(98 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 Sternal Cable System and primarily focuses on demonstrating substantial equivalence to a predicate device, particularly for the addition of Magnetic Resonance (MR) conditional safety labeling. It is not a study that evaluates the performance of an AI medical device, but rather a conventional medical device.
Therefore, many of the requested criteria, such as "acceptance criteria for an AI medical device," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth establishment," are not applicable to this document as it does not describe an AI medical device or its performance study.
However, I can extract information relevant to the device's MR Conditional safety labeling, which is the core of this submission's "study" aspect:
1. A table of acceptance criteria and the reported device performance (for MR safety):
| Acceptance Criteria (from referenced ASTM standards) | Reported Device Performance |
|---|---|
| Magnetically Induced Displacement Force: Sufficiently low so as not to pose an additional hazard. | The device meets the acceptance criteria (implied by "MR Safety Evaluation following standards listed below" and "Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable."). |
| Magnetically Induced Torque: Sufficiently low so as not to pose an additional hazard. | The device meets the acceptance criteria. |
| Radio-Frequency (RF) Induced Heating: Heating within acceptable limits (e.g., < 2°C or 2.4°C for certain scenarios, commonly). | The device meets the acceptance criteria. |
| MR Image Artifacts: Artifacts do not obscure the region of interest or clinical information. | The device meets the acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of patient cases, but rather as the number of devices or configurations tested. Given the nature of MR safety testing (physical properties of materials and device geometry), it would involve testing representative samples of each cable and crimp material/configuration.
- Data Provenance: This is non-clinical testing performed on the devices themselves. There is no patient data involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for MR safety is established by physical measurements and adherence to engineering standards (ASTM), not by expert consensus on clinical images or outcomes.
4. Adjudication method for the test set:
- Not applicable. The "test set" here refers to physical devices undergoing MR safety testing, not clinical data requiring adjudication.
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. This is not an AI device, and therefore no MRMC study for AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used:
- For MR safety, the "ground truth" is based on objective physical measurements (e.g., direct measurement of displacement force, temperature change, and visual assessment of artifact size) conducted according to the specified ASTM standards. These standards define the acceptable limits for each parameter.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 23, 2020
A&E Medical Corporation Peter Browne RA Specialist 5206 Asbury Road, PO Box 758 Farmingdale, New Jersey 07727
Re: K193479
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: February 28, 2020 Received: March 2, 2020
Dear Peter Browne:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, MBE Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K193479
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}------------------------------------------------
510(k) Summary
| Date Prepared | December 10th, 2019 |
|---|---|
| 510(k) Owner/Manufacturer: | A&E Medical Corporation5206 Asbury Road, PO Box 758Farmingdale, NJ 07727 USAEstablishment Registration #: 2242056 |
| Contact Person: | Peter Browne - RA SpecialistA&E Medical CorporationPhone: (732) 378-7337Fax: (732) 938-2399Email: p.browne@aemedical.com |
| Trade name: | Sternal Cable System |
| Common name: | Sternal Cable System |
| Classification: | Class II;JDQ; 21 CFR 888.3010; Cerclage, Fixation |
| Panel: | Panel Code 87 |
| Predicate: | K180582 Sternal 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 ofsubmission: | Obtain clearance for the following modification to the predicate K180582 Sternal Cable System: add magnetic resonance (MR) conditional safety labeling based on completed non-clinical testing. |
| Indications for Use: | Cardiovascular surgery - closure of the sternum following sternotomy. |
| Summary ofTechnologicalCharacteristics: | The subject Sternal Cable System has the same technological characteristics asthe predicate K180582 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, manufacturing processes and biocompatibility:metallic devices, stainless steel and titanium- Same principles of operation and fundamental technology:○ Cable and crimp cerclages built in "figure 8" constructs toclose the sternum following sternotomy○ Cables are provided with a preassembled needle and leaderwhich are used to facilitate intra-operative placement, but areremoved prior to wound closure○ Cables are tensioned then secured using crimps- Same instrumentation: tensioner/crimper, torque wrench, crimpholder, and cable cutter- Same general surgical technique method: pass cable around sternumthen through crimp, tension cable, secure crimps, remove excesscable. Emergent re-entry available if necessary, using cutters.- Same sterility and shelf life: gamma irradiation (implants) and steamsterilization by the user (non-sterile instruments)- Same packaging: double sterile barrier (implants) and polybag (non-sterile instruments)- Same bacterial endotoxin evaluation and limit (20 EU/device)- Same mechanical performance- Same screw features and cable subassembly components.The modification to the labeling is supported by nonclinical testing listedbelow. |
| Discussion ofSupporting ClinicalEvidence and Non-Clinical Testing: | The following nonclinical tests were submitted and relied on in this premarketnotification submission for a determination of substantial equivalence. Testingidentified in this summary has all passed acceptance criteria established by thepredicate device where applicable.MR Safety Evaluation following standards listed below:• ASTM F2052-15, "Standard Test Method for Measurement of MagneticallyInduced Displacement Force on Medical Devices in the Magnetic ResonanceEnvironment"• ASTM F2213-17, "Standard Test Method for Measurement of MagneticallyInduced Torque on Medical Devices in the Magnetic Resonance Environment"• ASTM F2182-11a, "Standard Test Method for Measurement of RadioFrequency Induced Heating Near Passive Implants During Magnetic ResonanceImaging"• ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation ofMR Image Artifacts from Passive Implants" |
| Conclusion | The subject Sternal Cable System was shown to be substantially equivalent tothe predicate system. The devices are determined to be MR Conditional basedon the results of testing completed according to FDA Guidance document"Establishing Safety and Compatibility of Passive Implants in the MagneticResonance (MR) Environment", December 11, 2014. |
{4}------------------------------------------------
§ 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.