(91 days)
Not Found
No
The summary describes a physical interbody fusion device made of ceramic material with a mechanical design for gripping bone. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on mechanical and biological safety standards, not algorithmic performance.
Yes.
The device is used to facilitate intervertebral body fusion to treat degenerative disc disease and accompanying symptoms.
No
Explanation: The provided text describes an interbody fusion device, which is an implant used to facilitate spinal fusion. It is a treatment device, not a device used for diagnosis.
No
The device description clearly states that the device is a physical implant made of Si3N4 ceramic material, designed to hold bone graft material and grip end plates. 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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Valeo II Interbody Fusion Devices are physical implants made of ceramic material designed to be surgically placed in the spine to facilitate bone fusion. They are used in skeletally mature patients with degenerative disc disease.
- Lack of Biological Sample Analysis: The description and intended use do not involve the analysis of any biological samples from the patient. The device is a therapeutic implant, not a diagnostic test.
Therefore, the Valeo II Interbody Fusion 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 II Interbody Fusion Devices - Cervical are 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 radios. Valeo II Interbody Fusion Devices-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 using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.
Valeo II Interbody Fusion Devices-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 II Interbody Fusion Devices-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 desenerative disc disease (DD) 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 II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Product codes
MAX, OPD
Device Description
The Valeo II Interbody Fusion Devices 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 comprised of cancellous and/or corticocancelous bone graft).
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 II Interbody Fusion Device is manufactured from Si3N4 ceramic material (silicon nitride), and is:
- provided sterile (gamma sterilization)
- single use
The purpose of the subject 510(k) is to add additional sizes to the Lateral Lumbar Interbody Fusion Device - Valeo II LL.
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 C7-T1 disc space); Lumbar spine (L2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Failure Effects Analysis was performed to determine if the new sizes created a new worst case with respect to ASTM F2077 and ASTM F2267. No new worst cases were identified with regard to the ASTM standards requirements. No additional testing required.
Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST-72:2011 confirm an endotoxin limit of 0.5EU/mL.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged 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
August 19, 2016
AMEDICA® Corporation Mr. William D. Jordan Senior Director, Regulatory Affairs & Ouality Assurance 1885 West 2100 South Salt Lake City, Utah 84119
Re: K161405
Trade/Device Name: 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, OPD Dated: July 20, 2016 Received: July 21, 2016
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 Parts 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/ResourcesforYou/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,
Lori A. Wiggins -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) K161405
Device Name
Valeo II™ Interbody Fusion Device System
Indications for Use (Describe)
Valeo II Interbody Fusion Devices - Cervical are 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 radios. Valeo II Interbody Fusion Devices-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 using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.
Valeo II Interbody Fusion Devices-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 II Interbody Fusion Devices-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 desenerative disc disease (DD) 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 II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. 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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
510(k) Summary
| Device Trade Name: | Valeo IITM Interbody Fusion Device System |
|---|---|
| Device Common Name: | Interbody Fusion Device |
| Manufacturer: | AMEDICA® Corporation |
| 1885 West 2100 South | |
| Salt Lake City, UT 84119 | |
| Phone: (855) 839-3500 | |
| Contact: | William D. Jordan |
| Senior Director Regulatory Affairs | |
| Date Prepared: | May 19, 2016 |
| Classifications: | 21 CFR §888.3080, Intervertebral body fusion device |
| Class: | II |
| Product Codes: | MAX, ODP |
| Primary Predicate: | Valeo IITM Interbody Fusion Device (K121892) |
| Additional Predicates: | Globus PATRIOT® TransContinental® Llif Spacer (K093242) |
| Valeo IITM Interbody Fusion Device (K143518) |
Indications For Use:
Valeo II Interbody Fusion Devices - 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 II Interbody Fusion Devices-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 C7-T1 disc space using autograft or allogenicbone graft comprised of cancellous and/or corticocancelous bone graft.
Valeo II Interbody Fusion Devices-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.
4
Valeo II Interbody Fusion Devices-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 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 II Interbody Fusion Devices-Lumbar are intended to be used with supplemental spinal fixation systems. Patients should be skeletally mature and have six months of non-operative therapy prior to treatment with an intervertebral cage.
Device Description:
The Valeo II Interbody Fusion Devices 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 comprised of cancellous and/or corticocancelous bone graft).
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 II Interbody Fusion Device is manufactured from Si3N4 ceramic material (silicon nitride), and is:
- provided sterile (gamma sterilization)
- single use
The purpose of the subject 510(k) is to add additional sizes to the Lateral Lumbar Interbody Fusion Device - Valeo II LL.
Predicate Device:
The Valeo II™ Interbody Fusion Device – Lumbar is substantially equivalent to the predicate Valeo II™ Interbody Fusion Device - Lumbar with respect to indications, design, performance and materials of manufacture. Additionally, the Valeo II™ Interbody Fusion Device – Lumbar is substantially equivalent to the Patriot Transcontinental Llif Spacer with respect to available configurations.
Performance Testing:
Failure Effects Analysis was performed to determine if the new sizes created a new worst case with respect to ASTM F2077 and ASTM F2267. No new worst cases were identified with regard to the ASTM standards requirements. No additional testing required.
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Bacterial endotoxin testing (BET) as specified in ANSVAAMI ST-72:2011 confirm an endotoxin limit of 0.5EU/mL.
Guidance Referenced:
Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device
Conclusion:
The Valeo II Interbody Fusion device has the same intended use, material of manufacture and is manufactured using the same processes. Performance evaluation demonstrates that the Valeo II Interbody Fusion Device is substantially equivalent to the predicate devices.