(108 days)
Not Found
No
The summary describes a physical implant and associated instruments for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is an interbody fusion system designed to treat degenerative disc disease of the cervical spine, which is a condition that causes pain and limits function, aiming to restore proper spinal alignment and promote fusion, thereby providing a therapeutic benefit to the patient.
No
The device description clearly states it is an "Anterior Cervical Standalone System" consisting of a cervical spacer, plate, screws, and locking cover, designed for "anterior cervical interbody fusion procedures." Its purpose is to physically support and stabilize the spine, not to identify or assess a medical condition.
No
The device description clearly outlines physical components made of PEEK, titanium alloy, and tantalum, including spacers, plates, screws, and instruments. It also mentions sterilization and packaging, indicating a physical medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The SeaSpine® Shoreline™ ACS is a surgical implant designed for anterior cervical interbody fusion procedures. It is a physical device implanted into the body to provide structural support and facilitate bone fusion.
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any biological specimens. Its function is mechanical and structural within the body.
Therefore, the SeaSpine® Shoreline™ ACS falls under the category of a surgical implant or medical device, 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 (comma separated list FDA assigned to the subject device)
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 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).
The no profile versions of the spacers are available in a standard lordotic angle, while the low profile spacer is offered in multiple lordosis 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 trays 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The SeaSpine® Shoreline™ ACS System demonstrated equivalent performance to the predicate Shoreline system through engineering analysis of static and dynamic compression, compression shear, and torsion per ASTM F2077, subsidence per ASTM F2267, and wear particle analysis per ASTM F1877, as well as screw push out testing.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing:
No clinical testing was required to demonstrate equivalence.
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.
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
§ 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
June 15, 2017
Public Health Service
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a symbolic representation of a parent and child.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SeaSpine Orthopedics Corporation Ms. Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K170569
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: May 12, 2017 Received: May 15, 2017
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 (reporting of medical device
1
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.
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" (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 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, Vincent J. Devlin -S 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) K170569
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) 216-5136 |
| Fax number: | (760) 683-6874 |
| Contact person: | Gina Flores, Regulatory Specialist |
| Email address: | gina.flores@seaspine.com |
| Date Prepared: | May 9, 2017 |
| 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 | |||
| K161081 | OVE | Shoreline™ ACS- Anterior | |
| Cervical Standalone System | SeaSpine® Orthopedics | ||
| Corporation | |||
| Additional PREDICATE Devices | |||
| K151939 | OVE, ODP, | ||
| KWQ | Coalition™ | Globus® Medical, Inc. | |
| K162715 | ODP | Cambria NanoMetalene Sterile | SeaSpine® Orthopedics |
| Corporation |
4
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 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).
The no profile versions of the spacers are available in a standard lordotic angle, while the low profile spacer is offered in multiple lordosis 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 trays 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 Shoreline bone screw fixation and the Shoreline locking cover.
5
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 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
- o Spacer Lordotic Angles
- Screw Sizes and Lengths
- Anterior Plates ●
Non-Clinical Testing
The SeaSpine® Shoreline™ ACS System demonstrated equivalent performance to the predicate Shoreline system through engineering analysis of static and dynamic compression, compression shear, and torsion per ASTM F2077, subsidence per ASTM F2267, and wear particle analysis per ASTM F1877, as well as screw push out testing.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing
No clinical testing was required to demonstrate equivalence.
Conclusions
The submitted data demonstrate that the SeaSpine® Shoreline™ ACS System is substantially equivalent to the cited legally marketed predicate.