The Jazz Systems 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:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. 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 cobaltchromium-molybdenum allov whenever "wiring" may help secure the attachment of other implants.

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.

AI/ML Overview

This document is a 510(k) summary for the JAZZ Passer Band. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study against specific acceptance criteria for a novel device. Therefore, much of the requested information (like expert-established ground truth, MRMC studies, or training set details) is not applicable or not provided in the given text.

Here's an analysis based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from the study's perspective)	Reported Device Performance
Mechanical Strength (Static Tensile Testing)	The JAZZ Passer Band's changes were assessed via static tensile testing to evaluate the strength of the hole at the band extremity.
No new or different issues of safety or effectiveness	Performance data demonstrated that the modified JAZZ Passer Band is as safe and effective as the predicate JAZZ Band.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "static tensile testing," which inherently involves a test set of physical devices. However, the specific sample size (e.g., number of JAZZ Passer Bands tested) is not provided.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given it's a 510(k) submission, the testing would generally be conducted by the manufacturer (Implanet, S.A., based in France) or a contracted lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this submission. The "ground truth" for mechanical testing is typically based on engineering specifications and material properties, not expert clinical consensus.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical testing results are objectively measured and do not require an adjudication method like clinical assessments.

5. 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, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or imaging interpretation devices. The JAZZ Passer Band is a physical orthopedic implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This is not relevant for a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on engineering specifications and established mechanical testing standards for medical implants. The specific and detailed acceptance criteria for the static tensile testing (e.g., passing a certain load threshold without failure) are not explicitly detailed in this summary but would be part of the full submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" of data in the context of this physical device's mechanical performance testing.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set.

Summary

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August 8, 2017

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 Partner Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K171881

Trade/Device Name: JAZZ Passer Band Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: June 23, 2017 Received: June 23, 2017

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

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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

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510(k) Number (if known)

K171881

Device Name

JAZZ Passer Band Indications for Use (Describe)

The indications for use include the following applications:

1. Spinal trauma surgery, used in sublaminar or facet wiring techniques;
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondylolisthesis;
1. Spinal degenerative surgery, as an adjunct to spinal fusions.

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 Implanet's JAZZ System Including JAZZ Passer Band

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

lmplanet. S.A. Technopole Bordeaux Montesquieu Allée François 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 23, 2017

Application Correspondent:

Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103 Phone: (267) 675-4611

Name of Device

JAZZ Passer Band

Common or Usual Name

Bone, Fixation, Cerclage, Sublaminar

Classification Name

Bone, Fixation, Cerclage

Primary Product Code

OWI

Regulation Number

21 CFR § 888.3010

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Device Class

Class II

Predicate Devices

Implanet's JAZZ Band (K170730) (primary) Implanet's JAZZ Frame (K162764) (additional) Implanet's JAZZ Lock (K153348) (additional) lmplanet's JAZZ Claw (K160226) (additional) Implanet's Jazz Systems (K151740) (additional)

Device Description

Intended Use/Indications for Use

The indications for use include the following applications:

Spinal trauma surgery, used in sublaminar or facet wiring techniques; 4.
1. Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as adolescent idiopathic scoliosis, adult scoliosis, kyphosis and spondvlolisthesis:
1. 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.

Purpose of 510(k)

The purpose of this 510(k) is to modify the Jazz Band component of the Jazz Systems, renaming it the JAZZ Passer Band. The band is being modified to allow use of different surgical instruments.

Technological Characteristics

The JAZZ Passer Band is identical to the predicate in terms of materials, overall dimensions, with only minor modifications to the manufacturing method. The two braids primarily differ in that the Passer Band does not have a distal metal strip for insertion and contains a small

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hole for interfacing with the new surgical instruments. No changes are being made to other components in the JAZZ System.

Performance Data

These changes were assessed per static tensile testing to evaluate the strength of the hole at the band extremity.

Conclusions

The modified JAZZ Passer Band is as safe and effective as the predicate JAZZ Band. The JAZZ Passer 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 Passer Band and its predicate devices raise no new or different issues of safety or effectiveness. Performance data demonstrate that the modified JAZZ Passer Band is as safe and effective as the predicate JAZZ Band. Thus, the JAZZ Passer Band is substantially equivalent.

Regulation Number and Section

§ 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.