(87 days)
No
The summary describes a mechanical sternal fixation system made of various metal alloys. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the stabilization of fractures and sternal fixation, which are direct treatments for medical conditions.
No
Explanation: The device description and intended use clearly state that the Tritium® Sternal Cable Plate System is for the stabilization of fractures of the anterior chest wall following surgical procedures. This indicates a therapeutic or reconstructive function, not a diagnostic one. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description explicitly states it includes implants, plates, cables, screws, needles, and a leader, all made of various metallic materials. It also mentions manual surgical instruments. This clearly indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details the materials and design of plates, cables, screws, needles, and leaders, all of which are components of a surgical implant system.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with biological specimens for diagnostic purposes.
Therefore, the Tritium® Sternal Cable Plate System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
JDQ, HRS, HWC
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall, 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
Nonclinical tests were submitted and relied on in this premarket notification submission for a determination of substantial equivalence. Testing identified in this summary has all passed acceptance criteria established by the predicate device where applicable.
MR Safety Evaluation following standards listed below:
• ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
• ASTM F2213-17, "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
• ASTM F2182-11a, "Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging"
• ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants"
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.
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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
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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) |
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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 Circle | |
| Marquette, MI 49855 USA | |
| http://www.rtix.com | |
| Establishment Registration #1833824 | |
| Contact | |
| Person/Consultant: | Peter Browne - RA Specialist |
| A&E Medical Corporation | |
| Phone: (732) 378-7337 | |
| Fax: (732) 938-2399 | |
| Email: 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, Fixation | |
| HRS; 21 CFR 888.3030; Plate, Fixation, Bone | |
| HWC; 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 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. |
| Purpose of
submission: | 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. |
| Indications for Use: | The Tritium® Sternal Cable Plate System is intended for use in the stabilization
and fixation of fractures of the anterior chest wall including sternal fixation
following sternotomy and sternal reconstructive surgical procedures. |
| Summary of
Technological
Characteristics: | The subject Tritium® Sternal Cable Plate System has the same technological
characteristics as the predicate K161876 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: intended to
stabilize and fixate fractures of the anterior chest wall (e.g. sternal
fixation) 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) and
steam sterilization by the user (non-sterile implants and instruments) - Same packaging: double sterile barrier (sterile implants) and
polybag/carton (non-sterile implants and 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 non-clinical testing listed
below. |
| Discussion of
Supporting Clinical
Evidence and Non-
Clinical Testing: | The following nonclinical tests were submitted and relied on in this premarket
notification submission for a determination of substantial equivalence. Testing
identified in this summary has all passed acceptance criteria established by the
predicate device where applicable.
MR Safety Evaluation following standards listed below:
• ASTM F2052-15, "Standard Test Method for Measurement of Magnetically
Induced Displacement Force on Medical Devices in the Magnetic Resonance
Environment"
• ASTM F2213-17, "Standard Test Method for Measurement of Magnetically
Induced Torque on Medical Devices in the Magnetic Resonance Environment"
• ASTM F2182-11a, "Standard Test Method for Measurement of Radio
Frequency Induced Heating Near Passive Implants During Magnetic Resonance
Imaging"
• ASTM F2119-07 (Reapproved 2013), “Standard Test Method for Evaluation of
MR Image Artifacts from Passive Implants" |
| Conclusion | The subject Tritium® Sternal Cable Plate System was shown to be
substantially equivalent to the predicate system. The devices are determined to
be MR Conditional based on the results of testing completed according to
FDA Guidance document "Establishing Safety and Compatibility of Passive |
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