(241 days)
Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
The Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:
· Preliminary fixation before ORIF
· Unstable fractures of the distal radius (both intra- and extra-articular)
· Open and/or comminuted bilateral fractures
· Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
· Fracture dislocations
· Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
· Pediatric open fractures with bone loss and osteotomies
The Synthes Large External Fixation Systems is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
• Stabilization of soft tissues and fractures
• Poyltrauma/multiple orthopedic trauma
• Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
• Arthrodeses and osteotomies with soft tissue problems; failures of total joints
• Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
• Intra-operative reductions/stabilization tool to assist with indirect reduction
• Unilateral rectilinear bone segment transport or leg lengthening
Synthes Reprocessed External Fixation Devices consist of various clamps, rods, bars and rings which are used to construct an external fixation frames in the treatment of various types of fractures.
This document describes the acceptance criteria and study proving the "Synthes Small and Large External Fixation Systems - MR Conditional" devices meet these criteria for safe use in an MRI environment.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Parameter | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Displacement | Meets requirements in ASTM F2052 | Met the requirements |
| Torque | Meets requirements in ASTM F2213 | Met the requirements |
| RF Heating | Acceptable heating in accordance with ASTM F2182 | Shown to have acceptable heating |
| Image Artifact | Determined through testing in accordance with ASTM F2119 | Determined through testing in accordance with ASTM F2119 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (number of individual devices or configurations) used for the testing. It mentions "The devices" (plural) were tested, implying multiple units or configurations were evaluated.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The study is a performance study for medical devices in an MR environment, not a diagnostic study requiring expert ground truth for interpretation. The acceptance criteria are based on established ASTM standards for MR compatibility, which define objective, measurable physical parameters.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving subjective human interpretation of data for ground truth establishment. This study relies on objective physical measurements against predefined engineering standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is not relevant for testing the MR compatibility of physical implants. The study is focused on the physical interaction of the device with an MRI field.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was effectively done. The testing described (displacement, torque, RF heating, image artifact) evaluates the intrinsic physical properties of the devices themselves in an MRI environment, independent of human interaction or interpretation beyond setting up the test and recording measurements. There is no "algorithm" in the context of this device; it is a physical implant.
7. The Type of Ground Truth Used
The "ground truth" for this study is the set of established, quantifiable physical limits and measurement methodologies defined by the ASTM standards (ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119) for assessing MR compatibility of medical implants. The device performance is compared directly to these objective standards.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a performance study of physical devices, not a machine learning model or diagnostic algorithm.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set in this context.
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Attachment A - Updated 510(k) Summary
Date Prepared: March 4, 2013
| Sponsor: | SynthesAngela F. Lassandro1301 Goshen ParkwayWest Chester, PA 19380(610) 719-6854 |
|---|---|
| Device Name: | Synthes Small and Large External Fixation Systems - MR Conditional |
| Classification: | Classification: Class II, §888.3030, Single/multiple component metallicbone fixation appliances and accessories.Product Code: KTT |
| Predicate Device: | Synthes Small External Fixation System (K031724, K033158, K961350,K031724, K050631, K090658, K082650, K952296, K040701)Synthes Large External Fixation System (K082650, K033158, K030390,K031428, K962913, K952296, K950384, K043039, K914558) |
| Device Description: | Synthes Reprocessed External Fixation Devices consist of various clamps,rods, bars and rings which are used to construct an external fixation framesin the treatment of various types of fractures. |
| Intended Use: | Synthes External Fixation Devices are intended for use in the construction ofan external fixation frame for treatment of various fracture types that requireexternal fixation. |
| Indications for Use: | The Synthes Small External Fixation System is intended to stabilize and providetreatment for fractures of the small bones, such as the hand, wrist, forearm, foot,and ankle. Specifically, the components can be used for:· Preliminary fixation before ORIF· Unstable fractures of the distal radius (both intra- and extra-articular)· Open and/or comminuted bilateral fractures· Fractures in combination with extensive soft tissue injury, bone loss, andvascular and/or neural involvement· Fracture dislocations· Failed closed reduction with casting resulting in secondary deformity(radial shortening and angulations)· Pediatric open fractures with bone loss and osteotomies |
| The Synthes Large External Fixation Systems is intended to provide treatmentfor long bone and pelvic fractures that require external fixation. Specifically, thecomponents can be used for:• Stabilization of soft tissues and fractures• Poyltrauma/multiple orthopedic trauma• Vertically stable pelvic fractures, or as a treatment adjunct for verticallyunstable pelvic fractures• Arthrodeses and osteotomies with soft tissue problems; failures of totaljoints• Neutralization of fractures stabilized with limited internal fixation• Non-unions/septic non-unions• Intra-operative reductions/stabilization tool to assist with indirectreduction• Unilateral rectilinear bone segment transport or leg lengthening | |
| SubstantialEquivalence: | Performance testing has been completed to demonstrate the use of SynthesSmall and Large External Fixation Systems in the MR environment.Displacement and torque testing has met the requirements in ASTM F2052and ASTM F2213, respectively. The devices were shown to have acceptableheating when tested for RF Heating in accordance with ASTM F2182.Image artifact for the devices was determined through testing in accordancewith ASTM F2119. Additionally, an engineering analysis was conducted toassess mechanical strength of the Bridging Rod Component of the SynthesLarge External Fixation System. |
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.122455
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:
and the comments of the comments of the comments of
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Synthes % Angela Lassandro Regulatory Affairs Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
Letter dated: April 11, 2013
Re: K122455
Trade/Device Name: Synthes Small External Fixation System - MR Conditional, Synthes Large External Fixation System - MR Conditional Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliance and Accessories Regulatory Class: Class II Product Code: KTT Dated: March 4, 2013 Received: March 5, 2013
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
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Page 2 – Angela Lassandro
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.htm 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/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N.Melkerson-S
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 Statement
510(k) Number (if known): K122455
Device Name: Synthes Small External Fixation System - MR Conditional
Indications for Use:
The Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:
- · Preliminary fixation before ORIF
- · Unstable fractures of the distal radius (both intra- and extra-articular)
- · Open and/or comminuted bilateral fractures
- · Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement
- · Fracture dislocations
- Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)
- · Pediatric open fractures with bone loss and osteotomies
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)
Image /page/4/Picture/17 description: The image shows the name "Michael Owens" in a stylized font. The first name, "Michael," is written in a clear, bold font. The last name, "Owens," is also in bold, but the letters are stylized with decorative elements. There are some symbols between the first and last name.
Division of Orthopaedic Devices
p. 1 of 2
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Indications for Use Statement
510(k) Number (if known): K122455
Device Name: Synthes Large External Fixation System - MR Conditional
Indications for Use:
The Synthes Large External Fixation Systems is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
- · Stabilization of soft tissues and fractures
- · Poyltrauma/multiple orthopedic trauma
- · Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
- · Arthrodeses and osteotomies with soft tissue problems; failures of total joints
- · Neutralization of fractures stabilized with limited internal fixation
- · Non-unions/septic non-unions
- · Intra-operative reductions/stabilization tool to assist with indirect reduction
- · Unilateral rectilinear bone segment transport or leg lengthening
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)
Image /page/5/Picture/18 description: The image shows the name "Michael Owens" in a bold, sans-serif font. The letters are black against a white background. There is some decorative imagery between the first and last name.
Division of Orthopaedic Devices
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.