Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical implant (interbody fusion device) and associated instruments. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The testing described is mechanical performance testing.

Therapeutic

Yes
The device is described as an "interbody fusion device" and is intended to treat degenerative disc disease, which involves mitigating a medical condition.

Diagnostic

No

Explanation: The device is described as an "interbody fusion device" and an "additively manufactured implant comprised of cervical spacers" used in spinal fusion procedures. Its purpose is treatment, not diagnosis, as it aids in fusing vertebrae rather than identifying a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "additively manufactured implant comprised of cervical spacers" made from "Ti-6Al-4V titanium alloy," which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the SeaSpine WaveForm™ C Interbody System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The SeaSpine WaveForm™ C Interbody System is an implantable medical device (a cervical spacer) used in spinal fusion surgery. It is physically placed within the patient's body.
Intended Use: The intended use is for surgical treatment of degenerative disc disease in the cervical spine by providing structural support and facilitating bone fusion. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.

The description clearly indicates a surgical implant and associated instruments for a surgical procedure, which falls under the category of medical devices, but not IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1), and must be used with bone screw fixation and locking covers.

When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).

Product codes

OVE, ODP

Device Description

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™C Interbody System offers spacers in low profile (TruProfile) and no profile versions and are manufactured from Ti-6Al-4V titanium alloy per ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine (C2-T1)

Indicated Patient Age Range

skeletally mature patients

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The WaveForm™ C Interbody System has been testing in accordance with requirements outlined in ASTM F2077, F2267, and F1877.

The submitted data demonstrates that the SeaSpine WaveForm™ C Interbody System performs at least as safely and effectively as the cited legally marketed predicate.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161081, K151939, K173115, K183083

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

Image /page/0/Picture/0 description: The image shows 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.

September 18, 2020

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

Re: K201073

Trade/Device Name: SeaSpine WaveForm™ C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: August 18, 2020 Received: August 19, 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.

1

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 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 medical devices and radiation-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 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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K201073

Device Name WaveForm™ C Interbody System

Indications for Use (Describe)

Intended Use/Indications for Use

The SeaSpine WaveForm™ C Interbody System are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two contiguous levels, depending on the system. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.

When used as a standalone system, the WaveForm™ C Interbody System, including the Low Profile and No-Profile standalone interfixated spacer, is intended to be used as an adjunct to spinal fusion procedures at a single level of the cervical spine (C2-T1), and must be used with bone screw fixation and locking covers.

When used with supplemental fixation, such as anterior cervical plates, the WaveForm™ C Interbody System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C2-T1).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

3

510(k) Summary

Contact Details

Applicant Name:	SeaSpine Orthopedics Corporation
Address:	5770 Armada Drive, Carlsbad CA
Phone number:	(619) 884-4342
Fax number:	(760) 683-6874
Contact person:	Aly Alvarez, Sr. Regulatory Affairs Specialist
Date Prepared:	April 21, 2020
Device Name
Trade Name:	SeaSpine WaveForm™ C Interbody System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral fusion device with bone graft, cervical
(21 CFR 888.3080)
Class:	II
Product Code:	OVE, ODP

Legally Marketed Predicate Devices

510(k) Number	Product Code	Trade Name
Primary Predicate Device
K161081	OVE	SeaSpine Shoreline ACS –
Anterior Cervical Standalone
System	SeaSpine Orthopedics
Corporation
Additional Predicate Devices
K151939	OVE, ODP,
KWQ	Coalition Spacers	Globus Medical, Inc.
K173115	ODP, KWQ,
OVE	Coalition Spacers	Globus Medical, Inc.
K183083	ODP, OVE	Shoreline Cervical Interbody RT
System	SeaSpine Orthopedics
Corporation

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Device Description

The SeaSpine WaveForm™ C Interbody System is an additively manufactured implant comprised of cervical spacers. Each spacer consists of central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical and/or corticocancellous bone prior to implantation. The WaveForm™C Interbody System offers spacers in low profile (TruProfile) and no profile versions and are manufactured from Ti-6Al-4V titanium alloy per ASTM F3001.

The WaveForm™ C Interbody System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with bone screw fixation and locking cover. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.