(165 days)
No
The document describes a mechanical spinal screw system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an "adjunct to fusion" and provides "immobilization of spinal segments" to aid in the repair of bone fractures and correct deformities, which are therapeutic functions.
No
The device is a screw system and associated components intended for spinal immobilization and fusion, not for diagnosing conditions.
No
The device description clearly outlines physical components like screws, rods, caps, and bases, indicating it is a hardware-based medical device for spinal fusion.
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 surgical implant system designed to provide mechanical support and stabilization to the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details physical components like screws, rods, caps, and bands, all used for surgical fixation. This aligns with a medical device used in surgery, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are specifically designed for these purposes.
- Performance Studies: The performance studies described are mechanical tests (dynamic compression, static axial load) to assess the structural integrity and equivalence of the implant, not clinical studies evaluating diagnostic accuracy.
Therefore, the ISS-JAZZ Screw System is a medical device used for surgical intervention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ISS-JAZZ Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The ISS-JAZZ Screw System is intended for posterior, non-cervical pedicle and non-pedicle 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, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1.
-
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
Product codes (comma separated list FDA assigned to the subject device)
NKB, OWI
Device Description
The JAZZ CAP SP is composed of three components, the Cap SP, the Base SP, and the Insert Lock. The head shape ISS pedicle screws is modified from the current tulip shape to a cylindrical shape to match the Cap SP, resulting in the JAZZ Screw. The ISS-JAZZ Screw System is composed of monoaxial and polyaxial screws and straight and pre bent rods. The JAZZ CAP SP is added to the proximal end of the JAZZ Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method of using a JAZZ Connector (K171881).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and/or sacral spine, non-cervical
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
Intended User / Care Setting
orthopedic surgery
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)
Dynamic compression testing per ASTM F1717 has been performed on the worst-case construct to establish equivalence to the predicate. Detailed rationales were provided to demonstrate why the device did not constitute a new worst-case in terms of sterilization, cleaning and biocompatibility. Additional static axial load testing was conducted to characterize the maximum load placed by the Band on the JAZZ CAP SP to cause a displacement on the JAZZ Screw. These test results demonstrated that the proposed device has substantially equivalent performance as the predicate device.
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.
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.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 12, 2019
Implanet. S.A. % Ms. Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103
Re: K182771
Trade/Device Name: ISS-JAZZ Screw System and JAZZ CAP SP Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB, OWI Dated: February 6, 2019 Received: February 6, 2019
Dear Ms. Hogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K182771
Device Name
ISS-JAZZ Screw System and JAZZ CAP SP
Indications for Use (Describe)
The ISS-JAZZ Screw System is intended to provide immobilization of soinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The ISS-JAZZ Screw System is intended for posterior, non-cervical pedicle and non-pedicle 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 deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondvlolisthesis:
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobaltchromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
ISS-JAZZ Screw System and JAZZ CAP SP
Submitter
Implanet, S.A. Technopole Bordeaux Montesquieu Allée Francois Magendi 33650 Martillac Phone: (+33) 557 995 555 Facsimile: (+33) 557 995 700
Contact Person: Fabienne Larquey Cadiere
Date Prepared: February 6, 2019
Name of Device: ISS-JAZZ Screw System and JAZZ CAP SP
Classification Name: Thoracocolumbar pedicle screw system
Regulatory Class: 21 C.F.R. 888.3070; 21 CFR 888.3010
Product Code: NKB, OWI
Predicate and Reference Devices
- Implanet Spine System (ISS) (K143731) (Primary predicate for ISS-JAZZ Screw System)
- JAZZ System (K171881) (Reference device for JAZZ CAP SP) ●
- JAZZ Lock (K153348) (Reference device for JAZZ CAP SP)
Device Description
The JAZZ CAP SP is composed of three components, the Cap SP, the Base SP, and the Insert Lock. The head shape ISS pedicle screws is modified from the current tulip shape to a cylindrical shape to match the Cap SP, resulting in the JAZZ Screw. The ISS-JAZZ Screw System is composed of monoaxial and polyaxial screws and straight and pre bent rods. The JAZZ CAP SP is added to the proximal end of the JAZZ Screw and provides for an alternate method to attach the JAZZ Band and JAZZ Passer Band to skeletal structures as compared to the current method of using a JAZZ Connector (K171881).
Intended Use / Indications for Use
The ISS-JAZZ Screw System is intended to provide immobilization of spinal seqments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The ISS-JAZZ Screw System is intended for posterior, non-cervical pedicle and non-pedicle 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,
4
spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudoarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ISS-JAZZ Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The JAZZ systems (including the JAZZ Claw Connector) are temporary implants to be used in orthopedic surgery. The JAZZ systems are intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures.
The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1.
-
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ Systems may also be used in conjunction with other medical implants made of titanium alloy or Cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
Comparison of Technological Characteristics
The ISS-JAZZ Screw System and the JAZZ CAP SP System provide an alternate way to allow for braid attachment to the spine. Currently, like any pedicle screw system, the ISS can be combined with the JAZZ System that contains JAZZ Connectors that attach to the rods. These connectors also contain the JAZZ Band or JAZZ Passer Band, which is then attached to the spine. The ISS-JAZZ Screw System and the JAZZ CAP SP System subject of this submission provide a more efficient, lower profile method of adding the braid attachment by modifying the pedicle screw to directly attach to the JAZZ Passer Band to the JAZZ CAP SP on the proximal end of the screw. The locking mechanism used for the braid component in the JAZZ CAP SP is identical to that already cleared in the JAZZ Lock (K153348).
In order to be compatible with the JAZZ CAP SP, the head of the ISS screws have been modified from tulip shaped to cylindrical shaped, creating the JAZZ Pedicle Screw. Both systems have identical pedicle screw and rods diameters and lengths. The same materials and manufacturing methods as have been previously cleared are used to manufacture the ISS-JAZZ Screw System and JAZZ CAP SP. Similarly, the same sterilization methods are used.
Performance Data
Dynamic compression testing per ASTM F1717 has been performed on the worst-case construct to establish equivalence to the predicate. Detailed rationales were provided to demonstrate why the device did not constitute a new worst-case in terms of sterilization,
5
cleaning and biocompatibility. Additional static axial load testing was conducted to characterize the maximum load placed by the Band on the JAZZ CAP SP to cause a displacement on the JAZZ Screw. These test results demonstrated that the proposed device has substantially equivalent performance as the predicate device.
Conclusions
The ISS-JAZZ Screw System and JAZZ CAP SP are as safe and effective as the predicate devices. The subject devices have the same intended uses and similar indications, technological characteristics, and principles of operation as their predicate and reference devices. The minor differences in indications do not alter the intended therapeutic use of the devices and do not affect their safety and effectiveness when used as labeled. In addition, the minor technological differences between the subject devices and their predicate and reference devices raise no new issues of safety or Performance data demonstrate that the ISS-JAZZ Screw System and effectiveness. JAZZ CAP SP are as safe and effective as the predicate and reference devices. Thus, the ISS-JAZZ Screw System and JAZZ CAP SP are substantially equivalent.