(207 days)
Not Found
No
The summary describes a passive interbody fusion device made of PEEK with no mention of AI/ML capabilities or data processing beyond standard radiographic studies for diagnosis and post-operative assessment.
Yes.
The device is intended for use in patients with degenerative disc disease to alleviate discogenic pain and aid in interbody fusion, which is a therapeutic intervention.
No
The device is an interbody fusion device (implant) used for treating degenerative disc disease, not for diagnosing it. The diagnosis is confirmed by history and radiographic studies, which are separate from the device itself.
No
The device description clearly states it is a "box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK)" and includes physical components like "teeth" and "radiopaque markers," indicating it is a physical implant, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical implantation in skeletally mature patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as a box-shaped implant made of PEEK for interbody fusion. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
The device is an implantable medical device used in surgery.
N/A
Intended Use / Indications for Use
The Vista -S Device is intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista -S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.
Product codes
ODP
Device Description
The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of 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
Radiographic studies
Anatomical Site
C2-T1 (spinal)
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)
Finite Element Analysis (FEA) testing was conducted and included in this submission. The FEA model simulated testing conditions described in ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices and satisfy the testing requirements as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. The FEA tests that were performed are as follows:
- . Axial Compression
- . Torsion
- . Compression Shear
An engineering rationale along with the FEA testing determined that the proposed line extension to the Vista-S device does not represent a new worst case for testing and are therefore considered substantially equivalent to the predicates referenced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111983, K070382, K11119, K103033, K081730
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.
0
JUL 07 2014
510(k) Summary
Submitter: Zimmer Trabecular Metal Technology, Inc. 10 Pomeroy Road Parsippany, New Jersey 07054 Contact Person: Judith Rosen Sr. Regulatory Affairs Specialist Telephone: 973-576-0032 ext. 28138 Fax: (973) 884-8792 ទ Email: judith.rosen@zimmer.com May 29, 2014 Date: Vista®-S Device Trade Name: Common Name: Intervertebral body fusion device Classification Name: Intervertebral fusion device. 21 CFR § 888.3080, Device Panel/Product Code: Orthopedic / ODP
Device Description:
The purpose of this submission is a line extension to the Vista®-S Device adding additional height and footprint options. The Vista -S Device is a box-shaped device for interbody fusion fabricated from polyetheretherketone (PEEK). The device is available in a variety of cross sections and heights to accommodate variations in the individual pathology and anatomic condition of 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 intended for use in skeletally mature patients with degenerative disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista -S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vista -S Device is implanted via an anterior approach.
Device Technological Characteristics and Comparison to Predicate Device(s):
The Vista -S Device was shown to be substantially equivalent to legally marketed predicate devices. The predicate devices include this Vista® S Device as an IBF and VBR (K111983 and K070382), TM-S Fusion Device by Zimmer (K11119 and K103033), and Alphatec Spine Novel XS (K081730).
The Vista -S Device has the identical material as previously cleared predicate devices. The intended use and indications for use of the subject device are the same as those of its predicate devices. The sizes, design features and overall geometry of the device in the current submission are similar to the cleared predicate devices.
1
There are no significant differences between the Vista® -S Device and the predicate devices currently being marketed that would adversely affect the use of the product. Any differences in technological characteristics do not raise new issues of safety or efficacy. The subject device is similar to its predicate devices with respect to intended use/indications for use, material, technological characteristics and basic principles of operation.
Performance Data:
Finite Element Analysis (FEA) testing was conducted and included in this submission. The FEA model simulated testing conditions described in ASTM F2077-03 Test Methods for Intervertebral Body Fusion Devices and satisfy the testing requirements as recommended by the FDA Class II Special Controls Guidance Document: Intervertebral Fusion Device. The FEA tests that were performed are as follows:
- . Axial Compression
- . Torsion
- . Compression Shear
An engineering rationale along with the FEA testing determined that the proposed line extension to the Vista-S device does not represent a new worst case for testing and are therefore considered substantially equivalent to the predicates referenced.
Substantial Equivalence:
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 as demonstrated by the supporting performance testing data.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
Zimmer Trabecular Metal Technology, Incorporated Ms. Judith Rosen Senior Regulatory Affairs Specialist 10 Pomeroy Road Parsippany, New Jersey 07054
Re: K133784
Trade/Device Name: Vista@-S Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: May 29, 2014 Received: May 30, 2014
Dear Ms. Rosen:
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 - Ms. Judith Rosen
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/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/ReportalProblem/default.htm for the CDRI+'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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ronald P. Jean -S for
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) K133784
Device Name Vista@-S Device
Indications for Use (Describe)
The Vista@-S Device is intended for use in skeletally mature patients with disc disease (DDD) with/without radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Vista®-S Device is intended for use with supplemental spinal fixation systems and with autogenous bone graft. The Vistal S Device is implanted via an anterior approach.
Type of Use (Select one or both, as applicable)
2 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
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