(362 days)
No
The summary describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is intended for spinal fusion procedures in patients with degenerative disc disease, which addresses a medical condition and aims to restore function or provide therapy.
No
This device is an implantable intervertebral body fusion device used in spinal fusion procedures, not a diagnostic tool. Its purpose is to facilitate fusion and provide structural support, not to diagnose a condition.
No
The device description clearly states it is an "intervertebral body fusion device" made of titanium alloy, which is a physical implantable medical device, not software.
Based on the provided information, 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, or tissue) to provide information about a person's health.
- Device Function: The Integral Titanium Cervical Interbody is an implantable device used in spinal fusion surgery. It is a physical structure placed within the body to facilitate bone growth and stabilize the spine.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease, not a diagnostic test performed on a sample.
- Device Description: The description focuses on the physical characteristics and material of the implant, not on any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies listed are mechanical tests evaluating the structural integrity and stability of the implant, not studies evaluating the accuracy or reliability of a diagnostic test.
Therefore, the Integral Titanium Cervical Interbody falls under the category of a surgical implant or medical device used in a therapeutic procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
Product codes
ODP
Device Description
The Integral Titanium Cervical Interbody is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are additively manufactured using titanium alloy per ASTM F3001.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1 (cervical spine)
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)
- Static and dynamic compression (per ASTM F2077)
- Static and dynamic torsion (per ASTM F2077)
- . Subsidence (per ASTM F2267)
- Expulsion
The results of these tests, as well as engineering analysis of device characteristics, indicate that the Integral Titanium Cervical Interbody is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which stands for U.S. Food & Drug Administration. The FDA logo is in blue.
July 5, 2023
Nvision Biomedical Technologies, Inc Analaura Villarreal-Berain Extremity Project Engineer 4590 Lockhill Selma San Antonio, Texas 78249
Re: K222015
Trade/Device Name: Integral Titanium Cervical Interbody Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: Mav 31, 2023 Received: June 5, 2023
Dear Analaura Villarreal-Berain:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
Katherine D. Kavlock -S
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)
K22015
Device Name Integral Titanium Cervical Interbody
Indications for Use (Describe)
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skettally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
| 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
DATE PREPARED
June 21, 2023
MANUFACTURER AND 510(k) OWNER
Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249, USA Telephone: (210) 545-3713 Fax: (866) 764-1139 Official Contact: Diana Langham, Director of Regulatory and Corporate Compliance
REPRESENTATIVE/CONSULTANT
Analaura Villarreal-Berain, Extremity Project Engineer Nvision Biomedical Technologies Telephone: (210) 545-3713 ext. 109 Email: analauravillarreal@nvisionbiomed.com
PROPRIETARY NAME OF SUBJECT DEVICE
Integral Titanium Cervical Interbody
COMMON NAME
Cervical Intervertebral Body Fusion Device
DEVICE CLASSIFICATION
Intervertebral Body Fusion Device with Bone Graft, Cervical (21 CFR 888.3080, Product Code ODP, Class II)
INDICATIONS FOR USE
The Integral Titanium Cervical Interbody is intended for spinal fusion procedures at one level, from C2-T1, in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. One device is to be used per intervertebral space. Patients should receive six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The Integral Titanium Cervical Interbody devices must be used with supplemental fixation and are designed for use with autograft bone to facilitate fusion. The devices are to be implanted via an anterior approach.
DEVICE DESCRIPTION
The Integral Titanium Cervical Interbody is an intervertebral body fusion device used in the cervical spine following discectomy. All devices are additively manufactured using titanium alloy per ASTM F3001.
The devices have multiple footprints to adapt to the general shape of the vertebral endplates and have a hollow center to accommodate bone graft. The devices are implanted via an anterior (ACIF) surgical approach. Each footprint is available in multiple heights to accommodate patient
4
variability and there are anti-migration features on the superior and inferior surfaces designed to improve fixation, stability and prevent back out.
PREDICATE DEVICE IDENTIFICATION
The Integral Titanium Cervical Interbody is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---|---|---|
| K190380 | Nvision Biomedical Technologies nvc System | Primary |
| K171140 | Nexxt Spine Matrixx System | Additional |
| K203342 | Orthofix CONSTRUX Mini Ti Spacer System | Additional |
The following reference devices are also cited in this submission:
- Nvision Biomedical's Quantum Cervical Plate (K210424) ●
SUMMARY OF NON-CLINICAL TESTING
No FDA performance standards have been established for the Integral Titanium Cervical Interbody. The following tests were performed to demonstrate safety based on recognized consensus standards and current industry practice:
- Static and dynamic compression (per ASTM F2077)
- Static and dynamic torsion (per ASTM F2077) ●
- . Subsidence (per ASTM F2267)
- Expulsion
The results of these tests, as well as engineering analysis of device characteristics, indicate that the Integral Titanium Cervical Interbody is substantially equivalent to the predicate devices.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Nvision believes that the Integral Titanium Cervical Interbody is substantially equivalent to the predicate devices based on the information summarized here:
The subject device has a similar design, similar dimensions, and uses similar or identical materials as the devices cleared in K190380, K171140 and K203342. The subject device also has the same intended use, as well as similar technological characteristics (graft windows, insertion features) as these predicates. The Indications for Use are equivalent and any minor differences in wording choices are insignificant. These technological characteristics have undergone testing and engineering analysis to ensure the device is as safe and effective as the predicates.
CONCLUSION
Based on the testing performed, including static compression, dynamic compression, static torsion, dynamic torsion, subsidence, expulsion as well as engineering analysis of device characteristics, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Integral Titanium Cervical Interbody are assessed to be substantially equivalent to the predicate devices.