(77 days)
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 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 made of Ti-6Al-4V Titanium or 316L Stainless Steel.
This document describes the premarket notification (510(k)) for the Sonoma FasTrac Clavicle Fracture Repair Device, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (from predicate equivalence) | Reported Device Performance (Sonoma FasTrac) |
|---|---|---|
| Dynamic Compression, Bending and Torsion | Equivalent to Ensplint CMx biomechanical loads in a simulated in-vivo environment. | Substantially equivalent to the Ensplint CMx under compressive, bending, and torsional loads in a simulated in-vivo environment with respect to biomechanical loads. |
| Cyclic Bending Fatigue | Equivalent to predicate Depuy Rockwood Pin under similar loading. | Substantially equivalent to the predicate Depuy Rockwood Pin when tested under similar loading. |
| Static Bending | Equivalent to predicate Depuy Rockwood Pin under similar loading. | Substantially equivalent to the predicate Depuy Rockwood Pin when tested under similar loading. |
| Static Torsion | Equivalent to predicate device (Rockwood Pin) static torsional stiffness properties under similar loading. | Substantially equivalent to the predicate device (Rockwood Pin) when tested under similar loading. |
| Indications for Use | Equivalent in size, configuration, and fixation methods to predicate devices. | Equivalent in size, configuration, and fixation methods to the predicate devices, demonstrating equivalent fixation and alignment properties. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for cyclic bending fatigue). The performance data is derived from non-clinical, empirical testing, and engineering analysis, as stated in the "Performance Data (Non clinical)" section and the "Performance Testing Summary" table headers. There is no information about data provenance in terms of country of origin or whether it's retrospective or prospective, as it's mechanical testing of physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as this is a 510(k) submission for a mechanical medical device, and the "ground truth" is established through engineering and biomechanical testing against established standards and predicate devices (e.g., ASTM F1264-03). Expert clinical opinion or medical imaging interpretation is not the primary mode of evaluation for this type of device submission.
4. Adjudication method for the test set
This information is not applicable for mechanical device testing. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert interpretation (e.g., radiology reads) to resolve discrepancies.
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
This information is not applicable. An MRMC study is relevant for diagnostic imaging AI systems where human readers interpret medical images. This 510(k) is for an intramedullary fixation device, which is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the performance evaluation of the Sonoma FasTrac device is established through:
- Mechanical requirements of ASTM F1264-03 (07): These are established industry standards for intramedullary fixation devices.
- Performance of predicate devices: The predicate devices (Ensplint CMX and Depuy Rockwood Pin) against which the Sonoma FasTrac device's performance is compared serve as the benchmark or "ground truth" for substantial equivalence.
8. The sample size for the training set
This information is not applicable. This is a physical medical device, not an AI system that requires a "training set." The device is manufactured and tested based on design specifications and material properties.
9. How the ground truth for the training set was established
This information is not applicable, as there is no "training set" in the context of this device's evaluation.
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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.
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| Test | ApplicableStandard | Protocol/ReportNumber(SonomaFastrac) | Protocol/ReportNumber (RockwoodPin and/or EnsplintCMx) | Conclusion | Equivalent |
|---|---|---|---|---|---|
| Dynamic Compression,Bending and Torsion | N/A | DVP-003-0046DVR-003-0046 | DVP/DVR-003-0013 | The Sonoma FasTracis substantiallyequivalent to theEnsplint CMx undercompressive, bendingand torsional loads ina simulated in-vivoenvironment withrespect to thebiomechanical loads. | Equivalent |
| Cyclic Bending Fatigue | ASTM F1264-03(07) | DVP-003-0044DVR-003-0044 | DVP/DVR-003-0002DVP/DVR-003-0021 | The bending fatigueproperties of thepredicate DepuyRockwood Pin and the-Sonoma FasTrac aresubstantiallyequivalent when testedunder similar loading. | Equivalent |
| Static Bending | ASTM F1264-03(07) | DVP-003-0044DVR-003-0044 | DVP/DVR-003-0001DVP/DVR-003-0022TR-003-0009TR-003-0018 | The bendingproperties of thepredicate DepuyRockwood Pin and theSonoma FasTrac aresubstantiallyequivalent when testedunder similar loading. | Equivalent |
| Static Torsion | ASTM F1264-03(07) | DVP-003-0044DVR-003-0044 | DVR-003-0008 | ||
| The static torsionalstiffness properties ofthe predicate deviceand the SonomaFasTrac aresubstantiallyequivalent when testedunder similar loading. | Equivalent | ||||
| Indications for Use | N/A | None | DVP/DVR-003-0010 | The Sonoma Fastracis equivalent in size,configuration andfixation methods to thepredicate devices andthereforedemonstratesequivalent fixation andalignment properties. | Equivalent |
Performance Testing Summar
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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
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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
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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)
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Ar m.Mellerm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111550
§ 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.