(111 days)
Not Found
Not Found
No
The description focuses on the material, shape, and intended use of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is intended for partial replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma, which is a therapeutic intervention.
No
Explanation: The device is described as a "vertebral body replacement device" intended for surgical implantation to replace a damaged vertebral body. Its function is to provide structural support, not to diagnose a condition.
No
The device description clearly states it is a physical implant fabricated from PEEK, designed for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Vista -S Device is a vertebral body replacement device for surgical implantation in the spine. It is used to replace a damaged or unstable vertebral body.
- Device Description: The description details a physical implant made of PEEK, designed to be surgically placed in the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. This device does not interact with biological specimens in this way.
The Vista -S Device is a medical device, specifically an implantable surgical device.
N/A
Intended Use / Indications for Use
The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.
Product codes
MQP
Device Description
The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
510(k) Summary
MAY 3 0 2007
| Submitter: | Zimmer Trabecular Metal Technology, Inc.
10 Pomeroy Road
Parsippany, New Jersey 07054 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer P. Harakal
Senior Specialist, Regulatory Affairs
Telephone: (973) 576-0133
Fax: (973) 884-8795 |
| Date: | April 25, 2007 |
| Trade Name: | Vista®-S Device |
| Common Name: | Vertebral Body Replacement Device |
| Classification Name and
Reference: | Spinal Intervertebral Body Fixation Orthosis
21 CFR § 888.3060, MQP |
DEVICE DESCRIPTION
The Vista -S Device is a box-shaped vertebral body replacement fabricated from polyetheretherketone (PEEK) that is designed to accommodate the partial replacement of a vertebral body in the thoracic and lumbar region of the spine. The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of the patient. The superior and inferior surfaces of the device contain a pattern of teeth to provide for initial stability. Radiopaque markers are press fit into the device to aid in determining the location of the implant postoperatively.
INDICATIONS FOR USE
The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.
SUBSTANTIAL EQUIVALENCE
Documentation was provided which demonstrated that the Vista -S Device is substantially equivalent to its predicate devices with respect to intended use/indications for use, materials, technological characteristics and basic principles of operation.
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Image /page/1/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, sans-serif font. The text is centered in the image and is the only element present.
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer Trabecular Metal Technology, Inc. % Ms. Jennifer P. Harakal Senior Specialist, Regulatory Affairs 10 Pomeroy Road Parsippany, New Jersey 07054
MAY 3 0 2007
Re: K070382
Trade Name: Vista®-S Device Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Codes: MOP Dated: February 6, 2007 Received: February 8, 2007
Dear Ms. Harakal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your 510(k) premarket
2
Page 2 -- Ms. Harakal
notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address: http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for
Mark N. Mcl Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _
Device Name: Vista®-S Device
Indications for Use:
The Vista -S Device is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) for partial replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vista -S Device is intended for use with supplemental internal spinal fixation systems. The Vista -S Device may be used with bone graft.
Prescription Use_ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
R
Division Sign-Off (Division Signeral, Restorative, Division of Neurological Devices
510(k) Number L090382