When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and supplemental fixation.

Device Description

The SeaSpine Skipjack System is an intervertebral fusion device with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacers are manufactured from Titanium Alloy per ASTM F136 and consist of two different options: an adjustable, expanding spacer and an adjustable, lordotic angle option. All implants and instruments are provided non-sterile in system-specific travs and are to be sterilized by the end user. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SeaSpine Skipjack System, an intervertebral body fusion device. This type of submission to the FDA focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance through clinical studies. Therefore, the document explicitly states:

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

Based on this statement, it is impossible to provide information regarding device performance, acceptance criteria, or the details of a study proving the device meets these criteria as requested in your prompt.

The document is for a medical device (an intervertebral body fusion device), not an Artificial Intelligence (AI) or software as a medical device (SaMD) product. Your request for information regarding AI-specific criteria such as MRMC studies, standalone algorithm performance, training/test set sample sizes, and ground truth establishment is not applicable to the device described in this 510(k) submission.

Therefore, I cannot fulfill your request with the information provided in the input text.

Summary

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March 13, 2020

SeaSpine Orthopedics Corporation Ms. Aly Alvarez Sr. Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008

Re: K193418

Trade/Device Name: SeaSpine Skipjack System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: February 13, 2020 Received: February 18, 2020

Dear Ms. Alvarez:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 L. Showalter, PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193418

Device Name SeaSpine Skipjack System

Indications for Use (Describe)

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

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:Phone number:Fax number:	5770 Armada Drive, Carlsbad CA(760) 216-5622(760) 683-6874
Contact person:	Aly Alvarez, Sr. Regulatory Affairs Specialist
Date Prepared:	February 13, 2020
Device Name

Trade Name:	SeaSpine Skipjack System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral fusion device with bone graft, lumbar(21 CFR 888.3080)
Class:	II
Product Code:	MAX

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name	Manufacturer
Primary Predicate Device
K153786	MAX	Prow Fusion-V (Rebranded toSkipjack System)	SeaSpine OrthopedicsCorporation (originallysubmitted by NLTSpine)
Additional Predicate Devices
K133418	MAX	Expandable Intervertebral BodyFusion Device (IBD) System	SeaSpine OrthopedicsCorporation (formerlyIntegra)
	MAX	SeaSpine Spacer System(NanoMetalene) – Hollywood,Hollywood VI, Ventura, Pacifica
K173260	MAX, MQP	SeaSpine Spacer System –Hollywood, Hollywood VI,Ventura, Pacifica	SeaSpine OrthopedicsCorporation
	MAX, MQP	SeaSpine Vu e-POD System

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Device Description

Intended Use/Indications for Use

Summary of Technological Characteristics

The SeaSpine Skipiack System is identical or similar to the cited predicate devices in regard to components, device description, intended use/indications for use, technological characteristics (operating principle, design, materials, manufacturing, etc.) and performance (mechanical safety).

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.

Non-Clinical Testing

The SeaSpine Skipjack System demonstrated equivalent mechanical performance to the predicate system in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), expulsion and wear particulate testing (ASTM F1877).

Clinical Testing

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

Conclusions

The submitted data demonstrates that the SeaSpine Skipiack System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.

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.