(283 days)
The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.
The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138.
The provided text is a 510(k) summary for the Sonoma Fifth Metatarsal Repair System, an intramedullary fixation rod. It describes the device, its intended use, and its substantial equivalence to a predicate device (K032548 IP-XS Compression Nail).
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured?) | Reported Device Performance (Result) |
|---|---|
| Cyclic fatigue strength | Confirmed that the subject rods are equivalent to the predicate device in cyclic fatigue testing within a clinically relevant fracture model. |
| Static fatigue strength | Confirmed that the subject rods are equivalent to the predicate device in static fatigue testing within a clinically relevant fracture model. |
| Fixation during insertion | Demonstrated adequate fixation during insertion. |
| Fixation over time | Demonstrated adequate fixation over time. |
| Pyrogenicity | The Sonoma Fifth Metatarsal Repair System meets the pyrogen limit specifications. |
| Material composition | The implants are composed of 316 stainless steel per ASTM F138, which is the same material as the predicate device (IP-XS Nails K032548). |
| Device dimensions | The dimensions of the subject device are within the range of the predicate device. |
| Compressive end cap | The subject device utilizes a compressive end cap similar to the predicate IP-XS nail. |
2. Sample size used for the test set and the data provenance
The document states "Engineering analysis and mechanical testing in a clinically relevant fracture model." However, it does not specify the sample size for these tests.
The data provenance is also not explicitly stated beyond being "engineering analysis and mechanical testing." It's typically laboratory-based testing rather than patient data for this type of device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is mechanical and engineering-based, not clinical interpretation requiring expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the testing is mechanical and comparative to a predicate device, not interpretative and requiring adjudication.
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
An MRMC comparative effectiveness study was not performed. This device is an orthopedic implant, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance testing appears to be based on established engineering standards and comparisons to the performance of a predicate device. For instance, material composition is verified against ASTM F138, and mechanical properties are compared to the predicate's known performance.
8. The sample size for the training set
This information is not applicable as the device is an intramedullary fixation rod, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Sonoma Orthopedic Products, Inc. % Dawn Norman Executive Vice President MRC-X, LLC 6075 Poplar Avenue Suite 500 Memphis, Tennessee 38119
Re: K161371
Trade/Device Name: Sonoma Fifth Metatarsal Repair System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: January 26, 2017 Received: January 27, 2017
Dear Ms. Norman:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Vincent J. Devlin -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161371
Device Name
Sonoma Fifth Metatarsal Repair System
Indications for Use (Describe)
The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures of the fifth metatarsal, including Jones, avulsion and shaft fractures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K161371
510(k) Summary
Sonoma Fifth Metatarsal Repair System February 24, 2017
| Company: | Sonoma Orthopedics Products, Inc.1388 Busch ParkwayBuffalo Grove, IL 60089Phone: 707-526-1335Fax: 707-526-2022 | |
|---|---|---|
| Establishment Registration: | 3007038372 | |
| Primary Contact: | Dawn Norman, MSExec. Vice PresidentMRC-X, LLC6075 Poplar Avenue, Suite 500Memphis, TN, 38119, USAPhone: 618-604-3064Fax: 707-526-2022 | |
| Company/Secondary Contact: | Kyle LappinSonoma Orthopedics Products, Inc.1388 Busch ParkwayBuffalo Grove, IL 60089Phone: 707-526-1335Fax: 707-526-2022 | |
| Trade Name: | Sonoma Fifth Metatarsal Repair System | |
| Common Name: | Rod, Fixation, Intramedullary and Accessories | |
| Classification: | Class II | |
| Classification Name: | Intramedullary fixation rod |
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| Panel: | 87 - Orthopedic |
|---|---|
| Product Code: | HSB |
| Predicate Device: | K032548 IP-XS Compression Nail |
| Device Description: | The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion, and shaft fractures. The Fifth Metatarsal Repair System includes the Sonoma Fifth Metatarsal Nail, End Caps and related instruments. Sonoma's Fifth Metatarsal Nail differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the distal end of the rod to supplement distal fixation without the use of screws, threads or K-wires. The implants are composed of 316 stainless steel per ASTM F138. |
| Indications for Use: | The Sonoma Fifth Metatarsal Repair System is intended for use in the fixation of fractures and osteotomies of the fifth metatarsal, including Jones, avulsion and shaft fractures. |
| Substantial Equivalence: | The intended use of the subject device is substantially equivalent to the predicate device. The indications for use for the subject |
- device are limited to the fifth metatarsal as opposed to additional anatomic locations indicated for the predicate device. The material of the subject device is the same as the IP-XS Nails (K032548). The dimensions of the subject device are within the range of the predicate device. The subject device utilizes a compressive end cap similar to the predicate IP-XS nail. Thus, the subject device is substantially equivalent to the predicate device.
- Performance Testing: Engineering analysis and mechanical testing in a clinically relevant fracture model confirmed that the subject rods are equivalent to the predicate device in cyclic and static fatigue testing. Additional testing was performed demonstrating adequate fixation both during insertion and over time. The Sonoma Fifth Metatarsal Repair System meets the pyrogen limit specifications.
§ 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.