(112 days)
The Jazz System is a temporary implant for use in orthopedic surgery. The 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, interspinous, or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
-
- 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 CALYPSO pedicle screw system.
The device consists of the following components and accessories: polyester (polyethyleneterephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.
The K121541 filing for Implanet S.A.'s Jazz System focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility assessments, rather than clinical studies or reader performance evaluations. Therefore, many of the requested categories related to clinical study design, expert ground truth, and reader performance cannot be populated from the provided text.
Here's a breakdown of the information that can be extracted:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Jazz System were based on meeting the "necessary specifications" through bench testing. The specific quantitative acceptance criteria are not detailed in the provided document, but the general requirement was to confirm "adequate mechanical strength for its intended use."
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Adequate for intended use, met necessary specifications | "All bench testing confirmed that the product met the necessary specifications." |
| Biocompatibility | In accordance with ISO-10993 | "The biocompatibility of the device has been confirmed in accordance with ISO-10993, through performance of the following tests: Cytotoxicity, Intracutaneous irritation, Systemic toxicity (acute, sub-acute, sub-chronic, pyrogenicity), Sensitization, Genotoxicity, Implantation." |
| Sterilization and Shelf Life Validation | In accordance with recognized industry standards | "The company has conducted sterilization and shelf life validation in accordance with recognized industry standards." |
Study Information
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided document. The testing described is bench testing, not human or image data.
- Data Provenance: The document does not specify country of origin for any data beyond the manufacturer being located in Martillac, France. The studies are described as "bench testing," meaning they were conducted in a laboratory setting. This is a form of prospective testing of the device hardware.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a bench testing study, not one requiring expert human interpretation or ground truth establishment in a clinical context.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This was a bench testing study, not one requiring adjudication of human interpretations.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done. This filing is for a surgical implant (bone fixation cerclage) and relies on mechanical and biocompatibility testing, not AI or reader performance studies.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical implant, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench testing was established through engineering specifications and industry standards for mechanical strength and biocompatibility (e.g., ISO-10993). There is no "expert consensus" in the clinical sense, pathology, or outcomes data mentioned for the performance testing.
-
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
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K121541 - Page 1 of 2
510(k) SUMMARY
SEP 13 2012
IMPLANET S.A.'S JAZZ SYSTEM
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Implanet S.A. Technopole Bordeaux Montesquieu Allée Francois Magendie 33650 Martillac France Phone: +33 557 995 555 . Facsimile: +33 557 995 700
Contact Person: Franck Rigal, Director of Quality and Regulatory Affairs
Date Prepared: August 30, 2012
Name of Device and Name/Address of Sponsor
Jazz System
Common or Usual Name
Bone fixation cerclage
Classification Name
888.3010 - Bone Fixation Cerclage
Predicate Devices
Zimmer Spine, Inc.'s Universal Clamp System (K060009, K081622, K091190, K110348).
Intended Use / Indications for Use
The Jazz System is a temporary implant for use in orthopedic surgery. The 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, interspinous, or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
-
- 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 CALYPSO pedicle screw system.
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K121541 - page 2 of 2
Technological Characteristics
The device consists of the following components and accessories: polyester (polyethyleneterephthalate) braid; titanium alloy connector and screw; and stainless steel malleable strip and buckle.
Performance Data
In support of this 510(k) Premarket Notification, Implanet S.A. has conducted bench testing to demonstrate that the Jazz System provides adequate mechanical strength for its intended use. The company has conducted these tests based on current version of standards when available and has initiated its own test protocols when necessary to validate certain loading conditions. All bench testing confirmed that the product met the necessary specifications, In addition, the biocompatibility of the device has been confirmed in accordance with ISO-10993, through performance of the following tests:
- Cytotoxicity
- Intracutaneous irritation .
- Systemic toxicity (acute, sub-acute, sub-chronic, pyrogenicity) .
- � Sensitization
- Genotoxicity (bacterial reverse mutation assay, mouse micronucleus test, . chromosomal aberration test)
- Implantation .
The company has conducted sterilization and shelf life validation in accordance with recognized industry standards.
A list of the tests performed to support substantial equivalence is provided below:
- Static Tensile Test (braid) .
- Viscoelastic Characteristics (braid) ●
- Static Tensile Testing .
- . Static Axial Compression Corpectomy Construct Testing
- Dynamic Tension Testing .
- Dynamic Axial Compression Corpectomy Construct Testing .
Substantial Equivalence
The Jazz is very similar to the Zimmer Universal Clamp System. The Jazz has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the Jazz and its predicate device raise no new issues of safety or effectiveness. Performance data, including mechanical testing, demonstrate that the Jazz is as safe and effective as the Zimmer Universal Clamp System. Thus, the Jazz is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
SEP 13.2012
Implanet S.A. % Hogan Lovells US, LLP Ms. Janice Hogan 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K121541
Trade/Device Name: Jazz System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 04, 2012 Received: September 04, 2012
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 r ea may , more sprovisions 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 or unf 1 vith all the Act's requirements, including, but not limited to: registration and listing (21
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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K121541
Device Name: Jazz System
Indications for Use:
The Jazz System is a temporary implant for use in orthopedic surgery. The 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, interspinous, or facet wiring techniques; 1.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of 2. spinal deformities such as scoliosis, kyphosis, spondylolisthesis;
-
- 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 CALYPSO pedicle screw system.
Prescription Use _ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
| K12154110(k) Number__________________________________________________________________________________________________________________________________________________________________ | ||
|---|---|---|
§ 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.