(87 days)
The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
The Tritium® Sternal Cable Plate System includes implants of various sizes; plates and cable plugs comprised of commercially pure titanium, Grade IV (ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy (ASTM F136). The system also includes needles comprised of Custom 470 stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leader comprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).
The system is designed to enhance the stability and strength of traditional sternal closure techniques. Utilizing a unique load sharing concept, the device can be implanted to distribute lateral force across the osteotomy. The system can be used with traditional monofilament wire or Pioneer Sternal Cable. The device system should be implanted using only the manual surgical instruments designed specifically for this system of implants, which may be implanted via an open or minimally invasive approach.
The provided document is an FDA 510(k) clearance letter for the Tritium® Sternal Cable Plate System. It is a premarket notification for a medical device and not for a digital health/AI device. Therefore, the content does not describe acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML-based medical device.
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K161876 Tritium® Sternal Cable Plate System), primarily based on:
- Same indications for use.
- Same materials, manufacturing processes, and biocompatibility.
- Same principles of operation and fundamental technology.
- Same instrumentation and general surgical technique.
- Same sterility, shelf life, packaging, and bacterial endotoxin evaluation.
- Same mechanical performance.
The "Purpose of submission" states: "Obtain clearance for the following modification to the predicate K161876 Tritium® Sternal Cable Plate System: add magnetic resonance (MR) conditional safety labeling based on completed non-clinical testing." This indicates the primary study performed was related to MR compatibility.
Therefore, it is not possible to extract the requested information (acceptance criteria for AI/ML performance, study details for an AI/ML device, ground truth establishment, etc.) from this document.
The document describes non-clinical testing for MR safety. Below is a summary of the MR safety testing mentioned, which is not related to AI/ML device performance or clinical outcomes:
Acceptance Criteria and Study for MR Safety (Non-Clinical)
| Acceptance Criteria (for MR Safety) | Reported Device Performance (Satisfied) |
|---|---|
| Magnetic Resonance (MR) Conditional Safety Labeling | Determined to be MR Conditional based on test results. |
| Magnetic Induced Displacement Force (ASTM F2052-15) | Passed Acceptance Criteria |
| Magnetic Induced Torque (ASTM F2213-17) | Passed Acceptance Criteria |
| Radio Frequency Induced Heating (ASTM F2182-11a) | Passed Acceptance Criteria |
| MR Image Artifacts from Passive Implants (ASTM F2119-07) | Passed Acceptance Criteria |
Study Details (for MR Safety - Non-Clinical):
- Sample size used for the test set and the data provenance: Not applicable in the context of a typical clinical test set for AI. The "test set" here refers to the physical device components tested in an MR environment. The document does not specify the number of devices tested, but implied it was sufficient to meet the ASTM standards. Data provenance is not described as it is a non-clinical, in-vitro test.
- 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 adherence to international standards (ASTM) and measurable physical phenomena. No human experts are involved in establishing ground truth for these physical tests.
- Adjudication method: Not applicable for non-clinical physical testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this was a non-clinical MR safety study, not a clinical effectiveness study.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
- The type of ground truth used: Ground truth for MR safety is defined by the physical principles of magnetic resonance and the quantitative limits set by ASTM standards (e.g., displacement force, torque, temperature rise, artifact size).
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring training data.
- How the ground truth for the training set was established: Not applicable.
Summary of why the requested information cannot be provided:
The provided FDA document is for a physical medical device (Tritium® Sternal Cable Plate System) used for bone fixation, and the clearance is based on substantial equivalence and non-clinical MR safety testing. It is not for a digital health product, an AI/ML device, or any software as a medical device. Therefore, the questions related to AI/ML device performance, human reader studies, ground truth establishment for AI, and training/test set sizes for AI algorithms are not relevant to this document.
{0}------------------------------------------------
March 12, 2020
Image /page/0/Picture/1 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.
Pioneer Surgical Technology, Inc. (dba RTI Surgical, Inc.) % Peter Browne RA Specialist A&E Medical Corporation 5206 Asbury Road, PO BOX 758 Farmingdale, New Jersey 07727
Re: K193468
Trade/Device Name: Tritium Sternal Cable Plate System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC Dated: December 10, 2019 Received: December 16, 2019
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,
for
Ronald P. Jean, Ph.D. Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K193468
Device Name Tritium® Sternal Cable Plate System
Indications for Use (Describe)
The Tritium® Sternal Cable Plate System is intended for use in the stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
| 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}------------------------------------------------
K193468 Page 1 of 2
510(k) Summary
| Date Prepared | December 10th, 2019 |
|---|---|
| 510(k) Owner/Manufacturer: | Pioneer Surgical Technology, Inc. dba RTI Surgical, Inc.375 River Park CircleMarquette, MI 49855 USAhttp://www.rtix.comEstablishment Registration #1833824 |
| ContactPerson/Consultant: | Peter Browne - RA SpecialistA&E Medical CorporationPhone: (732) 378-7337Fax: (732) 938-2399Email: p.browne@aemedical.com |
| Trade name: | Tritium® Sternal Cable Plate System |
| Common name: | Sternal Cable Plate System |
| Classification: | Class II;JDQ; 21 CFR 888.3010; Cerclage, FixationHRS; 21 CFR 888.3030; Plate, Fixation, BoneHWC; 21 CFR 888.3040; Screw, Fixation, Bone |
| Panel: | Panel Code 87 |
| Predicate: | K161876 Tritium® Sternal Cable Plate System |
| Description: | The Tritium® Sternal Cable Plate System includes implants of various sizes;plates and cable plugs comprised of commercially pure titanium, Grade IV(ASTM F67), and cables and screws comprised of Titanium 6AI 4V Alloy(ASTM F136). The system also includes needles comprised of Custom 470stainless steel, 420 stainless steel (ASTM F899, Custom 470 SST) and leadercomprised of Titanium 3AI/ 2.5V Alloy (ASTM F2146).The system is designed to enhance the stability and strength of traditional sternalclosure techniques. Utilizing a unique load sharing concept, the device can beimplanted to distribute lateral force across the osteotomy. The system can be usedwith traditional monofilament wire or Pioneer Sternal Cable. The device systemshould be implanted using only the manual surgical instruments designedspecifically for this system of implants, which may be implanted via an open orminimally invasive approach. |
| Purpose ofsubmission: | Obtain clearance for the following modification to the predicate K161876Tritium® Sternal Cable Plate System: add magnetic resonance (MR) conditionalsafety labeling based on completed non-clinical testing. |
| Indications for Use: | The Tritium® Sternal Cable Plate System is intended for use in the stabilizationand fixation of fractures of the anterior chest wall including sternal fixationfollowing sternotomy and sternal reconstructive surgical procedures. |
| Summary ofTechnologicalCharacteristics: | The subject Tritium® Sternal Cable Plate System has the same technologicalcharacteristics as the predicate K161876 devices cleared for use in closure ofthe 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: intended tostabilize and fixate fractures of the anterior chest wall (e.g. sternalfixation) through the use of plates, screws that lock into system plates,and integrated cable sub-assemblies- Same instrumentation: trial plates, screw sizer, cable and plate cutters,tensioner, crimper, screw driver, sterilization case and caddy- Same general surgical technique method:- Same sterility and shelf life: gamma irradiation (sterile implants) andsteam sterilization by the user (non-sterile implants and instruments)- Same packaging: double sterile barrier (sterile implants) andpolybag/carton (non-sterile implants and instruments)- Same bacterial endotoxin evaluation and limit (20 EU/device)- Same mechanical performance- Same screw features and cable subassembly componentsThe modification to the labeling is supported by non-clinical 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 Tritium® Sternal Cable Plate System was shown to besubstantially equivalent to the predicate system. The devices are determined tobe MR Conditional based on the results of testing completed according toFDA Guidance document "Establishing Safety and Compatibility of Passive |
{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.