(145 days)
Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
The Synthes MultiLoc Proximal Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the proximal humerus for the fixation of fractures. The system features intramedullary nail devices, as well as 4.5mm bone screw and end cap accessories. The nails are cannulated, are offered in 8.0mm and 9.0mm diameters, and 160mm in overall length. The nail, screw, and end cap devices are composed of titanium alloy. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc proximal locking screws. The 4.5mm MultiLoc Screws which are used to facilitate the proximal locking of the nail construct can be interlocked with existing Synthes 3.5mm Locking Screws to enhance the stability of the construct.
This document describes the Synthes MultiLoc Proximal Humeral Nailing System, a medical device for fixing proximal humerus fractures. However, it does not include information about acceptance criteria or a study demonstrating device performance against such criteria in the manner requested (e.g., accuracy, sensitivity, specificity, or clinical outcomes in a human population).
The primary focus of this 510(k) summary is to establish substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and therefore does not require a new Premarket Approval (PMA).
Here's a breakdown of what is and is not in the provided text, in relation to your questions:
Summary of Information Provided vs. Requested:
The document details the engineering and material characteristics of the device and compares them to predicate devices to establish substantial equivalence, rather than providing performance metrics against pre-defined acceptance criteria for a diagnostic or AI device.
Detailed Response to Your Questions:
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A table of acceptance criteria and the reported device performance:
- Not provided. The document does not contain a table of acceptance criteria (e.g., clinical efficacy rates, accuracy metrics) or reported performance data in terms of human clinical outcomes. Instead, it describes in vitro mechanical testing results to demonstrate comparable performance to predicate devices from an engineering standpoint.
- The "performance" discussed is related to mechanical strength and material characteristics (bending strength, torsional strength, dynamic fatigue strength) compared to predicate devices, not clinical efficacy in a patient population.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. The "test set" in this context refers to in vitro mechanical testing, not a clinical data set. Therefore, concepts like country of origin or retrospective/prospective do not apply. The document does not specify the sample size used for the mechanical tests, only that they were performed "in comparison with the predicate devices."
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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):
- Not applicable / Not provided. This device is an implantable medical device, not a diagnostic or AI algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for mechanical testing would be the physical properties and performance under specific loads, measured by engineering methods.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are typically relevant for clinical studies or studies involving human judgment (e.g., reading images), which is not the nature of the testing described here.
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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:
- No. An MRMC study is not relevant for this type of implantable device. This study focuses on physical and mechanical properties.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an implantable hardware device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Mechanical properties and material characteristics. The "ground truth" for demonstrating substantial equivalence for this device relies on ASTM F1295-05 standard and in vitro mechanical tests, comparing the device's physical performance (bending strength, torsional strength, dynamic fatigue strength) to predicate devices.
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The sample size for the training set:
- Not applicable / Not provided. This medical device is not an AI/ML algorithm that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable / Not provided. As it's not an AI/ML algorithm, there is no training set or associated ground truth establishment process in that context.
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Image /page/0/Picture/0 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a logo that appears to be a stylized representation of a human figure inside of a circle. There is a horizontal line underneath the word "SYNTHES".
| 3.0 510(k) Summary | K103002 Page 1 of 2 |
|---|---|
| Sponsor: | Synthes (USA)Karl J. Nittinger1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6941FAX (484) 356-9682MAR - 2 2011 |
| Date Prepared: | October 4, 2010 |
| Device Name: | Synthes MultiLoc Proximal Humeral Nailing System |
| Classification: | Class II, §888.3020 – Intramedullary fixation rodProduct Code: HSB |
| Predicate Device: | Synthes Cannulated Titanium Humeral Nail System (K033071)Tornier Aequalis Humeral Nail System (K082754)Synthes Angular Stable Locking System [ASLS] (K090241)Synthes 4.0mm and 5.0mm Locking Screws (K000089)Synthes 3.5mm LCP Proximal Humerus Plates (K041860)Synthes 3.5mm Locking Screws (K000684) |
| Device Description: | The Synthes MultiLoc Proximal Humeral Nailing System consistsof metallic rods and accessories which are intended forimplantation in the medullary canal of the proximal humerus for thefixation of fractures.The system features intramedullary nail devices, as well as 4.5mmbone screw and end cap accessories. The nails are cannulated, areoffered in 8.0mm and 9.0mm diameters, and 160mm in overalllength. The nail, screw, and end cap devices are composed oftitanium alloy. The nails additionally feature a polymer inlay in theproximal end to enhance the stability of the 4.5mm MultiLocproximal locking screws. The 4.5mm MultiLoc Screws which areused to facilitate the proximal locking of the nail construct can beinterlocked with existing Synthes 3.5mm Locking Screws toenhance the stability of the construct. |
| Indications for use: | The Synthes MultiLoc Proximal Humeral Nailing System isindicated for fractures of the proximal humerus, including 2-partsurgical neck fractures, 3-part fractures, and 4-part fractures. |
| SubstantialEquivalence: | Information presented supports substantial equivalence of theSynthes MultiLoc Proximal Humeral Nailing System to thepredicate devices. The proposed system has the same indicationsfor use, is similar in design, incorporates the same fundamentalproduct technology and is composed of the same materials |
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Substantial Equivalence (continued):
To additionally support substantial equivalence, calculations comparing the bending strength of the subject and predicate devices based on geometric analyses and material characteristics defined in standard ASTM F1295-05 were performed as well as in vitro mechanical testing. The in vitro bench testing included static and dynamic bend, torsional strength, and dynamic fatigue strength of the construct and was conducted in comparison with the predicate devices and the results support substantial equivalence.
KIO3008 ***
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 2 2011
Synthes (USA) % Mr. Karl J. Nittinger 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K103002
Trade/Device Name: Synthes Multiloc Proximal Humeral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 07, 2011 Received: February 09, 2011
Dear Mr. Nittinger:
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
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Page 2 - Mr. Karl J. Nittinger
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 forth in the quality systems (OS) 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/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/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 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.
A. B. n h
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0
Indications for Use
510(k) Number (if known):
Synthes MultiLoc Proximal Humeral Nailing System Device Name:
Indications for Use:
Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
Prescription Use X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.Mellerson
(Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Orthopedic,
Division starstive Devices Division of Surgious, and Restorative Devices
510(k) Number
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.