(100 days)
Not Found
No
The summary describes a physical interbody fusion device made of PEEK and titanium, with no mention of software, algorithms, or any AI/ML related terms. The performance studies focus on mechanical properties and sterility, not algorithmic performance.
Yes
The device is an interbody fusion device intended for use in patients with degenerative disc disease of the cervical spine, designed to aid in spinal fusion procedures.
No
Explanation: The device is an interbody fusion device intended for use in spinal fusion procedures, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one, even though degenerative disc disease is confirmed by "radios", suggesting imaging-based diagnosis.
No
The device description clearly details physical components made of PEEK and titanium alloy, which are hardware. The intended use also describes an implantable device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is a physical device used to treat a condition within the body.
- Device Description: The description details the materials and construction of a surgical implant (PEEK spacer, titanium alloy plate, screws, and locking cover).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a surgical implant.
N/A
Intended Use / Indications for Use
The Shoreline Cervical Interbody RT 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 radios. 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 graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System 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 the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVE, ODP
Device Description
The SeaSpine Shoreline Anterior Cervical Standalone (ACS) System consists of the implant assembly 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.
The Shoreline ACS System offers spacers in low profile (TruProfile) and no profile versions. Both TruProfile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).
The subject Shoreline Cervical Interbody RT System is a NanoMetalene titanium bonded device offered in a variety of footprints and heights to accommodate variations in patient anatomy. The low-profile spacer is box-shaped with a central canal for receiving autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone material.
The Shoreline Cervical Interbody RT System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with the Shoreline ACS bone screw fixation and locking cover.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Cervical spine (C3-C7)
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 Shoreline Cervical Interbody RT System demonstrated equivalent performance to the predicate Shoreline ACS system through static and dynamic compression, compression shear, and torsion per ASTM F2077, and subsidence per ASTM F2267.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 106 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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.
K170569, K161081, K162715, K171046, K172926, K111675, K101363, K050058, K032064, K173722
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
February 14, 2019
SeaSpine Orthopedics Corporation Gina Flores Specialist, Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K183083
Trade/Device Name: Shoreline Cervical Interbody RT System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: January 16, 2019 Received: January 17, 2019
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. 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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).
Sincerelv.
Katherine D. Kavlock -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) K183083
Device Name Shoreline Cervical Interbody RT System
Indications for Use (Describe)
The Shoreline Cervical Interbody RT 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 radios. 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 graft and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When used as a standalone system, the Shoreline Cervical Interbody RT System 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 the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two contiguous levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
| 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: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (760) 216-5136 | |
| (760) 683-6874 | |
| Contact person: | |
| Email address: | Gina Flores, Sr. Regulatory Specialist |
| gina.flores@seaspine.com | |
| Date Prepared: | February 11, 2019 |
| Device Name |
| Trade Name: | Shoreline Cervical Interbody RT 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 | Manufacturer | ||
|---|---|---|---|---|---|
| PRIMARY PREDICATE Device | |||||
| K170569 | OVE | Shoreline ACS- | |||
| Anterior Cervical | |||||
| System | SeaSpine Orthopedics | ||||
| Corporation | |||||
| Additional Predicate Device | |||||
| K161081 | OVE | Shoreline ACS- | |||
| Anterior Cervical | |||||
| System | SeaSpine Orthopedics | ||||
| Corporation | |||||
| K162715,K171046 | ODP, MAX | Cambria | |||
| NanoMetalene Sterile | SeaSpine Orthopedics | ||||
| Corporation | |||||
| K172926, K111675, | |||||
| K101363, K050058, | |||||
| K032064 | ODP, OVE | Vu c·POD | SeaSpine Orthopedics | ||
| Corporation | |||||
| (originally manufactured by | |||||
| Integra LifeSciences, now | |||||
| SeaSpine Orthopedics | |||||
| Corporation) |
4
| K173722 | ODP | Patriot Colonial
Spacer | Globus Medical Inc. |
| --------- | ----- | ---------------------------- | --------------------- |
|---|
Device Description
The SeaSpine Shoreline Anterior Cervical Standalone (ACS) System consists of the implant assembly 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.
The Shoreline ACS System offers spacers in low profile (TruProfile) and no profile versions. Both TruProfile and no profile spacers are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene (NM).
The subject Shoreline Cervical Interbody RT System is a NanoMetalene titanium bonded device offered in a variety of footprints and heights to accommodate variations in patient anatomy. The low-profile spacer is box-shaped with a central canal for receiving autograft bone and/or allogenic bone graft composed of cancellous, cortical and/or corticocancellous bone material.
The Shoreline Cervical Interbody RT System can be used with supplemental fixation, such as an anterior plate or as a standalone construct to be used with the Shoreline ACS bone screw fixation and locking cover.
Intended Use/Indications for use
Shoreline Cervical Interbody RT System
The Shoreline Cervical Interbody RT 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 Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at a single level (C2-T1) and must be used with the Shoreline ACS bone screw fixation and locking cover.
When used with supplemental fixation, such as anterior cervical plates, the Shoreline Cervical Interbody Spacer Shoreline Cervical Interbody RT System is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C3-C7).
When the system is used at two contiguous levels, the Shoreline Cervical Interbody RT System must be used with supplemental fixation.
5
Summary of Technological Characteristics
The Shoreline Cervical Interbody RT System and predicate devices have the same operational principle; they act as a disc spacer and hold bone graft. The Shoreline Cervical Interbody RT System 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 Shoreline ACS devices are based on the following similar technological elements:
- Implant Spacer Heights
- Spacer Footprints
- Spacer Lordotic Angles ●
- Screw Sizes and Lengths .
Non-Clinical Testing
The Shoreline Cervical Interbody RT System demonstrated equivalent performance to the predicate Shoreline ACS system through static and dynamic compression, compression shear, and torsion per ASTM F2077, and subsidence per ASTM F2267.
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 106 and ensure maintenance of a sterile barrier. Bacterial Endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrate that the Shoreline Cervical Interbody RT System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.