(134 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to treat a diseased or damaged vertebral body, decompress the spinal cord, and restore spinal height and biomechanical integrity. These actions classify it as a therapeutic intervention.
No
The device is a vertebral body replacement system, an implant used in surgery to replace part of the spine, and is not designed for diagnostic purposes.
No
The device description explicitly details physical components made of PEEK polymer, tantalum, stainless steel, Radel, and Pomalux, indicating it is a hardware-based medical device.
Based on the provided information, the SeaSpine VBR System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the materials and components of a surgical implant and associated instruments. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays
The SeaSpine VBR System is a medical device, specifically a surgical implant, used for structural support and restoration in the spine.
N/A
Intended Use / Indications for Use
The SeaSpine VBR 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 spiral cord and neural tissues, and to restore the height of a collapsed vertebral body.
The SeaSpine VBR 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 SeaSpine VBR System is intended for use with bone graft.
Product codes (comma separated list FDA assigned to the subject device)
MOP
Device Description
The SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are manufactured out of PEEK OPTIMA polymer with tantalum wires and/or beads. All VBR configurations will be offered in numerous lengths and sizes. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The SeaSpine VBR System will offer a wide variety of instruments that range from paddle scrapers to inserters. These various instruments will be made primarily from stainless steel with handles made from Radel or Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1 to L5)
Indicated Patient Age Range
Not Found
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)
The devices in this submission also underwent appropriate mechanical testing and those results were found to be substantially equivalent to those of the predicate devices.
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.
K050553, K042201, K010530, K020048, K040168, K050449, K033517
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
K052170 p/3
CONFIDENTIAL
DEC 2 1 2005
SeaSpine VBR System
510(K) SUMMARY
Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.
| Submitter Information: | SeaSpine, Inc.
Contact: Diana Smith
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Registration Number: | 2032593 |
| Submission Correspondent: | SeaSpine, Inc.
Contact: Diana Smith, Manager of
Regulatory Affairs and Quality Assurance
2302 La Mirada Drive
Vista, CA 92081-7862
Phone: 760-727-8399 Fax: 760-727-8809 |
| Date Summary Prepared: | August 5, 2005 |
| Classification Name: | Spinal Intervertebral Body Fixation
Orthosis
MQP (Class II) - 888.3060 |
| Common/Usual Name: | Straight Vertebral Body Replacement
(VBR), Curved VBR, Round VBR,
Trapezoidal VBR, and Instruments |
| Device Trade Name: | SeaSpine VBR System |
The devices used for comparison in this summary are the Alphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K033517).
- Intended Use: (The statements of intended use are identical.)
The intended use of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs is substantially equivalent to the intended use of the predicate devices.
The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters, "K052170. P2/3", written in black ink on a white background. Below the string of characters, the word "CONFIDENTIAL" is printed in a serif font. The handwriting is somewhat stylized, with some characters being more distinct than others.
SeaSpine VBR System
body due to tumor or trauma/fracture, to achieve anterior decompression of the spiral cord and neural tissues, and to restore the height of a collapsed vertebral body.
The SeaSpine VBR 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 SeaSpine VBR System is intended for use with bone graft.
2. Description:
The SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are manufactured out of PEEK OPTIMA® polymer with tantalum wires and/or beads. All VBR configurations will be offered in numerous lengths and sizes. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The SeaSpine VBR System will offer a wide variety of instruments that range from paddle scrapers to inserters. These various instruments will be made primarily from stainless steel with handles made from Radel or Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.
3. Technological Characteristics:
The straight, curved, round, and trapezoidal VBRs and instruments in this notification are components of a new stand alone system called the SeaSpine VBR System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. The devices in this submission also underwent appropriate mechanical testing and those results were found to be substantially equivalent to those of the predicate devices. Refer to Table 1 on the following page, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, material, and testing.
4. Comparison Analysis:
The overall designs of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs to the predicate devices.
2
13 K052 1 CONFIDENTIAL
A STATUS FOR COLLECT PRODUCTS AND AN AND AN AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN
SeaSpine VBR System
ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
| Feature | SeaSpine VBR
System | Alphatec
NOVEL VBR
Spinal
System | Interpore
Cross GEO
VBR Spinal
System | Quantum
Vertebral
Body
Replacement | Spinal
Concepts
Cadence
and
Traxis | Substantially
Equivalent |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------------|---------------------------------------------|------------------------------------------------|-----------------------------|
| Intended Use | The intended use of
the SeaSpine VBR
System is as a
vertebral body
replacement to
correct spinal
disorders and
provide stabilization
of the spine to permit
the biological
process of spinal
fusions to occur. | Similar | Similar | Similar | Similar | Yes |
| Indications
for Use | • Trauma/fracture
• Tumor | Similar | Similar | Similar | Similar | Yes |
| Design | • PEEK implants with
tantalum markers
• Multiple shapes | Similar | • Titanium
implants
• Multiple shapes | Similar | Similar | Yes |
| Straight VBR | Various sizes | Similar | Similar | Similar | Similar | Yes |
| Curved VBR | Various sizes | Similar | Similar | Similar | Similar | Yes |
| Round VBR | Various sizes | Similar | Similar | NA | NA | Yes |
| Trapezoidal
VBR | Various sizes | Similar | Similar | NA | NA | Yes |
| Material | PEEK and Tantalum | Similar | Titanium (per
ASTM F-1108) | Similar | Similar | Yes |
| Sterile | Non-sterile | Similar | Sterile and Non-
Sterile | Similar | Similar | Yes |
| Mechanical
Testing | Conducted according
to recognized
standards | Similar | Similar | Similar | Similar | Yes |
| Method of
Sterilization | High-temperature
steam | Similar | Similar | Similar | Similar | Yes |
Table 1: Summary of Design Comparison
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 2005
Ms. Diana Smith Manager of Regulatory Affairs & Quality Assurance SeaSpine, Inc. 2302 La Mirada Drive Vista, California 92081-7862
Re: K052170
Trade/Device Name: SeaSpine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MOP Dated: December 1, 2005 Received: December 2, 2005
Dear Ms. Smith:
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.
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 mav 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.
4
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, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson,
ﮨﮯ Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): 1052170
Device Name: SeaSpine VBR System
Indications for Use:
2100-1 Niin
The SeaSpine VBR 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 VBR 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 SeaSpine VBR System is intended for use with bone graft.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter-Use | |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).
(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices
23