(73 days)
No
The description focuses on a mobile app for schedule communication and adherence tracking, not on AI/ML for diagnosis, treatment planning, or image analysis. The core functionality relies on existing software, not new AI/ML algorithms.
Yes
The device is an external fixation system used for various conditions like fractures, joint contractures, limb lengthening, and deformity correction, which directly treat medical conditions.
No
The device description and intended use indicate that the Taylor Spatial Frame and its mobile app are used for treatment purposes (e.g., fracture fixation, limb lengthening, correction of deformities) by providing a treatment schedule and enabling communication. It does not mention any function for diagnosing conditions.
No
The device description explicitly states that the mobile app is an addition to the existing Taylor Spatial Frame external fixator, which is a hardware device. While the app itself is software, the overall system includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Device Description: The description clearly states that this is an external fixation system used for treating bone and soft tissue issues. It involves hardware applied externally to the body and a mobile app to manage a treatment schedule.
- Intended Use: The intended uses listed are all related to the mechanical manipulation and stabilization of bones and joints (fracture fixation, limb lengthening, deformity correction, etc.). None of these involve the examination of human specimens in vitro.
The device is a therapeutic device used for musculoskeletal treatment, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
Smith & Nephew External Fixation Systems
-
- 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 6.
-
- Correction of segmental bony or soft tissue defects
-
- Joint arthrodesis
- Infected fractures or nonunions 9.
Product codes
KTT, OSN
Device Description
The Taylor Spatial Frame Spatialframe.com V5.0 includes a mobile app which is a mobile medical device that aids in the communication between a patient/caregiver and physician. The Taylor Spatial Frame external fixator relies on existing Spatialframe.com software to generate a treatment schedule for limb restoration. The new Taylor Spatial Frame mobile app (iADJUST) will allow the prescribed schedule (currently provided in paper form) to be available and viewable to the patient on a mobile device. Feedback information related to schedule adherence will be available to the physician.
No changes to the hardware of the fixation device will result from the addition of the mobile app. No changes to the treatment schedule or core functionality of Spatialframe.com software will result from the addition of the mobile app.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, patient/caregiver
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)
Software validation has been documented to ensure that the information displayed on the mobile medical app is accurate. No other changes to the existing treatment software algorithm (spatialframe.com) are included in this submission.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human profile, composed of three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 20, 2014
Smith and Nephew, Incorporated Mr. Martin Ostmann Regulatory Affairs Specialist II 1450 Brooks Road Memphis, Tennessee 38116
Re: K142520
Trade/Device Name: Spatialframe.com V5.0 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: October 23, 2014 Received: October 27, 2014
Dear Mr. Ostmann:
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
1
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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Premarket Notification Indications for Use Statement
510(k) Number (if known): K142520
Device Name: Spatialframe.com V5.0
Indications for Use: Smith & Nephew External Fixation Systems
-
- 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 ဒေ
-
- Pseudoarthrosis of long bones
-
- Limb lengthening by epiphyseal or metaphyseal distraction
- Correction of bony or soft tissue deformities 6.
-
- Correction of segmental bony or soft tissue defects
-
- Joint arthrodesis
- Infected fractures or nonunions 9.
Prescription Use X (Part 21 CFR 801 Subpart D) 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)
Page 1 of _1
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Image /page/3/Picture/0 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are" in gray, and then "smith&nephew" in orange. The text is aligned horizontally, creating a clean and professional look.
| Submitted by: | Smith & Nephew, Inc.
Orthopaedic Division
1450 East Brooks Road
Memphis, Tennessee 38116 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------|
| Date of Summary: | October 22, 2014 |
| Contact Person and Address: | Martin Ostmann
Regulatory Affairs Specialist II
T 901-399-1809 |
| Name of Device: | Spatialframe.com V5.0 |
| Common Name: | Multilateral fixators and assemblies |
| Device Classification Name and
Reference: | 21 CFR 888.3030 Single/Multiple component metallic bone
fixation appliances and |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | KTT/OSN |
Device Description
The Taylor Spatial Frame Spatialframe.com V5.0 includes a mobile app which is a mobile medical device that aids in the communication between a patient/caregiver and physician. The Taylor Spatial Frame external fixator relies on existing Spatialframe.com software to generate a treatment schedule for limb restoration. The new Taylor Spatial Frame mobile app (iADJUST) will allow the prescribed schedule (currently provided in paper form) to be available and viewable to the patient on a mobile device. Feedback information related to schedule adherence will be available to the physician.
No changes to the hardware of the fixation device will result from the addition of the mobile app. No changes to the treatment schedule or core functionality of Spatialframe.com software will result from the addition of the mobile app.
Indications for Use
-
- 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 2. 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 segmental bony or soft tissue defects 7.
-
- Joint arthrodesis
-
- Infected fractures or nonunion
4
Technological Characteristics
Software validation has been documented to ensure that the information displayed on the mobile medical app is accurate. No other changes to the existing treatment software algorithm (spatialframe.com) are included in this submission.
Substantial Equivalence Information
The proposed mobile device in Spatalframe.com V5.0 is an extension of the existing class II Spatialframe.com software. The new software is intended to be used within the same indications for use; does not make any changes to the fundamental technology of the Taylor Spatial Frame fixation device or Spatialframe.com software; and has been fully validated to ensure that it is substantially equivalent to the existing Spatialframe.com software in performance and technological characteristics. The Taylor Spatial Frame Mobile App does not alter the intended use of the existing medical device. The new mobile app is designed only to make communication of the existing treatment plan more convenient for the patient and caregiver. The Taylor Spatial Frame mobile app is substantially equivalent to the existing Spatialframe.com software.
| Manufacturer | Description | Submission
Number | Clearance Date |
|----------------------|-----------------------------------------------------|----------------------|----------------|
| Smith & Nephew, Inc. | Spatialframe.com version 4.1
(Primary Predicate) | K110069 | 2/8/11 |
| Smith & Nephew, Inc. | Circular Fixation
(Reference Predicate) | K093047 | 9/27/10 |
Table 1: Substantially Equivalent Predicates to the Taylor Spatial Frame Mobile App
Conclusion
Spatialframe.com V 5.0 is substantially equivalent to the existing Spatialframe.com version 4.1 cleared in K110069, and the Circular Fixation medical device cleared in K093047 in that the indications for use for these devices are identical and the core technological principles for these devices are also equivalent.