(92 days)
Not Found
No
The summary describes a mechanical implant system for spinal surgery and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as a temporary implant used in orthopedic surgery to provide temporary stabilization as a bone anchor during solid bony fusion and aid in the repair of bone fractures, which fits the definition of a therapeutic device.
No
The JAZZ System is a temporary implant used in orthopedic surgery to provide temporary stabilization and aid in the repair of bone fractures, not to diagnose medical conditions.
No
The device description clearly lists physical components like connectors, rods, and a band, indicating it is a hardware-based implant system, not software only.
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 device used within the body for structural support and repair.
- Device Description: The components listed (connectors, hooks, rods, braid, buckle) are all physical components designed for surgical implantation and attachment to the spine.
- Anatomical Site: The anatomical site is the spine, indicating a device used directly on or within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) 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. The JAZZ system does not perform any such tests on samples.
The JAZZ system is a surgical implant, not a diagnostic device that analyzes biological samples.
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:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent 2. idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- ന് 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 or cobalt-chromium-molybenum alloy whenever "wiring" may help secure the attachment of other implants.
Product codes (comma separated list FDA assigned to the subject device)
OWI
Device Description
The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
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)
These changes were assessed per ISO 10993 and static tensile testing to show equivalent biocompatibility and mechanical performance to the predicate.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2017
Implanet, S.A. % Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, Pennsylvania 19103
Re: K170730
Trade/Device Name: JAZZ System, including JAZZ Band Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: OWI Dated: April 3, 2017 Received: April 3, 2017
Dear Janice 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 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. 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.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement on last page
510(k) Number (if known) K170730
Device Name JAZZ System, including JAZZ Band
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:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques; 1.
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent 2. idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
- ന് 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 or cobalt-chromium-molybenum alloy whenever "wiring" may help secure the attachment of other implants.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) |
---|
Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 EF
3
510(k) SUMMARY Implanet's JAZZ System. including JAZZ Band K170730
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: Regis Le Couedic, Director of Quality and Regulatory Affairs; Chief Technology Officer
Date Prepared: June 8, 2017
Application Correspondent:
Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: (267) 675-4611
Name of Device:
JAZZ System, including JAZZ Band
Common or Usual Name:
Bone, Fixation, Cerclage, Sublaminar
Classification Name:
Bone, Fixation, Cerclage
Primary Product Code
OWI
Regulation Number
21 CFR § 888.3010
Device Class
Class II
4
Predicate Devices
Implanet's JAZZ System (K151740) (primary)
Implanet's JAZZ Systems (K162764) (additional)
Implanet's JAZZ Lock (K153348) (additional)
Device Description
The JAZZ Systems consists of the following components: JAZZ Connector, JAZZ Claw Connector, JAZZ Claw hooks, JAZZ Lock Connector, various rods, and JAZZ Braid (a.k.a. Band) with buckle. The JAZZ Band is inserted into various JAZZ connectors and is used to attach them to the spine.
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:
-
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinaldeformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis:
-
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The JAZZ System may also be used in coniunction with other medical implants made of titanium alloy or cobalt-chromium-molybdenum alloy whenever "wiring" may help secure the attachment of other implants.
Purpose of 510(k)
The purpose of this 510(k) is to modify the Jazz Band component of the JAZZ Systems. Minor changes are being made to the ultrasonic welding of the braid and the design of the metal buckle used to tighten the braid.
Performance Data
These changes were assessed per ISO 10993 and static tensile testing to show equivalent biocompatibility and mechanical performance to the predicate.
Conclusions
The modified JAZZ Band is as safe and effective as the predicate JAZZ Braid. The JAZZ Band has the same intended uses and indications, as well as similar technological characteristics and principles of operation as its predicate device. In addition, the minor technological differences between the JAZZ Band and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the modified JAZZ
5
Band is as safe and effective as the predicate JAZZ Braid. Thus, the JAZZ Band is substantially equivalent.