(418 days)
No
The document describes physical interbody fusion devices and their mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The devices are intended for spinal fusion procedures to treat degenerative disc disease, which involves addressing a medical condition (neck pain of discogenic origin) to restore function and alleviate symptoms.
No
The devices (Crystal, Mosaic, Vertu) are described as intervertebral body fusion devices intended for spinal fusion procedures. Their purpose is to treat degenerative disc disease by being implanted in the spine, not to diagnose medical conditions.
No
The device descriptions clearly indicate physical implants (intervertebral body fusion devices) made of materials with specific shapes, holes, teeth, and screw accommodations. The performance studies also focus on physical properties like torsion, wear, shear, tension, and abrasion resistance, which are relevant to hardware. There is no mention of software as the primary or sole component.
Based on the provided text, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- IVDs are used to examine specimens from the human body. The descriptions of Crystal, Mosaic, and Vertu clearly state they are implants intended for surgical placement within the cervical spine. They are physical devices used in the body, not for testing samples from the body.
- The intended use is for spinal fusion procedures. This is a surgical intervention, not a diagnostic test performed on a sample.
- The device descriptions detail the physical characteristics of the implants. They describe the shape, holes for graft material, teeth for migration prevention, and screw holes for fixation. This aligns with the description of a surgical implant, not a diagnostic device.
Therefore, these devices are surgical implants used for spinal fusion, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Mosaic®:
The Mosaic® device is an interbody fusion device intended for 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. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.
Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Product codes
ODP, OVE
Device Description
Crystal
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.
Mosaic
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.
Vertu
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (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)
Non-clinical testing were used to support the decision of substantial equivalence. Nonclinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:
- Dynamic Torsion Testing ASTM F2077-03
- Gravimetric Measurement for Wear Assessment ASTM F2025-06
- . Particle Characterization ASTM F1877-89
- Static Shear ASTM F1044-05
- Static Tension ASTM F1147-05
- . Abrasion Resistance ASTM F1978-00
The wear debris data including number of particulates generated, and particulate size indicates that the device coating performs similarly to predicate Calix PC (K112036).
No animal studies were performed.
No clinical studies were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112036, K073351, K071833, K122771
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized eagle or bird with three profiles of human faces incorporated into the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Spinal Elements, Incorporated Julie Lamothe, Ph.D. Regulatory Affairs and Quality Assurance Director 3115 Melrose Drive, Suite 200 Carlsbad, California 92010
Re: K133218
Trade/Device Name: Crystal®; Mosaic®; Vertu® Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP, OVE Dated: November 7, 2014 Received: November 10, 2014
Dear Dr. Lamothe:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Julie Lamothe, Ph.D
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.
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 vours.
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) K133218
Device Name Crystal®; Mosaic®; Vertu®
Indications for Use (Describe)
Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in sketally 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. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.
Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level ( C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
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.
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510(k) Summary Crystal®, Mosaic®, and Vertu®
510(k) Number K133218
I. SUBMITTER
Spinal Elements, Inc. 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 P. 760-607-0121 F. 760-607-0125
| Contact Information: | Julie Lamothe |
|---|---|
| Director Regulatory Affairs | |
| Spinal Elements, Inc. | |
| 3115 Melrose Dr., Suite 200 | |
| Carlsbad, CA 92010 | |
| 760-607-1816 | |
| jlamothe@spinalelements.com |
Date Prepared: December 4, 2014
II. DEVICE
Proprietary Name Common Name Device Classification
Device Product Code
Crystal®; Mosaic®; Vertu® Systems Intervertebral Body Fusion Device 21 CFR 888.3080 (Appliance, Fixation Spinal Intervertebral Body) Class II ODP - Crystal OVE - Mosaic and Vertu
III. PREDICATE DEVICE
Proposed Regulatory Class
Primary Predicate Name Regulatory Class Submission No Device Code
Predicate Name Regulatory Class Submission No Device Code
Calix PC Class II K112036 ODP
Crystal®; Mosaic®; Vertu® Systems Class II K073351 - K071833 - K122771 ODP - Crystal OVE - Mosaic and Vertu
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IV. DEVICE DESCRIPTION
Crystal
Crystal is an intervertebral body fusion device for use in cervical spinal surgery. The device is generally box-shaped with various holes throughout its geometry to allow for the placement of autograft. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned.
Mosaic
The Mosaic Spinal Implant System is composed of a device body and fixation screws. The body is a generally box-shaped device with various holes located throughout its geometry for the placement of graft material. Additionally, it has teeth on its superior and inferior external surfaces to keep the device from migrating once placed in its desired location. The box-shaped body has projections (or flanges) that encompass screw holes. Screws pass through screw holes and affix to bone to help prevent implant migration.
Vertu
The Vertu Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration.
V. INDICATION FOR USE
Crvstal®
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
The Crystal® device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
Mosaic®
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
6
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two. three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the impant.
Vertu®
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the impant.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject Crystal, Mosaic and Vertu devices are identical in indications for use, surgical technique, design features and instrumentation to the predicate devices cleared in K073351, K071833 and K122771, respectively. The difference to the Crystal, Mosaic, and Vertu devices is the addition of the plasma sprayed commercial pure titanium coating on the superior and inferior surfaces of the devices. The performance of the Ti- coating is equivalent to the one of predicate Calix PC cleared in K112036. The addition of this coating does not raise any new issues of safety or effectiveness. In addition to the plasma sprayed commercial pure titanium coating on the Crystal device, line items (sizes) have been added to Crystal. Neither modification raises any new issues of safety or effectiveness.
VII. PERFORMANCE DATA
Biocompatibility Testing
Biocompatibility testing were performed in accordance with FDA Memorandum #G95-1 and ISO 10993-1 Part 1. The Crystal, Mosaic and Vertu devices are considered permanent implant devices contacting tissue/bone.
The PEEK material biocompatibility relevant to the device contact type is presented in Invibio device master file (MAF 1209). The titanium coating material is commercially pure titanium. The coating is in accordance with ASTMF 1580, which address the biocompatibility of the material. No further testing were required,
Electrical safety and electromagnetic compatibility (EMC)
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No electrical and electromagnetic compatibility testing were performed.
Software Verification and Validation Testing
The device does not contain software. Therefore no software verification and validation testing were performed.
Mechanical testing
Non-clinical testing were used to support the decision of substantial equivalence. Nonclinical testing consisted of the following testing performed in accordance with the FDA guidance Class II Special Controls Guidance Document: Intervertebral Body Fusion Device:
- Dynamic Torsion Testing ASTM F2077-03
- Gravimetric Measurement for Wear Assessment ASTM F2025-06
- . Particle Characterization ASTM F1877-89
- Static Shear ASTM F1044-05
- Static Tension ASTM F1147-05
- . Abrasion Resistance ASTM F1978-00
The wear debris data including number of particulates generated, and particulate size indicates that the device coating performs similarly to predicate Calix PC (K112036).
Animal Study
No animal studies were performed.
Clinical Studies
No clinical studies were performed.
VIII. CONCLUSIONS
Based on our analysis of the test data, the device performs comparably to the predicate device that is currently marketed for the same intended use.