(148 days)
Not Found
No
The summary describes a mechanical spine system with no mention of AI or ML capabilities.
Yes
The device is described as providing "immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities." This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is described as an implant system (VIPER Spine System, EXPEDIUM Spine System) intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosing conditions.
No
The device description explicitly states that the device is comprised of physical components (rods and setscrews made of PEEK, tantalum wire, and titanium alloy) intended for surgical implantation. This is a hardware device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device designed for surgical implantation to provide immobilization and stabilization of spinal segments. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details components made from materials like PEEK, barium sulfate, tantalum wire, and titanium alloy, which are typical for implantable medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, the VIPER Spine System and EXPEDIUM Spine System, as described, are surgical implants and not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The VIPERTM 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.
With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.
The EXPEDIUM 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 EXPEDIUM™ 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, 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 per ASTM F 1717 and ASTM F 1798 were submitted to characterize the subject spine system components addressed 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.
K050809, K063670, K041801, K071860, K011182, K033901, K062174
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
Traditional 510(k) Submission -- VIPERTM and EXPEDIUM™ PB
5. 510(K) SUMMARY
510(k) Summary - VIPERTM Spine System 5.1.
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 |
| ------------ | --------------------------------------------------------------- |
|---|
MAY 15 2008
| Contact Person: | Christopher Klaczyk |
|---|---|
| Regulatory Project Manager | |
| Voice: | (508) 828-2852 |
| Fax: | (508) 828-3797 |
| E-Mail: | cklaczyk@dpyus.jnj.com |
February 21, 2008 Date Prepared:
- 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, MNI, MNH, KWP, KWQ |
|---|---|
| ------------------ | ------------------------- |
Proprietary Name: VIPERTM Spine System
CD HORIZON® Legacy Spinal System (Medtronic Predicate Devices: Sofamor Danek: K050809, K063670) VIPER Spine System (K041801, K071860) MOSS Miami Spine System (K011182)
Device Description: This submission addresses additional rod components.
The VIPER Spine System is intended to provide Intended Use: 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.
ﯿ
1
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.
With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.
- Materials: Rod components are manufactured from medical grade PEEK (polyetheretherketone) polymer both with and without 6% barium sulfate (BaSO4) filler and ASTM F 560 implant grade tantalum wire. Setscrew components are manufactured from ASTM F 136 implant grade titanium allov.
Performance Data: Performance data per ASTM F 1717 and ASTM F 1798 were submitted to characterize the subject spine system components addressed in this notification.
2
Traditional 510(k) Submission – VIPER™ and EXPEDIUM™ PEEK Rods
5.2. 510(k) Summary - EXPEDIUM™ Spine System
| Submitter: | DePuy Spine, Inc.
325 Paramount Drive
Raynham, MA 02767 | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Christopher Klaczyk
Regulatory Project Manager
Voice: (508) 828-2852
Fax: (508) 828-3797
E-Mail: cklaczyk@dpyus.jnj.com | | |
| Date Prepared: | February 21, 2008 | | |
| 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, MNI, MNH, KWP, KWQ | | |
| Proprietary Name: | EXPEDIUM™ Spine System | | |
| Predicate Devices: | CD HORIZON® Legacy Spinal System (Medtronic
Sofamor Danek; K050809, K063670)
EXPEDIUM Spine System (K033901, K062174)
MOSS Miami Spine System (K011182) | | |
| Device Description: | This submission addresses additional rod components | | |
The EXPEDIUM Spine System is intended to provide Intended Use: 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.
3
| | The EXPEDIUM 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; pseudarthrosis; and failed previous fusion
in skeletally mature patients. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | With the exception of degenerative disc disease (DDD), the
PEEK rods and associated components of the EXPEDIUM
Spine System may be used for the aforementioned
indications in skeletally mature patients. |
| Materials: | Rod components are manufactured from medical grade
PEEK (polyetheretherketone) polymer both with and
without 6% barium sulfate (BaSO4) filler and ASTM F 560
implant grade tantalum wire. Setscrew components are
manufactured from ASTM F 136 implant grade titanium
alloy. |
| Performance Data: | Performance data per ASTM F 1717 and ASTM F 1798
were submitted to characterize the subject spine system
components addressed in this notification. |
.
DePuy Spine, Inc., a Johnson & Johnson Company
:
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 15 2008
DePuy Spine % Mr. Christopher Klaczyk Regulatory Project Manager 325 Paramount Drive Raynham, MA 02767
Re: K073562
Trade/Device Name: VIPER™ and EXPEDIUM™M Spine Systems Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: May 12, 2008 Received: May 13, 2008
Dear Mr. Klaczyk:
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.
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.
5
Page 2 – Mr. Christopher Klaczyk
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
4. INDICATIONS FOR USE STATEMENT 4.1. INDICATIONS FOR USE STATEMENT - VIPER SPINE SYSTEM
510(k) Number (if known): K073562
Device Name: VIPERTM 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.
With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the VIPER Spine System may be used for the aforementioned indications in skeletally mature patients.
Prescription Use ﻷ (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 | |
| Page | |
| DePuy Spine, Inc., a Johnson & Johnson Company | |
| 510(k) Number | K073562 |
| Page 4-1 |
7
INDICATIONS FOR USE STATEMENT - EXPEDIUM SPINE 4.2. SYSTEM
510(k) Number (if known): K073562
Device Name: EXPEDIUM™ Spine System
Indications For Use:
The EXPEDIUM 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 EXPEDIUM™ 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; pseudarthrosis; and failed previous fusion in skeletally mature patients.
With the exception of degenerative disc disease (DDD), the PEEK rods and associated components of the EXPEDIUM Spine System may be used for the aforementioned indications in skeletally mature patients.
Prescription Use X (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)
NihleO, for mxn
Division of General, Restorative. and Neurological Devices
Page 1 of 1
ohnson & Johnson Company
Page 4-2