(294 days)
Not Found
No
The summary describes a physical intervertebral body spacer made of ceramic material. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies section focuses on a literature review comparing the device to predicates, not on the performance of an AI/ML model.
Yes
The device is used to facilitate intervertebral body fusion in patients with degenerative disc disease, which qualifies it as a therapeutic device.
No
The device is an intervertebral body fusion device (spacer/cage) used to facilitate fusion in the cervical and lumbar spine, not for diagnosing conditions.
No
The device description clearly states that the device consists of physical intervertebral body spacers made from Si3N4 ceramic material. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 Valeo® Spacer System and Valeo II™ Interbody Fusion Device System are physical implants designed to be surgically placed in the spine to facilitate bone fusion. They are used in the body, not to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, this device falls under the category of a surgical implant or medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Valeo® Spacer System and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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.
Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System – Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The Valeo® Spacer System and Valeo IIIM Interbody Fusion Device System consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material (autograft or allograft). The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo® Spacer System and Valeo II™ Interbody Fusion Device System is manufactured from Si3N4 ceramic material (silicon nitride), 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, C2-C3 disc space to the C7-T1 disc space, lumbar, L2 to S1
Indicated Patient Age Range
skeletally mature patients, skeletally mature
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)
A comprehensive, clinical literature review has been provided to investigate the risks and benefits associated with the use of the Valeo® Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar devices in lumbar fusion procedures with allograft.
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 2, 2015
AMEDICA® Corporation Mr. William D. Jordan Senior Director Regulatory Affairs and Quality Assurance 1885 West 2100 South Salt Lake City, Utah 84119
Re: K143518
Trade/Device Name: Valeo® Spacer System; Valeo II™ Interbody Fusion Device System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP Dated: September 2, 2015 Received: September 4, 2015
Dear Mr. Jordan:
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
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 yours,
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) K143518
Device Name
Valeo® Spacer System; Valeo II™ Interbody Fusion Device System
Indications for Use (Describe)
Valeo® Spacer System and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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.
Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo® Spacer System-L and Valeo II™ Interbody Fusion Device System – Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
| 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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3
510(k) Summary
| Device Trade Name: | Valeo® Spacer System
Valeo IIT™ Interbody Fusion Device System |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | AMEDICA® Corporation
1885 West 2100 South
Salt Lake City, UT 84119
Phone: (855) 839-3500 |
| Contact: | Mr. William D. Jordan
Senior Director Regulatory Affairs
1885 W 2100 S
Salt Lake City, UT 84119
Phone: (801)839-3562
wjordan@amedica.com |
| Date Prepared: | September 28, 2015 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX, ODP |
| Primary Predicate: | Valeo II™ Interbody Fusion Device (K142264) |
| Additional Predicate: | Valeo® Spacer System (K091278) |
Indications for Use:
Valeo® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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® Spacer System-C and Valeo II™ Interbody Fusion Device System -Cervical are 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.
Valeo® Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar are indicated for use with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one level
4
or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Valeo@ Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar are intended to be used with supplemental spinal fixation systems, such as Preference Pedicle Screw System. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Summary of Technological Characteristics:
The Valeo® Spacer System and Valeo IIIM Interbody Fusion Device System consist of a variety of hollow intervertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material (autograft or allograft). The subject device is offered in various geometries to accommodate different surgical approaches and vertebral body dimensions. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The Valeo® Spacer System and Valeo II™ Interbody Fusion Device System is manufactured from Si3N4 ceramic material (silicon nitride), and is provided sterile.
The purpose of the subject 510(k) was to expand the indications to include use with allograft in the lumbar spine.
Predicate Device:
The Valeo® Spacer System and Valeo II™ Interbody Fusion Device System - Lumbar is substantially equivalent to the predicate Valeo® Spacer System (K091278) and Valeo II™ Interbody Fusion Device (K142264) with respect to indications, design, and performance.
Substantial Equivalence:
The predicates Valeo® Spacer System (K091278), Valeo II™ Interbody Fusion Device System (K142264) are similar in design, material, and indicated use, and are both cleared devices. A comprehensive clinical literature review was conducted to assess any additional safety concern for the use of this device with the use of allograft in the lumbar spine. The review of the literature concluded that there were no additional risks due to the modifications for this device and that the device was substantially equivalent to the predicate device.
Performance Testing:
A comprehensive, clinical literature review has been provided to investigate the risks and benefits associated with the use of the Valeo® Spacer System - L and Valeo II™ Interbody Fusion Device System - Lumbar devices in lumbar fusion procedures with allograft.
Conclusion:
This 510(k) was submitted on behalf of the Valeo® Spacer System and Valeo II™ Interbody Fusion Device System to expand the indications for use to include use with allograft in lumbar interbody fusions. Substantial equivalence was determined in response to sufficient comparisons to a predicate device.