(93 days)
Not Found
No
The document describes a spinal implant made of titanium alloy with specific structural features for fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical and material testing, not algorithmic performance.
Yes
The device is clearly indicated for spinal fusion procedures in patients with degenerative disc disease or degenerative spondylolisthesis, which are medical conditions that require treatment. It is designed to facilitate fusion and provide support, directly contributing to the patient's physical well-being and recovery.
No
The device is an interbody fusion system designed to be implanted in the lumbar spine to facilitate spinal fusion. Its purpose is mechanical support and to aid bone growth, not to diagnose a condition.
No
The device description explicitly states that the device is an interbody implant manufactured from titanium alloy, which is a physical hardware component.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The NuVasive 3DP Interfixated ALIF System is an implantable device designed for spinal fusion procedures. It is a physical structure made of titanium alloy that is surgically placed in the lumbar spine.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to provide diagnostic information. Its function is structural support and to facilitate bone fusion.
Therefore, the NuVasive 3DP Interfixated ALIF System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nu Vasive® 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10° 20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
Product codes
OVD
Device Description
The subject NuVasive 3DP Interfixated System are interbody implants manufactured from titanium alloy (Ti-6A1-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25° - 30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine from L2 to S1
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)
Nonclinical testing was performed to demonstrate that the subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression (per ASTM F2077)
- Dynamic Compression (per ASTM F2077)
- Static Compression Shear (per ASTM F2077)
- Dynamic Compression Shear (per ASTM F2077)
- Static Torsion (per ASTM F2077)
- Dynamic Torsion (per ASTM F2077)
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Subsidence and screw push-out analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
The results demonstrate that the subject NuVasive 3DP Interfixated ALIF System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K170592, K163230, K192760, K172341, K152943, K161230
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 25, 2020
NuVasive, Incorporated Jessica LeBlanc Sr. Specialist, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121
Re: K193593
Trade/Device Name: NuVasive® 3DP Interfixated ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: February 27, 2020 Received: February 28, 2020
Dear Jessica LeBlanc:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193593
Device Name NuVasive® 3DP Interfixated ALIF System
Indications for Use (Describe)
The Nu Vasive® 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10° 20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The Nu Vasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectorny in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
| 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) |
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3
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: A.
Jessica LeBlanc Sr. Specialist, Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego. California 92121 Telephone: (858) 909-3302
Date Prepared: March 24, 2020
510(k) Number: K193593
B. Device Name
| Trade or Proprietary Name: | NuVasive® 3DP Interfixated ALIF System |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral Body Fusion Device |
| Device Class: | Class II |
|---|---|
| Classification: | 21 CFR § 888.3080 |
| Product Code: | OVD |
C. Predicate Devices
The subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to the primary predicate device NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230).
D. Device Description
The subject NuVasive 3DP Interfixated System are interbody implants manufactured from titanium alloy (Ti-6A1-4V ELI) powder conforming to ASTM F3001. The solid and porous structures are simultaneously built using a powder bed fusion method. The hollow core, or graft aperture, allows for packing of graft to aid in the promotion of a solid fusion. Similarly, the macroporous internal lattice structure provides additional space for graft packing. The microporous, textured surface on the superior and inferior ends of the device serves to grip the adjacent vertebrae to resist migration of the device. The implants are available in a variety sizes and lordotic angles to suit the individual pathology and anatomical conditions of the patient. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25° - 30° lordotic cages must be used
4
with supplemental internal spinal fixation systems (e.g. posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine.
E. Indications for Use
The NuVasive 3DP Interfixated ALIF System is indicated for spinal fusion procedures in skeletally mature patients. The 3DP Interfixated ALIF System 10°-20° lordotic cages may be used as a standalone system. The 3DP Interfixated ALIF System 25°-30° lordotic cages must be used with supplemental internal spinal fixation systems (e.g., posterior pedicle screw and rod system) that are cleared by the FDA for use in the lumbar spine. The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. The devices are to be used in patients who have had at least six months of non-operative treatment.
The NuVasive 3DP Interfixated ALIF System is intended for use in interbody fusions in the lumbar spine from L2 to S1, following discectomy in the treatment of symptomatic degenerative disc disease (DDD) or degenerative spondylolisthesis at one or two adjacent levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The 3DP Interfixated ALIF System implants can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis; however, when used in these patients at multiple levels and for patients with degenerative spondylolisthesis, the 3DP Interfixated ALIF System must be used with a supplemental internal spinal fixation system (e.g., pedicle screw system) cleared by the FDA for use in the lumbar spine in addition to the integrated screws.
F. Technological Characteristics
As was established in this submission, the subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and function. This device does not contain software or electrical equipment.
Performance Data G.
Nonclinical testing was performed to demonstrate that the subject NuVasive 3DP Interfixated ALIF System is substantially equivalent to other predicate devices. The following testing was performed:
- Static Compression (per ASTM F2077) ●
- Dynamic Compression (per ASTM F2077) ●
- Static Compression Shear (per ASTM F2077) ●
- Dynamic Compression Shear (per ASTM F2077)
- Static Torsion (per ASTM F2077) ●
- Dynamic Torsion (per ASTM F2077)
- Gravimetric and Particulate analysis (ASTM F1714 and F1877)
- Subsidence and screw push-out analysis
- Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2011/(R)2016
5
The results demonstrate that the subject NuVasive 3DP Interfixated ALIF System meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicates.
Conclusions H.
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject NuVasive 3DP Interfixated ALIF System has been shown to be substantially equivalent to legally marketed predicate devices.