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® MAXI 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.

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).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cavetto® [MAX] Cervical Cage System. This submission is for changing the name of an already cleared device (Cavetto® Cervical Cage System, K172320). No changes were made to the device itself. Therefore, the information regarding acceptance criteria and performance data primarily refers to mechanical testing performed on the predicate device, which is identical to the subject device.

Here's an breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in numerical terms for the mechanical tests. Instead, it states that the performance data for the predicate device, also known as the Cavetto® Cervical Cage System (K172320), was leveraged. The conclusion drawn is that the strength of the Cavetto® [MAX] Cervical Cage System (which is identical to the predicate) is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

Acceptance Criteria	Reported Device Performance (based on predicate device testing)
Sufficient strength for intended use and substantial equivalence to legally marketed predicate devices.	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 is sufficient for its intended use and substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the mechanical tests. It also does not provide information on the provenance of the data (e.g., country of origin, retrospective/prospective), as these are typical considerations for clinical studies, not mechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The study described is mechanical bench testing, not a clinical study involving human readers or expert consensus to establish ground truth for diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are relevant for clinical studies where multiple experts interpret data. This submission focuses on mechanical performance testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance.

This question is not applicable. The device described is a cervical cage system, an implantable medical device, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.

This question is not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing, the "ground truth" is defined by the physical properties and performance characteristics measured according to established ASTM standards. There is no expert consensus, pathology, or outcomes data used to establish ground truth for this type of evaluation.

8. The sample size for the training set

This question is not applicable. There is no training set as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This question is not applicable. There is no training set.

Summary

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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

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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 110Irvine, CA 92618
Contact Person	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary wasPrepared	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:

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.

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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 Proprietaryor Model Name	Manufacturer	PredicateType
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.

Regulation Number and Section

§ 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.