(222 days)
Not Found
No
The summary describes a physical implantable device (interbody fusion system) and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI/ML.
Yes
The device is described as an interbody fusion device used in anterior cervical fusion procedures to treat cervical disc disease, which involves addressing radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation, indicating a direct therapeutic action to alleviate symptoms and promote healing.
No
The device description clearly states it is an "interbody device indicated for use in anterior cervical interbody fusion procedures," which is a treatment, not a diagnostic, function.
No
The device description explicitly states it is comprised of a PEEK interbody cage and screws, which are physical hardware components.
Based on the provided text, 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: The DIVERGENCE™ Anterior Cervical Fusion System is a physical implantable device (interbody cage and screws) used in surgical procedures to fuse vertebrae in the cervical spine.
- Intended Use: The intended use is for anterior cervical interbody fusion procedures, which is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody fusion device with internal screw fixation. The DIVERGENCE™ Anterior Cervical Fusion System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. This system is indicated for single-level use only in the C2-T1 anterior spine. The system is comprised of a PEEK interbody cage and screws.
The DIVERGENCE™ anterior cervical cages are provided in 0 and 6 degrees of lordosis, 5-12mm heights, 15-20mm widths and 12-16mm depths. This device is intended to be radiolucent, and the interior space of the product is to be used with autogenous bone graft. The DIVERGENCE™ stand-alone cervical interbody device is manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism.
The bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths.
The PEEK material (PEEK OPTIMA™ LT-1) used conforms to ASTM F2026 and the titanium alloy material (Ti-6Al-4V ELI) used conforms to ASTM F136 standards. These devices are offered in sterile form.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc
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 subject DIVERGENCE™ Anterior Cervical Fusion System devices were tested in accordance with ASTM F2077-11 "Test Methods For Intervertebral Body Fusion Devices" for static and dynamic compression, static and dynamic compression shear, and static and dynamic torsion testing, and ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" for subsidence testing. The subject devices met the pre-determined acceptance criteria for all the tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the 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.
PEEK PREVAIL® Cervical Interbody Device (K113252), CORNERSTONE® PSR Cervical Fusion System (K111264), CORNERSTONE® PSR Cervical Fusion System (K100214), AFFINITY® Anterior Cervical Cage System (P000028), ZEPHIR® Anterior Cervical System (K030327), ATLANTIS® Anterior Cervical Plate System (K130640)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three faces overlapping to represent the department's focus on people. The logo is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 21, 2015
Medtronic Sofamor Danek USA, Incorporated Ms. Shweta Sharma Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
Re: K141599
Trade/Device Name: DIVERGENCE™ Anterior Cervical Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 23, 2014 Received: December 24, 2014
Dear Ms. Sharma:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Ms. Shweta Sharma
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141599
Device Name
DIVERGENCE™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only)
Indications for Use (Describe)
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in sketally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
DIVERGENCE™ Anterior Cervical Fusion System 510(k) Summary
January 2015
| I. | Company | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
(901) 396-3133 |
|------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. | Contact | Shweta Sharma
Senior Regulatory Affairs Specialist |
| III. | Proprietary Trade Name | DIVERGENCETM Anterior Cervical
Fusion System |
| IV. | Common Name | Cervical Intervertebral Fusion Device
with Bone Graft |
| V. | Classification Name | 21 CFR 888.3080 - Intervertebral Body
Fusion Device |
| | Classification | Class II |
| | Product Codes | OVE |
| | Primary Predicate | PEEK PREVAIL® Cervical Interbody
Device (K113252, SE 01/17/2012) |
| | Secondary Predicates | •CORNERSTONE® PSR Cervical
Fusion System (K111264; K100214)
•AFFINITY® Anterior Cervical Cage
System (P000028, down-classified to
Class II special controls, Date of Final
Order 06/12/2007)
•ZEPHIR® Anterior Cervical System
(K030327)
•ATLANTIS® Anterior Cervical Plate |
4
System (K130640)
Product Description VI.
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody fusion device with internal screw fixation. The DIVERGENCE™ Anterior Cervical Fusion System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. This system is indicated for single-level use only in the C2-T1 anterior spine. The system is comprised of a PEEK interbody cage and screws.
The DIVERGENCE™ anterior cervical cages are provided in 0 and 6 degrees of lordosis, 5-12mm heights, 15-20mm widths and 12-16mm depths. This device is intended to be radiolucent, and the interior space of the product is to be used with autogenous bone graft. The DIVERGENCE™ stand-alone cervical interbody device is manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism.
The bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical grade titanium alloy. The bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths.
The PEEK material (PEEK OPTIMA™ LT-1) used conforms to ASTM F2026 and the titanium alloy material (Ti-6Al-4V ELI) used conforms to ASTM F136 standards. These devices are offered in sterile form.
Indications for Use VII.
The DIVERGENCE™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc
5
to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The DIVERGENCE™ stand-alone cervical interbody device must be used with internal screw fixation. The DIVERGENCE™ stand-alone cervical interbody device is also required to be used with autogenous bone graft and is to be implanted via an open, anterior approach. This cervical device is to be used in patients who have had six weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
Summary of Technological Characteristics VIII.
The subject DIVERGENCE™ Anterior Cervical Fusion System interbody cage component has the same fundamental scientific technology as the predicate PEEK PREVAIL® Cervical Interbody Device. CORNERSTONE® PSR Cervical Fusion System and AFFINITY® Anterior Cervical Cage System. The subject interbody cage is manufactured from the same PEEK and titanium alloy material as the predicate devices. The predicate and subject devices are also both interbody devices designed to contain graft material and facilitate a fusion between two vertebral bodies.
The subject DIVERGENCE™ Anterior Cervical Fusion System bone screws have the same fundamental scientific technology as the predicate ZEPHIR® Anterior Cervical System and ATLANTIS® Anterior Cervical Plate System screws. The subject devices are manufactured from the same titanium alloy material as the predicates. In both predicate and subject devices, fixation is provided by bone screws inserted into the vertebral body of the cervical spine.
Identification of Legally Marketed Predicate Devices Used to Claim Substantial IX. Equivalence
The subject interbody cage is substantially equivalent to the predicates:
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- PEEK PREVAIL® Cervical Interbody Device (K113252, SE 01/17/2012; . K094042, SE 06/30/2010)
- CORNERSTONE® PSR Cervical Fusion System (K111264, SE 10/12/2011; . K100214, SE 06/25/2010)
- AFFINITY® Anterior Cervical Cage System (P000028, Approval Date . 06/13/2002, down-classified to Class II special controls, Date of Final Order 06/12/2007)
The subject bone screw is substantially equivalent to the predicates:
- ZEPHIR® Anterior Cervical System (K030327, SE 02/26/2003) .
- ATLANTIS® Anterior Cervical Plate System (K130640, SE 06/04/2013) .
X. Brief Discussion of the Non-Clinical Tests Submitted
The subject DIVERGENCE™ Anterior Cervical Fusion System devices were tested in accordance with ASTM F2077-11 "Test Methods For Intervertebral Body Fusion Devices" for static and dynamic compression, static and dynamic compression shear, and static and dynamic torsion testing, and ASTM F2267-04(2011) "Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression" for subsidence testing.
The subject devices met the pre-determined acceptance criteria for all the tests. The test results are provided to demonstrate that the subject devices are substantially equivalent to the predicate devices.
XI. Conclusions Drawn from the Non-Clinical Tests
Based on the non-clinical test results and additional supporting documentation provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the listed predicate devices.