(97 days)
Not Found
No
The description focuses on mechanical components for spinal fixation and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device is a spinal fixation system, which stabilizes the spine during fusion but is intended to be removed after fusion is complete. It is not designed to directly treat or cure a disease itself, but rather to support the healing process.
No
The device is a spinal fixation system, meaning it is used for surgical stabilization of the spine, not for diagnosing medical conditions.
No
The device description explicitly states that the CapSure® PS System consists of physical components made of titanium alloy and cobalt chrome alloy (screws, connectors, rods) that are assembled and attached to the spine. This indicates a hardware-based medical device, not a software-only one.
No, 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.
- CapSure® PS System Function: The provided text clearly describes the CapSure® PS System as a spinal fixation system intended for posterior pedicle screw fixation in the spine. It is a physical implant used to stabilize the spine during fusion.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze biological samples or provide diagnostic information. Its purpose is mechanical support and stabilization.
The description focuses on the surgical application, the components of the implant, and mechanical testing to demonstrate its structural integrity. This aligns with the characteristics of a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
Product codes
MNI, MNH
Device Description
The CapSure® PS System consists of a selection of non-sterile, single use, titanium allov polyaxial screw and connector components, and titanium alloy and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine, T1-S2/ilium, L5-S1 vertebral joint, lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium)
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)
Mechanical testing according to ASTM F1717, including static and dynamic compression bending and static torsion, were performed to demonstrate that the subject CapSure® PS System is substantially equivalent to the predicate CapSure® PS System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070245, K081228, K083353, K083743, K100122, K111913, K083393, K111358
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUN - 7 2012
SPINE WAVE
510(k) Summary CapSure® PS System
1. Submitter Information
| Submitter: | Spine Wave, Inc. |
|---|---|
| Address: | Three Enterprise Drive |
| Suite 210 | |
| Shelton, CT 06484 | |
| Telephone: | 203-712-1839 |
| Telefax: | 203-944-9493 |
| Contact: | Roaida Rizkallah |
| Date Prepared: | June 4, 2012 |
2. Device Information
| Trade Name: | CapSure® PS System |
|---|---|
| Common Name: | Pedicle Screw Spinal System |
| Classification Name: | Pedicle Screw Spinal System |
| Classification/ Code: | Class II per 21 CFR 888.3070 / MNH, MNI |
3. Purpose of Submission
The purpose of this submission is to gain clearance for additional components for the CapSure® PS System, including hex-end titanium alloy and cobalt chrome alloy rods, additional screw sizes, and offset connectors. The indications for use is also being modified as a result of these line additions.
4. Predicate Device Information
The CapSure® PS System described in this submission is substantially equivalent to the following predicates:
| Predicate Device | Manufacturer | 510(k) No. |
|---|---|---|
| CapSure® PS System | Spine Wave, Inc. | K070245, K081228, |
| K083353, K083743, | ||
| K100122, and K111913 | ||
| XIA® 3 System | Stryker Spine | K083393 |
| USS System | Synthes | K111358 |
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5. Device Description
The CapSure® PS System consists of a selection of non-sterile, single use, titanium allov polyaxial screw and connector components, and titanium alloy and cobalt chrome alloy rod components that are assembled to create a rigid spinal construct. The components of the CapSure® PS System are attached to the non-cervical spine in order to stabilize the spine during fusion of the vertebral bodies, and are intended to be removed after spinal fusion is achieved.
6. Intended Use
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
7. Comparison of Technological Characteristics
The substantial equivalence of the subject CapSure® PS System to the predicates is shown by similarity in intended use, indications for use, materials and performance.
8. Performance Data
Mechanical testing according to ASTM F1717, including static and dynamic compression bending and static torsion, were performed to demonstrate that the subject CapSure® PS System is substantially equivalent to the predicate CapSure® PS System.
9. Conclusion
Based on the indications for use, technological characteristics, performance testing and comparison to the predicates, the subject CapSure® PS System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 7- 2012
Spine Wave, Inc. % Ms. Roaida Rizkallah Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484
Re: K120646
Trade/Device Name: CapSure PS System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system . Regulatory Class: Class II Product Code: MNI, MNH Dated: May 14, 2012 Received: May 15, 2012
Dear Ms. Rizkallah:
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
3
Page 2 – Ms. Roaida Rizkallah
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 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
cerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KIZOGGG
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _
CapSure® PS System
Indications for Use:
The CapSure® PS System is a non-cervical spinal fixation system intended for posterior pedicle screw fixation (T1-S2/ilium) in skeletally mature patients. The CapSure® PS System is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The CapSure® PS System is also indicated for pedicle screw fixation in skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebral joint, having fusions with autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3-S2/ilium), and for whom the device is intended to be removed after solid fusion is attained.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K120646 510(k) Number
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