(29 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The VIPER systems are explicitly stated as being intended for the "treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine," which is a therapeutic purpose.
No
The VIPER system is described as an implantable device used for immobilization and stabilization of spinal segments, indicating a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states the system consists of physical components made of stainless steel and titanium (screws, rods, implants), indicating it is a hardware-based medical device.
Based on the provided information, 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 and Intended Use: The VIPER system is described as a system of screws and rods intended for the immobilization and stabilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly on the patient's body, not a device used to analyze samples outside the body.
The information clearly indicates a surgical implant for spinal fixation, which falls under the category of medical devices used for treatment and structural support, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The VIPER systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine.
The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
NKB, KWP, MNH, MNI
Device Description
The VIPER® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral 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)
Performance data in the form of an engineering rationale that included Finite Element Analysis was conducted to prove there was no new worst case component for the proposed VIPER System's components contained in this notification.
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.
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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
长121020
MAY - 3 2012
510(K) SUMMARY
B.
C.
D.
Submitter Information A.
DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02767
Contact Person: Kirsten Lehmuller Address: 325 Paramount Drive Raynham, MA 02767 Telephone number: (508) 828-3291 Fax number: (508) 828-3797 Email: klehmull@its.jnj.com Date Prepared May 2, 2012 Device Class Class III Device Name Trade/Proprietary Name: VIPER® Systems
Pedicle Screw Spinal System Common/Usual Name:
Classification Name: Spinal interlaminar fixation orthosis per 21 CFR §888.3050 Pedicle screw spinal fixation per 21 CFR §888.3070 Classification Panel: Orthopaedics
87
E. NKB, KWP, MNH, MNI Product Code(s):
FDA Panel Number:
1
F. Predicate Device Name
Trade name: DePuy Spine VIPER® Spinal System (K102701) DePuy Spine VIPER® System (K111571)
G. Device Description
The VIPER® System is a 5.5mm rod system offered in both stainless steels and titanium materials. The system consists of monoaxial screws. polyaxial screws. uni-planar screws, and extended tab implants. They are available in various geometries and sizes to accommodate patient anatomy.
H. Intended Use
The VIPER systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine.
The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS instrumentation, the VIPER Systems are intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudoarthrosis; and failed previous fusion in skeletally mature patients.
Summary of Similarities and Differences in Technological Characteristics, Performance l. and Intended Use
The proposed modifications to the DePuy Spine VIPER® Systems are identical to predicate devices (K111571) except for the addition of fully threaded and partially threaded favored angle polyaxial screws in various sizes to the systems,
2
which are outside the range of the currently cleared screw offerings. The design, materials, and technology remain identical to the predicate systems.
J. Materials
Manufactured from ASTM F 138 implant grade stainless steel, ASTM F 139 implant grade stainless steel, and ASTM F 136 implant grade titanium alloy.
K. Performance Data
Performance data in the form of an engineering rationale that included Finite Element Analysis was conducted to prove there was no new worst case component for the proposed VIPER System's components contained in this notification.
ﻧ Conclusion
Both the engineering rationale that included Finite Element Analysis and the Substantial Equivalence Justification demonstrate that the device is as safe, as effective, and performs as well as the predicate device.
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Image /page/3/Picture/1 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.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DePuy Spine, Incorporated % Ms. Kirsten Lehmuller Regulatory Affairs Associate 325 Paramount Drive Raynham, Massachusetts 02767
Re: K121020
Trade/Device Name: VIPER® Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: April 3, 2012 Received: April 4, 2012
MAY - 3 2012
Dear Ms. Lehmuller:
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
4
Page 2 – Ms. Kirsten Lehmuller
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Eunel Keith
~Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: VIPER® Systems
Indications For Use:
The VIPER systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of deformities of the thoracic, lumbar, and sacral spine.
The VIPER System is intended for noncervical pedicle fixation and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with following indications: acgeneration by history and radiographic studies); spondylolisthesis; deechelon of the "dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or tradination of also of alled of and failed previous fusion in skeletally mature patients.
When used in a percutaneous, posterior approach with MIS instrumentation, VIPER Systems are vvilen used in a percutaneous) postories and nonpedicle fixation for the following indications: Intended for nonecrited pounds marked on of discogenic origin with degeneration of the degenerative and radiographic studies); spondylolisthesis; trauma(i.e., fracture or disc collinthea by motory curvatures (i.e., scoliosis, and/or lordosis, and/or lordosis); tumor, alsfocation), "Specious fusion in skeletally mature patients.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use _
(Part 21 CFR 801 Subpart D)
(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)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, | |
| And Restorative Devices | |
| 510(k) Number | K121020 |
DePuy Spine, Inc., a Johnson & Johnson Company