(27 days)
No
The summary describes a spine implant system and does not mention any AI or ML components or functionalities.
Yes
The device is intended to treat various spinal conditions such as degenerative disc disease, trauma, spinal stenosis, and curvatures, which aligns with the definition of a therapeutic device.
No
The VIPER Spine System is described as a device providing immobilization and stabilization for spinal segments, used as an adjunct to fusion for treatment of various spinal conditions. It is a surgical implant, not a device used to diagnose medical conditions.
No
The device description explicitly states it addresses "additional rod components," which are physical hardware used in spinal surgery. The intended use also describes a physical implant system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical implantation to stabilize and immobilize the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description mentions "additional rod components," which are physical implants used in surgery.
- Anatomical Site: The device is used on the "thoracic, lumbar and sacral spine," which is an in-vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
The requested information is extracted from the provided text as follows:
Intended Use / Indications for Use
The VIPER Spine System is 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 or deformities of the thoracic, lumbar and sacral spine.
The VIPER Spine 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 posterior percutaneous approach with MIS instrumentation, 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.
Product codes
NKB, MNH, MNI, KWP, KWQ
Device Description
This submission addresses additional rod components.
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 were submitted to characterize the subject VIPER™ Spine System components addressed in this notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EXPEDIUM™ 5.5mm Spine System (K033901), VIPER™ Spine System (K041801, K061520)
Reference Device(s)
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
Special 510(k) Submission – Additions to VIPER Spine System
5. 510(K) SUMMARY
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 | | | | | AUG - 1 2007 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|------------------------|--|--|--------------|
| Contact Person: | Christopher Klaczyk
Regulatory Project Manager | Voice: | (508) 828-2852 | | | |
| | | Fax: | (508) 828-3797 | | | |
| | | E-Mail: | cklaczyk@dpyus.jnj.com | | | |
| Date Prepared: | July 3, 2007 | | | | | |
| Device Class: | Class III | | | | | |
| Classification Name: | Pedicle screw spinal fixation
per 21 CFR §888.3070
Spinal interlaminar fixation orthosis
per 21 CFR §888.3050
Spinal intervertebral body fixation orthosis
per 21 CFR §888.3060 | | | | | |
| Classification Panel: | Orthopedics | | | | | |
| FDA Panel Number: | 87 | | | | | |
| Product Code(s): | NKB, MNH, MNI, KWP, KWQ | | | | | |
| Proprietary Name: | VIPER™ Spine System | | | | | |
| Predicate Devices: | EXPEDIUM™ 5.5mm Spine System (K033901)
VIPER™ Spine System (K041801, K061520) | | | | | |
| Device Description: | This submission addresses additional rod components. | | | | | |
| Intended Use: | The VIPER Spine System is 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 or deformities
of the thoracic, lumbar and sacral spine.
The VIPER Spine System is intended for noncervical
pedicle fixation and nonpedicle fixation for the following
indications: degenerative disc disease (defined as back pain | | | | | |
DePuy Spine, Inc., a Johnson & Johnson Company
1
Special 510(k) Submission - Additions to VIPER Spine System
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 posterior percutaneous approach with MIS instrumentation, 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.
- Manufactured from ASTM F 136 implant grade titanium Materials: alloy.
- Performance Data: Performance data were submitted to characterize the subject VIPER™ Spine System components addressed in this notification.
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract design of three human profiles facing right, arranged in a staggered formation. The profiles are depicted in black against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DePuy Spine % Mr. Christopher Klaczyk Regulatory Project Manager 325 Paramount Drive Raynham, Massachusetts 02767
AUG - 1 2007
Re: K071860
Trade/Device Name: VIPERTM Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, KWP, MNH, MNI, KWQ Dated: July 3, 2007 Received: July 5, 2007
Dear Mr. Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave teviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally names date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the enaonance with the provisions of the Federal Food, Drug.
devices that have been reclassified in accordance with the provisions of the simp devices that have been recuire approval of a premarket approval application (PMA). and Costinetic 700 (710) that the novement controls provisions of the Act. The You may, therefore, market the device, basjer of the ments for annual registration, listing of general controls provisions of the rice, 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 If your device is onashined (600 a00 royals. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations a PD may be subject to subli duditional combrions, Title 21, Parts 800 to 898. In addition, FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oe advised that I Dri 3 issualites of wouldevice complies with other requirements of the Act that I DA has made a determination administered by other Federal agencies. You must of any I cuttar statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, not 801); good manufacturing practice requirements as set CITY art 6077, adomig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Christopher Klacyzk
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, 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). You may obtain other general information on your responsibilities under the Act 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,
Mark A. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 4.
510(k) Number (if known):
Device Name: VIPER Spine System
Indications For Use:
The VIPER Spine System is 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 or deformities of the thoracic, lumbar and sacral spine.
The VIPER Spine 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 posterior percutaneous approach with MIS instrumentation, 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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 General, Restorative, and Neurological Devices |
| 510(k) Number | K07 1860 |
|---|---|
| --------------- | ---------- |
DePuy Spine, Inc., a Johnson & Johnson Company
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