(139 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and surgical implantation of a physical interbody cage. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to treat degenerative disc disease in the cervical spine to alleviate accompanying radicular symptoms, which is a therapeutic purpose.
No
This device, the Spine Wave Anterior Cervical Spine System, is an interbody cage used in spine surgery. Its function is to provide structural support and promote fusion between vertebrae, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description explicitly details physical components (cages, anchor plates, graft caps, inserter) made of materials like titanium and PEEK, and describes a surgical procedure involving their physical placement and assembly. This is a hardware-based medical device.
Based on the provided information, the Spine Wave Anterior Cervical Spine System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Spine Wave Anterior Cervical Spine System is a surgical implant (interbody cage) used to treat degenerative disc disease in the cervical spine. It is physically placed within the patient's body during surgery.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is structural support and facilitating fusion, not diagnostic testing of samples.
Therefore, the Spine Wave Anterior Cervical Spine System falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spine Wave Anterior Cervical Spine System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Spine Wave Anterior Cervical Spine System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.
Product codes
OVE
Device Description
The Spine Wave Anterior Cervical Spine (ACS) System consists of a selection of non-sterile, single use cervical interbody cages indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1.
The Spine Wave ACS cages are multi-component devices comprised of a cage body, anchor plate and graft cap. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Spine Wave ACS cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4.
Using the Spine Wave ACS Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, disc level from C2-T1
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)
The following mechanical tests were performed to demonstrate the substantial equivalence of the system to its predicates:
- Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic compression-shear (per ASTM F2077)
- Static and dynamic torsion
- Subsidence (per ASTM F2267)
- Static expulsion (per ASTM Draft Standard F-04.25.02.02)
- Simulated use testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K150765, K091531, K152620, K153222, K081228
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Spine Wave, Inc. Amnon Talmor Senior Regulatory Affairs Manager 3 Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K162760
Trade/Device Name: Spine Wave Anterior Cervical Spine System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 9, 2017 Received: January 10, 2017
Dear Mr. Talmor:
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 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.
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 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,
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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)
K162760
Device Name
Spine Wave Anterior Cervical Spine System
Indications for Use (Describe)
The Spine Wave Anterior Cervical Spine System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Spine Wave Anterior Cervical Spine System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.
X | 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/0 description: The image shows the words "Spine Wave" in a bold, sans-serif font. The words are arranged horizontally, with "Spine" on the left and "Wave" on the right. A blue wave design is located under the words, adding a visual element to the logo. The overall design is simple and modern.
510(k) Summary Spine Wave Anterior Cervical Spine System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Contact: | Amnon Talmor |
| Date Prepared: | February 15, 2017 |
2. Device Information
| Trade Name: | Spine Wave Anterior Cervical Spine System |
|---|---|
| Common Name: | Intervertebral Fusion Device with Integrated Fixation, |
| Cervical | |
| Classification: | Class II (special controls) per 21 CFR 888.3080 |
| Classification Name: | Intervertebral Body Fusion Device |
| Product Code: | OVE |
3. Predicate Device Information
The Spine Wave Anterior Cervical Spine System described in this submission is substantially equivalent to the following:
| Primary Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| ROI-C Cervical Cage System | LDR Spine USA | K150765 |
| Additional Predicate Devices | Manufacturer | 510(k) No. |
|---|---|---|
| Cervical Interbody Spacer System | Choice Spine | K091531 |
| Gen II Expandable Interbody System | Spine Wave | K152620 |
| Leva® Interbody Device | Spine Wave | K153222 |
| CapSure® PS Spine System | Spine Wave | K081228 |
4. Device Description
The Spine Wave Anterior Cervical Spine (ACS) System consists of a selection of non-sterile, single use cervical interbody cages indicated for skeletally mature
4
patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1.
The Spine Wave ACS cages are multi-component devices comprised of a cage body, anchor plate and graft cap. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Spine Wave ACS cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4.
Using the Spine Wave ACS Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.
5. Indications for Use
The Spine Wave Anterior Cervical Spine System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disk level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Spine Wave Anterior Cervical Spine System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.
6. Comparison of Technological Characteristics
The substantial equivalence of the Spine Wave Anterior Cervical Fusion Cage System to the listed predicate is shown by similarity in intended use, indications for use, materials and performance.
7. Non-Clinical Performance Data
The following mechanical tests were performed to demonstrate the substantial equivalence of the system to its predicates:
- Static and dynamic axial compression (per ASTM F2077) ●
- Static and dynamic compression-shear (per ASTM F2077)
- Static and dynamic torsion ●
- Subsidence (per ASTM F2267) ●
- Static expulsion (per ASTM Draft Standard F-04.25.02.02) ●
- o Simulated use testing
5
8. Conclusion
Based on the indications for use, technical characteristics, performance testing, and comparison to the predicates, the Spine Wave Anterior Cervical Spine System is substantially equivalent to the predicate devices identified in this submission and does not present any new issues of safety or effectiveness.