(149 days)
No
The description focuses on the physical components, materials, and mechanical properties of the device, with no mention of AI or ML capabilities.
Yes
The device is described as an implant assembly used for cervical interbody fusion procedures to treat degenerative disc disease, which aims to alleviate symptoms and restore function, classifying it as therapeutic.
No
The Shoreline ACS device is an interbody fusion device designed to provide stability and promote fusion in the cervical spine. It is a therapy device, not a diagnostic one.
No
The device description clearly outlines physical components made of PEEK, titanium alloy, and tantalum, including implants, plates, screws, and locking covers. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the Shoreline ACS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a physical implant designed to be placed within the body.
- Performance Studies: The performance studies focus on mechanical testing (compression, shear, torsion, subsidence, wear particle analysis) which are relevant to the structural integrity and biocompatibility of an implant, not the diagnostic performance of a test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Shoreline ACS device is a surgical implant used to treat a condition, not to diagnose it.
N/A
Intended Use / Indications for Use
The Shoreline ACS device 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 nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.
Product codes
OVE
Device Description
The SeaSpine Shoreline™ ACS (Anterior Cervical Standalone) System consists of the implant assembly, associated instrumentation as well as caddies and trays that may be used for storage and organization. The implant assembly is composed of a 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. Low profile versions have minimal profile anterior to the disc space (1.6mm), while no profile versions have zero profile. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM). Alternatively, the no profile spacer is available without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine at a single level (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical Testing: The SeaSpine Shoreline™ ACS demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877.
Clinical Testing: No clinical testing was required to demonstrate equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 14, 2016
SeaSpine Orthopedics Corporation Ms. Jenny Fam Sr. Director, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K161081
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: August 12, 2016 Received: August 15, 2016
Dear Ms. Fam:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161081
Device Name
SeaSpine Shoreline™ ACS - Anterior Cervical Standalone System
Indications for Use (Describe)
The Shoreline ACS device is a stand-alone device interior cervical interbody fusion procedures in sketally mature patients with degenerative disc disease of the cervical spine at a single level (C2-T ). 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 (0) weeks of nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline 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) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
K161081 510(k) Summary
Contact Details
| Applicant Name: | SeaSpine Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad, CA 92008 |
| (760) 216-5104 | |
| (760) 683-6874 | |
| Contact person: | |
| Email address: | Jenny Fam, Sr. Director, Regulatory Affairs |
| jenny.fam@seaspine.com | |
| Date Prepared: | September 6, 2016 |
| 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 per 21 CFR |
| 888.3080 | |
| Product Code: | OVE |
| Class: | II |
Legally Marketed Predicate and Reference Devices
| 510(k)
| Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| PREDICATE Device | |||
| K151939 | OVE | Coalition | Globus Medical, Inc. |
| REFERENCE Devices | |||
| K150053 | OVE | Stalif c; Stalif c-ti | Centinel Spine,Inc. |
| K092521 | OVE | Zuma-C | SeaSpine, Inc. |
| K142488 | ODP | Cambria NanoMetalene | SeaSpine, Inc. |
Device Description
The SeaSpine Shoreline™ ACS (Anterior Cervical Standalone) System consists of the implant assembly, associated instrumentation as well as caddies and trays that may be used for storage and organization. The implant assembly is composed of a 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. Low profile versions have minimal profile anterior to the disc space (1.6mm), while no profile versions have zero profile. Both low profile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM). Alternatively, the no profile spacer is available
4
without a NanoMetalene® coating. Both low profile and no profile versions of the spacers are available in a standard lordotic angle. The Low Profile spacer will also be offered in multiple lordosis versions. The SeaSpine 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.
Intended Use/Indications for Use
The Shoreline ACS device 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 nonoperative treatment. The cervical device is to be used with Shoreline bone screw fixation and the Shoreline locking cover.
Comparison of Technological Characteristics
The SeaSpine Shoreline™ ACS is substantially equivalent to the cited predicate and reference devices in areas including intended use/indications for use, technological characteristics (operating principle, design, materials, sterility, manufacturing, etc.) and performance (mechanical safety).
| Intended Use | Materials | Design | Mechanical Testing | |
|---|---|---|---|---|
| Subject Device: | ||||
| SeaSpine Shoreline™ | ||||
| ACS | Single level | |||
| cervical spinal | ||||
| fusion via anterior | ||||
| approach for | ||||
| skeletally mature | ||||
| patients with | ||||
| Degenerative Disc | ||||
| Disease (DDD) | Equivalent or | |||
| similar materials: | ||||
| PEEK-OPTIMA per | ||||
| ASTM 2026 | ||||
| Titanium alloy | ||||
| (ASTM F136), | ||||
| Tantalum, (ASTM | ||||
| F560), CP Titanium | ||||
| Surface (ASTM | ||||
| F67) | Equivalent or | |||
| similar spacer | ||||
| height, | ||||
| footprint, | ||||
| lordotic angle | ||||
| and screw/plate | ||||
| dimensions | Mechanical testing: | |||
| Static/Dynamic torsion | ||||
| (ASTM F2077), | ||||
| Static/Dynamic axial | ||||
| compression (ASTM F2077), | ||||
| Static/Dynamic compression | ||||
| shear (ASTM F2077), | ||||
| Subsidence (ASTM F2267), | ||||
| Wear evaluation (ASTM | ||||
| F1877) | ||||
| Predicate/Reference | ||||
| Devices: | ||||
| Globus Coalition | ||||
| SeaSpine Cambria NM | ||||
| SeaSpine Zuma-C | ||||
| Centinel Spine Stalif | ||||
| C/C-Ti | Single level | |||
| cervical spinal | ||||
| fusion via anterior | ||||
| approach for | ||||
| skeletally mature | ||||
| patients with | ||||
| Degenerative Disc | ||||
| Disease (DDD) | Some or all of the | |||
| following materials: | ||||
| PEEK-OPTIMA per | ||||
| ASTM 2026 | ||||
| Titanium alloy | ||||
| (ASTM F136), | ||||
| Tantalum, (ASTM | ||||
| F560), CP Titanium | ||||
| Surface (ASTM | ||||
| F67) | Various spacer | |||
| height, | ||||
| footprint, | ||||
| lordotic angle | ||||
| and screw/plate | ||||
| dimensions | Some or all of the following | |||
| testing: Static/Dynamic | ||||
| torsion (ASTM F2077), | ||||
| Static/Dynamic axial | ||||
| compression (ASTM F2077), | ||||
| Static/Dynamic compression | ||||
| shear (ASTM F2077), | ||||
| Subsidence (ASTM F2267), | ||||
| Wear evaluation (ASTM | ||||
| F1877), Expulsion |
Non-clinical Testing
The SeaSpine Shoreline™ ACS demonstrated equivalent performance to the Globus predicate through static and dynamic compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and wear particle analysis per ASTM F1877.
Clinical Testing
No clinical testing was required to demonstrate equivalence.
Conclusions
The submitted data demonstrate that the SeaSpine Shoreline™ ACS is substantially equivalent to the cited legally marketed predicate devices; it is as safe, as effective, and performs at least as safely and effectively.