(257 days)
Not Found
No
The summary describes a mechanical orthopedic implant and does not mention any software, image processing, AI, or ML capabilities.
No
A therapeutic device is one that treats a disease or condition. This device repairs a fracture which is a mechanical fix for an injury, not a treatment for a disease or condition as typically defined for therapeutic devices.
No
The document describes the Sonoma CWG Clavicle fracture repair device as an intramedullary fixation device used to repair fractures. This indicates it is a therapeutic device used for treatment, not a diagnostic device used for identifying or characterizing a disease or condition.
No
The device description explicitly states it is a physical intramedullary fixation device made of 316L SS, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair an acute fracture, mal-union or non-union of the clavicle." This describes a surgical implant used to fix a broken bone, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a "316L SS intramedullary fixation device" with internal grippers and a compression screw. This is a physical implant designed to be placed inside the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (blood, urine, tissue, etc.). There's no mention of reagents, assays, or any process for generating diagnostic information from a specimen.
This device is clearly a surgical implant used for orthopedic repair.
N/A
Intended Use / 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.
Product codes
HSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
clavicle
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Sonoma Orthopedics CMx Clavicle Pin (K081832), DePuy Rockwood Clavicle Pin (K991649)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
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510(k) Summary of Non-clinical Performance Data Specifically Conducted for Sonoma CRx CWG
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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.
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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
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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
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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)
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Shute for mxn
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100112