(284 days)
Not Found
No
The document describes a physical implant system (plates, screws, and cages) 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 described as being "intended for interbody fusion in skeletally mature patients" and used "in patients with degenerative disc disease (DDD)." Its purpose is to support and correct the lumbar spine during fusion surgeries, which clearly indicates a therapeutic intent.
No
Because the device is an implantable system (plates, bone screws, and interbody cages) used for spinal fusion and stabilization, not for diagnosing conditions.
No
The device description clearly states that the system consists of physical components: plates, bone screws, and interbody cages, which are made from materials like PEEK and titanium alloy. These are hardware components, not software.
Based on the provided text, the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DIVERGENCE-LTM system is a collection of implants (interbody cages, plates, and bone screws) designed to be surgically implanted into the lumbar spine to facilitate fusion and provide stabilization. It is used directly on the patient's body, not for testing specimens outside the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System is a surgical implant device, not an IVD.
N/A
Intended Use / Indications for Use
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Interbody device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vasular structures or anterior oblique above the bifurcation (1-L5) of the vascular structures. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
Product codes
MAX, KWQ
Device Description
The DIVERGENCE-LIM Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages.
The DIVERGENCE-L™ Anterior/Oblique Lumbar interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cages are manufactured from medical grade Polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The DIVERGENCE-L™ Anterior/Oblique Lumbar plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-L™ Anterior/Oblique Lumbar plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 -Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation. The subject instruments are reusable and provided non-sterile. The subject instruments must be cleaned and sterilized by the hospital.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, lumbosacral level (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)
Published retrospective clinical data for the lumbar interbody fusion devices similar to the DIVERGENCE-L™ device is being provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft in interbody fusion procedures to treat the patient population referenced in the indications statement, poses no new risks to the patients. Additionally, the usage of similar devices to provide anterior column support when used as an adjunct to pedicle screw fixation in the treatment of deformity conditions was also found to pose no new risks to the patients. No changes were made to the existing devices, nor were any new components added to the systems. Therefore, no additional testing was required or performed.
The bacterial endotoxin test, also known as Limulus Amebocyte Lysate (LAL) test, was performed utilizing worst case subject DIVERGENCE-L™ interbody implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Transfusion and Infusion Assemblies and Similar Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
Medtronic Sofamor Danek USA, Inc. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis. Tennessee 38132
Re: K162212
Trade/Device Name: DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, KWQ Dated: April 13, 2017 Received: April 20, 2017
Dear Mr. Grant:
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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/7 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is black and appears to be against a white or light background. The name is written in a clear and legible manner.
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162212
Device Name
DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System
Indications for Use (Describe)
The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Interbody device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches include anterior and oblique.
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vasular structures or anterior oblique above the bifurcation (1-L5) of the vascular structures. The indications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
| 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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DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System 510(k) SUMMARY – K162212 May 2017
| I. | Submitter | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901)396-3133 |
|-----|---------------------|--------------------------------------------------------------------------------------------------|
| | Contact | Lee Grant
Distinguished Regulatory Affairs Advisor |
| | Date Prepared | May 16, 2017 |
| II. | Device | |
| | Name of Device | DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System |
| | Classification Name | Intervertebral Body Lumbar Fusion Device with Bone Graft
(CFR 888.3080) |
| | | Intervertebral Body Lumbar Fusion Device
(CFR 888.3080) |
| | | Spinal Intervertebral Body Fixation Orthosis
(CFR 888.3060) |
| | Classification | Class II |
| | Product Codes | MAX (Interbody Cages) |
| | | KWQ (Plates and Screws) |
| | Predicates | Primary Predicate
CLYDESDALE® Spinal System
K133577 (S.E. 09/26/2014 – Primary Predicate) |
| | | DIVERGENCE-LTM Anterior/Oblique Fusion System
K150135 (S.E. 06/11/2015 – Secondary Predicate) |
| | | CAPSTONE®/CLYDESDALE® Spinal System
K151128 (S.E. 08/06/2015 – Secondary Predicate) |
| | | The predicates have not been subject to a design related recall. |
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III. Product Description
The DIVERGENCE-LIM Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages.
The DIVERGENCE-L™ Anterior/Oblique Lumbar interbody cages are available in various widths, heights, and lordosis inserted between two lumbar vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The cages are manufactured from medical grade Polyetheretherketone (PEEK) and titanium alloy with tantalum markers and are provided sterile.
The DIVERGENCE-L™ Anterior/Oblique Lumbar plates and bone screws are available in a broad range of size offerings intended for anterior screw fixation and stabilization during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws inserted into the vertebral body of the lumbar spine using an anterior or oblique approach. The DIVERGENCE-L™ Anterior/Oblique Lumbar plate and bone screws are made from titanium alloy and are provided sterile.
The subject devices are manufactured from ASTM F2026 - Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications, ASTM F136 -Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications, and ASTM F560 - Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The subject interbody cages, plates, and bone screws are implants that are single use only. The subject implants are provided sterile by gamma irradiation. The subject instruments are reusable and provided non-sterile. The subject instruments must be cleaned and sterilized by the hospital.
IV. Indications for Use:
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The DIVERGENCE-LTM Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Interbody device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non-operative treatment. The DIVERGENCE-L™ Interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.
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The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) Degenerative Disc Disease (DDD) defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (including fractures); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions.
Summary of Technological Characteristics V.
The subject devices found within this submission have the same fundamental scientific technology as their predicate counterparts. They are intended to provide correction and stabilization during intervertebral body fusion procedures for the aforementioned indications. They are all manufactured from the same materials as their respective predicates and there have been no changes to the implants' designs. With the exception of the expanded indication to include deformity conditions and the inclusion of the allogenic bone graft material option, there have been no changes to subject DIVERENGENCE-L™ Anterior/ Oblique Fusion Lumbar System's offerings and they are therefore substantially equivalent to their predicates
VI. Discussion of Supporting Retrospective Clinical Data and Non-Clinical Testing:
Published retrospective clinical data for the lumbar interbody fusion devices similar to the DIVERGENCE-L™ device is being provided in support of this application. The published clinical outcomes demonstrated that the use of allogenic bone graft in interbody fusion procedures to treat the patient population referenced in the indications statement, poses no new risks to the patients. Additionally, the usage of similar devices to provide anterior column support when used as an adjunct to pedicle screw fixation in the treatment of deformity conditions was also found to pose no new risks to the patients. No changes were made to the existing devices, nor were any new components added to the systems. Therefore, no additional testing was required or performed.
VII. Non-Pyrogenicity Endotoxin Testing:
The bacterial endotoxin test, also known as Limulus Amebocyte Lysate (LAL) test, was performed utilizing worst case subject DIVERGENCE-L™ interbody implants to verify that the subject implants meet the 20 endotoxin units (EU)/device pyrogen limit specification. Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit for general medical devices that are implanted as outlined in ANSI/AAMI ST72, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing and USP , Transfusion and Infusion Assemblies and Similar Medical Devices.
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VIII. Conclusions
The subject DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System is substantially equivalent to the primary predicate devices cleared in K133577 for the CLYDESDALE® Spinal System and to the additional predicate, K150135 application, for the original DIVERGENCE-L™ device as well as to both CAPSTONE®/CLYDESDALE® Spinal System application K151128. The published clinical outcomes demonstrate these devices may be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Additionally, the subject interbody devices may also be used to provide anterior column support in patients diagnosed with deformity conditions as an adjunct to pedicle screw fixation. Based on the outcomes presented in the literature review and comparisons to the three predicate applications presented in this pre-market notification, Medtronic believes the subject devices demonstrated substantial equivalence to the legally marketed predicate devices.