(91 days)
Not Found
No
The summary describes a mechanical interbody fusion device and its associated hardware, with no mention of software, algorithms, or any capabilities beyond structural support and fixation.
Yes
The device is an interbody fusion system used in the lumbosacral spine to treat conditions like degenerative disc disease and spinal deformity, with the goal of providing clinical benefit to patients.
No
Explanation: The device is an interbody fusion system designed for surgical implantation, not for diagnosing medical conditions. Its purpose is to provide stability and support in the lumbosacral spine, not to identify diseases or pathologies.
No
The device description clearly describes physical implants (interbody cages, screws, retention plates) made of titanium alloy, which are hardware components. The performance studies also focus on mechanical testing of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed 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 OneLIF™ Interbody Fusion System is a physical implant designed to be surgically placed in the spine to facilitate fusion. It is a medical device used in vivo (within the body), not a test performed in vitro (in a lab).
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing.
Therefore, the OneLIF™ Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
Product codes (comma separated list FDA assigned to the subject device)
OVD, MAX
Device Description
The OneLIFTM Interbody implant system includes interbody cages that provide six holes designed to accept bone screws of various styles and sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-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)
The OneLIF™ Intervertebral Body Replacement System has been tested in the following test modes:
- ASTM F2077 Static Axial Compression
- ASTM F2077 Static Compressive Shear
- ASTM F2077 Dynamic Axial Compression
- ASTM F2077 Dynamic Compressive Shear
- ASTM F2267 - Subsidence
The results of this non-clinical testing show that the strength of the OneLIF™ Intervertebral Body Replacement 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 7, 2021
NovApproach Spine % Meredith May Director of Consulting Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K211769
Trade/Device Name: OneLIFTM Intervertebral Body Replacement System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD, MAX Dated: June 7, 2021 Received: June 8, 2021
Dear Meredith May:
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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
| 510(k) Number ( if known ) | |
|---|---|
| K211769 |
Device Name
OneLIFTM Intervertebral Body Replacement System
Indications for Use (Describe)
The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when Prescription Use (Part 21 CFR 801 Subpart D) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. |
|---|
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov " An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. '
3
5.510(K) SUMMARY
| Submitter's Name: | NovApproach Spine, LLC |
|---|---|
| Submitter's Address: | 13900 Tech City Circle, Suite 300 |
| Alachua, FL 32615 | |
| Submitter's Telephone: | 352-318-2584 |
| Contact Person: | Meredith May MS, RAC |
| Empirical Testing Corp. | |
| 719-337-7579 | |
| MMay@EmpiricalTech.com | |
| Date Summary was Prepared: | 07-Jun-2021 |
| Trade or Proprietary Name: | OneLIFTM Intervertebral Body Replacement System |
| Common or Usual Name: | Intervertebral Fusion Device with Integrated Fixation, |
| Lumbar | |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVD, MAX |
| Classification Panel: | Orthopedic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The OneLIFTM Interbody implant system includes interbody cages that provide six holes designed to accept bone screws of various styles and sizes.
INDICATIONS FOR USE
The OneLIF™ Interbody Fusion System is an interbody fusion device system indicated for use in skeletally mature patients at one or more levels of the lumbosacral spine (L2-S1), in patients with the following indications: degenerative disc disease (DDD) defined as back pain with degeneration of the disc confirmed by patient history and radiographic studies, spinal deformity (degenerative scoliosis or kyphosis), spondylolisthesis or retrolisthesis, and failed previous fusion (pseudoarthrosis). Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.
The OneLIF™ Interbody Fusion System is intended to be used with or without the screws which accompany the implants. These devices are intended for stand-alone use in patients with DDD or degenerative spondylolisthesis at one or two contiguous levels only when used with at least three screws per implant (including at least one screw in each endplate) and when ≤ 20° lordotic implants are used. When used at more than 2 contiguous levels, or for treatment of conditions other than DDD or degenerative spondylolisthesis, or with fewer than 3 accompanying screws, or when using implants greater than a 20° lordotic angle, the system must be supplemented by posterior fixation (e.g., pedicle screw system) cleared for use in the lumbar spine.
4
The implants can be placed via a variety of open or minimally invasive approaches. These include anterior and oblique approaches. The implant is designed for use with autograft bone and/or allogenic bone graft comprised of cancellous or corticocancellous bone graft.
TECHNOLOGICAL CHARACTERISTICS
The titanium allov (per ASTM F1472) OneLIF™ Interbody implant system includes an interbody that provides six holes designed to accept bone screws of various styles and sizes. The titanium alloy (per ASTM F1472) Retention Plate fastens to the Interbody with a Retention Plate Screw.
The subject 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:
- . Indications for Use
- Materials of manufacture ●
- Structural support mechanism ●
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------------------------|--------------------------------|-------------------|
| K150135 | DIVERGENCE™
Anterior/Oblique Lumbar
Fusion System | Medtronic Sofamor
Danek USA | Primary |
| K170592 | BASE Interfixated Titanium
System | NuVasive | Additional |
| K180814 | M3™ Stand-Alone Anterior
Lumbar System | CoreLink | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The OneLIF™ Intervertebral Body Replacement System has been tested in the following test modes:
- ASTM F2077 Static Axial Compression ●
- ASTM F2077 Static Compressive Shear .
- ASTM F2077 Dynamic Axial Compression ●
- ASTM F2077 Dynamic Compressive Shear ●
- . ASTM F2267 - Subsidence
The results of this non-clinical testing show that the strength of the OneLIF™ Intervertebral Body Replacement System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
5
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the OneLIF™ Intervertebral Body Replacement System is substantially equivalent to the predicate device.