(89 days)
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 the use of AI/ML.
Yes
The device is an interbody fusion device intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease, which aims to treat a medical condition.
No
Explanation: The device is described as an interbody fusion device intended for use in surgical procedures to treat degenerative disc disease, not to diagnose it.
No
The device description explicitly states that the Shoreline Anterior Cervical System (ACS) consists of physical components including a PEEK cervical spacer, a titanium alloy plate, bone screws, and a locking cover. It also mentions instruments for placement and sterilization. This indicates it is a hardware medical device, not software-only.
Based on the provided text, 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 procedures. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device description details physical components like spacers, plates, screws, and instruments used for implantation.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant placed within the body.
N/A
Intended Use / Indications for Use
The Shoreline ACS (Anterior Cervical System) are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one 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 low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
Product codes
OVE, ODP
Device Description
The Shoreline Anterior Cervical System (ACS) 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, cortical, and/or corticocancellous bone. The system is implanted via an anterior approach.
The system offers spacers in low profile (TruProfile) and no profile versions. Both are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM), bonded to PEEK. The 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
healthcare facility
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 subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject device does not introduce a new worst-case. Engineering analyses of the modifications to Shoreline ACS determined that no additional mechanical testing was necessary.
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)
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.
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September 14, 2020
SeaSpine® Orthopedics Corporation Ms. Jesse Albright Regulatory Affairs Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K201646
Trade/Device Name: Shoreline ACS (Anterior Cervical System) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE, ODP Dated: June 16, 2020 Received: June 17, 2020
Dear Ms. Albright:
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
1
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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Indications for Use
510(k) Number (if known) K201646
Device Name Shoreline ACS (Anterior Cervical System)
Indications for Use (Describe)
The Shoreline ACS (Anterior Cervical System) are interbody fusion devices intended for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous, cortical, and/ or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.
When used as a standalone system, Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one 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 low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two 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) |
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K201646 - 510(k) Summary
Contact Details
| Applicant Name: | SeaSpine® Orthopedics Corporation | |
|---|---|---|
| Address: | 5770 Armada Drive, Carlsbad CA | |
| Phone number: | (760) 216-5176 | |
| Fax number: | (760) 683-6874 | |
| Primary Contact: | Alicia McArthur, Regulatory Affairs Specialist | |
| Secondary Contact: | Jesse Albright, Regulatory Affairs Specialist | |
| Date Prepared: | August 7, 2020 | |
| Device Name | ||
| Trade Name: | Shoreline ACS (Anterior Cervical System) | |
| Common Name: | Intervertebral Body Fusion Device | |
| Classification Name: | Intervertebral fusion device with bone graft, cervica | |
| (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 | |||
| K190655 | OVE | Shoreline ACS (Anterior | |
| Cervical Standalone) | |||
| System | SeaSpine Orthopedics | ||
| Corporation | |||
| Additional Predicate Device | |||
| K183083 | OVE, ODP | Shoreline Cervical | |
| Interbody RT System | SeaSpine Orthopedics | ||
| Corporation |
Device Description
The Shoreline Anterior Cervical System (ACS) 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
4
graft material and/or allogeneic bone graft composed of cancellous, cortical, and/or corticocancellous bone. The system is implanted via an anterior approach.
The system offers spacers in low profile (TruProfile) and no profile versions. Both are available with a surface coating of commercially pure titanium (ASTM F67) referred to as NanoMetalene® (NM), bonded to PEEK. The 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.
Indications for Use
The Shoreline ACS (Anterior Cervical System) are interbody fusion devices intended for antenor cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Shoreline ACS implants are to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous, cortical, and /or corticocancellous bone and implanted via an anterior approach. The device is to be used in patients who have had at least six (6) weeks of non-operative treatment.
When used as a standalone system. Shoreline ACS is intended to be used as an adjunct to spinal fusion procedures at one 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 low profile (TruProfile) Interbody Spacer is intended to be used as an adjunct to spinal fusion procedures at one or two levels of the cervical spine (C2-T1).
Summary of Technological Characteristics
Shoreline ACS and predicate devices have 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. Shoreline ACS is substantially equivalent to the cited predicate device 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 ●
- Spacer Lordotic Angles
- Screw Sizes and Lengths
- Anterior Plates
K201646 510(k) Summary Page 2 of 3
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Non-Clinical Testing
The subject implants are the same as the predicate devices in terms of materials, sizes, and intended use. The subject device does not introduce a new worst-case. Engineering analyses of the modifications to Shoreline ACS determined that no additional mechanical testing was necessary.
Clinical Testing
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
Conclusions
The submitted data demonstrates that the subject Shoreline Anterior Cervical System (ACS) has been shown to be substantially equivalent to legally marketed predicate devices for its intended use.