(147 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
This device is intended to treat degenerative disc disease by facilitating fusion in the cervical spine, which is a therapeutic purpose.
No
This device is an interbody fusion system designed to treat degenerative disc disease by facilitating fusion in the cervical spine; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it consists of a PEEK cage, titanium alloy plate, and titanium bone screws, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Vault-C is a physical implant (a cage, plate, and screws) designed to be surgically placed in the cervical spine. It is a structural device used to facilitate fusion.
- Intended Use: The intended use is to treat degenerative disc disease by providing structural support and promoting bone fusion in the spine. This is a surgical intervention, not a diagnostic test performed on a sample.
The description clearly indicates a surgically implanted device, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-TI) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels. Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C3-T1)
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)
The Vault-C has been tested in the following test modes:
- Static Axial Compression (ASTM F-2077)
- Static Compression-Shear (ASTM F-2077)
- Static Torsion (ASTM F-2077)
- Dynamic Axial Compression (ASTM F-2077)
- Dynamic Compression-Shear (ASTM F-2077)
- Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077)
The results of this non-clinical testing show that the strength of the Vault-C is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
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.
Centinel Spine Stalif C System (K120819), Biomet Spine. Solitaire-C System (K113796), LDR Spine ROI-C (K091088, K113559), Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151), Globus Medical. Inc COALITION Spacer (K083389)
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
5.510(K) SUMMARY
| Submitter's Name: | Spinal USA, Inc. |
|---|---|
| Submitter's Address: | 2050 Executive Drive |
| Pearl. MS 39208 | |
| Submitter's Telephone: | 601-420-4244 |
| Contact Person: | Meredith L. May, MS |
| Empirical Testing Corp. | |
| 719.337.7579 | |
| Date Summary was | |
| Prepared: | 28 June 2013 |
| Trade or Proprietary Name: | Vault-C Standalone Cervical Interbody Fusion System |
| Common or Usual Name: | Intervertebral body fusion device. |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | OVE |
| Classification Panel: | Orthopedic and Rehabilitation Devices Panel |
| Predicate Devices: | Centinel Spine Stalif C System (K120819) |
| Biomet Spine. Solitaire-C System (K113796) | |
| LDR Spine ROI-C (K091088, K113559) | |
| Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151) | |
| Globus Medical. Inc COALITION Spacer (K083389) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Vault-C consists of a spacer assembly including a PEEK cage with a titanium alloy plate and titanium bone screws for intervertebral body fusion. Screws are available in a variety of diameter-length combinations. The titanium and PEEK spacers are available in a variety of depths, widths and heights. Fixation is achieved by inserting bone screws through the openings in the spacer into the vertebral bodies of the cervical spine.
INDICATIONS FOR USE
The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-TI) at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The Vault-C implants are used with two titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.
Spinal USA Vault-C Standalone Cervical Interbody Fusion System
1
Patients should have at least six weeks of non-operative treatment with an intervertebral fusion device.
The indication for use for the Spinal USA Vault-C is similar to that of the Centinel Spine Stalif C System (K120819). Biomet Spine Solitaire-C System (K113796). LDR Spine ROI-C (K091088, K 113559), Life Spine, Inc. Pro-Link Stand-Alone Cervical System (K121151) and Globus Medical. Inc. COALITION Spacer (K083389).
TECHNICAL CHARACTERISTICS
The spacers are manufactured from PEEK-OPTIMA® (ASTM F2026), titanium alloy (ASTM F136), and tantalum (ASTM F560-05). The predicate devices are manufactured from the same or similar materials. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture �
- t Structural support mechanism
PERFORMANCE DATA
The Vault-C has been tested in the following test modes:
- Static Axial Compression (ASTM F-2077) .
- . Static Compression-Shear (ASTM F-2077)
- Static Torsion (ASTM F-2077) . ●
- Dynamic Axial Compression (ASTM F-2077) ●
- Dynamic Compression-Shear (ASTM F-2077) .
- . Dynamic Torsion (ASTM F-2077)
- Subsidence (ASTM F-2267 and ASTM F-2077)
The results of this non-clinical testing show that the strength of the Vault-C is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Vault-C is substantially equivalent to the predicate device.
2
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 stylized eagle with its wings spread, superimposed over three horizontal bars. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2013
Spinal USA % Ms. Meredith May Partnership Manager Empirical Testing Corporation 4628 Northpark Drve Colorado Springs, Colorado 80918
Re: K132029
Trade/Device Name: Vault-C Standalone Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: October 8, 2013 Received: October 18, 2013
Dear Ms. May:
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
3
Page 2 - Ms. Meredith May
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.
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/ResourcesforYou/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark Nielkerson -S
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
ジェット・
.
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: December 31, 2013 | |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Indications for Use | See PRA Statement on last page. | |
| 510(k) Number (if known) | | | |
| K132029 | | | |
| Device Name
Vault-C Standalone Cervical Interbody Fusion System | | | |
| Indications for Use (Describe) | | | |
| intervertebral fusion device | The Vault-C Standalone Cervical Interbody Fusion System is a standalone cervical interbody
the disc confirmed by history and radiographic studies. The Vault-C implants are used with two
titanium alloy screws and filled with autogenous bone graft material to facilitate fusion in the
cervical spine. The device is placed via an anterior approach at the C-3 to T-1 disc levels.
Patients should have at least six weeks of non-operative treatment with an | device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the
cervical spine (C3-T1) at one disc level. DDD is defined as discogenic pain with degeneration of | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| 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) | |
| | 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) | | | |
| | Anton E. Dmitriev, PhD | | |
| | | | |
| | Division of Orthopedic Devices | | |
| | | | |
| | | | |
| | | | |
| FORM FDA 3881 (9/13) | Page 1 of 2 | PSC Publishing Bervices (301) 443-8 | |
Spinal USA Vault-C Standalone Cervical Interbody Fusion System
.
·
: