(29 days)
Not Found
No
The device description and intended use focus on the material composition, design, and surgical application of intervertebral fusion devices. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device function.
Yes
The device is described as an intervertebral body fusion device intended for spinal fusion procedures in patients with degenerative disc disease, which directly addresses a medical condition and is used for treatment.
No
The device is an intervertebral body fusion device, intended for surgical implantation during spinal fusion procedures, not for diagnosing medical conditions.
No
The device description explicitly states the device is manufactured from PEEK and titanium, which are hardware components. The 510(k) is for changes related to sterilization and packaging of these physical implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an intervertebral body fusion device used in spinal fusion procedures. This is a surgical implant, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device is described as an intervertebral fusion device manufactured from PEEK with markers and a titanium coating. This is a physical implant designed to be placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests.
The device is a surgical implant used to facilitate spinal fusion, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and 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.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® are intervertebral fusion devices manufactured from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. 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 receive clearance to offer the interbody devices of the noted systems gamma sterilized in individual packaging.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal fusion procedures at one or two contiguous levels (L2-S1)
Spinal fusion procedures at one level (C3-C7) of the cervical spine.
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: Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10^-6 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
SeaSpine® Orthopedics Corporation % Ms. Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
Re: K162715
Trade/Device Name: SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®; SeaSpine® Cambria NanoMetalene® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 28, 2016 Received: September 29, 2016
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 (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,
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) K162715
Device Name
SeaSpine® Spacer System - Hollywood NanoMetalene®, and Ventura NanoMetalene®
Indications for Use (Describe)
SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, and 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.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K162715
Device Name SeaSpine® Cambria NanoMetalene®
Indications for Use (Describe)
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 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, and used with autogenous bone and supplemental fixation, such as an anterior plating system.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K162715 Page 1 of 4
Contact Details
| Applicant Name: | SeaSpine® Orthopedics Corporation |
|---|---|
| Address: | |
| Phone number: | |
| Fax number: | 5770 Armada Drive, Carlsbad CA |
| (760) 216-5136 | |
| (760) 683-6874 | |
| Contact person: | |
| Email address: | Gina Flores, Regulatory Specialist |
| gina.flores@SeaSpine.com | |
| Date Prepared: | October 27, 2016 |
| Device Name | |
| Trade Name: | SeaSpine® Spacer System - Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene® |
| SeaSpine® Cambria NanoMetalene® | |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral body fusion device |
| (21 CFR 888.3080) | |
| Class: | II |
| Product Code: | MAX, ODP |
Legally Marketed Predicate Devices
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| Primary Predicate Device | |||
| K102026 | MAX, MQP | SeaSpine® Spacer System- | |
| (Hollywood NanoMetalene®) | SeaSpine® Orthopedics | ||
| Corporation | |||
| Predicate Device | |||
| K142488 | MAX, ODP | SeaSpine® Spacer System | |
| (Hollywood VI NanoMetalene®, | |||
| Ventura NanoMetalene®) | |||
| and Cambria NanoMetalene® | SeaSpine® Orthopedics | ||
| Corporation |
5
Device Description
The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® are intervertebral fusion devices manufactured from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6AI-4V ELI per ASTM F136) for radiographic visualization. The implants have a one-micron thick surface coat of commercially pure (CP) titanium. 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 receive clearance to offer the interbody devices of the noted systems gamma sterilized in individual packaging.
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®, Hollywood VI 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.
Summary of Technological Characteristics
The SeaSpine® Spacer System (Hollywood NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and the Cambria NanoMetalene® 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).
6
| Subject Devices: | Predicate Devices: | |
|---|---|---|
| Hollywood NanoMetalene® System | Hollywood NanoMetalene® System | |
| Hollywood VI NanoMetalene® System | Hollywood VI NanoMetalene® System | |
| Ventura NanoMetalene® System | Ventura NanoMetalene® System | |
| Cambria NanoMetalene® System | Cambria NanoMetalene® System | |
| Intended Use | Adjunct to spinal fusion procedures in | |
| skeletally mature patients with | ||
| degenerative disc disease (DDD) | Adjunct to spinal fusion procedures in | |
| skeletally mature patients with | ||
| degenerative disc disease (DDD) | ||
| Materials | PEEK-OPTIMA (ASTM 2026), | |
| Titanium alloy (ASTM F136), | ||
| Tantalum, (ASTM F560), | ||
| CP Titanium Surface (ASTM F67) | PEEK-OPTIMA (ASTM 2026), | |
| Titanium alloy (ASTM F136), | ||
| Tantalum, (ASTM F560), | ||
| CP Titanium Surface (ASTM F67) | ||
| Design | Varying footprints and heights with a | |
| central channel to be filled with | ||
| autogenous bone graft to allow for | ||
| bone fusion. | Varying footprints and heights with a | |
| central channel to be filled with | ||
| autogenous bone graft to allow for | ||
| bone fusion. | ||
| Performance | ||
| Testing | No new testing required | Analysis and static & dynamic |
| testing (ASTM F2027), | ||
| Wear Evaluation (ASTM F1877), | ||
| Subsidence (ASTM F2267) | ||
| Packaging | Implants will be double packaged in | |
| PETG trays with Tyvek lids. |
Components, accessories and
instruments are provided trays/caddies
intended for sterilization by the end
user | N/A - System implants, components,
accessories and instruments are
provided in trays/caddies intended for
sterilization by the end user |
| Sterilization | Implants will be provided in sterile
packaging validated to ensure a
SAL 10-6
Components, accessories and
instruments are sterilized by the end
user | System implants, components,
accessories and instruments are
sterilized by the end user |
Non-Clinical Testing
Packaging, shipping and sterilization tests were performed to validate a Sterility Assurance Level (SAL) of 10° 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.
7
Conclusions
data demonstrate that the SeaSpine® Spacer System (Hollywood The submitted NanoMetalene®, Hollywood VI NanoMetalene®, Ventura NanoMetalene®), and Cambria NanoMetalene® devices are as safe, as effective, and perform at least as safely and effectively as the cited legally marketed predicates.