(88 days)
No
The document describes a mechanical implant system for spinal surgery and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is described as a temporary implant used in orthopedic surgery to provide temporary stabilization as a bone anchor during bony fusion and to aid in the repair of bone fractures. While it assists in the healing process, it does not directly apply a therapeutic effect itself (e.g., drug delivery, energy delivery, or tissue modification for treatment). Its primary function is mechanical support.
No
The JAZZ systems are described as temporary implants used in orthopedic surgery to provide stabilization and aid in the repair of bone fractures, not to diagnose medical conditions.
No
The device description clearly describes a physical implant (JAZZ systems, JAZZ Claw Connector, JAZZ PF connector, JAZZ braid) and associated instruments (JAZZ PF Band Reducer) used in orthopedic surgery. It also mentions performance studies involving dynamic compression testing of a physical construct. There is no mention of software as the primary or sole component of the device.
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 and Intended Use: The provided text clearly describes the JAZZ systems as temporary implants used in orthopedic surgery for stabilizing bone during fusion and fracture repair. It details their use in spinal surgery for trauma, reconstruction, and degenerative conditions.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition. Its function is purely mechanical and structural within the body.
The device is an implantable medical device used in surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
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 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
OWI
Device Description
JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic surgery / 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)
Dynamic compression testing of the subject device was performed on a lumbar construct mounted on a test block and attached to the fixed test machine jaw. The JAZZ PF constructs passed 5 million cycles at a load of 600N. Detailed rationales were provided to demonstrate why the device did not constitute a new worst-case in terms of sterilization, cleaning and biocompatibility.
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 2, 2019
Implanet, S.A. % Janice M. Hogan Partner Hogan Lovells US LLP 1845 Market Street, Suite 230 Philadelphia, Pennsylvania 19103
Re: K191217
Trade/Device Name: JAZZ PF Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: May 6, 2019 Received: May 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 6/30/2020 See PRA Statement on last page
510(k) Number (if known)
Device Name
JAZZ PF
Indications for Use (Describe)
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 spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. 3.
The JAZZ Systems may also be used in coniunction with other medical implants made of titanium allov 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 JAZZ PF
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: August 1, 2019
Name of Device: JAZZ PF
Classification Name: Bone fixation cerclage
Regulatory Class: 21 CFR 888.3010
Product Code: OWI
Primary Predicate and Reference Devices
- . Primary Predicate: NuVasive VersaTie System (K173117)
- Additional Predicate: ISS-JAZZ Screw System and JAZZ CAP SP (K182771)
Device Description
JAZZ PF enables the passing of a JAZZ braid around or through the upper spinous process. The main difference with the JAZZ regular connector is that in the subject device the braid is locked horizontally, that is, along the spine axis, instead of vertically. On each side of the instrumented levels, a JAZZ PF connector is implanted on the union rod below the upper pedicle screw. A JAZZ braid is passed and locked through a 1st connector, above or through the spinous process and back through the second connector on the other side. The slack that can exist in the band is removed using the JAZZ PF Band Reducer (Enrouleur Instrument) without applying any tension in the band and the 2nd connector is locked. By doing so, flexion is controlled which helps in the primary stabilization of the levels where fusion has to be achieved.
Intended Use / Indications for Use
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.
4
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 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 JAZZ PF is an additional component of the JAZZ System that was cleared under K182771. The proposed device uses similar technological characteristics of braided bands as the primary predicate, VersaTie System, to stabilize the spine. Specifically, the subject device, similar to the NuVasive VersaTie System, is secured around posterior vertebral structures such as the lamina, facet, transverse processes, and spinous process from T1-L5. The system is comprised of braided bands and clamps designed to attach to c rods.
The following table compares the technological characteristics of the JAZZ PF with the predicate devices:
| | Subject Device
JAZZ PF | Primary Predicate
Device
NuVasive VersaTie
System | Additional Predicate
Device
JAZZ System | Comparison |
|-------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------|
| 510(k) | Subject | K173117 | K182771 | |
| Braid Connector | Yes | Yes | Yes | Same |
| Braid | Yes | Yes | Yes | Same |
| Materials | Ti alloy, polyester | Ti or CoCr alloy,
polyester | Ti alloy, polyester | Similar biocompatible
materials |
| Connection Method
to Spine | Braid, rods and pedicle
screws | Braid, rod and pedicle
screws | Braid, rod, and pedicle
screws | Same |
| Braid Locking
Method | As internal screw is
tightened, the connector
clamps the braid | As internal screw is
tightened, the connector
clamps the braid | As internal screw is
tightened, the connector
clamps the braid | Same |
| Sizes | 5.5-6mm | 5-6mm | 5.5-6mm | Similar range of sizes |
Performance Data
Dynamic compression testing of the subject device was performed on a lumbar construct mounted on a test block and attached to the fixed test machine jaw. The JAZZ PF constructs passed 5 million cycles at a load of 600N. Detailed rationales were provided to demonstrate why the device did not constitute a new worst-case in terms of sterilization, cleaning and biocompatibility.
5
Conclusions
The JAZZ PF is substantially equivalent to predicate devices. The subject devices have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. In addition, the minor technological differences between the subject device and the predicate devices raise no new issues of safety or effectiveness. In particular, the JAZZ PF provides an alternate way to allow for the braid attachment to the spine, similar to how the ISS-JAZZ Screw System and the JAZZ CAP SP System (cleared under K182771) provides an additional method for stabilization. In particular, the NuVasive VersaTie System (K173117) uses similar technological characteristics of braided bands and clamps in the same manner as the subject device around the same intended anatomical location. Performance data demonstrate that the JAZZ PF is as safe and effective as the predicate devices. Thus, the JAZZ PF is substantially equivalent to the predicate devices.