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.

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

AI/ML Overview

This document, a 510(k) Pre-market Notification for the SOVEREIGN® Spinal System, focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting primary clinical study data for acceptance criteria. As such, it does not contain the detailed information typically found in studies designed to prove a device meets specific performance acceptance criteria related to diagnostic or treatment efficacy.

Therefore, many of the requested details, such as the specific acceptance criteria for device performance in terms of clinical outcomes, sample sizes for test and training sets, expert qualifications, ground truth methods, and results of comparative effectiveness studies (MRMC or standalone AI performance), are not present in this regulatory submission.

This submission primarily relies on:

Comparison of Technological Characteristics: It argues that the new device is substantially equivalent to existing predicate devices based on design, materials, sterilization, intended use, indications, and surgical technique.
Performance Data (Validation and Mechanical Testing): It states that a pre-clinical validation study demonstrated the proposed instruments could be used as intended, and mechanical testing was performed in accordance with FDA guidance to support substantial equivalence. It explicitly states that "testing is not warranted for the subject instruments as they do not present a new worst case when compared to the predicate instruments".

Given this context, here is a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" for clinical performance are not explicitly defined in the provided text, as the focus is on substantial equivalence to predicate devices through technical and manufacturing aspects. The "performance" reported is primarily related to the mechanical and functional aspects of the hardware, not clinical outcomes in human subjects.

Acceptance Criteria (Implied from Substantial Equivalence)	Reported Device Performance
Functional/Mechanical Equivalence:
- Identical/Similar materials	Primary Predicate (K121982) has identical materials. Predicate 2 (K150135) has identical materials.
- Identical/Similar sterilization method	Primary Predicate (K121982) has identical sterilization method. Predicate 2 (K150135) has identical sterilization method.
- Identical/Similar intended use/indications	Primary Predicate (K121982) has identical sizes and intended use, and similar indications. Predicate 2 (K150135) has similar indications and intended use.
- Similar overall design and fundamental technology	Primary Predicate (K121982) has similar overall design and fundamental technology. Predicate 2 (K150135) has fundamental technology.
- No new worst-case scenario compared to predicates	"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."
Instrument Usability:
- Instruments can be used as intended	"A pre-clinical validation study was conducted in spine models which demonstrated that the proposed instruments could be used as intended."
Mechanical Integrity (for spinal systems):	"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." (Implies adherence to relevant mechanical testing standards for spinal fusion devices, but specific numerical results are not provided).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified in terms of human subjects or clinical cases. The "pre-clinical validation study" was conducted in "spine models," which suggests bench testing or cadaveric testing, not a clinical test set from human data.
Data Provenance: The nature of "spine models" doesn't allow for country of origin or retrospective/prospective classification in the typical sense of clinical data. It refers to laboratory or simulation environments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As the "test set" was in "spine models" for pre-clinical validation and mechanical testing, there would be no ground truth established by medical experts in the way it is done for clinical diagnostic or treatment studies. The "ground truth" for mechanical testing would be engineering specifications and successful functional operation within the models.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 refer to agreement among experts on clinical ground truth. For mechanical and pre-clinical validation studies, conformity to specifications and successful operation are typically assessed by engineers and technicians.

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

Not applicable. This is a spinal implant system (intervertebral body fusion device and associated instruments), not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study involving human readers and AI assistance would be relevant or performed for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical medical device (spinal implant system) and its instruments, not an algorithm or AI product.

7. The type of ground truth used

For the pre-clinical validation and mechanical testing, the "ground truth" would be:

Engineering Specifications: Adherence to design parameters, material properties, and dimensional tolerances.
Functional Success in Spine Models: The ability of instruments to perform their intended surgical steps without failure or deviation.
Compliance with Standards: Verification that mechanical properties meet or exceed requirements outlined in relevant FDA guidance (e.g., "Guidance for Industry and FDA Staff – Spinal System 510(k)'s").

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The "design predicate" information refers to existing devices that serve as comparators for substantial equivalence, not a training set for an algorithm.

9. How the ground truth for the training set was established

Not applicable, as no training set for an algorithm was used.

Summary

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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)

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, andDevice 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 FusionSystem (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 withautogenous bone graft in patients with degenerative disc disease
Comparison ofTechnologicalCharacteristics with thePredicate Devices:	defined as discogenic back pain with degeneration of the discconfirmed by history and radiographic studies. These patientsshould be skeletally mature and have had 6 months of non-operative treatment. These implants may be implanted via avariety 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.The primary predicate for the SOVEREIGN® Spinal System ispart 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 designpredicate for the trial handle, trials, coverplate inserter, andthe interbody inserters. This predicate has identical sizes,sterilization method, materials, and intended use.Additionally, this predicate has similar indications,surgical technique, overall design, and fundamentaltechnology as the subject instruments. Predicate 2 (K150135, S.E 06/11/2015) DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System- Thispredicate is a design predicate for the subject trial handle,trials, and oblique indication. This predicate has identicalmaterials, sterilization method, thread size, thread length,overall instrument length, surgical approach, andfundamental technology. Additionally, this predicate hassimilar indications, intended use, and surgical technique asthe subject trial handle and trials.
Performance Data:	The following performance data were provided in support ofsubstantial equivalence.Validation TestingA pre-clinical validation study was conducted in spine modelswhich demonstrated that the proposed instruments could be usedas intended.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 the predicatedevices.Medtronic believes that testing is not warranted for the subjectinstruments as they do not present a new worst case whencompared to the predicate instruments as outlined within theBench Performance Section.
Conclusion:	Based on the supporting documentation provided in this pre-market notification, the subject SOVEREIGN® Spinal Systeminstruments 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 LumbarFusion System (S.E. 06/11/2015)

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Regulation Number and Section

§ 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.