(124 days)
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on mechanical testing and design changes.
Yes.
The device is indicated for use as an "adjunct to fusion" in patients with degenerative disc disease, which implies it directly contributes to the treatment or management of a medical condition.
No
The device is an intervertebral body fusion system, which is a therapeutic device intended to promote bone fusion. It does not perform any diagnostic function.
No
The device description clearly states it is a "non-rigid, implanted spinal device" and describes its physical structure and function as a graft containment device, indicating it is a hardware medical device.
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 Function: The OptiMesh Multiplanar Expandable Interbody Fusion System is a physical implant designed to be placed within the spine to aid in fusion. It is a surgical device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease and spondylolisthesis, not a diagnostic process.
- Device Description: The description details the physical characteristics and function of the implant within the body.
Therefore, the OptiMesh Multiplanar Expandable Interbody Fusion System falls under the category of a medical device (specifically, an implantable surgical device), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
Product codes
OQB
Device Description
The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
The OptiMesh Lordotic device incorporates an asymmetrical dual chamber mesh with a larger chamber in the anterior portion of the disc space than in the posterior. Due to the asymmetry of the two mesh chambers when filled, the implant is designed to result in a lordotic shape.
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)
Non-clinical testing was conducted to support the subject lordotic implants confirming function and performance and to demonstrate substantial equivalence.
- A review of the design changes was performed and confirmed that these modifications do . not alter the intended use or present new technological characteristics.
- The design changes do not alter the primary control mechanism or operating principle.
- Benchtop performance ASTM testing and comparison confirmed that the subject lordotic implants perform as intended in comparison to the predicate device and ISO 23089-2 mechanical performance data.
- A risk assessment was performed and confirmed that the modifications introduced do not . alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.
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
§ 888.3085 Intervertebral body graft containment device.
(a)
Identification. An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must include an assessment of any adverse events observed during clinical use, as well as intervertebral body fusion, and compare this to a clinically acceptable fusion rate.
(2) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant, as well as the ability of the device to be inserted, deployed, and filled with bone graft consistently.
(3) Device must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components, and device-specific instruments.
(5) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(6) Labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device including identification of device materials, compatible components in the fusion construct, and the principles of device operation;
(ii) Intended use and indications for use, including levels of fixation;
(iii) Identification of magnetic resonance (MR) compatibility status;
(iv) Cleaning and sterilization instructions for devices and instruments that are provided nonsterile to the end user; and
(v) Detailed instructions of each surgical step, including device removal.
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October 18, 2023
Spineology Inc. Andrew Adams Group Director of Regulatory & Quality Affairs 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128
Re: K231781
Trade/Device Name: OptiMesh Multiplanar Expandable Interbody Fusion System Regulation Number: 21 CFR 888.3085 Regulation Name: Intervertebral Body Graft Containment Device Regulatory Class: Class II Product Code: OQB Dated: September 22, 2023 Received: September 25, 2023
Dear Andrew Adams:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Brent Showalter -S
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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510(k) Number (if known)
Device Name
OptiMesh Multiplanar Expandable Interbody Fusion System
Indications for Use (Describe)
The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radios. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
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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510(k) Summary
| Date Prepared: | October 13, 2023 |
|---|---|
| Submitter: | Spineology Inc. |
| 7800 3rd Street North | |
| Suite 600 | |
| Saint Paul, MN 55128 | |
| Establishment Registration Number: 2135156 | |
| Contact Person: | Andrew Adams |
| Group Director of Regulatory & Quality Affairs | |
| Phone: 651.256.8500 | |
| Fax: 651.256.8505 | |
| Email: aadams@spineology.com |
Device Name and Classification
| Trade Name: | OptiMesh Multiplanar Expandable Interbody Fusion System |
|---|---|
| Classification Name: | Intervertebral Body Graft Containment Device |
| Product Codes: | OQB |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3085 |
| Panel: | Orthopedic |
Predicate Device
| Primary: | DEN200010 | Spineology Interbody Fusion System |
|---|---|---|
| Reference: | K192047 | Rampart™ One Lumbar Interbody Fusion System |
1. Purpose
The purpose of this premarket notification is to obtain FDA clearance for a line extension of Implants to the OptiMesh Multiplanar Expandable Interbody Fusion System. The subject Implants add lordotic configurations to the Implant portfolio. This submission also includes Class II surgical instruments unique to the implantation of the device.
2. Device Description
The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that is a non-rigid, implanted spinal device designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
The OptiMesh Lordotic device incorporates an asymmetrical dual chamber mesh with a larger chamber in the anterior portion of the disc space than in the posterior. Due to the asymmetry of the two mesh chambers when filled, the implant is designed to result in a lordotic shape.
4
3. Indications for Use
The OptiMesh Multiplanar Expandable Interbody Fusion System is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. The OptiMesh device with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
4. Technological Characteristics
When compared to the predicate device, the subject lordotic implants have the same intended use and the same, or equivalent, technological characteristics, including:
- Indications for Use
- Primary Design Features ●
- Materials of Construction ●
- Function / Performance ●
- Fundamental Scientific ● Technology
- Device Design ●
- Principle of Operation ●
- Risk Profile ●
- Use with Compatible Fill Material ●
- . Use with Posterior Fixation Systems
5. Non-Clinical Testing
Non-clinical testing was conducted to support the subject lordotic implants confirming function and performance and to demonstrate substantial equivalence.
- A review of the design changes was performed and confirmed that these modifications do . not alter the intended use or present new technological characteristics.
- The design changes do not alter the primary control mechanism or operating principle.
- Benchtop performance ASTM testing and comparison confirmed that the subject lordotic implants perform as intended in comparison to the predicate device and ISO 23089-2 mechanical performance data.
- A risk assessment was performed and confirmed that the modifications introduced do not . alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.
6. Conclusion
Based on the intended use, technological characteristics, and comparison to the predicate device, the subject lordotic implants have been shown to be substantially equivalent to the legally marketed predicate device.