(87 days)
Cardiovascular surgery - closure of the sternum following sternotomy.
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.
The provided document is a 510(k) summary for the A&E Medical Corporation Sternal Cable System. It primarily discusses the device's substantial equivalence to a predicate device and its indications for use.
Based on the content of this document, no information is available regarding specific acceptance criteria for device performance, nor details of a study proving the device meets such criteria in terms of clinical or algorithmic performance. The document focuses on regulatory clearance based on substantial equivalence, materials, manufacturing processes, and general mechanical performance similarities to a predicate device, rather than detailed performance metrics.
Specifically, the following points pertinent to your request are addressed by the document:
- 1. A table of acceptance criteria and the reported device performance: This information is not provided. The document states, "This submission presents no changes to the devices which required new non-clinical or clinical evidence." It only mentions "Same mechanical performance" when comparing to the predicate, but no specific metrics or acceptance criteria are given.
- 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided. As no new non-clinical or clinical evidence was required or presented for performance evaluation, there is no test set in this context.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided.
- 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: This information is not provided. The device is a physical medical device (Sternal Cable System), not an AI algorithm for diagnostic reading.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not provided. The device is a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not provided.
- 8. The sample size for the training set: This information is not provided.
- 9. How the ground truth for the training set was established: This information is not provided.
The document mentions a "Pyrogenicity evaluation" for endotoxin levels, which can be considered a performance test.
- Acceptance Criteria for Pyrogenicity: Endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
- Reported Device Performance for Pyrogenicity: The device was tested to ensure the endotoxin level meets this requirement. However, the exact measured endotoxin level is not stated.
In summary, the document does not contain the detailed performance study information you are seeking for a medical device that would describe specific acceptance criteria and the results of a study demonstrating these criteria were met, particularly in the context of diagnostic performance or AI systems. The focus of this 510(k) submission is on demonstrating substantial equivalence to a predicate device based on similar technological characteristics, materials, and intended use, rather than presenting a de novo performance study with quantitative acceptance criteria and results.
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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);
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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
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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)
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510(k) Summary
Prepared on: May 2, 2018
| Prepared on: May 2, 2018 | |
|---|---|
| 510(k) Owner/Manufacturer: | A&E Medical Corporation5206 Asbury Road, PO Box 758Farmingdale, NJ 07727 USA |
| Contact Person/Consultant: | Sarah Pleaugh, RACSr. Specialist, Regulatory AffairsRTI Surgical, Inc.Telephone: 1(906)226-9909 x 5861Fax: (386) 418-1627Email: spleaugh@rtix.com |
| Trade name: | Sternal Cable System |
| Common name: | Sternal Cable System |
| Classification: | Class II; 21 CFR 888.3010Product Code JDQ, Bone fixation cerclage |
| Panel: | Panel Code 87 |
| Predicate: | K935481 Songer Cable System |
| Description: | The Sternal Cable System is an alternative over traditionalmonofilament sternal wire used for cardiovascular sternal closurefollowing sternotomy. The system consists of multi-strand stainlesssteel and titanium cables and crimps, which are tensioned andsecured around the bone using a tensioner/crimper instrument.Multiple "figure 8" constructs work as one unit to providestabilization.Cables are manufactured from titanium 6Al-4V ELI alloy (ASTMF136) or 316L stainless steel (ASTM F138); CP titanium (ASTMF67) or 316L stainless steel (ASTM F138) crimps are provided tomatch the corresponding cable materials. However, the differentmetals are never to be mixed. Non-implantable leaders aremanufactured from 316L stainless steel (ASTM F138) or titanium3Al/2.5V Alloy (ASTM B863) and needles are 420 or 470 stainlesssteel.The implants are provided sterile for single-use but must never bere-sterilized; reusable instruments are supplied non-sterile andmust be steam sterilized by the user prior to use in accordance withthe instructions for use. Cases are supplied for sterilization andtransport of the instruments. |
| Purpose ofsubmission: | The modifications subject to this 510(k) for the Sternal CableSystem include narrowing of the intended use within the previouslycleared cardiovascular indications and transfer of the 510(k)clearance to A&E Medical Corporation. |
| Indications forUse: | Cardiovascular surgery - closure of the sternum followingsternotomy. |
| Summary ofTechnologicalCharacteristics: | The subject Sternal Cable System has the same technologicalcharacteristics as the predicate K935481 devices cleared for usein closure of the sternum. Similarities to the predicate deviceinclude:- Same indications for use within cardiovascular surgeryapplications- Same materials and manufacturing processes: metallicdevices, 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 followingsternotomyo Cables are provided with a preassembled needleand leader which are used to facilitate intra-operative placement, but are removed prior towound closureo Cables are tensioned then secured using crimps- Same instrumentation: tensioner/crimper, torque wrench,crimp holder, and cable cutter- Same general surgical technique method: pass cablearound sternum then through crimp, tension cable, securecrimps, remove excess cable. Emergent re-entry availableif necessary using cutters.- Same sterility: gamma irradiation (implants) and steamsterilization by the user (non-sterile instruments)- Same packaging: double sterile barrier (implants)- Same mechanical performance |
| Discussion ofSupportingClinical Evidenceand Non-ClinicalTesting: | This submission presents no changes to the devices which requirednew non-clinical or clinical evidence.Pyrogenicity evaluation of the devices was added based on currentindustry practice and FDA guidance. Pyrogenicity of the steriledevices was evaluated using the Limulus amebocyte lysate (LAL)assay. The device was tested to ensure the endotoxin level meetsthe requirements of maximum endotoxin limit for implantablemedical devices [20 EU per device]. |
| Conclusion | The subject A&E Medical Corporation Sternal Cable System issubstantially equivalent to the predicate device. There are nonew risks to safety or effectiveness raised. |
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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".
§ 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.