(46 days)
No
The summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a stand-alone interbody fusion device used in anterior cervical fusion procedures for degenerative disc disease, which is designed to treat a medical condition.
No
Explanation: The device is an implantable system for anterior cervical interbody fusion procedures. It is used for treatment and not for diagnosing a condition.
No
The device description clearly outlines physical components made of PEEK and titanium alloy, including spacers, plates, screws, and a locking cover. It also mentions instruments for placement and sterilization. This is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine". This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "implant assembly composed of a single use PEEK cervical spacer... and a titanium alloy... plate with titanium alloy variable angle or fixed bone screws, and a titanium alloy locking cover." These are physical implants designed to be surgically placed within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. The description of the SeaSpine® Shoreline™ ACS does not involve any testing of biological samples.
Therefore, the SeaSpine® Shoreline™ ACS is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
OVE
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
April 29, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
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
1
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
2
Indications for Use
510(k) Number (if known) K190655
Device Name
SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System
Indications for Use (Describe)
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.
| 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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3
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 Cervical
Standalone 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- Anterior | |
| Cervical Standalone System | SeaSpine Orthopedics | ||
| Corporation | |||
| ADDITIONAL PREDICATE | |||
| K161081 | OVE | Shoreline™ ACS- Anterior | |
| Cervical Standalone System | SeaSpine Orthopedics | ||
| Corporation |
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
4
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.
Intended Use/Indications for use
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.
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
5
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.