(160 days)
No
The summary describes a mechanical external fixation system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
This device is an external fixator used for bone stabilization and reduction of fractures, which falls under orthopedic support rather than a therapeutic device that would treat a disease or condition itself.
No
Explanation: The device is an external fixator used for bone stabilization and fracture reduction, which are therapeutic interventions, not diagnostic ones.
No
The device description explicitly lists various hardware components such as frames, bars, clamps, accessories, and instruments, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an orthopedic device used for bone stabilization in trauma and orthopedic procedures. This involves direct interaction with the patient's body for structural support and manipulation.
- Device Description: The description details a system of frames, bars, clamps, and pins designed to be physically attached to bone for fixation and manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for mechanical support and manipulation of bone.
N/A
Intended Use / Indications for Use
The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.
The indications for use include:
- intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage;
- polytrauma;
- carpal dislocations;
- unreduced fractures following conservative treatment;
- bone-loss or other reconstructive procedures;
- infection.
Product codes
KTT
Device Description
The Orthofix Galaxy Wrist is a complimentary system for the current Galaxy Fixation system, engineered specifically for the wrist. The primary objective of the Galaxy Wrist is to offer the possibility of distraction/compression and the mobilization of the joint. The device includes various frames, bars, clamps, accessories and instruments. The system is designed to be used with commercially available Orthofix pins. The clamps enable the frame to be coupled to bone by securing the pins/wires for the intended use.
The system allows the surgeon to:
- Position screws where the condition of the bone and soft tissues permits
- Reduce the fracture in order to restore alignment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
adults and pediatric patients
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)
The potential hazards have been evaluated and controlled through a Risk Management Plan.
All testing met or exceeded the requirements as established by the test protocols and applicable standards. A review of the mechanical data indicates that the components of the Subject device are capable of withstanding expected loads without failure. The Subject device was therefore found to be substantially equivalent to the Predicates. Clinical data was not needed to support the safety and effectiveness of the Subject Device.
The following mechanical testing was performed:
- ASTM F 1541 "Standard Specification and Test Methods for External Skeletal Fixation Devices"
MRI compatibility testing was also conducted per: - ASTM F2182 "Standard test method for measurement of radio frequency induced heating near passive implants during magnetic resonance imaging"
- ASTM F2213 "Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment"
- ASTM F2052 "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 8, 2014
Orthofix Srl % Ms. Cheryl Wagoner Principal Consultant Cheryl Wagoner Consulting Po Box 15729 Wilmington, North Carolina 28408
Re: K141760
Trade/Device Name: Orthofix Galaxy Wrist Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT Dated: November 3, 2014 Received: November 4, 2014
Dear Ms. Wagoner:
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
1
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/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141760
Device Name Orthofix Galaxy Wrist
Indications for Use (Describe)
The Orthofix Galaxy Wrist external fixator is an orthopedic device intended to be used for bone stabilization in trauma and orthopedic procedures, both on adults and pediatric patients as required.
The indications for use include:
- intra-articular or extra-articular fractures and dislocations of the wrist with or without soft tissue damage:
- polytrauma;
- carpal dislocations;
- unreduced fractures following conservative treatment;
- bone-loss or other reconstructive procedures:
- infection.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo for Orthofix. The logo consists of a blue abstract shape above the word "ORTHOFIX" in a bold, sans-serif font. The "R" in "ORTHOFIX" has a registered trademark symbol next to it.
| Submitter | Orthofix Srl
Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy | |
|-------------------------------------------|--------------------------------------------------------------------------------|--------------|
| Telephone | + 39 045 6719.000 | |
| Fax | + 39 045 6719.380 | |
| Contact Person | Gianluca Ricadona
Quality & Regulatory Affairs Manager | |
| Address | Via delle Nazioni, 9
37012 Bussolengo (VR) - Italy | |
| Telephone | + 39 045 6719.000 | |
| Fax | + 39 045 6719.380 | |
| email | gianlucaricadona@orthofix.com | |
| Date Prepared | November 25, 2014 | |
| Trade Name | Orthofix Galaxy Wrist | |
| Common Name | External Fixation Device and Accessories | |
| Panel Code | Orthopaedics/87 | |
| Classification Name | Single/multiple component metallic bone fixation appliances and
accessories | |
| Class | Class II | |
| Regulation Number | 21 CFR 888.3030 | |
| Product Code | KTT | |
| Device Name | 510(k) Number | Manufacturer |
| Synthes Small External
Fixation System | K963618 | Synthes |
| Device Name | 510(k) Number | Manufacturer | Description | The Orthofix Galaxy Wrist is a complimentary system for the current
Galaxy Fixation system, engineered specifically for the wrist. The
primary objective of the Galaxy Wrist is to offer the possibility of
distraction/compression and the mobilization of the joint. The device
includes various frames, bars, clamps, accessories and instruments. |
|----------------------------------------------------------------|---------------|--------------|-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Synthes Small External
Fixation System | K963618 | Synthes | | The system is designed to be used with commercially available Orthofix
pins. The clamps enable the frame to be coupled to bone by securing
the pins/wires for the intended use. |
| Stryker Hoffmann II MRI
Compact External Fixation
System | K053038 | Stryker | | |
| Orthofix Penning Dynamic
Wrist Fixator | K955848 | Orthofix | | |
| Orthofix Galaxy Fixation
system | K113770 | Orthofix | | |
4
| | The system allows the surgeon to:
- Position screws where the condition of the bone and soft tissues
permits - Reduce the fracture in order to restore alignment |
|--------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications and
Intended Use | The Orthofix Galaxy Wrist external fixator is an orthopedic device,
intended to be used for bone stabilization in trauma and orthopedic
procedures, both on adults and pediatric patients as required.
The indications for use include: - intra-articular or extra-articular fractures and dislocations of the wrist
with or without soft tissue damage; - polytrauma;
- carpal dislocations;
- unreduced fractures following conservative treatment;
- bone-loss or other reconstructive procedures;
- infection. |
| Technological
Characteristics
and Substantial
Equivalence | Documentation was provided to demonstrate that the Orthofix Galaxy
Wrist is substantially equivalent to the legally marketed Predicates. The
Galaxy Wrist is substantially equivalent to the predicate devices in
intended use, indications for use, technological characteristics, and
labeling. The Galaxy Wrist is comparable to its predicate in size, shape
and materials. |
| Performance Data | The potential hazards have been evaluated and controlled through a
Risk Management Plan.
All testing met or exceeded the requirements as established by the test
protocols and applicable standards. A review of the mechanical data
indicates that the components of the Subject device are capable of
withstanding expected loads without failure. The Subject device was
therefore found to be substantially equivalent to the Predicates. Clinical
data was not needed to support the safety and effectiveness of the
Subject Device.
The following mechanical testing was performed: - ASTM F 1541 "Standard Specification and Test Methods for
External Skeletal Fixation Devices"
MRI compatibility testing was also conducted per: - ASTM F2182 "Standard test method for measurement of radio
frequency induced heating near passive implants during magnetic
resonance imaging" - ASTM F2213 "Standard Test Method for Measurement of
Magnetically Induced Torque on Medical Devices in the Magnetic
Resonance Environment" - ASTM F2052 "Standard Test Method for Measurement of
Magnetically Induced Displacement Force on Medical Devices in
the Magnetic Resonance Environment" |
| Conclusion | Based on the indications for use, technological characteristics,
materials, and comparison to predicate devices, the Subject Orthofix
Galaxy Wrist has been shown to be substantially equivalent to legally
marketed predicate devices. |