(92 days)
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 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) must be used. These implants may be implanted 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).
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.
The provided text describes a 510(k) summary for the Medtronic SOVEREIGN™ Spinal System, which is an intervertebral body fusion device. The submission focuses on adding new polyetheretherketone (PEEK) implant lordosis options and PTC implant options with a Commercially Pure Titanium (CP Ti) coating to the existing system. The document primarily discusses substantial equivalence to predicate devices based on mechanical testing and MRI compatibility. It does not describe an AI medical device or a study with clinical endpoints involving human readers or ground truth established by experts/pathology.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and AI performance metrics are not applicable to the information provided in the given text.
Based on the available information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the SOVEREIGN™ Spinal System are based on mechanical testing standards. The reported device performance indicates that the subject implants met these criteria.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Mechanical Testing: | |
| ASTM F2077, Test Methods For Intervertebral Body Fusion Devices | Subject implants met pre-determined acceptance criteria. |
| ASTM F2267, Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression | Subject implants met pre-determined acceptance criteria. |
| ASTM Draft Standard F-04.25.02.02, Static Push-out Test Method for Intervertebral Body Fusion Devices | Subject implants met pre-determined acceptance criteria. |
| Specific Tests Performed: | |
| Static Compression | Subject implants met pre-determined acceptance criteria. |
| Compression Fatigue | Subject implants met pre-determined acceptance criteria. |
| Static Compression Shear | Subject implants met pre-determined acceptance criteria. |
| Compression Shear Fatigue | Subject implants met pre-determined acceptance criteria. |
| Subsidence | Subject implants met pre-determined acceptance criteria. |
| Expulsion | Subject implants met pre-determined acceptance criteria. |
| MRI Testing: | |
| Guidance for Industry and FDA Staff – Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment | Subject devices were evaluated and can be classified as MR-Conditional. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device (intervertebral body fusion device), not a software or AI device with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device. Ground truth by experts is not established for this type of testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device. Adjudication methods are not used for this type of testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The document does not describe an AI medical device or any study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The document does not describe an AI medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is defined by the performance requirements set forth in the referenced ASTM standards. For MRI testing, it's about meeting safety and compatibility guidelines outlined by the FDA for the MR environment. These are objective engineering and regulatory standards, not clinical ground truth like pathology or expert consensus.
8. The sample size for the training set
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the document describes mechanical and MRI compatibility testing of a physical medical device, not an AI model requiring a training set.
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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
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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.
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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 (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
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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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510(k) SUMMARY
MEDTRONIC SOVEREIGN™ Spinal System
August 2021
| Submitter: | Medtronic Sofamor Danek, USA Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901)396-3133Fax: (901) 346-9738 |
|---|---|
| Contact Person | Raphael McInnisSr. Regulatory Affairs ManagerDirect 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 LumbarFusion System (K150135, S.E. 06/11/2015)Predicate 3 - BASE Interfixated Titanium System (K170592, S.E04/26/2017)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 LumbarFusion 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 ofTechnologicalCharacteristics with thePredicate Devices | variety of open or minimally invasive approaches. Theseapproaches 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™ interbodydevice is intended to be used with 3 titanium alloy fixed orvariable angle screws. The accompanying cover plate MUST beused anytime the device is used with any number of variable anglescrews. If the physician chooses to use less than 3 or none of theprovided screws, additional supplemental fixation in the lumbarspine must be used to augment stability. Implants with lordosisangles greater than 18° are intended to be used with supplementalfixation (e.g. facet screws or posterior fixation). | |
| SOVEREIGN™ Spinal System Implants | |
| The primary predicate for the SOVEREIGN™ Spinal System isthe predicate SOVEREIGN™ Spinal System (K091813, S.E11/17/2009). The subject SOVEREIGN™ Spinal System deviceshave identical intended use and similar indications and similarmaterials as the following FDA cleared Primary Predicate 1K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 6K162212 (S.E. 05/19/2017), Predicate 7 K132897 (S.E.12/11/2013), Predicate 8 P970015 (05/14/1999), and Predicate 9K122037 (S.E. 03/22/2013). The predicate and subject deviceshave the identical function and similar scientific fundamentaltechnology. | |
| SOVEREIGN™ PTC Spinal System Implants | |
| The primary predicate for the SOVEREIGN™ Spinal System isthe predicate SOVEREIGN™ Spinal System (K091813, S.E11/17/2009). The subject SOVEREIGN™ Spinal System deviceshave identical intended use and similar indications and similarmaterials as the following FDA cleared Primary Predicate 1K091813 (S.E 11/17/2009), Predicate 2 K150135 (S.E.06/11/2015), Predicate 3 K170592 (S.E. 04/26/2017), Predicate 4K133205 (S.E. 03/13/2014), Predicate 6 K162212 (S.E.05/19/2017), Predicate 7 K132897 (S.E. 12/11/2013), Predicate 8P970015 (05/14/1999), and Predicate 9 K122037 (S.E.03/22/2013). The predicate and subject devices have the identical | |
| SOVEREIGN™ Spinal System InstrumentsThe subject trials are identical in intended use and material as itspredicate in Predicate 5 K162680 (S.E 12/14/2016). Thedifference between the subject and predicate trials is that thesubject trials are designed for the sizes of the subject implants. | |
| Performance Data | Mechanical TestingIn accordance with the Guidance for Industry and FDA Staff -Spinal System 510(k)'s,Medtronic has evaluated the subjectdevices to demonstrate substantial equivalence to thepredicate devices.Design verification testing for the subject implants was completed |
| in accordance with- ASTM F2077, Test Methods For Intervertebral Body FusionDevices- ASTM F2267, Standard Test Method for Measuring LoadInduced Subsidence of Intervertebral Body Fusion Device UnderStatic Axial Compression | |
| - ASTM Draft Standard F-04.25.02.02, Static Push-out TestMethod for Intervertebral Body Fusion DevicesThe tests completed were:- Static Compression- Compression Fatigue- Static Compression Shear- Compression Shear Fatigue- Subsidence-Expulsion | |
| The subject implants met the pre-determined acceptance criteriafor all tests. Therefore, Medtronic believes design verificationtesting demonstrated that the subject implants are substantiallyequivalent to the predicate Medtronic devices. | |
| Medtronic believes that testing is not warranted for the subjectinstruments as they do not present a new worst case whencompared to the predicate devices. | |
| MRI Testing | |
| In accordance with the Guidance for Industry and FDA Staff –Establishing Safety and Compatibility of Passive Implants in theMagnetic Resonance (MR) Environment, Medtronic has evaluatedthe subject devices to demonstrate substantial equivalence to thepredicate devices. Medtronic believes that the subject instrumentsdo not present a new worst case and thus, can justifiably beclassified as MR-Conditional. | |
| Based on the test results and additional supporting informationprovided in this premarket notification, Medtronic believes thesubject devices are at least as safe as and effective as the legallymarketed predicate devices: | |
| Primary Predicate 1- SOVEREIGNTM Spinal System(K091813, S.E 11/17/2009) Predicate 2- DIVERGENCE-LTM Anterior/ObliqueLumbar 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/ObliqueLumbar Fusion System (K162212, S.E. 05/19/2017) Predicate 7- CLYDESDALETM Spinal System (K132897S.E. 12/11/2013) Predicate 8- LT-CAGETM PEEK Lumbar Tapered FusionDevice (P970015, 05/14/1999) Predicate 9- SOVEREIGNTM Spinal System (K122037,S.E. 03/22/2013) | |
| Conclusion |
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§ 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.