(92 days)
No
The document describes a spinal fusion device and its mechanical and MRI testing, with no mention of AI or ML capabilities.
Yes
This device, the Sovereign™ Spinal System, is indicated for therapeutic use in patients with degenerative disc disease, multilevel degenerative scoliosis, and sagittal deformity conditions as an adjunct to fusion, aiming to treat or alleviate these medical conditions.
No
The device is an intervertebral body fusion device and is indicated for use in surgical procedures to treat degenerative disc disease and degenerative scoliosis. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an "intervertebral body fusion device with internal screw fixation" and mentions physical components like PEEK implants and a Titanium coating. This indicates a physical medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
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: The Sovereign™ Spinal System is an implantable medical device designed for intervertebral body fusion in the spine. It is surgically placed within the body.
- Intended Use: The intended use describes the conditions the device is used to treat (degenerative disc disease, scoliosis, sagittal deformity) and how it is used (as an adjunct to fusion, with bone graft, with screws). This is a therapeutic use, not a diagnostic one based on in vitro analysis.
The information provided clearly indicates this is a surgical implant, not a device used for testing samples outside of the body.
N/A
Intended Use / Indications for Use
The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate 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. Additionally, the Sovereign™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be sketally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. These implants may be inplanted via a variety of open or minimally invasive approaches include anterior and oblique. The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Sovereign™ Spinal System 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. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).
Product codes
OVD
Device Description
The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The subject devices in this submission add additional polyetheretherketone (PEEK) implant lordosis options with corresponding trials and PTC implant options with a Commercially Pure Titanium (CP Ti) coating, to the existing SOVEREIGN™ Spinal System.
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)
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.
- Design verification testing for the subject implants was completed in accordance with:
- ASTM F2077, Test Methods For Intervertebral Body Fusion Devices
- ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
- ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices
- The tests completed were:
- Static Compression
- Compression Fatigue
- Static Compression Shear
- Compression Shear Fatigue
- Subsidence
- Expulsion
- The subject implants met the pre-determined acceptance criteria for all tests. Medtronic believes design verification testing demonstrated that the subject implants are substantially equivalent to the predicate Medtronic 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 devices.
MRI Testing:
- In accordance with the Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment, Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.
- Medtronic believes that the subject instruments do not present a new worst case and thus, can justifiably be classified as MR-Conditional.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K091813, K150135, K170592, K133205, K162680, K162212, K132897, P970015, K122037
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/0 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 30, 2021
Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
Re: K172328
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
Dear Ms. Hines:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated November 2, 2017. Specifically, FDA is updating this SE Letter as an administrative correction, to update the Indications for Use and labeling.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Brent Showalter, Ph.D., OHT6: Office of Orthopedic Devices, (240) 402-1840, Brent.Showalter@fda.hhs.gov.
Sincerely,
Brent Showalter -S
Brent L. 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Medtronic Sofamor Danek, USA Inc. Kanesha Hines Regulatory Affairs Specialist 1800 Pvramid Place Memphis, Tennessee 38132
November 2, 2017
Re: K172328
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: October 3, 2017 Received: October 4, 2017
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 device-related 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.
2
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K172328
Device Name Sovereign™ Spinal System
Indications for Use (Describe)
The Sovereign™ Spinal System is indicated for use with autogenous bone and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone marrow aspirate 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. Additionally, the Sovereign™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be sketally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation) must be used. These implants may be inplanted via a variety of open or minimally invasive approaches include anterior and oblique.
The Sovereign™ Spinal System may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the Sovereign™ Spinal System 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. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).
| 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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4
510(k) SUMMARY
MEDTRONIC SOVEREIGN™ Spinal System
August 2021
| Submitter: | Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901)396-3133
Fax: (901) 346-9738 |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Raphael McInnis
Sr. Regulatory Affairs Manager
Direct Telephone: (901)399-2057 |
| Date Prepared | August 6, 2021 |
| Name of Device | SOVEREIGN™ Spinal System |
| Common Name | Intervertebral body fusion device |
| Classification Name | Intervertebral Body Fusion Device: 21 CFR 888.3080 |
| Classification | Class II |
| Product Codes | OVD 21 CFR 888.3080 |
| Predicate Devices | There are 9 Predicates.
Primary Predicate 1 - SOVEREIGN™ Spinal System (K091813,
S.E 11/17/2009)
Predicate 2 - DIVERGENCE-L™ Anterior/Oblique Lumbar
Fusion System (K150135, S.E. 06/11/2015)
Predicate 3 - BASE Interfixated Titanium System (K170592, S.E
04/26/2017)
Predicate 4 - CLYDESDALE™ PTC Spinal System (K133205,
S.E. 03/13/2014)
Predicate 5 - SOVEREIGN™ Spinal System (K162680, S.E.
12/14/2016)
Predicate 6 - DIVERGENCE-L™ Anterior/Oblique Lumbar
Fusion System (K162212. S.E. 05/19/2017) |
| | |
| | Predicate 7- CLYDESDALE™ Spinal System (K132897 S.E. 12/11/2013) |
| | Predicate 8- LT-CAGE™ PEEK Lumbar Tapered Fusion Device (P970015, 05/14/1999)* |
| | Predicate 9- SOVEREIGN™ Spinal System (K122037, S.E. 03/22/2013) |
| | * The LT-CAGE™ PEEK Lumbar Tapered Fusion Device falls within the category of a Class II (Special Controls) Cervical Interbody Fusion Device due to the FDA down classification of cages from a Class III device to a Class II¹. The predicate device is a cage/interbody device used for anterior cervical interbody fusion procedures. The predicate components have been tested and found to be substantially equivalent to previously approved cages such as the AFFINITY® Anterior Cervical Cage (titanium), the PEEK PREVAIL™ Cervical Interbody Device and the BAK/C® Cervical Interbody Fusion System. [1] Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Intervertebral Body Fusion Device. Document issued on: June 12, 2007. The predicates have not been subject to a design related recall. |
| Description of Devices | The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The subject devices in this submission add additional polyetheretherketone (PEEK) implant lordosis options with corresponding trials and PTC implant options with a Commercially Pure Titanium (CP Ti) coating, to the existing SOVEREIGN™ Spinal System. SOVEREIGN™ Spinal System |
| Indications for Use | The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate 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. Additionally, the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non-operative treatment. When used in patients as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity conditions, additional supplemental fixation (e.g. posterior |
| Comparison of
Technological
Characteristics with the
Predicate Devices | 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. Implants with lordosis
angles greater than 18° are intended to be used with supplemental
fixation (e.g. facet screws or posterior fixation). |
| | SOVEREIGN™ Spinal System Implants |
| | The primary predicate for the SOVEREIGN™ Spinal System is
the predicate SOVEREIGN™ Spinal System (K091813, S.E
11/17/2009). The subject SOVEREIGN™ Spinal System devices
have identical intended use and similar indications and similar
materials as the following FDA cleared Primary Predicate 1
K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.
06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 6
K162212 (S.E. 05/19/2017), Predicate 7 K132897 (S.E.
12/11/2013), Predicate 8 P970015 (05/14/1999), and Predicate 9
K122037 (S.E. 03/22/2013). The predicate and subject devices
have the identical function and similar scientific fundamental
technology. |
| | SOVEREIGN™ PTC Spinal System Implants |
| | The primary predicate for the SOVEREIGN™ Spinal System is
the predicate SOVEREIGN™ Spinal System (K091813, S.E
11/17/2009). The subject SOVEREIGN™ Spinal System devices
have identical intended use and similar indications and similar
materials as the following FDA cleared Primary Predicate 1
K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.
06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 4
K133205 (S.E. 03/13/2014), Predicate 6 K162212 (S.E.
05/19/2017), Predicate 7 K132897 (S.E. 12/11/2013), Predicate 8
P970015 (05/14/1999), and Predicate 9 K122037 (S.E.
03/22/2013). The predicate and subject devices have the identical |
| | |
| | SOVEREIGN™ Spinal System Instruments
The subject trials are identical in intended use and material as its
predicate in Predicate 5 K162680 (S.E 12/14/2016). The
difference between the subject and predicate trials is that the
subject trials are designed for the sizes of the subject implants. |
| Performance Data | 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.
Design verification testing for the subject implants was completed |
| | in accordance with
- ASTM F2077, Test Methods For Intervertebral Body Fusion
Devices - ASTM F2267, Standard Test Method for Measuring Load
Induced Subsidence of Intervertebral Body Fusion Device Under
Static Axial Compression |
| | - ASTM Draft Standard F-04.25.02.02, Static Push-out Test
Method for Intervertebral Body Fusion Devices
The tests completed were: - Static Compression
- Compression Fatigue
- Static Compression Shear
- Compression Shear Fatigue
- Subsidence
-Expulsion |
| | The subject implants met the pre-determined acceptance criteria
for all tests. Therefore, Medtronic believes design verification
testing demonstrated that the subject implants are substantially
equivalent to the predicate Medtronic 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 devices. |
| | MRI Testing |
| | In accordance with the Guidance for Industry and FDA Staff –
Establishing Safety and Compatibility of Passive Implants in the
Magnetic Resonance (MR) Environment, Medtronic has evaluated
the subject devices to demonstrate substantial equivalence to the
predicate devices. Medtronic believes that the subject instruments
do not present a new worst case and thus, can justifiably be
classified as MR-Conditional. |
| | Based on the test results and additional supporting information
provided in this premarket notification, Medtronic believes the
subject devices are at least as safe as and effective as the legally
marketed predicate devices: |
| | Primary Predicate 1- SOVEREIGNTM Spinal System
(K091813, S.E 11/17/2009) Predicate 2- DIVERGENCE-LTM Anterior/Oblique
Lumbar Fusion System (K150135, S.E. 06/11/2015) Predicate 3- BASE Interfixated Titanium System
(K170592, S.E 04/26/2017) Predicate 4- CLYDESDALETM PTC Spinal System
(K133205, S.E. 03/13/2014) Predicate 5- SOVEREIGNTM Spinal System (K162680,
S.E. 12/14/2016) Predicate 6- DIVERGENCE-LTM Anterior/Oblique
Lumbar Fusion System (K162212, S.E. 05/19/2017) Predicate 7- CLYDESDALETM Spinal System (K132897
S.E. 12/11/2013) Predicate 8- LT-CAGETM PEEK Lumbar Tapered Fusion
Device (P970015, 05/14/1999) Predicate 9- SOVEREIGNTM Spinal System (K122037,
S.E. 03/22/2013) |
| Conclusion | |
5
6
7
8