(104 days)
Not Found
No
The description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as "intended for use in the fixation of fibula fractures" and includes implants and instruments for this purpose, indicating it is used to treat or stabilize a medical condition.
No
The device is described as a "Fibula Repair System" intended for "fixation of fibula fractures," which indicates a therapeutic or reparative function, not a diagnostic one.
No
The device description explicitly states that the system includes implants and instruments, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the fixation of fibula fractures." This describes a surgical procedure to repair a broken bone.
- Device Description: The device is a system of implants (rod, screws, end cap) and instruments used for surgical fixation.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests.
The Sonoma Fibula Repair System is a surgical implant/device used directly in the body for structural support and repair.
N/A
Intended Use / Indications for Use
The Sonoma Fibula Repair System is intended for use in the fixation of fibula fractures.
Product codes
HSB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fibula
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis and mechanical testing according to ASTM F1264-03(07) confirmed that the subject rods are equivalent to predicate Acumed rods in cyclic bending fatigue, static bending and static torsion.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K071994 Acumed Small Bone Locking Rod System II, K031438 Acumed Small Bone Locking Rod System II
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol.
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, Inc
1388 Busch Parkway
Buffalo 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 II | |
| K031438 Acumed Small Bone Locking Rod System II | ||
| Device Description: | 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. | ||
| Indications for Use: | The Sonoma Fibula Repair System is intended for use in the | |
| fixation of fibula fractures. | ||
| Substantial Equivalence: | The intended use of the subject device is the same as the predicate | |
| devices. The indications for use for the subject device is limited to | ||
| the fibula as opposed to additional anatomical locations for the | ||
| predicate devices. The material of the subject device is the same | ||
| as the Acumed Small Bone Locking Rod System (K071994). The | ||
| dimensions of the subject device are within the range of the | ||
| predicate devices for proximal and distal diameter, lateral bend, | ||
| length, screw orientation, and placement of screws from the end of | ||
| the rod. The subject device utilizes 2.7 mm diameter distal screws | ||
| as opposed to 3.5 mm diameter distal screws. The subject devices | ||
| use three (3) distal screws as opposed to two (2) distal screws. | ||
| Thus, the subject device is substantially equivalent to the predicate | ||
| devices. | ||
| Performance Testing: | Engineering analysis and mechanical testing according to ASTM | |
| F1264-03(07) confirmed that the subject rods are equivalent to | ||
| predicate Acumed rods in cyclic bending fatigue, static bending | ||
| and static torsion. |
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