(276 days)
Not Found
No
The device description focuses on mechanical and ultrasonic technology for fracture fixation, with no mention of AI or ML algorithms for analysis, decision-making, or image processing. The feedback mechanism is a simple force sensor and audible tone, not indicative of AI/ML.
Yes
The device is intended to treat shaft fractures of the ulna, impending pathological fractures, malunions, and nonunions, which falls under the definition of a therapeutic device as it is used to treat a disease, injury, or other condition.
No
The device is an orthopedic implant system and associated tools designed to treat ulna fractures, not diagnose them.
No
The device description clearly outlines hardware components including intramedullary nails, end caps, locking tacks, an ultrasonic generator, and a handpiece. The performance studies also detail testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat bone fractures (ulna shaft fractures, impending pathological fractures, malunions, and nonunions). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an intramedullary nail system designed to stabilize bone fractures. It involves implants (nails and tacks) and an ultrasonic generator for fixation. This is a surgical device used for internal fixation.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
This device does not perform any tests on samples taken from the body. It is a surgical implant and associated tools used to treat a physical condition within the body.
N/A
Intended Use / Indications for Use
The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of the ulna, impending pathological fractures, malunions, and nonunions.
Product codes (comma separated list FDA assigned to the subject device)
HSB
Device Description
The Synthes Synsonic Ulna Nail System consists of intramedullary nails with end caps and locking tacks designed to treat fractures of the ulna. The system makes use of an ultrasonic generator to deliver energy through a handpiece to securely fasten the locking tacks to the surface of the nail. The handpiece features a force sensor mechanism that provides feedback to the surgeon on the amount of load applied to the locking tack. An audible tone indicates when the correct pressure range is achieved to allow fixation of the tack to the nail.
The ulnar nail and locking tack implants are composed of PEEK-Optima® polymer material and implant grade stainless steel. Locking of the tack to the nail creates a fixed angle construct that provides rotational alignment,torsional stability and axial control of the fractured ulna.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ulna
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)
Bench testing was conducted on the subject device construct to support substantial equivalence to the predicate devices including:
Static Cantilever Bend Testing
Cyclic Torsion Testing
Tack Removal Testing
Nail Removal Testing
Design verification testing was conducted as part of the risk analysis to ensure the safe use of the subject device. This testing included:
Thermal Profile Testing: Conducted to analyze temperatures induced by the welding cycle and compared to criteria for thermal bone injury documented in clinical literature.
The ultrasonic generator, handpiece, and footswitch components the proposed Synsonic Ulna Nail System were evaluated for electrical safety in accordance with the IEC 60601-1.
The testing evaluated all of the components of proposed system, including the Synthes Synsonic Ultrasonic Generator, Handpiece, and Footswitch.
The results of the bench testing indicate that the performance of the proposed Synsonic Ulna Nail System support its substantial equivalence to the predicate devices and will present no new issues with regard to safety or effectiveness. Additionally, the results of the safety tests conducted on the subject system met the established criteria and conform to the requirements of the relevant standards.
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.
Synthes Titanium Elastic Intramedullary Nail System (K042135), Synthes Olecranon Osteotomy Nail System (K073402), Bonutti Research, Inc. Unity Ultrasonic System (K090175)
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.
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Image /page/0/Picture/2 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a stylized image inside. A small trademark symbol is located to the right of the word.
MAR 3 1 2014
6.0 - 510(k) Summary
Date Prepared: June 28, 2013
| Sponsor: | Synthes
Angela F. Lassandro
1301 Goshen Parkway
West Chester, PA 19380
Office: (610) 719-6854
Fax: (484)-356-9682 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proprietary
Name: | Synthes Synsonic Ulna Nail System |
| Classification: | Classification: 888.3020
Product Code: HSB |
| Predicate
Device: | Synthes Titanium Elastic Intramedullary Nail System (K042135)
Synthes Olecranon Osteotomy Nail System (K073402)
Bonutti Research, Inc. Unity Ultrasonic System (K090175) |
| Device
Description: | The Synthes Synsonic Ulna Nail System consists of intramedullary nails with
end caps and locking tacks designed to treat fractures of the ulna. The system
makes use of an ultrasonic generator to deliver energy through a handpiece to
securely fasten the locking tacks to the surface of the nail. The handpiece
features a force sensor mechanism that provides feedback to the surgeon on
the amount of load applied to the locking tack. An audible tone indicates
when the correct pressure range is achieved to allow fixation of the tack to the
nail.
The ulnar nail and locking tack implants are composed of PEEK-Optima® polymer material and implant grade stainless steel. Locking of the tack to the nail creates a fixed angle construct that provides rotational alignment,torsional stability and axial control of the fractured ulna. |
| Indications
for Use: | The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of
the ulna, impending pathological fractures, malunions, and nonunions. |
| | The summary information presented supports the substantial equivalence of |
| Substantial | the Synthes Synsonic Ulna Nail System to the predicate devices. The |
| Equivalence: | proposed system has the same intended use, similar indications for use and |
| | employs the same technology. |
| | Bench testing was conducted on the subject device construct to support |
| | substantial equivalence to the predicate devices including: |
| | Static Cantilever Bend Testing |
| | Cyclic Torsion Testing |
| | Tack Removal Testing |
| | Nail Removal Testing |
| | Design verification testing was conducted as part of the risk analysis to ensure
the safe use of the subject device. This testing included: |
| | Thermal Profile Testing: Conducted to analyze temperatures induced
by the welding cycle and compared to criteria for thermal bone injury
documented in clinical literature. |
| | The ultrasonic generator, handpiece, and footswitch components the proposed
Synsonic Ulna Nail System were evaluated for electrical safety in accordance
with the IEC 60601-1. |
| | The testing evaluated all of the components of proposed system, including the
Synthes Synsonic Ultrasonic Generator, Handpiece, and Footswitch. |
| | The results of the bench testing indicate that the performance of the proposed
Synsonic Ulna Nail System support its substantial equivalence to the
predicate devices and will present no new issues with regard to safety or
effectiveness. Additionally, the results of the safety tests conducted on the
subject system met the established criteria and conform to the requirements of
the relevant standards. |
| | |
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Image /page/1/Picture/2 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a stylized design. A registered trademark symbol is located to the upper right of the word "SYNTHES".
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Public Health Service
ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 31, 2014
Synthes Ms. Angela F. Lassandro Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K131984
Trade/Device Name: Synthes Synsonic Ulna Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: March 7, 2014 Received: March 10, 2014
Dear Ms. Lassandro:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Angela F. Lassandro
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/Medica|Devices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Lori A. Wiggins
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 - Indications for Use Statement
K131984 510(k) Number (if known):
Device Name: Synthes Synsonic Ulna Nail System
Indications for Use:
The Synthes Synsonic Ulna Nail System is intended to treat shaft fractures of the ulna. impending pathological fractures, malunions, and nonunions.
Prescription Use _ X (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Casey L. Hanley, Ph.D.
Division of Orthopedic Devices