The Spinal Elements Cerclage System is intended for use in cardiovascular surgery. The indications for use include cardiovascular surgery for closure of the sternum following sternotomy. The system is intended to provide temporary stabilization during the development of solid bony fusion.

Device Description

The Spinal Elements Cerclage System consists of a strap manufactured from PEEK-Optima®. The leading tip of the device is tapered and smooth to help lead the cerclage through or around the bony structures to be secured. The device has teeth along its length that interact with a latching mechanism at the opposite end of the strap. The latch allows a loop, created by feeding the strap though the latch, to be made consecutively shorter or taught by continuing to pull the strap through the latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

AI/ML Overview

The provided document describes the Spinal Elements Cerclage System, a medical device intended for use in cardiovascular surgery for sternum closure after sternotomy. The submission focuses on substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria for the device. Instead, it refers to non-clinical mechanical testing and a comparison to predicate devices.

Acceptance Criterion	Reported Device Performance
Mechanical Performance	All test results indicate the cerclage will perform as intended. This is based on a comparison to devices cleared for similar or identical indications for use.
Static Tensile Strength	Performed (specific values not provided, but deemed acceptable compared to predicates).
Dynamic Tensile Strength	Performed (specific values not provided, but deemed acceptable compared to predicates).
Relative Abrasion	Performed (results not detailed, but deemed acceptable compared to predicates).
Creep Tensile Strength	Performed (specific values not provided, but deemed acceptable compared to predicates).

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

Sample Size for Test Set: Not specified. The document states "Non-clinical, mechanical testing was performed," but does not detail the number of samples or trials for each test.
Data Provenance: Not specified, but implied to be laboratory-generated mechanical test data, not patient-derived data.

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

Not applicable. The "ground truth" here refers to the physical properties measured in mechanical tests, not expert interpretation of clinical data. The tests themselves are designed to measure inherent material and structural performance.

4. Adjudication Method for the Test Set:

Not applicable. As mechanical tests are objective measurements, there is no need for expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a MRMC comparative effectiveness study was not done. The submission focuses on mechanical performance and substantial equivalence, not human reader performance with or without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI/software device.

7. The Type of Ground Truth Used:

For the mechanical testing, the "ground truth" would be the objectively measured physical properties of the device (tensile strength, abrasion resistance, creep resistance) according to established testing standards or methods.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable (see point 8).

Summary of Device Performance Study:

The primary study type conducted for the Spinal Elements Cerclage System was non-clinical, mechanical testing. The purpose was to demonstrate that the device performs as intended and is substantially equivalent to predicate devices already cleared for market. The performance was assessed by comparing the results of static tensile testing, dynamic tensile testing, relative abrasion testing, and creep tensile testing against the expected performance of predicate devices with similar or identical indications for use. No clinical studies, human reader studies, or AI-specific studies were performed or described in this 510(k) summary.

Summary

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Spinal Elements, Inc. Premarket Notification - Spinal Elements Cerclage System

510(k) Summary Cerclage System

510(k) Number: K120177

Manufacturer Identification Submitted by:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121 761-607-0125 (fax)

Contact Information:

Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-1816 Bkimball@spinalelements.com

Date Prepared:

Device Indentification Proprietary Name

Spinal Elements Cerclage System

Common Name

Cerclage

Device Classification

Classification Name:

Bone Fixation, Cerclage

21 CFR 888.3010

December 14, 2011

Proposed Regulatory Class Class II

Device Product Code: JDQ

Purpose of this 510(k)

This 510(k) seeks clearance for a new system.

Device Description

3 2012 JUL

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Spinal Elements, Inc. Premarket Notification - Spinal Elements Cerclage System

taught by continuing to pull the strap through the latch resists the lengthening of the loop due to forces that would pull the strap in the opposite direction, thereby securing the structures intended to be fixed. Once the desired loop length is reached, the unneeded portion of the strap may be cut off and discarded.

Intended Use of the Device

Performance Data

Non-clinical, mechanical testing was performed to determine the performance profile of the device. Testing included:

Static tensile testing
Dynamic tensile testing
Relative abrasion testing
Creep tensile testing

All test results indicate the cerclage will perform as intended based on a comparison to devices cleared for similar or identical indications for use.

Substantial Equivalence

Spinal Elements Cerclage system is substantially equivalent to the following predicate devices:

Ethicon Stainless Steel Suture Wire (K931271 and K946173) .
Synthes Sternal ZipFix System (K110789) .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings outstretched, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spinal Elements, Inc. % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K120177

Trade/Device Name: Spinal Elements Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: June 18, 2012 Received: June 22, 2012

JUL 3 2012

Dear Mr. Kimball:

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 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.

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Page 2- Mr. Benjamin A. Kimball

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/ucm11.5809.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 A. Millerman

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

510(k): · K120177

Spinal Elements Cerclage System Device Name:

Indications for Use:

Prescription Use X : (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

"" Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Dision of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

K120177 510(k) Number_

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.