(205 days)
Not Found
No
The document describes a mechanical implant system for sternal fixation and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as an implant system for stabilizing and fixing fractures of the anterior chest wall, including sternal fixation following surgery. This function directly aims to treat a medical condition or injury, classifying it as a therapeutic device.
No
The device is described as an implant system for stabilizing and fixating fractures of the anterior chest wall, specifically for sternal fixation. Its purpose is to provide mechanical support, not to diagnose a condition.
No
The device description explicitly states it consists of "implantable plates" and is made of "PEEK," which are physical hardware components. The summary also describes "static and dynamic testing" related to the strength and cut-through resistance of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The provided description clearly states that the Pioneer Sternal Assist Implant System consists of "implantable plates" and is used for "stabilization and fixation of fractures of the anterior chest wall". This is a device that is surgically implanted within the body to provide structural support.
Therefore, based on the intended use and device description, this is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pioneer Sternal Assist Implant 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.
Product codes
JDQ, HRS
Device Description
The Pioneer Sternal Assist Implant System consists of implantable plates for use with the Pioneer Sternal Cable System or USP #5, 6, or 7 Stainless Steel wire as a supplemental fixation to provide fixation for sternotomies and sternal fractures. The components are made of PEEK (polyetheretherketone) per ASTM F2026. The purpose of this submission is to introduce a new sternal closure system to interstate commerce.
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)
Static and dynamic testing of the subject device was completed to demonstrate that performance related to strength and cut-through resistance was equivalent to or better than the predicate. Testing and engineering analysis were also provided to mitigate the risk of wear and show that no new issues of safety or effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101170, K110789, K935481, K931271/K946173
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
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| 510(k) Summary
Sponsor: | Pioneer Surgical Technology
375 River Park Circle
Marquette, MI 49855
(906) 225-5861
Contact: Sarah McIntyre or Emily Downs
Prepared: July 25, 2012 | JUL 26 2012 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Pioneer Sternal Assist Implant System | |
| Classification: | Class II; JDQ, HRS
888.3030 - Plate, Fixation, Bone
888.3010 - Bone Fixation Cerclage
Panel Code: 87 | |
| Predicate Devices: | K101170 ACUTE Innovations Acutie Sternal Fixation System (SE 9/17/10)
K110789 Synthes ZipFix (SE 7/28/11)
K935481 Pioneer Songer Cable System (SE 1/26/94)
K931271/K946173 - Ethicon Stainless Steel Suture Wire (SE 1/9/95) | |
| Intended Use: | The Pioneer Sternal Assist Implant 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. | |
| Description: | The Pioneer Sternal Assist Implant System consists of implantable plates
for use with the Pioneer Sternal Cable System or USP #5, 6, or 7 Stainless
Steel wire as a supplemental fixation to provide fixation for sternotomies
and sternal fractures. The components are made of PEEK
(polyetheretherketone) per ASTM F2026.
The purpose of this submission is to introduce a new sternal closure system
to interstate commerce. | |
| Performance Data: | Static and dynamic testing of the subject device was completed to
demonstrate that performance related to strength and cut-through resistance
was equivalent to or better than the predicate. Testing and engineering
analysis were also provided to mitigate the risk of wear and show that no
new issues of safety or effectiveness were raised. | |
| Performance and
SE Determination: | Equivalence for the Pioneer Sternal Assist Implant System is based on
similarities of intended use, mechanical strength, design, and physical
characteristics when compared to predicate devices. Therefore, Pioneer
Surgical Technology believes that there is sufficient evidence to conclude
that the Pioneer Sternal Assist Implant System is substantially equivalent
to existing legally marketed devices. | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 26 2012
Pioneer Surgical Technology, Incorporated % Ms. Sarah McIntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855
Re: K120016
Trade/Device Name: Pioneer Sternal Assist Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: HRS, JDQ Dated: June 8, 2012 Received: June 12, 2012
Dear Ms. McIntyre:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2- Ms. Sarah McIntyre
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3.0 Indications for Use Statement
510(k) Number (if known): K12 OO) 6
Device Name: Pioneer Sternal Assist Implant System
Indications:
The Pioneer Sternal Assist Implant 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.
Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
166
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
And
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
120016 510(k) Number