SYNTHES MULTILOC HUMERAL NAILING SYSTEM by SYNTHES USA PRODUCTS LLC

The Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

Device Description

The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation. The system features intramedullary nail devices, as well as bone screws and end cap accessories. The nails are cannulated, offered in 7.0mm, 8.5mm, and 10mm diameters, and are available in 180mm -315mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5mm MultiLoc Screws, used to facilitate the proximal locking of the nail construct, can be interlocked with cleared Synthes 3.5mm Locking Screws to enhance the stability of the construct.

AI/ML Overview

The provided text describes a medical device, the Synthes MultiLoc Humeral Nailing System, seeking FDA clearance via a 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving meeting specific acceptance criteria through a clinical study with performance metrics in the way a novel medical AI/ML device would.

Therefore, many of the requested categories are not applicable to the information provided for this type of device submission. The existing information focuses on bench testing to demonstrate mechanical equivalence to predicate devices, rather than human performance metrics.

Here's an analysis based on the provided text, indicating where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from predicate device)	Reported Device Performance (Synthes MultiLoc Humeral Nailing System)
Same indications for use as predicate devices.	The proposed system has the same indications for use: fractures of the proximal humerus (2-part surgical neck, 3-part, 4-part), proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
Similar in design to predicate devices.	Similar in design to predicate devices.
Incorporates the same fundamental product technology as predicate devices.	Incorporates the same fundamental product technology as predicate devices.
Composed of the same materials as predicate devices.	Composed of the same materials as predicate devices.
Bending strength (static and dynamic) equivalent to predicate devices (according to ASTM F 1264-03).	In vitro bench testing, including static and dynamic 4-point bending, showed results supporting substantial equivalence compared to predicate devices.
Torsional strength equivalent to predicate devices.	In vitro bench testing showed results supporting substantial equivalence compared to predicate devices.
Eccentric dynamic fatigue strength of the construct equivalent to predicate devices.	In vitro bench testing showed results supporting substantial equivalence compared to predicate devices.

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a "test set" in the context of human data. The testing was in vitro bench testing. The number of samples for each type of mechanical test (static/dynamic bending, torsional, eccentric dynamic fatigue) is not provided.
Data Provenance: The testing was "in vitro bench testing" performed according to ASTM F 1264-03. This implies lab-based mechanical testing, rather than data from a specific country or retrospective/prospective clinical studies on human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device relies on mechanical testing against a standard and comparison to predicate devices, not on expert-established ground truth from clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 3.

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

Not Applicable. This is a medical implant, not an AI/ML diagnostic or assistive device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. See point 5.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is established through mechanical properties standards (ASTM F 1264-03) and demonstrating equivalence to the mechanical performance of legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This device does not involve a "training set" in the context of AI/ML or statistical learning.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

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K120807+"1/

3.0		510(k) Summary
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Sponsor:	Synthes (USA)Rebecca G. BlankAssociate Regulatory Affairs Specialist1301 Goshen ParkwayWest Chester, PA 19380(610) 719-1268FAX (484) 356-9682
Date Prepared:	March 15, 2012
Device Name:	Synthes MultiLoc Humeral Nailing System
Classification:	Class II, §888.3020 – Intramedullary fixation rodProduct Code: HSB
Predicate Device:	Synthes Cannulated Titanium Humeral Nail System	(K033071)
	Synthes MultiLoc Proximal Humeral Nailing System	(K103002)
	Synthes Angular Stable Locking System [ASLS]	(K090241)
	Synthes 4.0mm and 5.0mm Locking Screws	(K000089)
	Synthes 3.5mm Locking Screws	(K000684)

Device Description:

Indications for use:

Substantial Equivalence: The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation.

The system features intramedullary nail devices, as well as bone screws and end cap accessories. The nails are cannulated, offered in 7.0mm, 8.5mm, and 10mm diameters, and are available in 180mm -315mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5mm MultiLoc Screws, used to facilitate the proximal locking of the nail construct, can be interlocked with cleared Synthes 3.5mm Locking Screws to enhance the stability of the construct.

Information presented supports substantial equivalence of the Synthes MultiLoc Humeral Nail to the predicate devices. The proposed system has the same indications for use, is similar in design, incorporates the same fundamental product technology and is composed of the same materials.

To additionally support substantial equivalence, testing comparing the bending strength of the subject and predicate devices was performed according to ASTM F 1264-03. In vitro bench testing included static and dynamic 4-point bending, torsional strength, and eccentric dynamic fatigue strength of the construct, compared to the predicate devices. Results support substantial equivalence.

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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

Synthes (USA) % Ms. Rebecca Blank Associate Regulatory Affairs Specialist 1301 Goshen Parkway West Chester, Pennsylvania 19380

6 2012 JUL

Re: K120807

Trade/Device Name: Synthes MultiLoc Humeral Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: June 5, 2012 Received: June 6, 2012

Dear Ms. Blank:

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. Rebecca Blank

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

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):

Device Name: Synthes MultiLoc Humeral Nailing System

Indications for Use:

Humeral Nailing S ystem is indicated for fractures of the proximal The Synthes MultiLoc humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral frac tures with diaphy seal extension, di aphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Co unter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Asof

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

K120807 510(k) Number

Regulation Number and Section

§ 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.