(100 days)
Not Found
No
The document describes a physical intervertebral body fusion device and associated instruments, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
This device is an intervertebral body fusion device indicated for use in patients with degenerative disc disease, which clearly defines it as a therapeutic medical device.
No
The description explicitly states it is an "intervertebral body fusion device" used as an "adjunct to fusion." It is an implantable medical device designed for surgical intervention to stabilize the spine, not to diagnose a condition.
No
The device description clearly details physical components made of PEEK-OPTIMA® LT1 polymer, titanium, and tantalum, and mentions instruments for placement and sterilization. This indicates a hardware medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The SeaSpine® Vu a•POD™ Prime NanoMetalene® is an implantable medical device designed for spinal fusion surgery. It is a physical device inserted into the body to provide structural support and promote bone growth.
- Intended Use: The intended use clearly describes its function as an "adjunct to fusion in skeletally mature patients with degenerative disc disease." This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The text describes a surgical implant and its associated instruments, not a diagnostic test.
N/A
Intended Use / Indications for Use
When used with the bone screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have 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.
When used with the SpinPlate™, the Vu aªPOD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have 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. When used with the SpinPlate™, the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™ then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used 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.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The SeaSpine® Vu a•POD™ Prime NanoMetalene® is an anterior intervertebral body fusion device (IBD) which can be used in combination with two titanium Bone Screws, a titanium SpinPlate™, or both Bone Screws and SpinPlate™ together. When used with Bone Screws or Bone Screws and SpinPlate™, the system is a stand-alone device. When used with the SpinPlate™ alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The Vu a•POD™ Prime NanoMetalene® IBD spacers are comprised of PEEK-OPTIMA® LT1 polymer and include 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 spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers have a one-micrometer thick layer of commercially pure (CP) titanium. NanoMetalene® (NM), that is molecularly bonded to the surface. Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation. The spacer will be provided in sterile packaging; the Bone Screws and SpinPlate™ will be provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with the Vu a•POD™ Prime NanoMetalene® IBD 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
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: The SeaSpine® Vu a•POD™ Prime NanoMetalene® IBD System demonstrated equivalent performance to the predicate through static and dynamic axial compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and expulsion. Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10th 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
SeaSpine Orthopedics Corporation Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K162351
Trade/Device Name: SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: November 22, 2016 Received: November 23, 2016
Dear Gina 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Vincent J. Devlin -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
Page 1 of 2
510(k) Number (if known) K162351
Device Name
SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
Indications for Use (Describe)
When used with the bone screws, the SeaSpine® Vu aºPOD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have 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.
When used with the SpinPlate™, the Vu aªPOD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have 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. When used with the SpinPlate™, the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with bone screws or bone screws and the SpinPlate™, is a stand-alone device. If the Vu a POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™ then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used 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.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
510(k) Summary
_K162351
Contact Details
| 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, Regulatory Specialist |
| Email address: | gina.flores@SeaSpine.com |
| Date Prepared: | November 30, 2016 |
| Device Name | |
| Trade Name: | SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral body fusion device (21 CFR 888.3080) |
| Class: | II |
| Product Code: | OVD |
Legally Marketed Predicate Devices
| 510(k) Number | Product
Code | Trade Name | Manufacturer |
|--------------------------|-----------------|-------------------------------------------------------------------|-----------------------------|
| PRIMARY PREDICATE Device | | | |
| K121211 | OVD | Vu a•POD™ Intervertebral
Body Fusion Device | SeaSpine® Orthopedics Corp. |
| Predicate Devices | | | |
| K142488 | MAX | Vu a•POD-L™
Intervertebral Body Fusion
Device NanoMetalene® | SeaSpine® Orthopedics Corp. |
| K161379 | OVD, MAX | ELSA™ Spacers | Globus Medical, Inc. |
5
Device Description
The SeaSpine® Vu a•POD™ Prime NanoMetalene® is an anterior intervertebral body fusion device (IBD) which can be used in combination with two titanium Bone Screws, a titanium SpinPlate™, or both Bone Screws and SpinPlate™ together. When used with Bone Screws or Bone Screws and SpinPlate™, the system is a stand-alone device. When used with the SpinPlate™ alone, the system is intended for use with supplemental fixation. The spacer is intended to be used at one or two contiguous levels from L2 to S1 in the ALIF approach. Implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems).
The Vu a•POD™ Prime NanoMetalene® IBD spacers are comprised of PEEK-OPTIMA® LT1 polymer and include 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 spacers include toothed spikes/knurls on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The spacers have a one-micrometer thick layer of commercially pure (CP) titanium. NanoMetalene® (NM), that is molecularly bonded to the surface. Tantalum pins (i.e. radiopaque markers) are press fit into each end of the radiolucent spacer to allow easier radiological assessment of the position and orientation. The spacer will be provided in sterile packaging; the Bone Screws and SpinPlate™ will be provided non-sterile for subsequent sterilization at the healthcare facility.
The instruments included with the Vu a•POD™ Prime NanoMetalene® IBD 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.
Intended Use/Indications for use
When used with the Bone Screws, the SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have 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.
When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in skeletally mature patients with deqenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have 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
6
corticocancellous bone. When used with the SpinPlate™, the Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is intended for use with supplemental fixation.
The Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device, when used with Bone Screws or Bone Screws and the SpinPlate™, is a stand-alone device. If the Vu a+POD™ Prime NanoMetalene® Intervertebral Body Fusion Device is used only with the SpinPlate™ then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability. Additionally, implants with hyperlordotic angles of >20 must also be used with additional supplemental fixation (e.g. posterior pedicle screw and rod systems). This device is intended to be used 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.
Technological Characteristics
The SeaSpine® Vu a•POD™ Prime NanoMetalene® IBD 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).
Non-Clinical Testing
The SeaSpine® Vu a•POD™ Prime NanoMetalene® IBD System demonstrated equivalent performance to the predicate through static and dynamic axial compression shear, and torsion testing per ASTM F2077, subsidence testing per ASTM F2267, and expulsion. Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10th 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® Vu a•POD™ Prime NanoMetalene® IBD System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.