(28 days)
Not Found
No
The summary describes a physical intervertebral fusion device made of PEEK and titanium, with no mention of software, algorithms, or AI/ML capabilities. The device description and performance studies focus on material properties, sterilization, and mechanical testing, not data processing or analysis.
Yes
The device is described as an "intervertebral body fusion device" intended for "spinal fusion procedures," which is a medical intervention to treat degenerative disc disease and alleviate pain, qualifying it as a therapeutic device.
No
Explanation: The device is an intervertebral body fusion device used for spinal fusion procedures, not for diagnosing medical conditions. It is used as a treatment after a diagnosis of degenerative disc disease (DDD) has already been made.
No
The device description explicitly states the device is manufactured from PEEK with tantalum markers and has a titanium surface coat, indicating it is a physical implant, not software.
Based on the provided information, 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 Function: The description clearly states that the SeaSpine Ventura NanoMetalene System is an intervertebral body fusion device. Its purpose is to be surgically implanted to facilitate spinal fusion.
- Intended Use: The intended use describes a surgical procedure for spinal fusion, not a diagnostic test performed on a sample.
- Device Description: The device is made of PEEK with tantalum markers and is designed for implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
The device is a surgical implant used in the treatment of degenerative disc disease, not a diagnostic tool.
N/A
Intended Use / Indications for Use
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.
Product codes
MAX
Device Description
The SeaSpine Ventura NanoMetalene (NM) System is an intervertebral fusion device manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-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
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.
Key Metrics
Not Found
Predicate Device(s)
K162715, K142488, K082310, K102026
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.
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SeaSpine Orthopedics Corporation Gina Flores Regulatory Specialist 5770 Armada Drive Carlsbad, California 92008
October 26, 2017
Re: K173022
Trade/Device Name: SeaSpine Ventura NanoMetalene System Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: September 26, 2017 Received: September 28, 2017
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 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.
1
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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) 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
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Indications for Use
510(k) Number (if known) K173022
Device Name SeaSpine Ventura NanoMetalene System
Indications for Use (Describe)
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) |
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Image /page/3/Picture/2 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic in shades of blue on the left, followed by the word "SeaSpine" in orange. A thin gray line runs horizontally beneath the text.
510(k) Summary
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, Sr. Regulatory Specialist |
| gina.flores@seaspine.com | |
| Date Prepared: | October 26, 2017 |
| Device Name | |
| Trade Name: | SeaSpine Ventura NanoMetalene System |
| Common Name: | Intervertebral Body Fusion Device |
| Classification Name: | Intervertebral fusion device with bone graft, lumba |
| (21 CFR 888.3080) | |
| Class: | II |
| Product Code: | MAX |
Legally Marketed Predicate Devices
| 510(k) Number | Product
Code | Trade Name | Manufacturer |
|------------------------------|-----------------|--------------------------------------------------------------|----------------------------------------|
| PRIMARY PREDICATE Device | | | |
| K162715 | MAX | SeaSpine Ventura
NanoMetalene-Sterile | SeaSpine
Orthopedics
Corporation |
| Additional PREDICATE Devices | | | |
| K142488 | MAX | SeaSpine Spacer System-
NanoMetalene
Ventura, Pacifica | SeaSpine
Orthopedics
Corporation |
| K082310 | MAX | SeaSpine Spacer System-
Ventura, Pacifica | SeaSpine
Orthopedics
Corporation |
| K102026 | MAX | SeaSpine Spacer System-
Hollywood | SeaSpine
Orthopedics
Corporation |
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Image /page/4/Picture/2 description: The image shows the logo for SeaSpine. The logo consists of a stylized wave graphic on the left, with the word "SeaSpine" in orange text to the right. The wave graphic is made up of several curved lines in shades of blue. There is a trademark symbol to the bottom right of the word "SeaSpine".
Device Description
The SeaSpine Ventura NanoMetalene (NM) System is an intervertebral fusion device manufactured from polyetheretherketone (PEEK) per ASTM F2026 with tantalum markers per ASTM F560 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.
Intended Use/Indications for Use
The SeaSpine Ventura NM subject device has substantially equivalent indications and intended use as the cited predicates:
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.
Summary of Technological Characteristics
The SeaSpine Ventura NM System and predicate devices have the same operating principle; they act as a disc spacer and hold bone graft to promote fusion. The Ventura NM 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
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.
Conclusions
The submitted data demonstrate that the SeaSpine Ventura NM System is as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate.