(88 days)
Not Found
No
The summary describes a physical interbody fusion device and its mechanical and biocompatibility testing. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as "interbody fusion devices" used to "facilitate intervertebral body fusion" and address "degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms" or "back pain of discogenic origin." This direct therapeutic action indicates it is a therapeutic device.
No
Explanation: The device is an intervertebral fusion device, which is an implant used to facilitate fusion, not to diagnose a condition. Its function is to hold bone graft material and provide structural support, not to detect or identify a disease.
No
The device description clearly states it is a physical interbody fusion device made of material and designed with specific dimensions and features for surgical implantation. It is 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 Device is a physical implant designed to be surgically placed in the spine to facilitate bone fusion. Its intended use is to treat degenerative disc disease by providing structural support and space for bone graft.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic testing on biological samples. It is a therapeutic device used in a surgical procedure.
The information provided clearly describes a surgical implant, not a diagnostic test.
N/A
Intended Use / 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.
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 at the C3 to C7 disc levels using autograft bone. 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 autograft 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, such as the 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 II Interbody Fusion Device consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. 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 devices range from to 22mm in height and 14mm to 34mm in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine, C3 to C7 disc levels, 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)
Nonclinical testing performed: ASTM F2077-11
Test: Static compression, Results: Pass
Test: Dynamic compression, Results: Pass
Test: Static Torsion, Results: Pass
Test: Dynamic Torsion, Results: Pass
Biocompatibility: ISO 10993 -1: 2009
Standard: ISO 10993-5:2009, Test: Cytotoxicity (MEM/ISO Elution Test), Results: Pass
Standard: ISO 10993-5:2009, Test: Neural Cytotoxicity (MEM/ISO Elution Test), Results: Pass
Standard: ISO 10993-10:2010, Test: Maximization Sensitization, Results: Pass
Standard: ISO 10993-10:2010, Test: ISO Intracutaneous Irritation Study in Rabbits, Results: Pass
Standard: ISO 10993-11:2006, Test: Mutagenicity ISO Systemic Toxicity Study in Mice, Results: Pass
Standard: ISO 10993-3:2003, Test: Bacterial Reverse Mutation, Results: Pass
Standard: ISO 10993-3:2003, Test: Genotoxicity (Mouse Lymphoma), Results: Pass
Standard: ISO 10993-3:2003, Test: Mouse Peripheral Blood Micronucleus Study, Results: Pass
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 features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three overlapping profiles of human faces, creating a sense of community and connection. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 18, 2014
Amedica Corporation Mr. William D. Jordan Senior Director, Regulatory Affairs & Quality Assurance 1885 West 2100 South Salt Lake City, Utah 84119
Re: K142347
Trade/Device Name: Valeo II Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, ODP Dated: September 16, 2014 Received: September 17, 2014
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
Page 2 - Mr. William D. Jordan
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" (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 vours.
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) K142347
Device Name Valeo II Interbody Fusion Device
Indications for Use (Describe)
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.
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 at the C3 to C7 disc levels using autograft bone. 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 autograft 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, such as the 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
| Date Prepared: | August 20, 2014 |
|---|---|
| Contact: | William D. Jordan |
| Amedica Corp. | |
| 1885 West 2100 South | |
| Salt Lake City, UT 84119 | |
| Office: (801) 839-3562 | |
| Device Trade Name: | Valeo II Interbody Fusion Device |
| Manufacturer: | Amedica Corp. |
| 1885 West 2100 South | |
| Salt Lake City, UT 84119 | |
| Common Name: | Intervertebral body fusion device |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code: | MAX, ODP |
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.
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 at the C3 to C7 disc levels using autograft bone. Valeo II Interbody Fusion Devices-Cervical are to 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 autograft 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, 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.
4
Device Description:
The Valeo II Interbody Fusion Device consists of a variety of hollow vertebral body spacers featuring convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is offered in various lengths. 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 devices range from to 22mm in height and 14mm to 34mm in length.
Predicate Device(s):
Primary Predicate Device: Phantom Plus Ceramic Cage System K121892
Performance Testing:
The material change is supported by testing which demonstrates that the proposed device meets the same performance requirements as the predicate device and raises no new concerns with respect to biocompatibility.
Nonclinical testing performed: ASTM F2077-11
| Test | Results |
|---|---|
| Static compression | Pass |
| Dynamic compression | Pass |
| Static Torsion | Pass |
| Dynamic Torsion | Pass |
Biocompatibility: ISO 10993 -1: 2009
| Standard | Test | Results |
|---|---|---|
| ISO 10993-5:2009 | Cytotoxicity (MEM/ISO | |
| Elution Test) | Pass | |
| ISO 10993-5:2009 | Neural Cytotoxicity | |
| (MEM/ISO Elution Test | Pass | |
| ISO 10993-10:2010 | Maximization Sensitization | Pass |
| ISO 10993-10:2010 | ISO Intracutaneous Irritation | |
| Study in Rabbits | Pass | |
| ISO 10993-11:2006 | Mutagenicity ISO Systemic | |
| Toxicity Study in Mice | Pass | |
| ISO 10993-3:2003 | Bacterial Reverse Mutation | Pass |
| ISO 10993-3:2003 | Genotoxicity (Mouse | |
| Lymphoma) | Pass | |
| ISO 10993-3:2003 | Mouse Peripheral Blood | |
| Micronucleus Study | Pass |
Guidance Referenced
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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, comparable performance, and is manufactured using similar processes. Performance testing and biocompatibility evaluation demonstrate that the Valeo II Interbody Fusion Device is substantially equivalent to the predicate device.