(105 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of the intervertebral fusion devices. There is no mention of AI, ML, image processing, or any software-driven analysis or decision-making capabilities.
Yes.
The device is intended for spinal fusion procedures to treat degenerative disc disease and related conditions, which directly addresses a medical condition and aims to restore or improve physiological function.
No
This device is an intervertebral body fusion device, used to facilitate spinal fusion, not to diagnose medical conditions.
No
The device description explicitly states that the devices are made from physical materials (PEEK, tantalum, titanium) and are intended for surgical implantation as intervertebral fusion devices. 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The provided text clearly describes the devices as intervertebral body fusion devices intended for surgical implantation in the spine to facilitate spinal fusion. They are physical implants used in a surgical procedure, not devices that analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological samples. The "Input Imaging Modality" is "Radiographic studies," which are used for visualizing the spine, not for analyzing biological specimens.
Therefore, the SeaSpine Spacer System and related devices described are surgical implants, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
When used as an intervertebral body fusion device, the 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 (autograft) and supplemental fixation.
Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.
Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1, C3-C7
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)
Substantial equivalence was supported by engineering analysis and dynamic testing per ASTM F2077, wear particulate analysis per ASTM F1877, subsidence testing per ASTM F2267, as well as expulsion testing; analysis demonstrated that the titanium surface does not negatively impact mechanical performance of the NanoMetalene subject devices when compared to 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.
K102026, K082310, K103297, K082309, K082712, K112986
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 18, 2014
SeaSpine, Incorporated Ms. Michelle Willis Director of Regulatory Affairs 2302 La Mirada Drive Vista, California 92081
Re: K142488
Trade/Device Name: SeaSpine Spacer System - Hollywood™M NanoMetalene®, Pacifica™ NanoMetalene®, Redondo™ NanoMetalene®, Ventura ™ NanoMetalene"; Cambria™ NanoMetalene"; Vu aPOD-LTM NanoMetalene"; Vu ePOD™ NanoMetalene® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 22, 2014 Received: September 23, 2014
Dear Ms. Willis:
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
1
Page 2 - Ms. Michelle Willis
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 yours,
Mark N. Melkerson -S
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) K142488
Device Name
Hollywood NanoMetalene, Pacifica NanoMetalene, Ventura NanoMetalene, Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene
Indications for Use (Describe)
SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
When used as an intervertebral body fusion device, the 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 (autograft) and supplemental fixation.
Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.
Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
1. Contact Details
| Applicant Name: | SeaSpine, Inc. (A subsidiary of Integra LifeSciences Corporation) |
|---|---|
| Address: | 2302 La Mirada Drive, Vista, CA 92081 |
| Phone number: | (760) 216-5104 |
| Fax number: | (760) 727-8891 |
| Contact person: | Michelle Willis, Director of Regulatory Affairs |
| Contact Phone: | 760-216-5104 |
| Email address : | Michelle.Willis@integralife.com |
| Date Prepared: | November 24, 2014 |
2. Device Name
| Trade Name: | SeaSpine Spacer System™ – Hollywood™ NanoMetalene®, Pacifica™
NanoMetalene®, Redondo™ NanoMetalene®, Ventura™ NanoMetalene®,
Cambria™ NanoMetalene®;
Vu aPOD-L™ NanoMetalene®;
Vu ePOD™ NanoMetalene® |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Intervertebral body fusion device |
| Classification Name: | Intervertebral fusion device with bone graft, lumbar, Product Code: MAX;
Intervertebral Fusion device with bone graft, cervical, ODP |
3. Legally Marketed Predicate Device(s)
| Predicate | 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|---|
| Primary | K102026 | MAX | SeaSpine Spacer System - Hollywood™ NanoMetalene® | SeaSpine, Inc. |
| Additional | K082310 | MAX | SeaSpine Spacer - Hollywood™, Pacifica™, Redondo™, Ventura™ | SeaSpine, Inc. |
| K103297 | MAX | SeaSpine Spacer System - Redondo™, Redondo-L™ | SeaSpine, Inc. | |
| K082309 | ODP | Cambria™ | SeaSpine, Inc. | |
| K082712 | MAX | Vu ePOD™ | Theken Spine, LLC | |
| K112986 | MAX | Vu aPOD-L™ | Integra Spine |
4. Device Description
5
The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.
5. Intended Use/Indications for use
The NanoMetalene subject devices have substantially equivalent indications and intended use as the cited predicates:
SeaSpine Spacer System - Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
When used as an intervertebral body fusion device, the 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 (autograft) and supplemental fixation.
Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is
6
in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment.
Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
6. Substantial Equivalence Comparison
The NanoMetalene subject devices are 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).
7. Non-clinical Testing
Substantial equivalence was supported by engineering analysis and dynamic testing per ASTM F2077, wear particulate analysis per ASTM F1877, subsidence testing per ASTM F2267, as well as expulsion testing; analysis demonstrated that the titanium surface does not negatively impact mechanical performance of the NanoMetalene subject devices when compared to the predicate devices.
8. Clinical Testing
No clinical testing was required to demonstrate equivalence.
9. Conclusions
7
The non-clinical data demonstrate that the SeaSpine Spacer System - Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene, Cambria NanoMetalene, Vu aPOD-L NanoMetalene, and Vu ePOD NanoMetalene devices are substantially equivalent to the predicate devices.