(165 days)
Not Found
No
The device description and performance studies focus on the mechanical properties of a physical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended for temporary stabilization of the sternum following sternotomy to facilitate solid bony fusion, which is a structural or supportive function, not directly therapeutic in the sense of treating a disease or condition with a physiological or pharmacological action.
No
Explanation: The device is intended for temporary stabilization during bony fusion, acting as a mechanical support, not to diagnose a condition.
No
The device description clearly outlines a physical implantable device made of PEEK-Optima® with a strap, teeth, and latching mechanism, indicating it is a hardware device, 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 is for "cardiovascular surgery for closure of the sternum following sternotomy." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical strap and latching mechanism used to secure bony structures. It is a mechanical implant.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) as a surgical implant for mechanical stabilization.
N/A
Intended Use / Indications for Use
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.
Product codes
JDQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
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
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
3 2012 JUL
1
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
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.
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) .
2
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.
3
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
4
Indications for Use
510(k): · K120177
Spinal Elements Cerclage System Device Name:
Indications for Use:
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.
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
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K120177 510(k) Number_