(63 days)
Not Found
No
The 510(k) summary describes a physical implant device (intervertebral body fusion system) made of PEEK. There is no mention of software, algorithms, image processing, AI, DNN, or ML. The performance studies are mechanical tests, not related to data analysis or prediction.
Yes
The device is indicated for the treatment of degenerative disc disease and is used in a surgical procedure to facilitate intervertebral body fusion, which are therapeutic interventions.
No
The device is an intervertebral body fusion system designed to treat degenerative disc disease, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states that the system consists of implants and bone screws manufactured from PEEK, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as implants and bone screws made of PEEK, which are physical components for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic implant used directly in the body during surgery.
N/A
Intended Use / Indications for Use
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
Product codes
OVD
Device Description
The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and autogenous bone graft size. All components are manufactured from medical grade polyetheretherketone (PEEK LT1).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, from 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
The following tests were conducted:
- Dynamic axial compression per ASTM F2077 .
- Dynamic shear compression per ASTM F2077 .
The results of this testing indicate that the Redesigned Vault ALIF System is equivalent to predicate device.
No clinical studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Spinal USA Vault ALIF System - K103369
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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K130445 Page 1 of 2
510(k) Summary for the Vault ALIF System
APR 2 5 2013
In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the Vault ALIF System
1. GENERAL INFORMATION
Date Prepared: February 18, 2013
Trade Name: Vault ALIF System
Common Name: Intervertebral Body Fusion Device
Classification Name: Intervertebral Fusion Device With Integrated Fixation, Lumbar
Class: II
Product Code: OVD
CFR section: 21 CFR section 888.3080
Device panel: Orthopedic
Legally Marketed
Predicate Device: Spinal USA Vault ALIF System - K103369
Submitter: Spinal USA 2050 Executive Drive Pearl, MS 39208 601-420-424
Contact J.D. Webb 1001 Oakwood Blvd Round Rock, TX 78681 512-388-0199 Tele 512-692-3699 Fax e-mail: jdwebb@orthomedix.net
2. DEVICE DESCRIPTION
The Vault ALIF System consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and autogenous bone graft size. All components are manufactured from medical grade polyetheretherketone (PEEK LT1).
Change from Predicate:
This Special 510(k) is submitted in order to gain clearance for the Redesigned Vault ALIF System.
Materials:
Optima LT1 PEEK (ASTM F2026) Ti-6AL-4V (ASTM F136)
3. INTENDED USE
The Vault ALIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
1
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
4. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS / SUBSTANTIAL EQUIVALENCE
The Spinal USA Vault ALIF System is substantially equivalent to the predicate device(s) in terms of intended use, design, mechanical safety and performances. The Spinal USA Vault ALIF System is manufactured from an equivalent material, is packaged and sterilized the using the same methods as the predicate device(s).
5. NON-CLINICAL TEST SUMMARY
The following tests were conducted:
- Dynamic axial compression per ASTM F2077 .
- Dynamic shear compression per ASTM F2077 .
The results of this testing indicate that the Redesigned Vault ALIF System is equivalent to predicate device.
6. CLINICAL TEST SUMMARY
No clinical studies were performed
7. CONCLUSIONS NONCLINICAL AND CLINICAL
Spinal USA considers the Redesigned Vault ALIF System to be equivalent to the predicate device listed above. This conclusion is based upon the device's similarities in principles of operation, technology, materials and indications for use.
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Image /page/2/Picture/0 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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter dated: April 25, 2013
Spinal USA % The Orthomedix Group, Incorporated Mr. J.D. Webb -1001-Oakwood-Boulevard-Round Rock, Texas 78681
Re: K130445
Trade/Device Name: Vault ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 25, 2013 Received: March 27, 2013
Dear Mr. Webb
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
3
Page 2 - Mr. J.D. Webb
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers; International and Consumer Assistance 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.
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
4
INDICATIONS FOR USE
510(k) Number (if known): __K13 0445
Device Name: Vault ALIF System
Indications for Use:
The Vault. ALIE_System_is_indicated_for_intervertebral_body_fusion_of_the_spine_in_skeletally ... mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Vault ALIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with autogenous bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Vault ALIF System is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixations.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices