(269 days)
No
The description focuses on image processing techniques like stitching based on overlapping areas, which is a standard image processing function and does not explicitly mention or imply the use of AI or ML algorithms. The validation also focuses on functional testing rather than performance metrics typically associated with AI/ML models.
No
The device is described as software that facilitates diagnosis by stitching medical images for review, not by providing therapy or directly treating medical conditions.
No
The device description states that "Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting" and "is designed to facilitate diagnosis by easily stitching multiple medical images...from multiple captures to one image." It aids in the viewing of images for diagnosis but does not perform the diagnosis itself or produce diagnostic information from raw data.
Yes
The device description explicitly states "Smart Stitching software" and describes its function as processing existing medical images. There is no mention of hardware components being part of the device itself, only that it processes images from various sources.
Based on the provided information, it is highly likely that this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review." This describes image processing and manipulation for diagnostic review, not a test performed on biological samples.
- Device Description: The description focuses on reading, stitching, storing, and transmitting medical images. It explicitly states it "does not serve as acquisition software nor has control function for acquisition setting." This reinforces its role as a post-processing tool for existing images.
- Lack of Biological Sample Interaction: There is no mention of the device interacting with or analyzing biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Focus on Image Processing: The device's function is entirely centered around image processing and manipulation.
- Predicate and Reference Devices: The listed predicate and reference devices (Cedara I-Soft View and DR Long Length Imaging Software) are image viewing and processing software, not IVDs.
In summary, the Smart Stitching software is a medical image processing tool designed to facilitate the review of medical images. Its function does not involve the analysis of biological samples, which is the defining characteristic of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image.
Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
Mentions image processing
Yes
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
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)
No clinical testing is performed.
The complete system configuration has been assessed and tested by the manufacturer and passed all in house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by Smart Stitching Software. Each operational mode and the imaging stitching process are documented in the software validation report.
The auto stitching function and SW compatibility test have been conducted and the result demonstrated that the software functions as intended. In addition, the software validation testing ,from TS-0001 through TS-0017, verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.
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.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three parallel lines forming a wing-like shape above a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2017
OSKO, Inc. % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025
Re: K163048
Trade/Device Name: Smart Stitching Software System, Image Processing, Radiological Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 25, 2017 Received: July 26, 2017
Dear Mr. Kim:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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,
Michael D. O'Hara For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K163048
Device Name Smart Stitching Software System, Image Processing, Radiological
Indications for Use (Describe)
Smart Stitching software is indicated for use to allow postioning and joining of individual images to produce an additional composite image for two dimensional image review.
| 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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Image /page/3/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a wave or a sine wave. The graphic is composed of two curved lines that intersect in the middle, creating a symmetrical shape. The colors of the graphic are light blue and dark blue.
510(k) Summary
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: June 22, 2017
I. SUBMITTER
| Submitter's Name | OSKO, Inc. |
|---|---|
| Submitter's Address | 8085 NW 90TH ST, Medley, Florida 33166, USA |
| Submitter's Telephone | + 1 305-599-7161 |
| Contact person | Name: Thomas Kim |
| Position: Vice President | |
| E-mail: thomas@medisoneconet.com | |
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) |
| Address | 8310 Buffalo Speedway, Houston, TX 77025 |
| Telephone | +713-467-2607 |
| Fax: | +713-583-8988 |
II. DEVICE
| Trade/proprietary Name | Smart Stitching software |
|---|---|
| Common or Usual Name | System, Image Processing, Radiological |
| Regulation Name | Picture archiving and communications system |
| Regulation Number | 21 CFR 892.2050 (Product Code:LLZ) |
| Regulatory Class | Class II |
III. PREDICATE DEVICE
| Primary Manufacturer | Cedara Software Corporation |
|---|---|
| Device Name | Cedara I-Soft View |
| 510(k) Number | K022881 |
| Regulation Name | Picture archiving and communications system |
| Regulation Number | 21 CFR 892.2050 (Product Code:LLZ) |
| Regulatory Class | Class II |
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Image /page/4/Picture/0 description: The image contains the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a butterfly or a stylized plus sign, with the top and bottom portions in a darker blue and the left and right portions in a lighter blue.
IV. REFERENCE DEVICE
Primary Manufacturer Device Name
Carestream Health Inc DR Long Length Imaging Software
510(k) Number K130567 Regulation Name Regulation Number Regulatory Class Class II
Solid Stat X-ray Imager 21 CFR 892.1650 (Product Code:MQB)
V. DEVICE DESCRIPTION
Smart Stitching provides a function to read multiple medical images at one time by stitching them to one image based on overlapping areas. It supports DICOM 3.0 which is standard of medical image format as well as Tiff and Raw images. It provides additional functions such as image retrieval, storage, and transmission. Smart Stitching is designed to facilitate diagnosis by easily stitching multiple medical images, up to 5 images, from multiple captures to one image.
Smart Stitching software does not serve as acquisition software nor has control function for acquisition setting.
VI. INDICATIONS FOR USE:
Smart Stitching software is indicated for use to allow post-capture positioning and joining of individual images to produce an additional composite image for two dimensional image review.
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Image /page/5/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, sans-serif font, with the letters in a dark blue color. To the right of the word "OSKO" is a stylized graphic that resembles a butterfly or a stylized "X". The graphic is composed of two curved shapes, one in a darker shade of blue and the other in a lighter shade of blue, creating a sense of depth and movement.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
| Feature | New Device
Smart Stitching
K163048 | Reference Device
DR Long Length
Imaging Software
K130567 | Predicate Device
Ceara I-SoftView
K022881 |
|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | OSKO, Inc. | Carestream Health
Inc. | Cedara Software |
| Intended Use | Smart Stitching
software is indicated
for use to allow post-
capture positioning
and joining of
individual images to
produce an additional
composite image for
two dimensional
image review. | The software intended
use is to allow post-
capture positioning
and joining of
individual images to
produce an additional
composite image. The
software is sold only
for use on Carestream
Health System
solutions and is
available as an
integrated feature
within the DirectView
software | "Two and three dimensional
image review, manipulation,
analysis and therapy planning
capabilities that support
image management display
needs in the medical
environment from multiple
locations within and outside
the hospital"
"Productivity-Enhancing
Second Console Workstations
- Workstations designed to
perform automated, routine
tasks such as image review,
printing and archiving
as well as post processing
capabilities that enable
special services for referring
physicians."
"Diagnostic Review
Workstations - Workstations
designed to assist radiologists
and surgeons in conducting
primary diagnostic review
and planning through
flexible and interactive
manipulation of multi-
modality softcopy images.
This includes the use of
prosthetic template overlays"
"Physician's Review
Workstations - Workstations
designed to give easy and
economic access to multi-
modality softcopy images in
multiple locations within |
| | | | and outside the hospital. (e.g.
teleconferencing,
teleradiology etc.)" |
| How to store
patient data an
diagnostic
documents | Be comprised of a
central database to store
patient data and
diagnostic documents | Be comprised of a
central database to
store patient data and
diagnostic documents | Be comprised of a central
database to store patient data
and diagnostic documents |
| Type of image
format | Tiff, Raw, and DICOM
file | DICOM file | DICOM file |
| Ability to
provide the
management,
storage and
processing and
display of
patient,
diagnostic
image data | Provide the
management, storage
and processing and
display of patient,
diagnostic image data | Provide the
management, storage
and processing and
display of patient,
diagnostic image data | Provide the management,
storage and processing and
display of patient, diagnostic
image data |
| Function to
enhance image
brightness,
contrast and
sharpness | Provide functions to
enhance image, zoom
in/out, brightness,
contrast and sharpness | Provide functions to
enhance image
brightness, contrast
and sharpness | Provide functions to
enhance image brightness,
contrast and sharpness |
| Function to
search to
retrieve
medical
records lined
to a specific
patient | a search function to
retrieve medical records
linked to a specific
patient | a search function to
retrieve medical
records linked to a
specific patient | a search function to retrieve
medical records linked to a
specific patient |
| Function to
export and
import data | Include a function to
export and import data | Include a function to
export and import data | Include a function to export
and import data |
| Function to
print out the
stored data | Can produce printouts
of the stored data | Can produce printouts
of the stored data | Can produce printouts of the
stored data |
| Function to
connect to
LAN and have
DICOM
interface | Can connect to LAN
and have DICOM
interface (by default or
as a separate option) | Can connect to LAN
and have DICOM
interface (by default or
as a separate option) | Can connect to LAN and
have DICOM interface (by
default or as a separate
option) |
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Image /page/6/Picture/0 description: The image shows the logo for OSKO. The word "OSKO" is written in a bold, dark blue font on the left side of the logo. To the right of the word, there is a stylized graphic that resembles a butterfly or a stylized "X". The graphic is composed of two intersecting shapes, one in a darker shade of blue and the other in a lighter shade of blue.
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Image /page/7/Picture/0 description: The image shows the logo for OSKO. The logo consists of the word "OSKO" in a bold, dark blue font on the left side. To the right of the word, there is a stylized graphic that resembles two intersecting sine waves or curves, one in a lighter blue and the other in a darker blue. The overall design is clean and modern.
VIII. COMPARISON DISCUSSION
The indications for use statement for the subject device is similar to indications for use of the predicate device based on the description and the proposed labeling contained in this submission. Both the subject and the predicate software aligns captured images to stitch and generate a longlength composite image, while fine adjustments can be made using the manual stitch editor. The differences in the indications for use for the subject and predicate device, such as the image file type, do not affect the intended diagnostic use of the software. Smart Stitching software has the same technological characteristics as the reference device and the predicate device, "DR Long Length Imaging Stitching" and Cedara I-Softview "Accustitch" respectively. These devices allow a composite image to be formed from multiple general radiography images acquired separately. The new software device raises no new issues of safety or effectiveness.
No clinical testing is performed.
The complete system configuration has been assessed and tested by the manufacturer and passed all in house testing criteria. The software validation test was designed to evaluate all input functions, output functions, and actions performed by Smart Stitching Software. Each operational mode and the imaging stitching process are documented in the software validation report.
The auto stitching function and SW compatibility test have been conducted and the result demonstrated that the software functions as intended. In addition, the software validation testing ,from TS-0001 through TS-0017, verified and validated the risk analysis and individual performance results were within the predetermined acceptance criteria.
Safety and Performance Data:
- IEC 62304 Medical device software Software life-cycle processes : 2006
- ISO 14971 Medical Devices Application of risk management to medical device : 2007
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Image /page/8/Picture/0 description: The image contains the logo for OSKO. The logo consists of the word "OSKO" in bold, blue letters. To the right of the word is a blue graphic that resembles a sine wave or a stylized butterfly. The graphic is made up of two different shades of blue.
- NEMAPS 3.1-3.20 - Digital Imaging and Communications in Medicine (DICOM) Set (Radiology)
CONCLUSIONS IX.
Based on the information above, it is the sponsor's opinion that Smart Stitching software is substantially equivalent to the predicate software in design and performance. The differences between Smart Stitching software and its predicate do not raise different questions of safety and effectiveness.