Phantom™ Plus Cage System, K130699 Aleutian Spinal System, K120486 AVS AS PEEK Spacer, K103660 Breckenridge Cervical IBF
Reference Device(s)
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
FEB 1 2 2014
510(k) Summary Report:
C-Box® PEEK Cervical IBF System
| Company: | Innovasis, Inc.
614 E. 3900 South
Salt Lake City, UT 84107 |
| ---------- | ------------------------------------------------------------------ |
|---|
Contact: Marshall C. McCarty Phone: (801) 261-2236 mmccarty@innovasis.com
Trade Name: C-Box® PEEK Cervical IBF
Common Name: Intervertebral fusion device with bone graft, cervical
| Classification: | Regulation No.: 21CFR 888.3080 |
|---|---|
| Class 2 | |
| Product Code: ODP | |
| Review Panel: Orthopedic ASDB | |
| Applicable Standards: | |
| • ASTM F560-08 Standard Specification for Unalloyed | |
| Tantalum for Surgical Implant Applications | |
| • ASTM F983-86 Standard Practice for Permanent Marking | |
| of Orthopedic Implant Components | |
| • ASTM F2026-12 Standard Specification for | |
| Polyetheretherketone (PEEK) Polymers | |
| for Surgical Implant Applications | |
| • ASTM F2077-11 Test Methods for Intervertebral Body | |
| Fusion Devices | |
| • ASTM F2267-04 (Reapproved 2011) Standard Test Method | |
| for Measuring Load Induced Subsidence | |
| of Intervertebral Body Fusion Device | |
| Under Static Axial Compression | |
| • ISO 17665-1:2006 Sterilization of Healthcare Products – | |
| Moist Heat - Part 1 Requirements for the | |
| Development, Validation and Routine | |
| Control of a Sterilization Process for | |
| Medical Devices |
1
K132991 page 2 of 4
Substantially
| Phantom™ Plus Cage System (US Spine) | |
|---|---|
| Aleutian Spinal System | (K2M) |
| AVS AS PEEK Spacer | (Stryker) |
| Breckenridge Cervical IBF | (Lanx) |
Device Description: C-Box® PEEK Cervical IBF
The single use devices are rectangular in shape with rounded corners and are offered in a variety of different heights to accommodate patient anatomy. The design features include: · Proportional sizing for the cervical spine · 6º lordosis · Manufactured with Invibio PEEK OPTIMA® polyetheretherketone · Large central window for bone autograft material • Radiolucent · Tantalum markers to facilitate and verify device placement · Custom position instruments to facilitate proper implant placement · Proud tooth design on superior and inferior surfaces to resist migration Performance Data: (Non-clinical)-Performance testing per ASTM F2077-11 and F2267-04 for Static Compression, Static Compression Shear, Static Torsion, Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, Subsidence and Expulsion, indicates that the C-Box PEEK Cervical IBF is substantially equivalent to the predicate device. Materials: The implants are machined from medical grade polyetheretherketone (Invibio PEEK Optima®) per ASTM F-2026. The radiographic markers meet ASTM F-560 for unalloyed Tantalum. Intended Use: The C-Box PEEK Cervical IBF device is intended for use in Anterior Cervical Discectorny and Fusion (ACDF) procedures. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery.
2
Indications for Use: The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.
Contraindications (Exclusions for Use):
Use of this system is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials.
Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopedic implant.
Conditions that may place excessive stress on the bone and implant, such as severe obesity or degenerative diseases are relative contraindications. The decision whether to use these devices under these conditions must be made by the physician taking into account the risks versus the benefits to the patient.
Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, or lifestyle may interfere with their ability to follow postoperative restrictions and who may place undue stresses on the implant during bone healing and may be at a higher risk of implant failure.
3
Basis for Substantial Equivalence:
The C-Box PEEK Cervical IBF has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, K082801 Phantom™ Plus Cage System, K130699 Aleutian Spinal System, K120486 AVS AS PEEK Spacer, and K103660 Breckenridge Cervical IBF.
- · Design configurations are substantially equivalent.
- · Applied mechanical loads are substantially equivalent.
- · Product sizes and shapes are substantially equivalent.
- · Materials used are equivalent.
- · Biocompatibility requirements have been demonstrated.
- · Manufacturing and processing methods are substantially equivalent.
- · Shelf life is equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2014
Innovasis, Incorporated Mr. Marshall McCarty Director Quality Affairs/Regulatory Affairs 614 East 3900 South Salt Lake City, Utah 84107
Re: K132991
Trade/Device Name: C-Box® PEEK Cervical IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 16, 2014 Received: January 22, 2014
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. Ilisting 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
VATO
5
Page 2 - Mr. Marshall 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,
Vincent Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement 1.0
K132991 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: C-Box® PEEK Cervical IBF System
INDICATIONS FOR USE are as follows:
The Innovasis C-Box PEEK Cervical IBF device is indicated for cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
This device is to be used in patients who have had six weeks of non-operative treatment. The C-Box device is to be used with supplemental fixation, such as the Innovasis Opteryx® Cervical Plate System. The C-Box device is intended to be used with autograft bone and is to be implanted via an open, anterior approach.
x Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart D)
OR Over-The-Counter-Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE_CONTINUE_ON ANOTHER PAGE IF_ NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)