(87 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterility of the sternal cable system, with no mention of AI or ML capabilities.
No.
The device is described as an implantable system used for mechanical closure and stabilization of the sternum after surgery, not for directly treating a disease or condition. Its function is structural support rather than therapeutic in the medical sense.
No
This device is designed for the surgical closure of the sternum after a sternotomy, which is a treatment procedure, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description explicitly details physical components such as cables, crimps, tensioner/crimper instruments, leaders, needles, and cases, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics 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. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is a "Sternal Cable System" used for "closure of the sternum following sternotomy" in "Cardiovascular surgery." This is a surgical implant used within the body to physically stabilize bone.
- No Mention of Samples or Testing: The description focuses on the materials, components, and surgical application of the device. There is no mention of analyzing biological samples or performing diagnostic tests.
Therefore, based on the provided information, this device is a surgical implant, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cardiovascular surgery - closure of the sternum following sternotomy.
Product codes
JDQ
Device Description
The Sternal Cable System is an alternative over traditional monofilament sternal wire used for cardiovascular sternal closure following sternotomy. The system consists of multi-strand stainless steel and titanium cables and crimps, which are tensioned and secured around the bone using a tensioner/crimper instrument. Multiple "figure 8" constructs work as one unit to provide stabilization.
Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM F67) or 316L stainless steel (ASTM F138) crimps are provided to match the corresponding cable materials. However, the different metals are never to be mixed. Non-implantable leaders are manufactured from 316L stainless steel (ASTM F138) or titanium 3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless steel.
The implants are provided sterile for single-use but must never be re-sterilized; reusable instruments are supplied non-sterile and must be steam sterilized by the user prior to use in accordance with the instructions for use. Cases are supplied for sterilization and transport of the instruments.
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
This submission presents no changes to the devices which required new non-clinical or clinical evidence.
Pyrogenicity evaluation of the devices was added based on current industry practice and FDA guidance. Pyrogenicity of the sterile devices was evaluated using the Limulus amebocyte lysate (LAL) assay. The device was tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
A & E Medical Corporation % Sarah Pleaugh Sr. Specialist, Regulatory Affairs RTI Surgical, Inc. 375 River Park Circle Marquette, Michigan 49855
May 31, 2018
Re: K180582
Trade/Device Name: Sternal Cable System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: March 2, 2018 Received: March 5, 2018
Dear Sarah Pleaugh:
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 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);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
Indications for Use
510(k) Number (if known)
K180582
Device Name Sternal Cable System
Indications for Use (Describe)
Cardiovascular surgery - closure of the sternum following sternotomy.
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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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 complete 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.gov
"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."
3
Image /page/3/Picture/1 description: The image shows the logo for A&E Medical. The logo consists of a black circle with two white intertwined shapes resembling the letters 'a' and 'e'. To the right of the circle, the word 'MEDICAL' is written in bold, sans-serif font, with a small '®' symbol next to it.
510(k) Summary
Prepared on: May 2, 2018
| Prepared on: May 2, 2018 | |
|---|---|
| 510(k) Owner/ | |
| Manufacturer: | A&E Medical Corporation |
| 5206 Asbury Road, PO Box 758 | |
| Farmingdale, NJ 07727 USA | |
| Contact Person/ | |
| Consultant: | Sarah Pleaugh, RAC |
| Sr. Specialist, Regulatory Affairs | |
| RTI Surgical, Inc. | |
| Telephone: 1(906)226-9909 x 5861 | |
| Fax: (386) 418-1627 | |
| Email: spleaugh@rtix.com | |
| Trade name: | Sternal Cable System |
| Common name: | Sternal Cable System |
| Classification: | Class II; 21 CFR 888.3010 |
| Product Code JDQ, Bone fixation cerclage | |
| Panel: | Panel Code 87 |
| Predicate: | K935481 Songer Cable System |
| Description: | The Sternal Cable System is an alternative over traditional |
| monofilament sternal wire used for cardiovascular sternal closure | |
| following sternotomy. The system consists of multi-strand stainless | |
| steel and titanium cables and crimps, which are tensioned and | |
| secured around the bone using a tensioner/crimper instrument. | |
| Multiple "figure 8" constructs work as one unit to provide | |
| stabilization. |
Cables are manufactured from titanium 6Al-4V ELI alloy (ASTM
F136) or 316L stainless steel (ASTM F138); CP titanium (ASTM
F67) or 316L stainless steel (ASTM F138) crimps are provided to
match the corresponding cable materials. However, the different
metals are never to be mixed. Non-implantable leaders are
manufactured from 316L stainless steel (ASTM F138) or titanium
3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainless
steel.
The implants are provided sterile for single-use but must never be
re-sterilized; reusable instruments are supplied non-sterile and
must be steam sterilized by the user prior to use in accordance with
the instructions for use. Cases are supplied for sterilization and
transport of the instruments. |
| Purpose of
submission: | The modifications subject to this 510(k) for the Sternal Cable
System include narrowing of the intended use within the previously
cleared cardiovascular indications and transfer of the 510(k)
clearance to A&E Medical Corporation. |
| Indications for
Use: | Cardiovascular surgery - closure of the sternum following
sternotomy. |
| Summary of
Technological
Characteristics: | The subject Sternal Cable System has the same technological
characteristics as the predicate K935481 devices cleared for use
in closure of the sternum. Similarities to the predicate device
include:
- Same indications for use within cardiovascular surgery
applications - Same materials and manufacturing processes: metallic
devices, stainless steel and titanium - Same principles of operation and fundamental technology:
o Cable and crimp cerclages built in "figure 8"
constructs to close the sternum following
sternotomy
o Cables are provided with a preassembled needle
and leader which are used to facilitate intra-
operative placement, but are removed prior to
wound closure
o Cables are tensioned then secured using crimps - Same instrumentation: tensioner/crimper, torque wrench,
crimp holder, and cable cutter - Same general surgical technique method: pass cable
around sternum then through crimp, tension cable, secure
crimps, remove excess cable. Emergent re-entry available
if necessary using cutters. - Same sterility: gamma irradiation (implants) and steam
sterilization by the user (non-sterile instruments) - Same packaging: double sterile barrier (implants)
- Same mechanical performance |
| Discussion of
Supporting
Clinical Evidence
and Non-Clinical
Testing: | This submission presents no changes to the devices which required
new non-clinical or clinical evidence.
Pyrogenicity evaluation of the devices was added based on current
industry practice and FDA guidance. Pyrogenicity of the sterile
devices was evaluated using the Limulus amebocyte lysate (LAL)
assay. The device was tested to ensure the endotoxin level meets
the requirements of maximum endotoxin limit for implantable
medical devices [20 EU per device]. |
| Conclusion | The subject A&E Medical Corporation Sternal Cable System is
substantially equivalent to the predicate device. There are no
new risks to safety or effectiveness raised. |
4
Image /page/4/Picture/1 description: The image shows the logo for "A&E MEDICAL". The logo consists of a black circle with the letters "A" and "E" intertwined in white. To the right of the circle, the word "MEDICAL" is written in large, bold, black letters. A registered trademark symbol is located to the right of the word "MEDICAL".