(77 days)
No
The device description and performance studies focus on the mechanical properties and equivalence to predicate devices, with no mention of AI or ML.
Yes
The device is an intramedullary fixation device intended to repair clavicle fractures, mal-unions, or non-unions, directly addressing a health condition.
No
Explanation: The device is a surgical implant designed for repairing clavicle fractures, not for diagnosing medical conditions. Its function is reparative, not diagnostic.
No
The device description explicitly states it is a physical intramedullary fixation device made of stainless steel or titanium, with specific dimensions and mechanical properties. It is 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 is a surgical intervention to fix a physical problem within the body.
- Device Description: The device is an "intramedullary fixation device" made of metal, designed to be implanted within the bone.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
This device is a surgical implant used for structural repair, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Sonoma FasTrac 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
The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
clavicle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The Sonoma FasTrac device achieved equivalent strength and fatique performance to the predicate devices. The FasTrac device is secured in place with threads on one end and a cross screw or compression screw on the opposite end. The Sonoma FasTrac meets the mechanical requirements of ASTM F1264-03. The Sonoma FasTrac Clavicle Fracture Repair Device is equivalent to the predicate devices. the Sonoma Orthopedic Products, Inc. K081832, CMX and Depuy Rockwood Pin K991649. This determination was made from empirical testing and engineering analysis. Attached is the summary table of Performance Testing. Clinical evaluation of the device is not required.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
( 114)
510(k) Summary
Submitter's name Address
Phone Number Fax Number Name of contact person Date summary was prepared
Proprietary name/Trade name
Common Name
Classification Name
Predicate Device
Description of device
Intended use of device
Comparison to Predicate Device
Performance Data (Non clinical)
K11550
Sonoma Orthopedic Products, Inc. AUG 1 9 2011 3589 Westwind Blvd. Santa Rosa, CA 95403 707-526-1335 707-526-2022 Charles L. Nelson June 30, 2011 Sonoma FasTrac Clavicle Fracture Repair Device Clavicle Pin 888.3020 Intramedullary fixation rod. Sonoma Orthopedic Products, Inc. K081832, EnsplintCMX, Depuy Rockwood Pin K991649 The Sonoma FasTrac Clavicle Fracture Repair Devices are stainless steel or titanium intramedullary fixation devices that utilize threads for fixation and a hub with cross screw. The device is available in nominal 3, 4, 5, and 6mm nominal OD and sizes 70-150mm nominal lengths. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle. The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be made of Ti-6Al-4V Titanium or 316L Stainless Steel. The Sonoma Orthopedic Products, Inc. K081832, CMX and Depuy Rockwood Pin K991649 are also made of stainless steel. The Sonoma FasTrac device achieved equivalent strength and fatique performance to the predicate devices. The FasTrac device is secured in place with threads on one end and a cross screw or compression screw on the opposite end. The Sonoma FasTrac meets the mechanical requirements of ASTM F1264-03. The Sonoma FasTrac Clavicle Fracture Repair Device is equivalent to the predicate devices. the Sonoma Orthopedic Products, Inc. K081832, CMX and Depuy Rockwood Pin K991649. This determination was made from empirical testing and engineering analysis. Attached is the summary table of Performance Testing. Clinical evaluation of the device is not required.
1
| Test | Applicable
Standard | Protocol/Report
Number
(Sonoma
Fastrac) | Protocol/Report
Number (Rockwood
Pin and/or Ensplint
CMx) | Conclusion | Equivalent |
|---------------------------------------------|------------------------|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Dynamic Compression,
Bending and Torsion | N/A | DVP-003-0046
DVR-003-0046 | DVP/DVR-003-0013 | The Sonoma FasTrac
is substantially
equivalent to the
Ensplint CMx under
compressive, bending
and torsional loads in
a simulated in-vivo
environment with
respect to the
biomechanical loads. | Equivalent |
| Cyclic Bending Fatigue | ASTM F1264-
03(07) | DVP-003-0044
DVR-003-0044 | DVP/DVR-003-0002
DVP/DVR-003-0021 | The bending fatigue
properties of the
predicate Depuy
Rockwood Pin and the-
Sonoma FasTrac are
substantially
equivalent when tested
under similar loading. | Equivalent |
| Static Bending | ASTM F1264-
03(07) | DVP-003-0044
DVR-003-0044 | DVP/DVR-003-0001
DVP/DVR-003-0022
TR-003-0009
TR-003-0018 | The bending
properties of the
predicate Depuy
Rockwood Pin and the
Sonoma FasTrac are
substantially
equivalent when tested
under similar loading. | Equivalent |
| Static Torsion | ASTM F1264-
03(07) | DVP-003-0044
DVR-003-0044 | DVR-003-0008 | | |
| | | | The static torsional
stiffness properties of
the predicate device
and the Sonoma
FasTrac are
substantially
equivalent when tested
under similar loading. | Equivalent | |
| Indications for Use | N/A | None | DVP/DVR-003-0010 | The Sonoma Fastrac
is equivalent in size,
configuration and
fixation methods to the
predicate devices and
therefore
demonstrates
equivalent fixation and
alignment properties. | Equivalent |
Performance Testing Summar
.
2
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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter. Inside the seal is a stylized symbol that resembles three overlapping human figures or abstract shapes. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MIJ 20993-0002
Sonoma Orthopedic Products. Inc. % Mr. Charles L. Nelson Chief Operating Officer 3589 Westwind Boulevard Santa Rosa, California 95403
AUG 19 2011
Re: K111550
Trade/Device Name: Sonoma FasTrac Clavicle Fracture Repair Device Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Code: HSB Dated: June 28, 2011 Received: June 29, 2011
Dear Mr. Nelson:
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
5
Page 2 - Mr. Charles L. Nelson
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 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.html 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/Reportal?roblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Page 8/54
KIIISSO
Indications for Use
510(k) Number (if known): K111550
Device Name: Sonoma FasTrac Clavicle Fracture Repair Device
INDICATIONS FOR USE
The Sonoma FasTrac 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
Ar m.Mellerm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111550