(63 days)
Not Found
No
The description focuses on the mechanical properties and materials of the sternal cable plate system and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the stabilization of fractures and sternal fixation following sternotomy and sternal reconstructive surgical procedures, which are therapeutic interventions.
No
The device is described as a system for stabilizing fractures and enhancing sternal closure techniques, which are therapeutic rather than diagnostic actions.
No
The device description explicitly details physical implants (plates, cables, screws, needles, leader) made of various metallic materials and mentions the use of manual surgical instruments for implantation. This 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 is for the stabilization of fractures of the anterior chest wall, specifically the sternum, following surgery. This is a surgical implant used to provide structural support within the body.
- Device Description: The device is comprised of plates, cables, screws, needles, and a leader made of various metals. These are all components of a surgical implant system.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Anatomical Site: The device is implanted in the anterior chest wall, an internal anatomical site.
- Intended User/Care Setting: The device is used with manual surgical instruments in a surgical setting by trained professionals. This is consistent with a surgical implant, not an IVD.
In summary, the Tritium Sternal Cable Plate System is a surgical implant used for mechanical stabilization, not a device used for in vitro diagnostic testing.
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 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 6Al 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 3Al/ 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, sternal
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)
Engineering analysis was completed for the subject line extension product and demonstrated no new performance data was required for a determination of substantial equivalence.
Pyrogenicity will be evaluated using the Limulus amebocyte lysate (LAL) assay. The device will be tested to ensure the endotoxin level meets the requirements of maximum endotoxin limit for implantable medical devices [20 EU per device].
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 9, 2016
Pioneer Surgical Technology, Inc. % Ms. Sarah Pleaugh Regulatory Affairs Specialist DBA RTI Surgical, Inc. 375 River Park Circle Marquette, Michigan 49855
Re: K161876
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: August 18, 2016 Received: August 19, 2016
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161876
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
Image /page/3/Picture/1 description: The image shows the logo for "rti surgical". The "rti" is in a blue square with rounded corners, and the letters are white with a small green dot above the "i". The word "surgical" is in gray, and there is a trademark symbol to the right of the word.
K161876
510(k) Summary As required per 21 CFR Section 807.92
| Prepared: | September 8, 2016 |
|---|---|
| 510(k) Owner / | |
| Manufacturer: | Pioneer Surgical Technology, Inc. |
| DBA RTI Surgical, Inc. | |
| 375 River Park Circle | |
| Marquette, MI 49855 USA | |
| Telephone: 906-226-9909 | |
| Fax: 906-225-5868 | |
| Contact Person: | Sarah Pleaugh, RAC |
| Regulatory Affairs Specialist | |
| Device trade/ | |
| proprietary name: | Tritium® Sternal Cable Plate System |
| Common name: | Sternal Cable Plate System |
| Classification | |
| regulation: | 888.3010; Cerclage, Fixation, Metallic |
| 888.3030; Plate, Fixation, Bone, Non-Spinal, Metallic | |
| 888.3040; Screw, Fixation, Bone, Non-Spinal, Metallic | |
| Device class: | Class II |
| Product code: | JDQ, HRS, HWC |
| Review panel: | Panel Code 87; Orthopedic |
| Predicate device: | K150581 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 6Al 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 3Al/ 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. |
4
| Purpose of this
submission: | The purpose of this submission is to obtain clearance of
modifications (line extensions) to the predicate system (K150581). |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
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. |
| Technological
characteristics: | The subject system has the same or similar technological
characteristics (overall design, material, principles of operation,
and anatomical location of use) as the predicate. The subject
modifications do not impact the technological characteristics as
compared to K150581. |
| Non-Clinical
Performance
Data: | Engineering analysis was completed for the subject line extension
product and demonstrated no new performance data was required
for a determination of substantial equivalence.
Pyrogenicity will be evaluated using the Limulus amebocyte lysate
(LAL) assay. The device will be tested to ensure the endotoxin
level meets the requirements of maximum endotoxin limit for
implantable medical devices [20 EU per device]. |
| Clinical
Performance
Data: | No clinical performance data was required for a determination of
substantial equivalence. |
| Substantial
Equivalence: | The subject line extension product is substantially equivalent to
previously cleared anterior chest wall fixation systems based on
comparison of intended use, materials, minimum number of screw
holes per sternal half, screw hole geometry, cable/ needle/ leader/
plug geometry design, technological characteristics, mechanical
strength and performance. The modifications to the predicate
K150581 system do not raise new issues of safety or
effectiveness. |