(212 days)
No
The summary describes a physical medical device (an expandable interbody fusion system and a bone void filler) and its intended use, materials, and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or any data sets used for training or testing such technologies.
Yes
The device is used to treat degenerative disc disease and osseous defects, which are medical conditions, and it is intended as an adjunct to fusion for intervertebral body fusion.
No
The device is an intervertebral body graft containment device and a bone void filler intended for fusion in the spine and treatment of osseous defects. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is an "implanted spinal device" and includes a "disposable delivery tube," indicating it is a physical hardware device, not software only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the OptiMesh system and AFT is for surgical implantation to facilitate bone fusion in the spine and other anatomical sites. This is a therapeutic and structural purpose, not a diagnostic one.
- Device Description: The devices are described as an intervertebral body graft containment device and a bone void filler. These are physical implants and materials used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) or to provide information about a patient's health status or disease.
- Input Imaging Modality: While "radios" are mentioned, this is the imaging used to assess the patient's condition and the outcome of the surgery, not the input for the device itself to perform a diagnostic test.
- Performance Studies: The performance studies focus on mechanical testing, biocompatibility, and clinical outcomes related to fusion and safety, not on diagnostic accuracy metrics like sensitivity or specificity.
In vitro diagnostics are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The OptiMesh system and AFT do not fit this description. They are surgical implants and materials used in a therapeutic procedure.
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, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graff containment device cleared by FDA for use with a bone void filler.
AFT is intended for single patient use only.
Product codes (comma separated list FDA assigned to the subject device)
OQB, MBP
Device Description
The OptiMesh Multiplanar Expandable Interbody Fusion System is an intervertebral body graft containment device that 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.
AFT Allograft Filler Tube is composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
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, extremities, spine, intervertebral disc space, and pelvis
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 AFT as a compatible allograft for use with the OptiMesh device confirming function and performance.
- Benchtop mechanical ASTM testing and comparison confirmed that the OptiMesh device with AFT performs as intended in comparison to the reference device and ISO 23089-2 mechanical performance data.
- A critical comparison between AFT bone void filler and the reference bone graft and its impact on bone biology was conducted and assessed.
- Biocompatibility, pyrogenicity / endotoxin monitoring, sterilization, packaging, and shelf-life were compared and assessed.
- A risk assessment was performed and confirmed that the OptiMesh device with AFT does not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.
Clinical data has been utilized to demonstrate the performance and safety of the addition of AFT as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System. The clinical data includes evaluation through a critical engineering and clinical comparison to a bone graft that was used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation. This evaluation supports the performance of the subject device for its intended use.
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.
K203714 Thoracolumbar Interbody Systems and Attrax Putty
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.
DEN200010 Spineology Interbody Fusion System, K060161 AFT Allograft Filler Tube
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
§ 888.3085 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.
0
November 1, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
Spineology Inc. Andrew Adams Group Director of Regulatory & Ouality Affairs 7800 3rd Street North Suite 600 Saint Paul, Minnesota 55128
Re: K230927
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, MBP Dated: March 31, 2023 Received: April 3, 2023
Dear Mr. 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"
1
K230927 - Andrew Adams
(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).
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 (OS) 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, Jesse Muir -S Date: 2023.11.01 14:56:03 Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)
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, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, 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 GER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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3
Indications for Use
510(k) Number (if known)
Device Name
AFT Allograft Filler Tube
Indications for Use (Describe)
AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graff containment device cleared by FDA for use with a bone void filler.
AFT is intended for single patient use only.
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) |
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."
4
510(k) Summary
| Spineology | 510(k) Summary |
|---|---|
| Date Prepared: | October 25, 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 |
| Trade Name: | AFT Allograft Filler Tube |
| Classification Name: | Resorbable Calcium Salt Bone Void Filler Device |
| Product Codes: | MBP |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 888.3045 |
| Panel: | Orthopedic |
| Predicate Device | |
| Primary: | K203714 Thoracolumbar Interbody Systems and |
| Attrax Putty | |
| Reference: | DEN200010 Spineology Interbody Fusion System |
| Reference: | K060161 AFT Allograft Filler Tube |
5
1. Purpose
The purpose of this premarket notification is to obtain FDA clearance for the addition of AFT Allograft Filler Tube as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System (formerly branded as Spineology Interbody Fusion System).
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 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.
AFT Allograft Filler Tube is composed of human demineralized bone matrix, human nondemineralized bone, and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
Indications for Use 3.
OptiMesh Multiplanar Expandable Interbody Fusion System
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, or a bone void filler as cleared by FDA for use in intervertebral body fusion to facilitate fusion, is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
AFT Allograft Filler Tube
AFT is intended for use as a bone void filler in the extremities, spine, intervertebral disc space, and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury. When used in intervertebral body fusion procedures, AFT must be used on its own with an intervertebral body graft containment device cleared by FDA for use with a bone void filler.
AFT is intended for single patient use only.
4. Technological Characteristics
When compared to the predicate device, the OptiMesh Multiplanar Expandable Interbody Fusion System with AFT has the same intended use and the same or similar technological characteristics, including:
- Indications for Use ●
- Function / Performance ●
- Control Mechanism ●
- . Energy Type
- Principle of Operation ●
- . Use with Compatible Fill Material
- Use with Supplemental Fixation Systems .
6
Different technological characteristics exist, including:
- Materials of Construction ●
- Structure of Construction
- Mechanism of Mechanical Support ●
The subject OptiMesh interbody device and AFT bone void filler device are identical in technological characteristics to the reference devices. The reference devices support the comparison of the subject device to the primary predicate device, particularly that the differences in technological characteristics do not raise different questions of safety and effectiveness.
ട. Non-Clinical Testing
Non-clinical testing was conducted to support AFT as a compatible allograft for use with the OptiMesh device confirming function and performance.
- . Benchtop mechanical ASTM testing and comparison confirmed that the OptiMesh device with AFT performs as intended in comparison to the reference device and ISO 23089-2 mechanical performance data.
- A critical comparison between AFT bone void filler and the reference bone graft and its ● impact on bone biology was conducted and assessed.
- Biocompatibility, pyrogenicity / endotoxin monitoring, sterilization, packaging, and shelf-● life were compared and assessed.
- . A risk assessment was performed and confirmed that the OptiMesh device with AFT does not alter the risk profile for the device or present new issues of safety or effectiveness when compared to the predicate device.
6. Clinical Performance Data
Clinical data has been utilized to demonstrate the performance and safety of the addition of AFT as a compatible allograft for use with the OptiMesh Multiplanar Interbody Fusion System. The clinical data includes evaluation through a critical engineering and clinical comparison to a bone graft that was used in a prospective, multi-center, non-randomized, FDA and IRB approved performance goal clinical investigation. This evaluation supports the performance of the subject device for its intended use.
7. Conclusion
Based on the intended use, technological characteristics, comparison to the predicate device, and support from the reference devices, the subject addition of AFT Allograft Filler Tube as a compatible allograft for use with the OptiMesh Multiplanar Expandable Interbody Fusion System has been shown to be substantially equivalent to the legally marketed predicate device.