(85 days)
Not Found
No
The summary describes a physical intervertebral body fusion device and associated instruments, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is an intervertebral body fusion device indicated for use as an adjunct to fusion in patients with degenerative disc disease, which is a therapeutic intervention.
No
The device is an intervertebral body fusion device (IBD) intended for surgical implantation to treat degenerative disc disease, not to diagnose it. While its use is tied to confirmed diagnosis via radiographic studies, the device itself is a treatment, not a diagnostic tool.
No
The device description clearly states it is an intervertebral body fusion device (IBD) manufactured from PEEK with tantalum markers and a titanium surface, and includes instruments for placement. This indicates a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The SeaSpine Regatta Lateral System is an implantable intervertebral body fusion device. It is a physical object inserted into the body to aid in spinal fusion.
- Intended Use: The intended use is to provide structural support and facilitate fusion in the lumbar spine. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a surgical implant and its intended use in a surgical procedure, not a diagnostic test performed outside the body.
N/A
Intended Use / Indications for Use
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The SeaSpine Regatta Lateral System is an intervertebral body fusion device (IBD) with large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacer has a bulleted insertion end for ease of implantation and tantalum markers to allow easier radiological assessment of the spacer position and orientation. The spacers are manufactured from PEEK (ASTM F2026) with radiographic markers manufactured from tantalum (ASTM F560), with a one-micron thick surface of commercially pure (CP) titanium (ASTM F67), and sterile packaged. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays 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
lumbar spine, from L2 to S1
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: Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing was verified for the Regatta Lateral System through engineering analysis. 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.
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
Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
SeaSpine Orthopedics Corporation Ms. Gina Flores Specialist Regulatory Affairs 5770 Armada Drive Carlsbad, California 92008
Re: K181079
Trade/Device Name: SeaSpine Regatta Lateral System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: April 24, 2018 Received: April 25, 2018
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 of medical device-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.
July 18, 2018
1
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 mediation-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,
Brent Showalter -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)
K181079
Device Name SeaSpine Regatta Lateral System
Indications for Use (Describe)
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use 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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510(k) Summary
Contact Details
Class:
| 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, Sr. Regulatory Specialist |
| Email address: | gina.flores@seaspine.com |
| Date Prepared: | April 23, 2018 |
| Device Name | |
| Trade Name: | SeaSpine Regatta Lateral System |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| Product Code: | MAX |
Legally Marketed Predicate Devices
II
| 510(k)
Number | Product
Code | Trade Name | Manufacturer |
|-----------------------------|-----------------|--------------------------------------------|---------------------------------------------------------------------------------|
| PRIMARY PREDICATE Device | | | |
| K112986 | MAX,
OVD | Vu a•POD-L Intervertebral
Fusion Device | SeaSpine Orthopedics
Corporation
(formerly Integra LifeSciences,
Inc.) |
| Additional PREDICATE Device | | | |
| K142488 | MAX | Vu a•POD-L Intervertebral
Fusion Device | SeaSpine Orthopedics
Corporation |
| K162351 | OVD | Vu a•POD Prime
NanoMetalene | SeaSpine Orthopedics
Corporation |
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Image /page/4/Picture/2 description: The image contains the logo for SeaSpine. The logo consists of a stylized wave graphic in blue on the left, followed by the word "SeaSpine" in orange. The wave graphic appears to be made up of several curved lines, suggesting movement or water.
Device Description
The SeaSpine Regatta Lateral System is an intervertebral body fusion device (IBD) with large central graft windows, which are packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The spacer has a bulleted insertion end for ease of implantation and tantalum markers to allow easier radiological assessment of the spacer position and orientation. The spacers are manufactured from PEEK (ASTM F2026) with radiographic markers manufactured from tantalum (ASTM F560), with a one-micron thick surface of commercially pure (CP) titanium (ASTM F67), and sterile packaged. The instruments included with the system facilitate the placement and adjustment of the interbody spacer, and removal if necessary. The instruments are placed in trays for storage, protection, and organization prior to and during the steam sterilization process.
Intended Use/Indications for use
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft and/or allogeneic bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
Summary of Technological Characteristics
The SeaSpine Regatta Lateral System and the predicate device have the same operational principle; they act as a disc spacer and hold bone graft to promote fusion in the lumbar spine. The SeaSpine Regatta Lateral System is similar 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 device are based on the following similar technological elements:
- · Same widths and heights
- · Similar lordotic angles
- Implant Materials: PEEK, Tantalum, CP Titanium
- Markers for radiographic visualization
- · Instrumentation
The implants are used to treat the same conditions, have essentially the same precautions and contraindications for use, and represent a basic design concept in terms of safety and effectiveness, and differ only in design details and not functionality.
5
SeaSpine
Non-Clinical Testing
Mechanical performance in compression and compression-shear (ASTM F2077), subsidence (ASTM F2267), and expulsion testing was verified for the Regatta Lateral System through engineering analysis.
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 SeaSpine Regatta Lateral System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate device.