(66 days)
No
The document describes a physical implantable device (cervical cage) and its mechanical properties. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The submission is solely for a name change of a previously cleared device.
Yes
The device is used to treat degenerative disc disease and aid in spinal fusion, which are therapeutic medical interventions.
No
The device is an intervertebral fusion device intended to be implanted in the cervical spine to treat degenerative disc disease. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is an intervertebral fusion device made from medical grade PEEK and tantalum markers, which are physical materials, not software. The submission is for a name change of an existing physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is a physical implant made of PEEK and tantalum markers.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a therapeutic implant.
N/A
Intended Use / Indications for Use
The Cavetto® MAXI Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® MAXI Cervical Cage System is intended to be used with supplemental fixation.
Product codes
ODP
Device Description
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® MAXI Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
This 510(k) is submitted only for the purposes of changing the name of the Cavetto® Cervical Cage System (K172320) to the Cavetto® MAX) Cervical Cage System. The two devices are otherwise identical, and no changes whatsoever have been made to the Cavetto® Cervical Cage System (K172320).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at one disc level from C2-T1
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 devices in the Cavetto® [MAX] Cervical Cage System did not introduce a new worst-case construct compared to the predicate in terms of mechanical performance. Thus, testing previously conducted on the predicate was leveraged for this submission. This testing included:
- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Static expulsion
The results of this non-clinical testing show that the strength of the Cavetto® [MAX] 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)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
September 3, 2020
NeuroStructures, Inc. % Nathan Wright, M.S. Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201769
Trade/Device Name: Cavetto® [MAX] Cervical Cage System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: June 26, 2020 Received: June 29, 2020
Dear Mr. Wright:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201769
Device Name Cavetto® [MAX] Cervical Cage System
Indications for Use (Describe)
The Cavetto® MAXI Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Cavetto® [MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® MAXI Cervical Cage System is intended to be used with supplemental fixation.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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 | 199 Technology Drive, Suite 110 |
| Irvine, CA 92618 | |
| Contact Person | Nathan Wright MS |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was | |
| Prepared | September 1, 2020 |
| Trade or Proprietary Name | Cavetto® [MAX] Cervical Cage System |
| Common or Usual Name | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification | Class II per 21 CFR §888.3080 |
| Product Code | ODP |
| Classification Panel | Division of Orthopedic Devices |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Cavetto® [MAX] Cervical Cage System is an intervertebral fusion device made from medical grade PEEK per ASTM F2026 with tantalum markers per ASTM F560. The subject device is offered in a variety of footprints, styles, and sizes to accommodate various patient anatomies. The Cavetto® MAXI Cervical Cage System is offered in parallel and lordotic styles in heights of 4-10mm, widths of 13-19mm, and lengths of 11-16mm.
This 510(k) is submitted only for the purposes of changing the name of the Cavetto® Cervical Cage System (K172320) to the Cavetto® MAX) Cervical Cage System. The two devices are otherwise identical, and no changes whatsoever have been made to the Cavetto® Cervical Cage System (K172320).
INDICATIONS FOR USE
The Cavetto® [MAX] Cervical Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Cavetto® MAX] Cervical Cage System is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft and placed via an open, anterior approach. The Cavetto® MAXI Cervical Cage System is intended to be used with supplemental fixation.
The indications for use for the Cavetto® MAX] Cervical Cage System is identical to that of the primary predicate.
TECHNOLOGICAL CHARACTERISTICS
The Cavetto® MAX] Cervical Cage System and predicate device have identical technological characteristics.
4
Specifically, the following characteristics are identical between the subject and predicate:
- Indications for use
- Principles of operations
- Implant material PEEK
- Implant material tantalum
- Implant height
- Implant width
- . Implant length
- Implant lordosis .
- Surgical approach .
- Structural support mechanism
- Implant bone graft volume ●
Table 5-1: Predicate Devices
| 510k Number | Trade or Proprietary
or Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|-----------------|-------------------|
| K172320 | Cavetto® Cervical Cage System | NeuroStructures | Primary |
| K142041 | PorOsteon Phusion Metal Cervical Cage | PorOsteon | Additional |
PERFORMANCE DATA
The devices in the Cavetto® [MAX] Cervical Cage System did not introduce a new worst-case construct compared to the predicate in terms of mechanical performance. Thus, testing previously conducted on the predicate was leveraged for this submission. This testing included:
- Static axial compression per ASTM F2077
- Static torsion per ASTM F2077
- Dynamic axial compression per ASTM F2077 ●
- Dynamic torsion per ASTM F2077
- Static subsidence per ASTM F2267
- Static expulsion
The results of this non-clinical testing show that the strength of the Cavetto® [MAX] 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® MAXI Cervical Cage System is substantially equivalent to the predicate device.