(79 days)
No
The 510(k) summary describes a spinal implant system and associated instruments, focusing on mechanical properties and surgical approaches. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is described as an "interbody system" that is "implanted" to treat "discogenic back pain with degeneration of the disc," which suggests it directly treats a medical condition.
No
The device is an implantable spinal system used for treating degenerative disc disease, not for diagnosing it.
No
The device description explicitly lists hardware components such as interbody cages, screws, coverplates, instruments, and accessories.
Based on the provided text, the SOVEREIGN® Spinal System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion in patients with degenerative disc disease. This is a therapeutic device, not a diagnostic one.
- Device Description: The components listed (interbody cages, screws, coverplates, instruments) are all physical implants and surgical tools used in a procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The studies mentioned are validation and mechanical testing related to the physical performance and safety of the implant and instruments, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The SOVEREIGN® Spinal System does not fit this description.
N/A
Intended Use / Indications for Use
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of non-operative treatment. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.
Product codes
OVD
Device Description
The SOVEREIGN® Spinal System consists of interbody cages, screws, coverplates, instruments, and accessories. The subject instruments include:
• Trial Handle
• Trials
• Coverplate Inserter
• Interbody Inserters
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature
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)
Validation Testing: A pre-clinical validation study was conducted in spine models which demonstrated that the proposed instruments could be used as intended.
Mechanical Testing: In accordance with the Guidance for Industry and FDA Staff – Spinal System 510(k)'s, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
Medtronic believes that testing is not warranted for the subject instruments as they do not present a new worst case when compared to the predicate instruments as outlined within the Bench Performance Section.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of overlapping human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Inc. % Kanesha Hines Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K162680
Trade/Device Name: SOVEREIGN® Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: September 23, 2016 Received: September 26, 2016
Dear Ms. Hines:
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.
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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/Resourcesfor You/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162680
Device Name SOVEREIGN® Spinal System
Indications for Use (Describe)
The SOVEREIGN® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had 6 months of non-operative treatment. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.
The SOVEREIGN® interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN® interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability.
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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510(k) SUMMARY
MEDTRONIC SOVEREIGN® Spinal System
December 2016
| Submitter: | Medtronic Sofamor Danek USA, Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)396-3133 | |
| Fax: (901) 346-9738 | |
| Contact Person | Kanesha Hines |
| Regulatory Affairs Specialist | |
| Direct Telephone: (901)399-2670 | |
| Date Prepared | December 9, 2016 |
| Name of Device | SOVEREIGN® Spinal System |
| Common Name | Intervertebral Body Fusion Device |
| Trade Name | SOVEREIGN® Spinal System |
| Regulatory Class, | |
| Regulation Number, | |
| Regulation Name, and | |
| Device Product Code | • Class II |
| • 21 CFR 888.3080 Intervertebral Body Fusion Device; | |
| OVD | |
| Predicate Devices | K121982 SOVEREIGN® Spinal System (S.E. 07/06/2012) – |
| Primary Predicate | |
| K150135 DIVERGENCE-L™ Anterior Oblique Lumbar Fusion | |
| System (S.E. 06/11/2015) | |
| Description of Devices | The predicates have not been subject to a design related recall. |
| The SOVEREIGN® Spinal System consists of interbody cages, | |
| screws, coverplates, instruments, and accessories. The subject | |
| instruments include: | |
| • Trial Handle | |
| • Trials | |
| • Coverplate Inserter | |
| • Interbody Inserters | |
| Indications for Use | The SOVEREIGN® Spinal System is indicated for use with |
| autogenous bone graft in patients with degenerative disc disease | |
| Comparison of | |
| Technological | |
| Characteristics with the | |
| Predicate Devices: | defined as discogenic back pain with degeneration of the disc |
| confirmed by history and radiographic studies. These patients | |
| should be skeletally mature and have had 6 months of non- | |
| operative treatment. These implants may be implanted via a | |
| variety of open or minimally invasive approaches. These | |
| approaches include anterior and oblique. | |
| The SOVEREIGN® interbody system may be used as a stand- | |
| alone device or in conjunction with supplemental fixation. | |
| When used as a stand-alone device, the SOVEREIGN® interbody | |
| device is intended to be used with 3 titanium alloy fixed or | |
| variable angle screws. The accompanying cover plate MUST be | |
| used anytime the device is used with any number of variable angle | |
| screws. If the physician chooses to use less than 3 or none of the | |
| provided screws, additional supplemental fixation in the lumbar | |
| spine must be used to augment stability. | |
| The primary predicate for the SOVEREIGN® Spinal System is | |
| part of the predicate SOVEREIGN® Spinal System (K121982 – | |
| S.E. 07/06/2012), while Predicate 2 is part of the DIVERGENCE- | |
| L™ Anterior Oblique Lumbar Fusion System (K150135 – S.E. | |
| 06/11/2015). | |
| (Primary) Predicate 1 (K121982, S.E 07/06/2012) | |
| SOVEREIGN® Spinal System-This predicate is a design | |
| predicate for the trial handle, trials, coverplate inserter, and | |
| the interbody inserters. This predicate has identical sizes, | |
| sterilization method, materials, and intended use. | |
| Additionally, this predicate has similar indications, | |
| surgical technique, overall design, and fundamental | |
| technology as the subject instruments. Predicate 2 (K150135, S.E 06/11/2015) DIVERGENCE- | |
| L™ Anterior Oblique Lumbar Fusion System- This | |
| predicate is a design predicate for the subject trial handle, | |
| trials, and oblique indication. This predicate has identical | |
| materials, sterilization method, thread size, thread length, | |
| overall instrument length, surgical approach, and | |
| fundamental technology. Additionally, this predicate has | |
| similar indications, intended use, and surgical technique as | |
| the subject trial handle and trials. | |
| Performance Data: | The following performance data were provided in support of |
| substantial equivalence. |
Validation Testing
A pre-clinical validation study was conducted in spine models
which demonstrated that the proposed instruments could be used
as intended.
Mechanical Testing
In accordance with the Guidance for Industry and FDA Staff –
Spinal System 510(k)'s, Medtronic has evaluated the subject
devices to demonstrate substantial equivalence to the predicate
devices.
Medtronic believes that testing is not warranted for the subject
instruments as they do not present a new worst case when
compared to the predicate instruments as outlined within the
Bench Performance Section. |
| Conclusion: | Based on the supporting documentation provided in this pre-
market notification, the subject SOVEREIGN® Spinal System
instruments are as safe and effective as the following predicates:
• K121982 SOVEREIGN® Spinal System (S.E. 07/06/2012) -
(Primary Predicate)
• K150135 DIVERGENCE-LTM Anterior Oblique Lumbar
Fusion System (S.E. 06/11/2015) |
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