(119 days)
No
The summary describes a physical interbody fusion device and its associated instrumentation, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is used to facilitate intervertebral body fusion in the cervical spine to treat degenerative disc disease, which has a therapeutic effect.
No
The device is an interbody fusion device designed to facilitate spinal fusion in patients with degenerative disc disease, not to diagnose medical conditions.
No
The device description explicitly states it consists of "cervical spine interbody fusion devices" and "instrumentation," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to facilitate intervertebral body fusion in the cervical spine. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The device is described as an interbody fusion device made from ceramic material, designed for implantation. This aligns with a surgical implant, not a diagnostic tool.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the VALEO® C+CSC with Lumen Interbody Fusion Device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VALEO® C+CSC with Lumen Interbody Fusion Device 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Product codes
ODP
Device Description
The Valeo® C+CSC with Lumen Interbody Fusion Device consists of cervical spine interbody fusion devices, as well as instrumentation designed specifically for the implantation of these implants. The Valeo C+CSC with Lumen is manufactured from Amedica's Silicon Nitride ceramic material and is provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Performance Testing Summary
Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections.
Mechanical Testing
- Static Compression: PASS
- Dynamic Compression: PASS
- Static Torsion: PASS
- Dynamic Torsion: PASS
- Subsidence: PASS
- Expulsion: PASS
Biocompatibility evaluations
- Cytotoxicity: PASS (ISO 10993-5:1999)
- Maximization Sensitization: PASS (ISO 10993-10:2002)
- ISO Intracutaneous Extract: PASS (ISO 10993-10:2002)
- ISO Systemic Toxicity Study: PASS (ISO 10993-11:2006)
- Genotoxicity: PASS (ISO 10993-3:2003)
- ISO Muscle Implantation Study: PASS (ISO 10993-6:1994)
- System Toxicity: PASS (ISO 10993-11:2006)
- Bacterial Endotoxin Testing (LAL assay): PASS (ANSI/AAMI ST72:2011)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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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March 5, 2018
Amedica Corporation Shanna Ryan Regulatory Affairs Project Manager 63 East 11400 South 192 Sandy, Utah 84070
Re: K173453
Trade/Device Name: Valeo® C+CSC with Lumen Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 3, 2018 Received: February 5, 2018
Dear Ms. Ryan:
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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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)
K173453
Device Name
Valeo® C+CSC with Lumen Interbody Fusion Device
Indications for Use (Describe)
The VALEO® C+CSC with Lumen Interbody Fusion Device 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
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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SECTION 2
VOLUME 2
Date of summary: 2 February 2018 (Updated)
Applicant
AMEDICA® Corporation 1885 West 2100 South Salt Lake City, UT 84119 Phone: 801.839.3562 Fax: 801.839.3605 Contact: Shanna Ryan, Regulatory Affairs Project Manager Email: shanna.ryan@gmail.com
Device Classification
| Trade Name: | Valeo® C+CSC with Lumen Interbody Fusion Device System |
|---|---|
| Class: | II |
| Panel: | Orthopedic |
| Product Code: | ODP |
| Regulation: | 21 CFR 888.3080 |
| Classification Name: | Intervertebral body fusion device, cervical |
Predicate Device
| Primary | |
|---|---|
| 510k: | K142264 |
| Trade Name: | Valeo Spacer System and Valeo II Interbody Fusion Device |
| Manufacturer: | Amedica® Corporation |
| Secondary | |
| 510k: | K103033 |
| Trade Name: | Zimmer Trabecular Metal Fusion Device |
| Manufacturer: | Zimmer |
Device Description
The Valeo® C+CSC with Lumen Interbody Fusion Device consists of cervical spine interbody fusion devices, as well as instrumentation designed specifically for the implantation of these implants. The Valeo C+CSC with Lumen is manufactured from Amedica's Silicon Nitride ceramic material and is provided sterile.
4
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Valeo® C+CSC with Lumen Traditional 510(k) Summary 21 CFR 807.92(a)
VOLUME 2
SECTION 2
Indications for Use
The VALEO® C+CSC with Lumen Interbody Fusion Device 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 or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies.
Valeo® C+CSC with Lumen Interbody Fusion Device is used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach from the C2-C3 disc space to the C7-T1 disc space using autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
VALEO® C+CSC with Lumen Interbody Fusion Device is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.
Technological Characteristics and Comparison to the Predicate Device
The Valeo® C+CSC with Lumen Interbody Fusion Device System is substantially equivalent to the predicates with respect to intended use, indications, design, and performance.
Performance Testing Summary
Testing performed on this device indicates that the Valeo C+CsC with Lumen Device is substantially equivalent to the Valeo Spacer System-C devices cleared under K142264. ASTM F2077 and ASTM F2267 performance standards were adhered to and all applicable requirements were met. Any deviations to the standards are noted at appropriate sections.
Mechanical Testing
| Test | Result |
|---|---|
| Static Compression | PASS |
| Dynamic Compression | PASS |
| Static Torsion | PASS |
| Dynamic Torsion | PASS |
| Subsidence | PASS |
| Expulsion | PASS |
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VOLUME 2
Biocompatibility evaluations
| Test / Biological Endpoint | Standard | Result |
|---|---|---|
| Cytotoxicity | ISO 10993-5:1999 | PASS |
| Maximization Sensitization | ISO 10993-10:2002 | PASS |
| ISO Intracutaneous Extract | ISO 10993-10:2002 | PASS |
| ISO Systemic Toxicity Study | ISO 10993-11:2006 | PASS |
| Genotoxicity | ISO 10993-3:2003 | PASS |
| ISO Muscle Implantation Study | ISO 10993-6:1994 | PASS |
| System Toxicity | ISO 10993-11:2006 | PASS |
| Bacterial Endotoxin Testing (LAL assay) | ANSI/AAMI ST72:2011 | PASS |
Conclusions
In summary, the Valeo C+CSC with Lumen has the same indications for use, technological characteristics, principle of operation, materials, and sterilization method as the cited predicate devices. Based on this and data provided in this pre-market notification, the subject device has been shown to be substantially equivalent to the predicate devices. Performance testing demonstrate the subject device performs as well or better than the predicate, therefore, is substantially equivalent.