(205 days)
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.
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.
The provided text describes the Pioneer Sternal Assist Implant System and its 510(k) summary (K120016). This document is primarily concerned with the mechanical and design equivalence of a medical device (surgical sternal plates and cables) to predicate devices, rather than an AI/ML powered diagnostic device. Therefore, many of the requested categories for AI/ML device studies are not applicable to this submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance related to strength equivalent to or better than predicate devices. | Static and dynamic testing demonstrated that performance related to strength was equivalent to or better than the predicate devices. |
| Performance related to cut-through resistance equivalent to or better than predicate devices. | Static and dynamic testing demonstrated that performance related to cut-through resistance was equivalent to or better than the predicate devices. |
| Mitigation of risk of wear. | Testing and engineering analysis were provided to mitigate the risk of wear and show that no new issues of safety or effectiveness were raised. |
| Similarities of intended use, mechanical strength, design, and physical characteristics compared to predicate devices. | Equivalence for the Pioneer Sternal Assist Implant System is explicitly stated to be based on "similarities of intended use, mechanical strength, design, and physical characteristics when compared to predicate devices." The performance data section supports the mechanical strength, design, and physical characteristic claims, and the "Intended Use" section clearly outlines the intended use which is compared to predicates by the FDA's substantial equivalence determination. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. The study described is a mechanical performance study on the device itself, not a clinical study involving a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The study focuses on mechanical testing of the device, not on interpreting patient data with ground truth established by medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided for the same reasons as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/provided. The device is an implantable surgical system, not an AI/ML diagnostic reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through physical mechanical testing according to predefined engineering standards and comparisons to predicate device performance. It is not expert consensus on diagnostic images, pathology, or clinical outcomes data in the context of an AI/ML diagnostic.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of mechanical testing for a physical implantable device.
9. How the ground truth for the training set was established
This information is not applicable/provided. There is no training set for this type of device.
Summary of the Study that Proves Acceptance Criteria are Met:
The study proving the device meets the acceptance criteria was a series of static and dynamic mechanical tests and engineering analysis. These tests were designed to compare the performance of the Pioneer Sternal Assist Implant System against its predicate devices in terms of:
- Strength: The ability of the device to withstand forces without breaking or deforming excessively.
- Cut-through resistance: The ability of the implant components to resist being cut or damaged by the cerclage wires/cables used for fixation.
- Wear: Analysis and testing to ensure that the device does not excessively wear over time, which could lead to failure or adverse events.
The conclusion drawn from this testing and analysis was that the Pioneer Sternal Assist Implant System's performance was equivalent to or better than the predicate devices for strength and cut-through resistance, and that the risk of wear was mitigated. This mechanical equivalence, along with similarities in intended use, design, and physical characteristics, formed the basis for the FDA's substantial equivalence determination.
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| 510(k) SummarySponsor: | Pioneer Surgical Technology375 River Park CircleMarquette, MI 49855(906) 225-5861Contact: Sarah McIntyre or Emily DownsPrepared: July 25, 2012 | JUL 26 2012 |
|---|---|---|
| Device Name: | Pioneer Sternal Assist Implant System | |
| Classification: | Class II; JDQ, HRS888.3030 - Plate, Fixation, Bone888.3010 - Bone Fixation CerclagePanel 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 thestabilization and fixation of fractures of the anterior chest wall, includingsternal fixation following sternotomy and sternal reconstructive surgicalprocedures. | |
| Description: | The Pioneer Sternal Assist Implant System consists of implantable platesfor use with the Pioneer Sternal Cable System or USP #5, 6, or 7 StainlessSteel wire as a supplemental fixation to provide fixation for sternotomiesand sternal fractures. The components are made of PEEK(polyetheretherketone) per ASTM F2026.The purpose of this submission is to introduce a new sternal closure systemto interstate commerce. | |
| Performance Data: | Static and dynamic testing of the subject device was completed todemonstrate that performance related to strength and cut-through resistancewas equivalent to or better than the predicate. Testing and engineeringanalysis were also provided to mitigate the risk of wear and show that nonew issues of safety or effectiveness were raised. | |
| Performance andSE Determination: | Equivalence for the Pioneer Sternal Assist Implant System is based onsimilarities of intended use, mechanical strength, design, and physicalcharacteristics when compared to predicate devices. Therefore, PioneerSurgical Technology believes that there is sufficient evidence to concludethat the Pioneer Sternal Assist Implant System is substantially equivalentto existing legally marketed devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
And
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
120016 510(k) Number
§ 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.