(104 days)
The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures.
The Sonoma Fibula Repair System includes all implants and instruments required for the fixation of fibula fractures. The Fibula Repair System includes the Sonoma Fibula Rod, Sonoma Bone Screws, End Cap and related instruments. Sonoma's Fibula Rod differs from traditional nails or rods as it utilizes Sonoma's ActivLoc® fixation gripper system at the proximal end of the rod to allow for proximal fixation without the use of screws. The implants are composed of 316 stainless steel per ASTM F138.
The provided text describes the Sonoma Fibula Repair System, a medical device for fibula fracture fixation. It is a 510(k) premarket notification, which means it demonstrates substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness. Therefore, the information provided focuses on comparative performance rather than a standalone clinical study with detailed acceptance criteria and expert reviews, as would be typical for an AI/CADe device.
Based on the provided document, here's an analysis of the "acceptance criteria" and "study" as they relate to this specific device (a hardware implant):
1. Table of Acceptance Criteria and Reported Device Performance:
For a hardware implant like the Sonoma Fibula Repair System, "acceptance criteria" are generally based on mechanical performance standards to ensure the device is at least as safe and effective as existing predicate devices.
| Acceptance Criterion (Established by ASTM F1264-03(07) standards and comparison to predicate) | Reported Device Performance (Sonoma Fibula Repair System) |
|---|---|
| Mechanical Performance Equivalent to Predicate Acumed Rods: | Equivalent to predicate Acumed rods. |
| Cyclic Bending Fatigue | Confirmed equivalent |
| Static Bending | Confirmed equivalent |
| Static Torsion | Confirmed equivalent |
| Material Composition: 316 Stainless Steel per ASTM F138 | Implants composed of 316 stainless steel per ASTM F138 |
| Dimensions (proximal/distal diameter, lateral bend, length, screw orientation, screw placement): Within range of predicate devices | Dimensions are within the range of the predicate devices. Differences noted (e.g., 2.7 mm vs 3.5 mm distal screws, 3 vs 2 distal screws) did not affect substantial equivalence according to the performance testing. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of devices. The "test set" in this context refers to the physical devices (Sonoma Fibula Repair System) that underwent mechanical testing. Standard testing typically involves a sufficient number of samples to achieve statistical confidence in the results according to the ASTM standard, but the exact count isn't provided.
- Data Provenance: The testing was "engineering analysis and mechanical testing." This indicates in-vitro laboratory testing, not human or animal data. The country of origin of the data is implied to be within the US, given the FDA submission. It is prospective testing on newly manufactured devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Ground Truth for Mechanical Testing: For mechanical testing of an implant, the "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM F1264-03(07)) and comparison to the known performance of predicate devices. There wouldn't be "experts" establishing ground truth in the sense of clinical experts for interpretation of images or patient outcomes. The experts involved would be engineers and material scientists developing, conducting, and interpreting the mechanical tests according to established protocols.
- Qualifications: While not explicitly detailed, such testing would be overseen by qualified engineers with expertise in biomedical engineering, materials science, and mechanical testing, likely adhering to good laboratory practices.
4. Adjudication Method for the Test Set:
- Adjudication: Not applicable in the context of mechanical testing of devices. Adjudication methods like "2+1" typically apply to clinical studies where human readers interpret data or images. The "adjudication" here is the pass/fail criteria defined by the ASTM standards and the demonstration of equivalence to predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No MRMC Study: An MRMC comparative effectiveness study is not applicable as this is a physical implant, not an AI or imaging-based diagnostic/interpretive device. Therefore, there's no mention of human readers or AI assistance.
6. If a Standalone (Algorithm Only) Performance Study was Done:
- No Standalone Study (Algorithm): This device is a physical implant, not an algorithm or software. Therefore, an algorithm-only standalone performance study is not relevant or performed.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- Mechanical Performance Data: The ground truth for the device's mechanical performance is established by the results of standardized engineering tests (cyclic bending fatigue, static bending, static torsion) and direct comparison of these results to those of the predicate devices.
- Material Composition Standards: ASTM F138 for 316 stainless steel.
- Design Specifications: Comparison of dimensions and design features against predicate devices.
8. The Sample Size for the Training Set:
- Training Set (Not Applicable): This concept is specific to machine learning/AI algorithms. For a physical medical device, there isn't a "training set" in this sense. The design and manufacturing process are informed by engineering principles, material science, and the existing predicate device designs.
9. How the Ground Truth for the Training Set Was Established:
- Training Set (Not Applicable): As there is no "training set" in the AI sense, this question does not apply. The design of the Sonoma Fibula Repair System is informed by the principles proven by the predicate devices and established biomechanical understanding of fibula fixation.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2015
Sonoma Orthopedics Products, Incorporated % Ms. Dawn Norman Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlette, Tennessee 38133
Re: K142945
Trade/Device Name: Sonoma Fibula Repair System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: October 25, 2014 Received: October 28, 2014
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
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Page 2 - Ms. Dawn Norman
(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/Resourcesfor You/Industry/default.htm. 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 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.
Lori A. Wiggins -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Sonoma Fibula Repair System
Indications for Use (Describe)
The Sonoma Fibula Repair System is intended for use in the fixation of fibula 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Sonoma Fibula Repair System October 9, 2014
| Company: | Sonoma Orthopedics Products, Inc1388 Busch ParkwayBuffalo Grove, IL 60089 |
|---|---|
| Phone: | 707-526-1335 |
| Fax: | 707-526-2022 |
Establishment 3007038372 Registration:
- Primary Contact: Dawn Norman, MS Managing Partner Memphis Regulatory Consulting, LLC 3416 Roxee Run Cove Bartlett, TN 38133, USA Phone: 618-604-3064 Fax: 707-526-2022
Company/Secondary Contact:
Kyle Lappin
Sonoma Orthopedics Products, Inc 1388 Busch Parkway Buffalo Grove, IL 60089 Phone: 707-526-1335 Fax: 707-526-2022
| Trade Name: | Sonoma Fibula Repair System | |
|---|---|---|
| Common Name: | Rod, Fixation, Intramedullary and Accessories | |
| Classification: | Class II | |
| Regulation Number: | 888.3020 | |
| Panel: | 87- Orthopedic | |
| Product Code: | HSB | |
| Predicate Devices: | K071994 Acumed Small Bone Locking Rod System IIK031438 Acumed Small Bone Locking Rod System II | |
| Device Description: | The Sonoma Fibula Repair System includes all implants andinstruments required for the fixation of fibula fractures. The FibulaRepair System includes the Sonoma Fibula Rod, Sonoma BoneScrews, End Cap and related instruments. Sonoma's Fibula Roddiffers from traditional nails or rods as it utilizes Sonoma'sActivLoc® fixation gripper system at the proximal end of the rodto allow for proximal fixation without the use of screws. Theimplants are composed of 316 stainless steel per ASTM F138. | |
| Indications for Use: | The Sonoma Fibula Repair System is intended for use in thefixation of fibula fractures. | |
| Substantial Equivalence: | The intended use of the subject device is the same as the predicatedevices. The indications for use for the subject device is limited tothe fibula as opposed to additional anatomical locations for thepredicate devices. The material of the subject device is the sameas the Acumed Small Bone Locking Rod System (K071994). Thedimensions of the subject device are within the range of thepredicate devices for proximal and distal diameter, lateral bend,length, screw orientation, and placement of screws from the end ofthe rod. The subject device utilizes 2.7 mm diameter distal screwsas opposed to 3.5 mm diameter distal screws. The subject devicesuse three (3) distal screws as opposed to two (2) distal screws.Thus, the subject device is substantially equivalent to the predicatedevices. | |
| Performance Testing: | Engineering analysis and mechanical testing according to ASTMF1264-03(07) confirmed that the subject rods are equivalent topredicate Acumed rods in cyclic bending fatigue, static bendingand static torsion. |
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§ 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.