(362 days)
Not Found
No
The document mentions a "web-based software" component that assists the physician in adjusting struts by creating a patient adjustment schedule. However, it does not mention any AI, ML, or deep learning technologies being used in this software. The performance studies focus on mechanical testing and general software validation, not on the performance metrics typically associated with AI/ML models.
Yes.
The device is intended to treat various medical conditions, including post-traumatic joint contracture, fractures, pseudoarthrosis, and limb lengthening, which are therapeutic applications.
No
The device is an external fixation system used for fracture fixation, limb lengthening, and correction of deformities. It is a treatment device, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (rings, plates, struts, wires, etc.) in addition to the web-based software. While the software is a component, the system as a whole is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving bone fixation, limb lengthening, deformity correction, and joint arthrodesis. These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The device is described as a "multilateral external fixation system" with components like rings, struts, wires, and pins. These are all physical components designed to be applied externally to the body to stabilize bones.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information. The software component is described as assisting the physician in adjusting the struts, not in analyzing patient data for diagnostic purposes.
Therefore, the Smith & Nephew Circular Fixation system falls under the category of a surgical device or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Circular Fixation system is intended to be used for the following indications:
- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
- Open and closed fracture fixation .
- Pseudoarthrosis of long bones .
- Limb lengthening by epiphyseal or metaphyseal distraction .
- Correction of bony or soft tissue deformities ●
- Correction of bony or soft tissue defects .
- Joint arthrodesis ●
- Infected fractures or nonunions .
Components in the Smith & Nephew Circular Fixation System are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
KTT, OSN
Device Description
Subject of this Traditional 510(k) premarket notification is the Smith & Nephew Circular Fixation System. The subject device is a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. The Circular Fixation system can also be used with a software component that is designed to be used to assist the physician in adjusting the six struts by creating a patient adjustment schedule. Components of this premarket notification include the following:
- Full, half, 2/3 and foot rings manufactured from aluminum material. .
- . U-plates manufactured from aluminum material.
- Adjustable struts manufactured from aluminum material .
- . Drill tip wires manufactured from stainless steel material
- Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
- . Disc clips manufactured from polycarbonate material
- Half pin caps manufactured from PVC material
- . Web-based software
The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones
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)
A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure. In addition, software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. The results of the testing indicate that the software will perform as intended. The following mechanical and software testing of the Circular Fixation System was performed:
- . Cutting Performance Evaluation of Drill Tip Wires
- Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin . Connector Post
- . Mechanical Evaluation of the Pin Connector Assembly
- . Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt
- . Mechanical Evaluation of the ControlFx Strut
- Software Installation Qualification Protocol ●
- Software Operational Qualification Protocol .
- . Software Performance Qualification Protocol
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
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.
K870961, K962808, K970748, K994143, K072212, K090675
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
§ 888.3030 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
We are smith&nephew
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | September 27, 2010 |
| Contact Person and Address: | Shereen Myers, Regulatory Affairs Specialist
T (901) 399-6325 F (901) 566-7075 |
| Name of Device: | Smith & Nephew, Inc. Circular Fixation System |
| Common Name: | Multilateral Fixators and Accessories |
| Device Classification Name and
Reference: | 21 CFR 888.3030, Single/multiple component metallic bone
fixation appliances and accessories. |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT, OSN |
Device Description
Subject of this Traditional 510(k) premarket notification is the Smith & Nephew Circular Fixation System. The subject device is a multilateral external fixation system that is intended for fracture fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone. The Circular Fixation system can also be used with a software component that is designed to be used to assist the physician in adjusting the six struts by creating a patient adjustment schedule. Components of this premarket notification include the following:
- Full, half, 2/3 and foot rings manufactured from aluminum material. .
- . U-plates manufactured from aluminum material.
- Adjustable struts manufactured from aluminum material .
- . Drill tip wires manufactured from stainless steel material
- Accessory components such as rancho cubes, ring connectors, nuts, bolts and centering . sleeves manufactured from stainless steel material
- . Disc clips manufactured from polycarbonate material
- Half pin caps manufactured from PVC material �
- . Web-based software
The Circular Fixation System can also be used with other existing Smith and Nephew, Inc external fixation components.
Technological Characteristics
A review of the mechanical data indicates that the hardware components of the Circular Fixation System are capable of withstanding expected in vivo loading without failure. In addition, software verification and validation testing was completed in line with FDA's guidance document entitled, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," dated January 11, 2002. The results of the testing indicate that the software will perform as intended. The following mechanical and software testing of the Circular Fixation System was performed:
1
- . Cutting Performance Evaluation of Drill Tip Wires
- Evaluation of the maximum Tightening Torque of the Pin Connector Hinge and the Pin . Connector Post
- . Mechanical Evaluation of the Pin Connector Assembly
- . Evaluation of the Wire Pull-Out Force and Maximum Threading Torque of the Combo Wire Fixation Bolt
- . Mechanical Evaluation of the ControlFx Strut
- Software Installation Qualification Protocol ●
- Software Operational Qualification Protocol .
- . Software Performance Qualification Protocol
A review of this testing has demonstrated that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Intended Use
The Smith & Nephew Circular Fixation System is intended to be used for post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; open and closed fracture fixation; pseudoarthrosis of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of bony or soft tissue defects; joint arthrodesis; infected fractures or nonunions. Components in the Smith & Nephew Circular Fixation System are for single use only.
Substantial Equivalence Information
The substantial equivalence of the Circular Fixation System is based on its similarities in indications for use, design features, operational principles, and materials to the following predicate systems:
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------|---------------------------------------------------|----------------------|----------------|
| Smith & Nephew | Illizarov (Richards) External Fixation
System | K870961 | 03-19-1987 |
| Smith & Nephew | Illizarov External Fixation System | K962808 | 08-19-1996 |
| Smith & Nephew | Taylor Spatial Frame | K970748 | 05-09-1997 |
| Smith & Nephew | External Fixation System | K994143 | 02-18-2000 |
| Smith & Nephew | Jet-X Bar System Clamps, Bar and
Posts | K072212 | 03-07-2008 |
| Smith & Nephew | VLP Foot Plating, Screw system and
Accessories | K090675 | 06-04-2009 |
Conclusion
As previously noted, this Traditional Premarket Notification is being submitted to request clearance for the Circular Fixation system. Based on the similarities to the predicate components and a review of the mechanical and software testing performed, the devices are substantially equivalent to above predicate external fixation systems.
2
Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. 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 of the bird. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew Endoscopy, Inc. % Ms. Shereen Myers Regulatory Affairs Specialist 1450 E Brooks Road -Memphis, TN 38116
SEP 2 7 2010
Re: K093047
Trade/Device Name: Smith & Nephew Circular Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: August 13, 2010 Received: August 13, 2010
Dear Ms. Myers:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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
3
Page 2 - Ms. Shereen Myers
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as settonic device-related adverse events) (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (1580) html (2011) (1) ================================================ If you desire specific advice tor your device of to allothers/ucm II 1589.htm for a go to http://www.lda.gov/About/DA/CentersOft of CDRH's) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH) stocket natifiestion" (21C the Center for Devices and Radional by reference to premarket notification" (21 CFR Pat
note the regulation entitled, "Misbranding by reference to verder the MDP regulation ( note the regulation entitled, "Miscanding of reference wents under the MDR regulation (21 CFR Part 803), please go to
CFR Part 803), please go to Illip.77www.ida.gov.riednetrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may oftain other general information on your respected at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
(800) 038-2041 of (501) 770 7100 er artistics of You/Industry/default.htm.
Sincerely yours,
Mark McMillan
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Premarket Notification Indications for Use Statement
SEP 2 7 2010
510(k) Number (if known): K093047
Device Name: Smith & Nephew Circular Fixation System
Indications for Use:
The Smith & Nephew Circular Fixation system is intended to be used for the following indications:
- Post-traumatic joint contracture which has resulted in loss of range of motion .
- Fractures and disease which generally may result in joint contractures or loss of . range of motion and fractures requiring distraction
- Open and closed fracture fixation .
- Pseudoarthrosis of long bones .
- Limb lengthening by epiphyseal or metaphyseal distraction .
- Correction of bony or soft tissue deformities ●
- Correction of bony or soft tissue defects .
- Joint arthrodesis ●
- Infected fractures or nonunions .
Components in the Smith & Nephew Circular Fixation System are for single use only.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801.109) |
AND/OR
| Over-the-Counter Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
(PLEASE DO NOT WRITE BELOW THIS LINE ~ CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Srutu for mxm
(Division Sign Off)
Division of Surgical rthonedic and Restorative Devic
510(k) Number: K093047
4-1