(87 days)
Not Found
No
The 510(k) summary describes a mechanical sternal fixation system and its performance testing, with no mention of AI or ML.
Yes
The device is intended for stabilizing fractures and reconstructive surgical procedures, which are therapeutic interventions.
No
The device is described as a system for stabilizing and fixing fractures, which falls under therapeutic or surgical intervention, not diagnostic. Its purpose is to aid in alignment and stabilization of bones, not to diagnose a condition.
No
The device description explicitly states it is a "Sternal Cable Plate System" and mentions "implants" and "instrumentation," indicating it is a physical medical device, not software.
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 the "stabilization of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures." This describes a surgical implant used to physically support and stabilize bone, not a test performed on biological samples to diagnose a condition.
- Device Description: The description reinforces this by stating the system is for "stabilization and fixation of fractures... to aid in the alignment and stabilization of bone." It also mentions being used with wires or cables and implanted via surgical approaches.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is an in vivo device, used within the body during surgery.
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 (comma separated list FDA assigned to the subject device)
JDQ, HRS, HWC
Device Description
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 to aid in the alignment and stabilization of bone. The Sternal Cable Plate System can be used with traditional monofilament wire or Pioneer Sternal Cable. Instrumentation has been designed specifically for use with this system of implants, which may be implanted via an open or minimally invasive approach.
The purpose of this submission is to add an additional implant to the predicate Tritium Sternal Cable Plate System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior chest wall
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence was based on worst-case engineering analysis and non-clinical performance testing, which included static and dynamic tensile strength testing. Non-clinical performance testing concluded the subject product is expected to be as safe, as effective, and perform as well as or better than the predicate.
The determination of substantial equivalence was not based on clinical performance data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K133785 Pioneer Tritium Sternal Cable Plate System, K110574 Biomet SternaLock Blu Microfixation Sternal Closure System, K935481 Pioneer Sternal Cable System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Pioneer Surgical Technology, Incorporated (dba RTI Surgical, Incorporated) Ms. Sarah Pleaugh Regulatory Affairs Specialist 375 River Park Circle Marquette, Michigan 49855
Re: K150581
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: March 6, 2015 Received: March 9, 2015
Dear Ms. 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
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Page 2 - Ms. Sarah Pleaugh
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
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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Pg.1/1
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K150581
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:
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510(k) Summary As required by 21 CFR 807.92
| Sponsor: | Pioneer Surgical Technology, Inc.
(DBA RTI Surgical, Inc.)
375 River Park Circle
Marquette, MI 49855 USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sarah Pleaugh |
| Phone: | (906) 225-5861 |
| Fax: | (906) 226-4459 |
| Prepared: | May 1, 2015 |
| Trade name: | Tritium Sternal Cable Plate System |
| Common name: | Sternal Cable Plate System |
| Classification: | Class II
888.3010 Cerclage, Fixation, Metallic
888.3030 Plate, Fixation, Bone, Non-Spinal, Metallic
888.3040 Screw, Fixation, Bone, Non-Spinal, Metallic |
| Product Codes/
Panel: | JDQ, HRS, HWC
Panel Code 87 |
| Predicates: | K133785 Pioneer Tritium Sternal Cable Plate System
K110574 Biomet SternaLock Blu Microfixation Sternal Closure System
K935481 Pioneer Sternal Cable System |
| Description: | 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 to aid in the alignment and stabilization of bone. The Sternal
Cable Plate System can be used with traditional monofilament wire or
Pioneer Sternal Cable. Instrumentation has been designed specifically for
use with this system of implants, which may be implanted via an open or
minimally invasive approach.
The purpose of this submission is to add an additional implant to the
predicate Tritium Sternal Cable Plate System. |
| Materials: | The Tritium System components are manufactured from ASTM F-67
Commercially Pure (CP) Titanium and ASTM F-136 Titanium 6Al 4V
Alloy. CP Titanium and medical grade titanium alloy may be used
together. |
| Intended 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. |
| Technological
Characteristics: | The subject components are overall similar in technological characteristics
as compared to the predicates in terms of:
- Basic design: screws and plates of various sizes and configurations,
threaded plate-screw interface, may be used with cerclage (e.g. wire or
cable) - Materials: CP titanium and titanium alloy
- Design: sizes and dimensions equivalent or comparable to predicates
There are no significant differences between the subject and predicate
devices' technological characteristics which would raise new issues of
safety or effectiveness. |
| Non-Clinical
Performance Data: | The determination of substantial equivalence was based on worst-case
engineering analysis and non-clinical performance testing, which included
static and dynamic tensile strength testing. Non-clinical performance
testing concluded the subject product is expected to be as safe, as effective,
and perform as well as or better than the predicate. |
| Clinical
Performance Data: | The determination of substantial equivalence was not based on clinical
performance data. |
| Substantial
Equivalence: | The subject system is substantially equivalent to previously cleared
anterior chest wall fixation systems based on comparison of intended use,
materials, design, technological characteristics, and performance. |
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