(87 days)
No
The summary describes a mechanical implant for spinal surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is used as a temporary implant in orthopedic surgery to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, which is a therapeutic function.
No
Explanation: The JAZZ System is described as a temporary implant for orthopedic surgery, specifically for stabilization during bony fusion and fracture repair, and as part of a spinal posterior fixation system. Its function is to provide mechanical support rather than to diagnose medical conditions or diseases.
No
The device description clearly states it is a "temporary implant" and part of a "spinal posterior fixation system," indicating it is a physical medical device, 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 device used in vivo (within the body).
- Device Description: The description further clarifies that it's part of a "spinal posterior fixation system" secured around "vertebral structures." This reinforces its role as an implantable surgical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is implanted directly into the body for structural support.
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;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of 2 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 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
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 to L5
Indicated Patient Age Range
Not Found
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
Four custom tests were performed to assess the minor manufacturing modification to the polyester braid distal tip (static perforation testing, static tear testing using two different instruments, and manual perforation testing), These tests confirmed that the manufacturing process change to the braid satisfied the required performance of the subject device.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing performed for Implanet S:A.'s JAZZ System confirmed that the product met the necessary specifications and functioned as intended.
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
FEB 2 0 2014
K133617
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: Franck Rigal, Director of Quality and Regulatory Affairs Date Prepared: November 25, 2013
Name of Device
JAZZ System
Common Name / Classification Name
Bone fixation cerclage (21 C.F.R. 888.3030, Class II) (Product Code: OWI)
Predicate Devices
Implanet S.A.'s JAZZ System (K132287; K121541)
Purpose of the Special 510(k) Notice
The subject device is a modification to cleared JAZZ System. Specifically, the proposed modification involves a change in the closure method of the polyester braid distal end of the Jazz System.
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;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of 2 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 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.
1
K133617
Page 2 of 2
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.
Technological Characteristics
The JAZZ System consists of the following components and accessories: polyester (polyethylene-terephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle. Aside from the modification to the braid, all components are identical to those cleared in K132287. No new risks were identified in verification and validation testing.
Performance Data
Bench testing performed for Implanet S:A.'s JAZZ System confirmed that the product met the necessary specifications and functioned as intended. Four custom tests were performed to assess the minor manufacturing modification to the polyester braid distal tip (static perforation testing, static tear testing using two different instruments, and manual perforation testing), These tests confirmed that the manufacturing process change to the braid satisfied the required performance of the subject device.
Substantial Equivalence
The JAZZ System is substantially similar to the previously cleared JAZZ System (K132287; K121541). 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 one minor modification to the braid, all other components remain identical to those of the K132287 predicate. The one minor technological difference between the JAZZ System and its predicate devices raises no new issues of safety or effectiveness, as demonstrated by testing, Thus, the JAZZ System is substantially equivalent.
Conclusions
Therefore, the subject device presents one minor technological modification to the closure method of the polyester braid of the 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 modification does not raise any new types of safety or effectiveness concerns. Therefore, the Jazz System is substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, along with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the emblem. The caduceus is depicted with a staff entwined by two snakes and topped with wings, representing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 20, 2014
Implanet S.A. % Ms. Janice Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K133617
Trade/Device Name: JAZZ System Regulation Number: 21 CFR 888.3030 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: December 20, 2013 Received: December 20, 2013
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 I ou may) alorely mains 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 may of subject to accentered 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 of any I edolar of the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Janice Hogan
CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Safetv/ReportalProblem/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 Small Manufacturers. International and Consumer Assistance 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.
Sincerely yours,
Vincent J. Devlin -S
- for Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K133617
Device Name: JAZZ System
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:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2 spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- Spinal degenerative surgery, as an adjunct to spinal fusions. 3
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.
Prescription Use _ X (Per 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Colin O'Neill
(Division Sign-Off) Division of Orthopedic Devices 510K Number: K133617