The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation

Device Description

The SeaSpine Regatta Lateral System is an intervertebral body fusion device (IBD) with large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacer has a bulleted insertion end for ease of implantation and tantalum markers to allow easier radiological assessment of the spacer position and orientation. The spacers are manufactured from PEEK (ASTM F2026) with radiographic markers manufactured from tantalum (ASTM F560), with a one-micron thick surface of commercially pure (CP) titanium (ASTM F67), and sterile packaged. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.

AI/ML Overview

Based on the provided text, the document describes a 510(k) Premarket Notification for the SeaSpine Regatta Lateral System. This type of submission to the FDA focuses on establishing substantial equivalence to a predicate device, rather than proving efficacy or safety through new clinical studies measuring specific performance criteria against predefined acceptance thresholds.

Therefore, the requested information about acceptance criteria, device performance, sample size for test sets, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study proving the device meets acceptance criteria is not applicable to this specific submission.

The document explicitly states:

"Non-Clinical Testing" outlines mechanical performance, packaging, shipping, and sterilization tests. These are engineering and material validation tests, not clinical performance studies where the device's diagnostic or therapeutic accuracy is measured against patient outcomes or expert consensus.
"Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data." This directly confirms that no clinical studies were performed to establish performance metrics against acceptance criteria for this 510(k) submission.

Here's a breakdown of why each point is not applicable to this 510(k) submission:

A table of acceptance criteria and the reported device performance: Not applicable. Acceptance criteria for clinical performance are not mentioned because no clinical performance was assessed. The mechanical tests (compression, shear, subsidence, expulsion) have their own engineering acceptance criteria, but these are not for clinical "performance" in the sense of an AI algorithm's accuracy or a diagnostic device's sensitivity/specificity.
Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set was adjudicated.
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 medical device (intervertebral body fusion device), not an AI-assisted diagnostic tool. No MRMC study was done.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was established.
The sample size for the training set: Not applicable. This is a physical device, not a machine learning model.
How the ground truth for the training set was established: Not applicable. No training set was used.

In summary, the provided document clearly states that substantial equivalence for the SeaSpine Regatta Lateral System was determined based on non-clinical testing and comparison to predicate devices, not on new clinical performance data or studies involving human readers or AI algorithms.

Summary

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Image /page/0/Picture/10 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 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.

SeaSpine Orthopedics Corporation Ms. Gina Flores Specialist Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K181079

Trade/Device Name: SeaSpine Regatta Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 24, 2018 Received: April 25, 2018

Dear Ms. Flores:

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.

July 18, 2018

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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 mediation-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,

Brent Showalter -S

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)

K181079

Device Name SeaSpine Regatta Lateral System

Indications for Use (Describe)

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation

Type of Use (Select one or both, as applicable)
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

Class:

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(760) 216-5136
Fax number:	(760) 683-6874
Contact person:	Gina Flores, Sr. Regulatory Specialist
Email address:	gina.flores@seaspine.com
Date Prepared:	April 23, 2018
Device Name
Trade Name:	SeaSpine Regatta Lateral System
Common Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Classification Name:	Intervertebral body fusion device (21 CFR 888.3080)
Product Code:	MAX

Legally Marketed Predicate Devices

510(k)Number	ProductCode	Trade Name	Manufacturer
PRIMARY PREDICATE Device
K112986	MAX,OVD	Vu a•POD-L IntervertebralFusion Device	SeaSpine OrthopedicsCorporation(formerly Integra LifeSciences,Inc.)
Additional PREDICATE Device
K142488	MAX	Vu a•POD-L IntervertebralFusion Device	SeaSpine OrthopedicsCorporation
K162351	OVD	Vu a•POD PrimeNanoMetalene	SeaSpine OrthopedicsCorporation

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Image /page/4/Picture/2 description: The image contains the logo for SeaSpine. The logo consists of a stylized wave graphic in blue on the left, followed by the word "SeaSpine" in orange. The wave graphic appears to be made up of several curved lines, suggesting movement or water.

Device Description

Intended Use/Indications for use

The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.

The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.

Summary of Technological Characteristics

The SeaSpine Regatta Lateral System and the predicate device have the same operational principle; they act as a disc spacer and hold bone graft to promote fusion in the lumbar spine. The SeaSpine Regatta Lateral System is similar to the cited predicate devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).

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

· Same widths and heights
· Similar lordotic angles
Implant Materials: PEEK, Tantalum, CP Titanium
Markers for radiographic visualization
· Instrumentation

The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.

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SeaSpine

Non-Clinical Testing

Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing was verified for the Regatta Lateral System through engineering analysis.

Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 106 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.

Clinical Testing

Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.

Conclusions

The submitted data demonstrate that the SeaSpine Regatta Lateral System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate device.

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.