(292 days)
Not Found
No
The summary describes a passive implantable device made of PEEK and tantalum, with no mention of software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies are mechanical tests, not related to algorithmic performance.
No
The device is an implant for spinal fusion and is intended to provide mechanical support and facilitate fusion, not to treat a disease through a therapeutic action.
No
The device is an implant for spinal fusion procedures, intended for treatment rather than diagnosis.
No
The device description explicitly states the device is an implant made of PEEK and tantalum, which are physical materials, not software.
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 Function: The Vusion® CS Plus device is an implantable medical device designed to be surgically placed in the cervical spine to facilitate bone fusion. It is a physical structure used within the body, not a tool for analyzing biological samples.
- Intended Use: The intended use clearly describes a surgical procedure for spinal fusion, not a diagnostic test.
The information provided describes a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. This device is intended to be used in patients who have had six weeks of non-operative treatment.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PEEK Optima LT1 (ASTM F2026) implant body and two tantalum (ASTM F560) marker pins and is provided in multiple footprints, lordotic angles, and heights to match patient's anatomy. The implant includes machined fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
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 following non-clinical mechanical tests were conducted on the worst case configurations of Vusion® CS Plus: Static and dynamic compression testing per ASTM F2077, Static shear testing per ASTM F2077, Static and dynamic torsion testing per ASTM F2077, Subsidence testing per ASTM F2267. The mechanical test results demonstrate that Vusion® CS Plus devices perform as well as or better than the 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.
K091088, K113559, K083311, K113138, K073351
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/0 description: The image shows the logo for Ortho Development. The logo consists of a stylized symbol resembling concentric arcs emanating from a solid circle, followed by the word "ORTHO" in bold, sans-serif capital letters. Below "ORTHO" is the word "DEVELOPMENT" in smaller, sans-serif capital letters with an asterisk at the end.
K122588
Page 1 of 2
JUN 1 2 2013
510(k) Summary
NAME OF SPONSOR:
Ortho Development Corporation 12187 South Business Park Drive Draper, Utah 84020
510(k) CONTACT:
Tom Haueter Regulatory Affairs Manager Telephone: (801) 553-9991 Facsimile: (801) 553-9993 Email: thaueter@orthodevelopment.com
DATE PREPARED:
.
PROPRIETARY NAME:
COMMON NAME:
CLASSIFICATION:
DEVICE PRODUCT CODE:
PREDICATE DEVICES:
DEVICE DESCRIPTION:
Vusion® CS Plus 510(k)
July 11, 2012
Vusion® CS Plus
Intervertebral Body Fusion Device
21 CFR 888.3080, Intervertebral Body Fusion Device.
ODP
LDR Spine Cervical Interbody Fusion System (K091088) LDR Spine
ROI-C Cervical Cage (K113559) LDR Spine
Aesculap CeSpace PEEK Spinal Implant System (K083311) Aesculap® Implant Systems
Aleutian IBF System (K113138) K2M, Inc.
Crystal™ Intervertebral Body Fusion Device (K073351) Spinal Elements
The Vusion® CS Plus system is designed for cervical intervertebral body fusion. The implant is a non-sterile PEEK Optima LT1 (ASTM F2026) implant body and two tantalum (ASTM F560) marker pins and is provided in multiple footprints, lordotic angles, and heights to match patient's anatomy. The implant includes machined Section 5, 510(k) Summary Page 1 of 2
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Image /page/1/Picture/1 description: The image shows the logo for "Ortho Development". The logo consists of a circular icon with three curved lines emanating from the right side, followed by the word "ORTHO" in bold, sans-serif font. Below the word "ORTHO" is the word "DEVELOPMENT" in a smaller, sans-serif font.
fixation teeth on the superior and inferior surfaces, a graft window passing between the superior and inferior surfaces, and an insertion hole for implant placement . INTENDED USE: The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine. . This device is intended to be used in patients who have had six weeks of non-operative treatment. TECHNOLOGICAL Vusion® CS Plus has the same technological characteristics as the CHARACTERISTICS: predicate devices. These include: t Intended use (as described above) . Basic design Material (PEEK) . . Sizes (widths, lengths, heights are within range(s) offered by the predicate systems) Therefore the fundamental scientific technology of Vusion® CS Plus is the same as previously cleared devices. The following non-clinical mechanical tests were conducted on the PERFORMANCE DATA: worst case configurations of Vusion® CS Plus: . Static and dynamic compression testing per ASTM F2077 . Static shear testing per ASTM F2077 Static and dynamic torsion testing per ASTM F2077 . . Subsidence testing per ASTM F2267
The mechanical test results demonstrate that Vusion® CS Plus devices perform as well as or better than the predicate devices. Therefore, Vusion® CS Plus is as safe and effective as the predicates.
Based on similarities in intended use, design, materials, manufacturing methods, and packaging, Vusion® CS Plus is substantially equivalent to the previously cleared predicate devices. Mechanical test results demonstrate that the proposed Vusion® CS Plus is substantially equivalent to the predicate devices.
Vusion® CS Plus 510(k)
CONCLUSIONS:
Section 5, 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper portion of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Letter Dated: June 12, 2013
Ortho Development Corporation % Mr. Tom Haueter Regulatory Affairs Manager 12187 South Business Park Drive Draper, Utah 84020
Re: K122588
Trade/Device Name: Vusion® CS Plus Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 28, 2013 Received: May 29, 2013
Dear Mr. Haueter:
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. Tom Haueter
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 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/Safetv/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,
Laurence D. Coyne -A
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): K122588
Device Name: Ortho Development Vusion® CS Plus
Indications for Use:
The Vusion® CS Plus device is intended for spinal fusion procedures at one level (C2-T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone.
This device is intended to be used with a supplemental internal fixation system appropriate for use in the cervical spine.
This device is intended to be used in patients who have had six weeks of non-operative treatment.
| Prescription Use
(Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use
(Part 21 CFR 801 Subpart C) |
| ------------------------------------------------- | --- | -------- | ----------------------------------------------------- |
|---|
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, RhD Division of Orthopedic Devices