The SeaSpine® Shoreline™ ACS is a stand-alone device indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T1). The Shoreline™ ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and /or corticocancellous bone and implanted via an anterior approach. The cervical device is to be used in patients who have had at least six (6) weeks of non-operative treatment. The cervical device is to be used with bone screw fixation and a locking cover.

Device Description

The SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System consists of the implant assembly composed of a single use PEEK cervical spacer (ASTM F2026) and a titanium alloy (ASTM F136) plate with titanium alloy variable angle or fixed bone screws, and a titanium alloy locking cover. Shoreline™ ACS is offered in a variety of footprints and heights to accommodate variations in patient anatomy and is generally box-shaped with surface teeth and a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.

The system offers spacers in Low-Profile and No-Profile versions. Both Low-Profile and No-Profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM), bonded to PEEK. The Low-Profile version consists of a NanoMetalene bonded PEEK interbody and two-, three-, and four-hole titanium alloy plates. The No-Profile version consists of an interbody spacer with a two-hole anterior titanium alloy face section with a NanoMetalene bonded PEEK posterior section.

The No-Profile versions of the spacers are available in a standard lordotic angle, while the Low-Profile Spacer is offered in multiple lordotic versions. The Shoreline™ ACS spacers include radiographic markers manufactured from either titanium alloy (ASTM F136) or tantalum (ASTM F560).

No-Profile Implant versions are offered in a two-screw construct and the Low-Profile versions in two-, three-, and four-screw constructs to accommodate a range of surgeon preference. For all spacer, plate and screw variations, the locking cover attaches to the device and physically blocks the screw heads to prevent screw back out from the construct.

The No-Profile and Low-Profile NanoMetalene cervical spacers will be provided in gamma sterilized packaging; the bone screws, plate, and locking cover will be provided non-sterile for subsequent sterilization at the healthcare facility.

The instruments included with the Shoreline™ ACS System facilitate the placement, adjustment, and final locking of the interbody spacers, and removal if necessary. The instruments also include the travs and caddies for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

The provided FDA 510(k) summary for the SeaSpine® Shoreline™ ACS - Anterior Cervical Standalone System does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of device performance related to diagnostic or treatment efficacy.

This document pertains to a medical device being cleared for market based on "substantial equivalence" to existing predicate devices. The focus is on mechanical and material safety, and similarity in intended use and technological characteristics, rather than clinical performance outcomes or diagnostic accuracy.

Therefore, I cannot provide the requested information regarding:

A table of acceptance criteria and the reported device performance: This type of data is typically associated with studies demonstrating clinical efficacy or diagnostic accuracy, which are not present in this 510(k) summary.
Sample size used for the test set and the data provenance: No clinical test set involving patient data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical test set for ground truth evaluation.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not a diagnostic device involving AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does state regarding testing:

Non-Clinical Testing: "Non-clinical mechanical testing was not performed on the subject devices. The subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject (modified) devices do not introduce a new worst-case. Engineering analyses of the modifications to the SeaSpine® Shoreline™ ACS System determined that no additional mechanical testing is necessary." This indicates reliance on previous testing of predicate devices and engineering analysis for mechanical safety, rather than new performance testing.
Clinical Testing: "There was no clinical testing performed for this submission." This explicitly states that no clinical studies were conducted to prove the device's performance in patients for this submission.

In summary, the FDA 510(k) process for this device relies on demonstrating substantial equivalence to existing, legally marketed predicate devices through comparison of design, materials, manufacturing, intended use, and existing performance data (primarily mechanical for similar devices), rather than new clinical trials or performance studies against specific acceptance criteria.

Summary

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April 29, 2019

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SeaSpine® Orthopedics Corporation Alicia McArthur Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008

Re: K190655

Trade/Device Name: SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: March 28, 2019 Received: March 29, 2019

Dear Ms. McArthur:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for 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) K190655

Device Name

SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Contact Details

Applicant Name:	SeaSpine® Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5117
Fax number:	(760) 683-6874
Contact person:	Alicia McArthur, Specialist, Regulatory Affairs
Email address:	alicia.mcarthur@seaspine.com
Date Prepared:	March 13, 2019

Device Name

Trade Name:	SeaSpine® Shoreline™ ACS - Anterior CervicalStandalone System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral fusion device with integrated fixation, cervical(21 CFR 888.3080)
Class:	II
Product Code:	OVE

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K170569	OVE	Shoreline™ ACS- AnteriorCervical Standalone System	SeaSpine OrthopedicsCorporation
ADDITIONAL PREDICATE
K161081	OVE	Shoreline™ ACS- AnteriorCervical Standalone System	SeaSpine OrthopedicsCorporation

Device Description

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screws, and a titanium alloy locking cover. Shoreline™ ACS is offered in a variety of footprints and heights to accommodate variations in patient anatomy and is generally box-shaped with surface teeth and a central canal for receiving autograft bone graft material and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. The system is implanted via an anterior approach.

Intended Use/Indications for use

Summary of Technological Characteristics

The Shoreline™ ACS and predicate devices have the same operational principle; they act as a disc spacer and hold bone graft and include integrated fixation to maintain stability by direct purchase into the bony vertebral endplates. The SeaSpine® Shoreline™ ACS is substantially equivalent to the cited predicate devices in areas including intended

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use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

The subject and predicate devices are based on the following similar technological elements:

Implant Spacer Heights ●
Spacer Footprints ●
Spacer Lordotic Angles ●
Screw Sizes and Lengths ●
o Anterior Plates

Non-Clinical Testing

Non-clinical mechanical testing was not performed on the subject devices. The subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject (modified) devices do not introduce a new worst-case. Engineering analyses of the modifications to the SeaSpine® Shoreline™ ACS System determined that no additional mechanical testing is necessary.

Clinical Testing

There was no clinical testing performed for this submission.

Conclusions

The submitted data demonstrate that the SeaSpine® Shoreline™ ACS System is substantially equivalent to the cited legally marketed predicates.

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.

Re: K190655

Dear Ms. McArthur:

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Contact Details

Device Name

Legally Marketed Predicate Devices

Device Description

Intended Use/Indications for use

Summary of Technological Characteristics

Non-Clinical Testing

Clinical Testing

Conclusions

§ 888.3080 Intervertebral body fusion device.

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