Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and also use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.

AI/ML Overview

This submission describes the Sonama CWG Clavicle Fracture Repair Device, an intramedullary fixation device for clavicle fractures. The submission leverages non-clinical performance data against predicate devices to demonstrate substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
ASTM F1264-008 (Static Bending, Torque, Cyclic Bending Fatigue)	Equivalence to predicate device Sonoma CRx WG	Demonstrated subject device (Sonoma CRx CWG) is equivalent to predicate device (Sonoma CRx WG).
In-Vitro Cyclic Fatigue Test (Proprietary)	Equivalence to predicate device Sonoma CRx WG	Demonstrated subject design (Sonoma CRx CWG) is equivalent to predicate device (Sonoma CRx WG).
Indications for Use Test (Cadaveric Torso Specimens)	Substantial equivalence to predicate device Sonoma CRx WG for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage.	Demonstrated substantial equivalence to the predicated device (Sonoma CRx WG) for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage.
Fixation Verification Test (Explanted Cadaveric Clavicle Samples)	Equivalence to predicate device Sonoma CRx WG in terms of opposing tensile force to distract the fracture greater than 2 millimeters.	Demonstrated subject design (Sonoma CRx CWG) is equivalent to the predicate device (Sonoma CRx WG).

2. Sample Size Used for the Test Set and Data Provenance

This submission relies entirely on non-clinical (in-vitro and cadaveric) testing, not on human clinical data. Therefore, there isn't a "test set" in the traditional sense of patient data.

Cadaveric Torso Specimens: The "Indications for Use Test" and "Fixation Verification Test" were performed using cadaveric torso specimens. The exact number of specimens is not specified in the provided text, but it included "one clavicle" for the predicate device and "the opposite clavicle" for the subject device within the same specimens, implying paired testing.
Data Provenance: The data provenance is internal laboratory testing and cadaveric studies. The country of origin of the data is not explicitly stated but is implied to be in the USA given the company and FDA review. The studies are prospective in their conduct within the testing environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As this is a non-clinical study, there are no human experts establishing ground truth for a patient test set. The "ground truth" is established through the physical measurement and biomechanical performance directly observed in the testing environments (e.g., force required for distraction, range of motion).

4. Adjudication Method for the Test Set

Not applicable. There is no human test set or human interpretation involved that would require an adjudication method. The outcome measures are based on direct physical measurements and observations during mechanical and cadaveric performance tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This submission focuses on the biomechanical equivalence of the device to predicate devices through non-clinical testing, not on the effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a physical intramedullary fixation rod, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for these studies is based on direct biomechanical measurements and observations in controlled laboratory and cadaveric settings. This includes:

Static bending, torque, and cyclic bending fatigue measurements against defined standards (ASTM F1264-008).
Proprietary in-vitro cyclic fatigue data.
Observations of fracture fixation and anatomical alignment in cadaveric specimens.
Measurements of tensile force required to distract fractures in explanted cadaveric bones.

The comparison is made against the performance of a legally marketed predicate device (Sonoma CRx WG), establishing the "ground truth" for acceptable performance.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device. The device is a physical medical implant, not an AI or machine learning model that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

{0}------------------------------------------------

K100112

510(k) Summary

Submitter's name

Phone Number Fax Number

Name of contact person

Date summary was prepared

Proprietarv name/Trade name

Common Name

Classification Name

Predicate Devices

Description of device

Intended use of device

Comparison to Predicate Devi ces

Performance Data (Non clinical)

Sonoma Orthopedic Products, Inc. Santa Rosa, CA 95403 707-526-1335 ext 255 707-540-6001

Carlos Gonzalez

September 28, 2010

Sonoma CWG Clavicle Fracture Repair Device

Intramedullary Fixation Device

888.3020 Intramedullary fixation rod.

Sonoma Orthopedics CMx Clavicle Pin (K081832) DePuy Rockwood Clavicle Pin (K991649)

Sonoma CWG devices are 316L SS intramedullary fixation devices that utilize internal grippers for fixation, similar to the Sonoma CMx predicate and al so use a compression screw similar to the predicate Rockwood pin, to compress the fracture. The device is available in 4 & 5mm OD and sizes 90-120mm in length.

The Sonoma CWG Clavicle Fracture Repair device is intended to be used to repair an acute fracture, mal-union or non-unio n of the clavicle.

The Sonoma CWG Fracture repair device utilizes the same materials and similar construction as the predicate Sonoma CMx Clavicle pin (2 grippers, a wavy body and a straight section to carry the biomechanical load). The CWG does not include a crossscrew (as the predicate CMx) but rather includes a compression screw, similar to the DePuy Rockwood pin to compress the fracture fragments together.

The "working" components of the Sonoma CWG are equivalent to the Sonoma predicate CMx when evaluated against ASTM F1264-03, see the list below. Clinical evaluation of the device is not required .

SEP 28 2010

{1}------------------------------------------------

510(k) Summary of Non-clinical Performance Data Specifically Conducted for Sonoma CRx CWG

ู

Tests to ASTM F1264-008

An analysis of the Sonoma CRx CWG design versus the Sonoma CRx WG was conducted for static bending, torque, and cyclic bending fatigue test. The results are described in test report DVR 003-0035. This analysis demonstrates the subject device Sonoma CRx CWG is equivalent to the predicate device Sonoma CRx WG.

In-Vitro Cyclic Fatigue Test

Sonoma Orthopedic Products, Inc created a proprietary test that simulates representative biomechanical loading. These data demonstrated the subject design, Sonoma CRx CWG, is equivalent to the predicate device, Sonoma CRx WG. Data are included in TR 003-0031.

Indications for Use Test

Comparative, bilateral fixation and anatomical alignment tests were performed in cadaveric torso specimens with the Sonoma CRx WG in one clavicle and the Sonoma CRx CWG in the opposite clavicle. These data demonstrated substantial equivalence to the predicated device, Sonoma CRx WG, for fracture fixation and anatomical alignment through pendant range of motion of the affected appendage. Data are included in DVR 003-0042.

Fixation Verification Test

The cadaveric clavicle bone samples as implanted in the Indications for Use Tests (above) were explanted and the opposing tensile force to distract the fracture greater than 2 millimeters was measured. These data demonstrated the subject design, Sonoma CRx CWG, is equivalent to the predicate device. Sonoma CRx WG. Data are included in TR 003-0037.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of a bird with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Sonoma Orthopedic Products, Inc. % Mr. Carlos Gonzalez 650 Larkfield Center, Suite C Santa Rosa, CA 95403

SEP 2 8 2010

Re: K100112

Trade/Device Name: Sonoma CWG Clavicle Fracture Repair Device Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: September 17, 2010 Received: September 20, 2010

Dear Mr. Gonzalez:

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. Ilsting 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

{3}------------------------------------------------

Page 2 - Mr. Carlos Gonzalez

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/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.

Sincerely yours,

Mark A. Wilkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): _K100112

Device Name: Sonoma CWG Clavicle Fracture Repair Device

SEP 2 8 2010

INDICATIONS FOR USE

The Sonoma CWG Clavicle fracture repair device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Shute for mxn
(Division Sign Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100112

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.