(247 days)
No
The document describes a physical implant (cervical cage) and its intended use, material, and sizes. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The performance studies mentioned are related to material comparison, not algorithmic performance.
Yes
The device is intended for spinal fusion procedures to alleviate pain of discogenic origin, which is a therapeutic purpose.
No
The device is intended for spinal fusion procedures, not for identifying a disease or condition.
No
The device description explicitly states it is an intervertebral fusion device made from medical grade titanium, indicating it is a physical implant, not software.
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 surgical implant (a cervical cage) intended for spinal fusion procedures. It is physically implanted into the body to treat a structural issue in the spine.
- Lack of Diagnostic Activity: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
The Cavetto®-SA Cervical Cage System is a surgical implant used for treatment, not a 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 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 titanium per ASTM F136. 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)
A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K172064, K172320, K142041, K153097
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2020
NeuroStructures, Inc. % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K200115
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: August 26, 2020 Received: August 27, 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.
1
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) 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.
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) K200115
Device Name Cavetto(R)-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 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 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K200115 - 510(K) SUMMARY
| Submitter's Name: | NeuroStructures, Inc. |
|---|---|
| Submitter's Address: | 199 Technology Drive, Suite 110 |
| Irvine, CA 92618 | |
| Submitter's Telephone: | 800-352-6103 |
| Company Contact Person | Moti Altarac |
| Contact Person: | Nathan Wright |
| Empirical Testing Corp. | |
| nwright@empiricaltech.com | |
| 719-337-7579 | |
| Date Summary was Prepared: | January 15, 2020 |
| Trade or Proprietary Name: | Cavetto®-SA Cervical Cage System |
| Common or Usual Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 titanium per ASTM F136. 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 effectiveness. Specifically the following characteristics are identical between the subject and predicates:
4
- Principles of Operation ●
- Indications for Use .
- Implant Materials ●
- Implant Sizes ●
- Surgical Approach ●
| 510k
Number | Trade or Proprietary
or Model Name | Manufacturer | Predicate
Type |
|----------------|------------------------------------------|------------------------------|-------------------|
| K173077 | Cavetto-SA Cervical
Cage System | NeuroStructures | Primary |
| K172064 | Ti-Diagon Oblique
TLIF | Camber Spine
Technologies | Reference |
| K172320 | Cavetto® Cervical
Cage System | NeuroStructures,
Inc. | Reference |
| K142041 | PorOsteon Phusion
Metal Cervical Cage | PorOsteon, Inc. | Reference |
| K153097 | Belvedere™ Lateral
Plating System | Neurostructures | Reference |
Table 5-1: Predicate Devices
PERFORMANCE DATA
A comparison of the previously cleared device material and the subject device material was completed in lieu of mechanical testing.
CONCLUSION
The overall technology and material characteristics lead to the conclusion that the Cavetto®-SA Cervical Cage System is substantially equivalent to the predicate device.