(89 days)
MQP, MAX
Not Found
No
The summary describes a physical implantable device (spacer) made of PEEK for spinal fusion and vertebral body replacement. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on mechanical testing, not algorithmic performance.
Yes
The device is described as an implantable system used for spinal fusion and vertebral body replacement to treat degenerative disc disease, tumor, or trauma/fracture, aiming to restore biomechanical integrity and decompress neural tissues, which directly addresses therapeutic goals.
No
Explanation: The device is an implantable surgical spacer system intended for spinal fusion or vertebral body replacement, not for diagnosing medical conditions.
No
The device description explicitly states it is an "implantable device made from polyetheretherketone (PEEK) with markers for radiographic visualization," indicating it is 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 examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The SeaSpine Spacer System is an implantable surgical device used to replace or fuse parts of the spine. It is physically placed within the patient's body.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion or vertebral body replacement, not the analysis of biological specimens.
- Device Description: The description details the material (PEEK) and physical characteristics of an implant, not a diagnostic test kit or instrument.
The information provided describes a Class II or Class III medical device used in surgery, not an IVD.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
Product codes
MQP, MAX
Device Description
The SeaSpine Spacer System is an implantable device made from polyetheretherketone (PEEK) with markers for radiographic visualization. The device has a central canal for receiving bone graft and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal, L2-S1, Thoracolumbar Spine (T1 to L5)
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)
Mechanical testing results indicated that the SeaSpine Spacer System possessed appropriate properties for its intended use and is substantially equivalent to the predicate devices. Clinical data was not required for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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.
0
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K082310 Page 1 of 2
NOV 1 0 2008
510(k) Summary
| Company Name: | SeaSpine, Inc.
2302 La Mirada Drive
Vista, CA 92081 | | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Jeff Brittan
Senior Project Engineer
E-mail: jbrittan@seaspine.com
Phone: (760) 727-8399 x213, Fax: (760) 727-8809 | | |
| Date Prepared: | August 11, 2008 | | |
| Trade Name: | SeaSpine Spacer System - Hollywood™, Pacifica™, Redondo™, Ventura™ | | |
| Common Name: | Vertebral Body Replacement Device
Interbody Fusion Device | | |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis
Intervertebral Body Fusion Device | | |
| Classification Number (s)/Product Codes(s): | 21 CFR 888.3060, Product Code MQP, Class II
Orthopedic Review Committee
21 CFR 888.3080, Product Code MAX, Class II
Orthopedic Review Committee | | |
| Device Description: | The SeaSpine Spacer System is an implantable device made from
polyetheretherketone (PEEK) with markers for radiographic visualization.
The device has a central canal for receiving bone graft and is offered in a
variety of sizes and geometries to accommodate variations in pathology
and patient anatomy. | | |
| Intended Use: | When used as an intervertebral body fusion device, the SeaSpine Spacer
System is intended for spinal fusion procedures at one or two contiguous
levels (L2-S1) in skeletally mature patients with degenerative disc disease
(DDD). DDD is defined as back pain of discogenic origin with degeneration
of the disc confirmed by history and radiographic studies. DDD patients
may also have up to Grade 1 spondylolisthesis or retrolisthesis at the
involved level(s). These patients may have had a previous non-fusion spinal
surgery at the involved spinal level(s). These patients should have had six
months of non-operative treatment. The device is intended to be used
with autogenous bone graft and supplemental fixation. | | |
| | When used as a vertebral body replacement device (VBR), the SeaSpine
Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to
replace a collapsed, diseased, damaged or unstable complete or partial | | |
・
1
device.
·
| | vertebral body due to tumor or trauma/fracture, to achieve anterior
decompression of the spinal cord and neural tissues, and to restore the
height of a collapsed vertebral body. The SeaSpine Spacer System is
designed to restore the biomechanical integrity of the anterior, middle, and
posterior spinal column, even in the absence of fusion for a prolonged
period. Additionally, the device is intended for use with bone graft. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence: | The SeaSpine Spacer System was shown to be substantially equivalent to
the predicate devices through comparison in areas including use, design,
materials, and function. |
| Performance Data: | Mechanical testing results indicated that the SeaSpine Spacer System
possessed appropriate properties for its intended use and is substantially
equivalent to the predicate devices. Clinical data was not required for this |
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, alongside the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the emblem. The caduceus is depicted with a staff entwined by two snakes and topped with wings, a common representation of medicine and healing. The overall design is simple and monochromatic, emphasizing the official nature of the seal.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SeaSpine, Inc. % Mr. Jeffrey Brittan Senior Project Engineer 2302 La Mirada Drive Vista, California 92081-7862
NOV 1 0 2008
Re: K082310
Trade/Device Name: SeaSpine Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MQP Dated: August 11, 2008 Received: August 13. 2008
Dear Mr. Brittan:
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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
3
Page 2 - Mr. Jeffrey Brittan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, periods your levice to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmanlet Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M Wilkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
1082310 510(k) Number (if known): _
Device Name: SeaSpine Spacer System
Indications for Use:
When used as an intervertebral body fusion device, the SeaSpine Spacer System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft and supplemental fixation.
When used as a vertebral body replacement device (VBR), the SeaSpine Spacer System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SeaSpine Spacer System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the device is intended for use with bone graft.
Prescription Use א (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number