(158 days)
No
The device description focuses solely on the physical components and materials of a pediatric rod system for spinal fixation. There is no mention of any software, algorithms, or data processing capabilities 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".
No
The device is described as an implantable system (rods, clamps, and screws) for spinal fixation to aid in solid fusion following autologous bone grafting, which classifies it as a medical device but not specifically a therapeutic device that delivers therapy or treatment directly to a patient. Its purpose is structural support during healing.
No
Explanation: The device description indicates it is a surgical implant composed of rods, clamps, and screws used for pedicle screw fixation in specific spinal conditions, and is intended to be removed after fusion. This clearly defines it as a therapeutic device, not a diagnostic one.
No
The device description explicitly lists physical components (rods, clamps, screws) made of titanium, indicating it is a hardware 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 perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that this device is a surgical implant consisting of rods, clamps, and screws made of titanium. These components are intended to be surgically implanted into the spine for fixation.
- Intended Use: The intended use is for pedicle screw fixation in the spine to treat spondylolisthesis. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, the SYNTHES Spine Pediatric Rod System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 spondylolisthesis at the fifth lumber - first sacral vertebral joint (L5-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
Product codes
MNH
Device Description
The SYNTHES Spine Pediatic Rod System consists of rods. clamps and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295).
The rod is provided in four lengths, 80, 120, 240 and 300mm. The rod diameter is 3.5mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw. a 4.0mm cancellous screw. or a 4.0mm or 4.35mm cxpansion screw with 1.8mm locking screw.
The device functions as follows: The end of the rod, cut to an appropriate leagth, is inscried into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
This system is provided non-sterile; moist heat sterilization is recommended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fifth lumber - first sactal verrebral joint (LS-S1)
Indicated Patient Age Range
pediatric patients with a body weight of 50lbs or less.
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)
Not Found
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.
0
Summary of Safety and Effectiveness Information [510(k) Summary]
SYNTHES (U.S.A.) 1690 Russell Road Paoli. PA 19301
ﺴﻴﺮ ﺍﻟﻤﺴﺘﻮﻯ
(610) 647-9700 Contact: Barry E. Sands 2/19/1998
Device: SYNTHES Spine Pediatric Rod System compared to the Acromed ISOLA Pediatic Components (K962984).
The SYNTHES Spine Pediatic Rod System consists of rods. clamps and screws. The screws are composed of commercially pure grade 4 Titanium (ASTM F67). The clamps and rods are composed of the titanium alloy TAN (ASTM F1295).
The rod is provided in four lengths, 80, 120, 240 and 300mm. The rod diameter is 3.5mm. The clamps are designed to connect the 3.5mm rods and screws utilized for this system. The screws are provided in the following configurations: 3.5mm cancellous screw. a 4.0mm cancellous screw. or a 4.0mm or 4.35mm cxpansion screw with 1.8mm locking screw.
The device functions as follows: The end of the rod, cut to an appropriate leagth, is inscried into the rod opening of the clamps and loosely tightened into position with the set screws included in the clamps. The awl is used to open the cortex. The K-wire is used to manually extend the hole. The length of screw is determined with the depth gauge, then the hole is tapped. The screw is inserted through the clamp at the desired level. The set screws are then locked down to the rod.
The SYNTHES Spine Pediatic Rod System is a pedicle screw fixation system for use in grade 3 or 4 spondylolisthesis at the fifth lumber - first sactal verrebral joint (LS-S1) utilizing autologous bone graft and intended to be removed after solid fusion is attained. The STNTHES Spine Podiative Rod System is intended for pediatric patients with a body weight of 501bs or less.
This system is provided non-sterile; moist heat sterilization is recommended.
Based on the above, the SYNTHES Spine Pediativ Rod System is substantially coulvalcal to the Acromed ISOLA Pediatric Components.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 1998
Mr. Barry E. Sands Manager, Regulatory Affairs SYNTHES Spine P.O. Box 0548 1690 Russell Road Paoli, Pennsylvania 19301
K980761 Re : SYNTHES Spine Pediatric Rod System Regulatory Class: Unclassified Product Code: MNH June 9, 1998 Dated: Received: June 10, 1998
Dear Mr. Sands:
We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 or to devices that have been reclassified in accordance with the provisions of the Federal, Food, Drug, and Cosmetic Act This decision is based on your device system being (Act). found equivalent only to similar device systems labeled and intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. You may, therefore, market your device system subject to the general controls provisions of the Act and the limitations identified below.
The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than severe spondylolisthesis, as described above, would cause the device system to be adulterated under 501(f) (1) of the Act.
This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than
2
severe spondylolisthesis, as described above, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly:
- All labeling for this device, including the package 1. label, must state that there are labeling limitations. The package insert must prominently state that the device system using pedicle screws is intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
- You may not label or in anyway promote this device system 2. for pedicular, screw fixation/attachment to the cervical, thoracic or lumbar vertebral column for intended uses other than severe spondylolisthesis, as described above. The package insert must include the following statements:
WARNINGS :
- When used as a pedicle screw system, this device . system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral (L5-S1) vertebral joint.
- . The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 vertebral joint.
- . Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
- Potential risks identified with the use of this device system, which may require additional surgery, include:
device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.
3
See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.
- Any pedicular screw fixation/attachment for intended uses 3. other than severe spondylolisthesis, as described by item 1, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than severe spondylolisthesis, as described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
- Any previous warning statements identified as part of 4 . previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of items 1 and 2 above.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be reguired.
4
Page 4 - Mr. Barry E. Sands
This letter will allow you to begin marketing your device as mis feecer wirr allow your begin maification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M
a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure ----
5
Page 1 of 1
510(k) Number (if known): NA K98 076 l
Device Name: SYNTHES Spine Pediatric Rod System
Indications for Use:
When labeled for pedicle screw fixation, the Pediatric Rod System is intended for use in grade 3 or 4 which labered for podicts berew interest sacral vertebral joint (LS-S1) utilizing autologous bone graft and spondytonsticsla at also multion - interestained. The SYNTHES Spine Pediatric Rod System is intended for pediatric patients with a body weight of 50lbs or less.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-the-Counter Use _ OR Prescription Use (Per 21 CFR 801.109) (Divisir . Divisio 510(k) Number