(127 days)
Not Found
No
The 510(k) summary describes a mechanical implant for spinal fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on mechanical testing and biocompatibility.
Yes
The device is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, which are therapeutic actions.
No
The device is described as a temporary implant 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 states that the JAZZ System is a "temporary implant" and part of a "spinal posterior fixation system," indicating it is a physical hardware device. The performance studies also describe mechanical testing, sterilization, and biocompatibility, which are relevant to physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that JAZZ is a "temporary implant to be used in orthopedic surgery" for "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a surgical implant used directly on the patient's body.
- Device Description: The description reinforces that it's a "spinal posterior fixation system" designed to be "secured around vertebral structures." This is a physical device implanted in the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples from the body. This device is used inside the body as a surgical implant.
N/A
Intended Use / Indications for Use
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is 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:
- 1 Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- 2 Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- 3 Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.
The JAZZ System is intended to be used with the Implanet Spine System.
Product codes (comma separated list FDA assigned to the subject device)
OWI
Device Description
The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified JAZZ System is designed to function in the same manner as the cleared predicate device. The JAZZ System is intended to be used with the Implanet Spine System (K143731).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal structures (lamina, facet, or transverse processes) from T1 to L5
Indicated Patient Age Range
Not Found
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)
Mechanical testing performed for Implanet S.A.'s JAZZ System in accordance with ASTM F1717, static tensile testing, and dynamic tensile testing, confirmed that the product met the necessary specifications and functioned as intended. Sterilization and shelf life validation testing conducted for the JAZZ System in accordance with recognized industry standards are also incorporated by reference. In addition, the biocompatibility of the device was confirmed in accordance with ISO-10993.
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.
Not Found
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
§ 888.3010 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right. The profiles are rendered in a dark color, contrasting with the white background of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Implanet S.A. % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K143759
Trade/Device Name: JAZZ System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: April 15, 2015 Received: April 15, 2015
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. 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 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
May 7, 2015
1
Page 2 - Ms. Janice M. Hogan
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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K143759 Device Name JAZZ System
Indications for Use (Describe)
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is 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:
- 1 Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- 2 Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- 3 Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in conjunction with other medical implants made of titanium allov whenever "wiring" may help secure the attachment of other implants.
The JAZZ System is intended to be used with the Implanet Spine System.
Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
3
K143759 510(k) SUMMARY
Implanet S.A.'s JAZZ System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Implanet S.A. Technopole Bordeaux Montesquieu Allee Francois Magendie - 33650 Martillac Phone: (+33) 557 995 555 Facsimile: (+33) 557 995 700
Contact Person: Regis Le Couedic, Director of Quality and Regulatory Affairs; Chief Technology Officer
Date Prepared: April 15, 2015
Name of Device
JAZZ System
Common Name / Classification Name
Bone fixation cerclage (21 C.F.R. 888.3010, Class II) (Product Code: OWI)
Predicate Devices
Implanet S.A.'s JAZZ System (K133617) (Primary) Implanet S.A.'s JAZZ System (K121541) (Additional)
Purpose of the 510(k) Notice
The subject device is a modification to the cleared JAZZ System. Specifically, the proposed modification involves an expansion of the sizes of connectors available with the system, as well as several minor modifications to instrumentation.
Intended Use
JAZZ is a temporary implant to be used in orthopedic surgery. The JAZZ system is 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:
- 1 Spinal trauma surgery, used in sublaminar or facet wiring techniques;
4
- വ 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. ന
The JAZZ System may also be used in conjunction with other medical implants made of titanium alloy whenever "wiring" may help secure the attachment of other implants.
The JAZZ System is intended to be used with the Implanet Spine System.
Device Description
The Implanet JAZZ System is part of a spinal posterior fixation system that is designed to provide a stable interface between spinal constructs and the rod used in spinal surgery. The device is secured around vertebral structures such as the lamina, facet, or transverse processes from T1 to L5. The modified JAZZ System is designed to function in the same manner as the cleared predicate device. The JAZZ System is intended to be used with the Implanet Spine System (K143731).
Technological Characteristics
The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and stainless steel malleable strip and buckle. The principal design modifications described in this submission include additional sizes of connector available and several minor modifications to the instruments. All changes were evaluated via risk analysis. No new risks were identified in verification and validation testing.
Performance Data
Mechanical testing performed for Implanet S.A.'s JAZZ System in accordance with ASTM F1717, static tensile testing, and dynamic tensile testing, confirmed that the product met the necessary specifications and functioned as intended. Sterilization and shelf life validation testing conducted for the JAZZ System in accordance with recognized industry standards are also incorporated by reference. In addition, the biocompatibility of the device was confirmed in accordance with ISO-10993.
Substantial Equivalence
The JAZZ System is substantially similar to the previously cleared JAZZ System (K133617). The JAZZ System has the same intended uses / indications for use and principles of operation, as well as nearly identical technological characteristics as its predicate device. The modified JAZZ System is designed to function in the same manner as the cleared predicate device. Other than the modification to the sizes of connector available and the minor modifications to the instruments, all other components remain the same as those of the K132287 predicate. The minor technological differences between the JAZZ System and its predicate device raise no new issues of safety or effectiveness, as demonstrated by testing. Thus, the JAZZ System is substantially equivalent.
5
Conclusions
The subject device presents only minor modifications compared to the previously cleared JAZZ System. The intended use, indications for use, and principles of operation remain the same as the previously cleared system. The subject device is technologically very similar to the predicate device, and the minor modifications do not raise any new types of safety or effectiveness concerns, as confirmed through risk analysis and verification activities. Therefore, the JAZZ System is substantially equivalent.