(70 days)
Not Found
No
The document describes a mechanical spinal fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is a pedicle screw fixation system intended to stabilize the spine during fusion of vertebral bodies for various spinal conditions, which is a therapeutic intervention.
No
The document describes a pedicle screw fixation system used for stabilizing the spine during fusion, not for diagnosing medical conditions.
No
The device description explicitly states that the CapSure™ PS System consists of physical components (titanium alloy rod and screw components) that are assembled to create a rigid spinal construct. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The CapSure™ PS System is a spinal implant consisting of rods and screws. It is surgically implanted into the spine to provide stability during fusion.
- Intended Use: The intended use is for spinal fixation in skeletally mature patients with various spinal conditions. This is a surgical intervention, not a diagnostic test performed on a specimen outside the body.
The provided information clearly describes a surgical implant used for structural support and stabilization within the body, which is the opposite of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
When used as a pedicle screw fixation system of the noncervical spine 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-S1), and for whom the device is intended to be removed after solid fusion is attained.
Product codes
MNH, MNI
Device Description
The CapSure™ PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw 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
noncervical spine, L5-S1 vertebral joint, lumbar and sacral spine (levels of pedicle screw fixation are L3-S1)
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 demonstrated that the CapSure™ PS System has substantially equivalent mechanical properties to the predicate Moss Miami Spinal System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with the letters 'Ko' followed by the numbers '70245'. The characters are written in a bold, black font, and the handwriting appears somewhat messy. The image is simple, focusing solely on the handwritten string.
[on letterhead]
510(k) Summary CapSure™ PS System
1. Submitter Information
Spine Wave, Inc. Two Enterprise Drive Suite 302 Shelton, CT 06484 203-944-9494 Telephone: 203-944-9493 Telefax:
| Contact: | Ronald K. Smith |
|---|---|
| Date Prepared: | January 24, 2007 |
2. Device Information
| Trade Name: | CapSure™ PS System |
|---|---|
| Common Name: | Pedicle Screw Spinal System |
| Classification: | Class II per 21 CFR 888.3070 |
| Classification Name: | Pedicle Screw Spinal System |
| Product Code: | MNH, MNI |
3. Device Information
The CapSure™ PS System consists of a selection of non-sterile, single use titanium alloy rod and screw components that are assembled to create a rigid spinal construct. The rod and screw 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.
4. Intended Use
When used as a pedicle screw fixation system of the noncervical spine 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
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are L3-S1), and for whom the device is intended to be removed after solid fusion is attained.
5. Substantial equivalence
The CapSure™ PS System is substantially equivalent to the Moss Miami Spinal System (K030383), the Issys Pedicle Screw System (K043522), and the ST360™ Spinal Fixation System (K041925). Mechanical testing according to ASTM F1717 demonstrated that the CapSure™ PS System has substantially equivalent mechanical properties to the predicate Moss Miami Spinal System. Since the CapSure™ PS System is substantially equivalent in intended use, design, materials, and construction to the predicate devices, the CapSure™ PS System does not raise any new issues of safety and efficacy when compared to these legally marketed devices.
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" Use of the terms "substantially equivalence" in this application is intended only to denote a comparison of the subject device to predicate devices for the purpose of an FDA review of the safety and effectiveness of the subject device in accordance with 21 CFR 807. Statements comparing the subject device to predicate devices, including statements regarding "substantial equivalence", contained in any way to relate to patentability, patent infringement, or any analysis of the subject device under foreign or United States patent laws including 35 U.S.C. paragraph 100 et seq. or related judicial doctrines
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white and appears to be a scanned or printed image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 5 = 2007
Spine Wave, Inc. % Mr. Ronald K. Smith Director, Quality and Regulatory Affairs Two Enterprise Drive, Suite 302 Shelton, Connecticut 06484
K070245 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: March 23, 2007 Received: March 26, 2007
Dear Mr. Smith:
Re:
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.
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Page 2 - Mr. Ronald K. Smith
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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dan Dave Buchup
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Indications for Use | ||
|---|---|---|
510(k) Number (if known): 长670245
Device Name:
CapSure™ PS System
Indications for Use:
When used as a pedicle screw fixation system of the noncervical spine 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-S1), 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)
Valbare buelum
al. Restorative. Division of Gene and Neurological Devices
510(k) Number K070245
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