(147 days)
Not Found
No
The summary describes a physical implant (cervical cage) and its mechanical testing, with no mention of software, algorithms, image processing, or AI/ML terms.
No.
A therapeutic device is typically one that directly treats or cures a disease. This device is an implant for spinal fusion, which is a structural support and stabilization method, not a direct treatment for the underlying degenerative disc disease.
No
The device is an intervertebral fusion device (cervical cage system) intended for spinal fusion procedures, not for diagnosing medical conditions. Its purpose is to treat degenerative disc disease by fusing vertebrae, not to identify or characterize it.
No
The device description explicitly states that the Cavetto®-SA Cervical Cage System is made from physical materials (PEEK, titanium, and tantalum) and is an intervertebral fusion device, indicating it is a physical implant, not software. The performance studies also describe mechanical testing of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text clearly describes a physical implant (a cervical cage system) intended for surgical implantation in the spine to facilitate fusion. It is a device used within the body, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, performing chemical reactions, or providing diagnostic information based on laboratory tests.
Therefore, based on the provided information, the Cavetto®-SA Cervical Cage System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.
Product codes
OVE
Device Description
The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2 to T1)
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 Cavetto®-SA Cervical Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077
- Static compressive shear per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic compressive shear per ASTM F2077
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Expulsion per ASTM F-04.25.02.02
The results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K132894, K153250, K150053, K152515, K102606
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 23, 2018
NeuroStructures, Inc. % Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, California 80918
Re: K173077
Trade/Device Name: Cavetto®-SA Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 19, 2018 Received: January 22, 2018
Dear Mr. Maxwell:
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 of medical device-related adverse events) (21 CFR 803); good
1
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173077 Device Name Cavetto®-SA Cervical Cage System
Indications for Use (Describe)
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Submitter's Name: | Neurostructures, Inc. |
|---|---|
| Submitter's Address: | 16 Technology Drive, Suite 165 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | Kathleen Wong |
| kw@neurostructures.com | |
| 949.370.4497 | |
| Contact Person: | Kenneth C. Maxwell II |
| Empirical Testing Corp. | |
| 719.291.6874 | |
| kmaxwell@empiricalconsulting.com | |
| Date Summary was Prepared: | 20 February 2018 |
| Trade or Proprietary Name: | Cavetto®-SA Cervical Cage System |
| Common or Usual Name: | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Cavetto®-SA Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026, titanium per ASTM F560, and tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies.
INDICATIONS FOR USE
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.
TECHNOLOGICAL CHARACTERISTICS
The Cavetto®-SA Cervical Cage System and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and
4
effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Principle of operation ●
- Implant material PEEK ●
- Implant material titanium ●
- Screw implant diameter and length ●
- Structural support mechanism .
- . Cage implant sizes
Table 5-1: Predicate Devices
| 510k
Number | Trade or Proprietary
or Model Name | Manufacturer | Predicate
Type |
|----------------|---------------------------------------|----------------|-------------------|
| K132894 | Optio-CTM | Zimmer Spine | Primary |
| K153250 | Tesera | Renovis | Additional |
| K150053 | STALIF C® | Centinel Spine | Additional |
| K152515 | TOMCAT™ | Choice Spine | Additional |
| K102606 | AVS Anchor-C | Stryker Spine | Additional |
PERFORMANCE DATA
The Cavetto®-SA Cervical Cage System has been tested in the following test modes:
- Static axial compression per ASTM F2077 ●
- Static compressive shear per ASTM F2077 .
- Static torsion per ASTM F2077 ●
- Dynamic axial compression per ASTM F2077 .
- Dynamic compressive shear per ASTM F2077 .
- Dynamic torsion per ASTM F2077 ●
- Static subsidence per ASTM F2267 .
- Expulsion per ASTM F-04.25.02.02 ●
The results of this non-clinical testing show that the strength of the Cavetto®-SA Cervical Cage System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Cavetto@-SA Cervical Cage System is substantially equivalent to the predicate device.