(115 days)
No
The summary describes a physical implant (cervical cage) and its mechanical testing, with no mention of software, algorithms, or AI/ML terms.
Yes
Explanation: The device is a cervical intervertebral body fusion device indicated for use in patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms. Its purpose is to treat a medical condition and is permanently implanted, making it a therapeutic device.
No
This device is a cervical intervertebral body fusion device, used to treat degenerative disc disease by promoting fusion of the cervical spine. While its use requires a prior diagnosis, the device itself is a treatment implant, not a diagnostic tool.
No
The device description clearly states it is a "cervical intervertebral body fusion device" made of "medical grade titanium alloy" and is an "implantable component." This indicates it is a physical hardware device, not software.
Based on the provided information, the CAVUX™ Cervical Cage is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a cervical intervertebral body fusion device used in surgery to treat degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically placed in the spine. This is consistent with a medical device used for treatment, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine samples (like blood, tissue, or urine) or to provide information about a patient's health status based on such examination.
In summary, the CAVUX™ Cervical Cage is a surgical implant used for spinal fusion, which falls under the category of a medical device for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The CAVUX™ Cervical Cage is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomies and pathology. All implantable components are manufactured from medical grade titanium alloy (6AI4V —ELI Ti). The center of the implant is hollow and is to be filled with autogenous bone material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C3-C7)
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 following testing was performed using the subject device and results were compared to those of the predicate device:
Static and Dynamic Axial Compression Testing
- ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .
Static and Dynamic Torsion Testing - ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .
Subsidence Testing - . ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
Expulsion Testing - ASTM Draft Standard F-04.25.02.02 Static Push-out Test Method for Intervertebral . Body Fusion Devices
Pyrogenicity Testing - . Pyrogenicity Testing was conducted and in compliance with FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket Notification o (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"
- "Pyrogen and Endotoxins Testing: Questions and Answers" O
In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the CAVUX™ Cervical Cage exceeded those of the predicate PMT Cervical Cage. Therefore, the performance characteristics of the CAVUX ™ Cervical Cage are substantially equivalent to those of the PMT Cervical Cage.
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.
PMT Cervical Cage (K122801)
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.
Titan Spine, LLC: Endoskeleton® TC (K100889)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 7, 2016
Providence Medical Technology, Inc. Mr. Edward Liou Chief Operating Officer 1331 North California Boulevard, Suite 320 Walnut Creek, California 94596
Re: K161642
Trade/Device Name: CAVUX™ Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 7, 2016 Received: September 9, 2016
Dear Mr. Liou:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161642
Device Name CAVUX™ Cervical Cage
Indications for Use (Describe)
CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenc pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
Providence Medical Technology, Inc.'s CAVUX™ Cervical Cages
- Date Prepared: September 7, 2016
- Company: Providence Medical Technology, Inc. 1331 N. California Blvd., Suite 320 Walnut Creek, CA 94596
- Contact Person: Edward Liou ed@providencemt.com Phone: 415.923.9376 Facsimile: 415.923.9377
- CAVUX™ Cervical Cage Trade Name:
- Common Name: Cervical Cage
Classification Name: Intervertebral Fusion Device With Bone Graft, Cervical
Regulation Number: 21 CFR 888.3080
- ODP Product Code: Class: Class II
Predicate Devices:
Primary Predicate: PMT Cervical Cage (K122801, Cleared 5/24/13) (This device has not been subject to recall.)
Reference Device: Titan Spine, LLC: Endoskeleton® TC (K100889, Cleared 7/29/10)
Device Description:
The CAVUX™ Cervical Cage is a cervical intervertebral body fusion device. The system is comprised of a variety of implant sizes to accommodate various patient anatomies and pathology. All implantable components are manufactured from medical grade titanium alloy (6AI4V —ELI Ti). The center of the implant is hollow and is to be filled with autogenous bone material. The design incorporates "windows" through the implant to permit visualization of the graft material and, over time, formation of new bone.
4
Indications for Use:
CAVUX™ Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
Technological Characteristics:
The CAVUX™ Cervical Cage consists of the following:
- CAVUX™ Cervical Cage Implant .
- . Delivery Instrument packaged with the Implant
The CAVUX™ Cervical Cage implants are manufactured from Titanium-6AL-4V ELI alloy, which conforms to ASTM F136 and are available in a variety of sizes and lordotic angles to accommodate patient anatomy. Superior and inferior surfaces of the implant feature teeth that provide bony contact with the endplates while a box shape in the center of the implant with fenestrations (windows) is intended to house autogenous bone. The superior and inferior surfaces of the implant are grit blasted and acid etched to improve fixation to adjacent bone.
The CAVUX™ Cervical Cage is held within the delivery instrument which facilitates insertion of the implant into the interbody space. The delivery instrument features a physical stop to prevent over-insertion.
Devices are supplied sterile and single use only.
Performance Testing
The following testing was performed using the subject device and results were compared to those of the predicate device:
Static and Dynamic Axial Compression Testing
- ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .
Static and Dynamic Torsion Testing
- ASTM F2077-14 Standard Test methods for Intervertebral Body Fusion Devices .
Subsidence Testing
- . ASTM F2267-04 Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
5
Expulsion Testing
- ASTM Draft Standard F-04.25.02.02 Static Push-out Test Method for Intervertebral . Body Fusion Devices
Pyrogenicity Testing
- . Pyrogenicity Testing was conducted and in compliance with FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket Notification o (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"
- "Pyrogen and Endotoxins Testing: Questions and Answers" O
In all instances, the CAVUX™ Cervical Cage functioned as intended and met all pre-determined acceptance criteria. Bench testing results of the CAVUX™ Cervical Cage exceeded those of the predicate PMT Cervical Cage. Therefore, the performance characteristics of the CAVUX ™ Cervical Cage are substantially equivalent to those of the PMT Cervical Cage.
Conclusions
The CAVUX™ Cervical Cage has the same indication for use, technological characteristics, and principles of operation as the predicate device. The differences between the subject and predicate devices are that the subject device includes a surface treatment and is available in different sizes than the predicate device. These minor differences between the CAVUX™ Cervical Cage and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the CAVUX™ Cervical Cage is as safe and effective as the PMT Cervical Cage. Thus, the CAVUX™ Cervical Cage is substantially equivalent to the PMT Cervical Cage.