Who is the manufacturer of Smart Stitching Software System, Image Processing, Radiological?

Osko, Inc. filed the 510(k) submission for Smart Stitching Software System, Image Processing, Radiological (K163048).

What is the FDA product code for Smart Stitching Software System, Image Processing, Radiological?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Smart Stitching Software System, Image Processing, Radiological?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Smart Stitching Software System, Image Processing, Radiological?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Smart Stitching Software System, Image Processing, Radiological

K163048 · Osko, Inc. · LLZ · Jul 28, 2017 · Radiology

Device Facts

Record ID	K163048
Device Name	Smart Stitching Software System, Image Processing, Radiological
Applicant	Osko, Inc.
Product Code	LLZ · Radiology
Decision Date	Jul 28, 2017
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

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.

Device Story

Smart Stitching software processes multiple medical images (up to 5) to create a single composite image. Inputs include DICOM 3.0, TIFF, and Raw image formats. The device uses an auto-stitching function based on overlapping areas to join images; manual stitch editing is available for fine adjustments. It provides additional functions for image retrieval, storage, transmission, and enhancement (brightness, contrast, sharpness, zoom). The software does not control image acquisition hardware. It is intended for use by healthcare professionals to facilitate diagnostic review. The output is a composite image used to assist in clinical decision-making by providing a long-length view of anatomy.

Clinical Evidence

No clinical testing performed. Bench testing only. Software validation (TS-0001 through TS-0017) verified input/output functions, auto-stitching performance, and software compatibility against predetermined acceptance criteria.

Technological Characteristics

Software-based image processing system. Supports DICOM 3.0, TIFF, and Raw formats. Features include auto-stitching based on image overlap, manual stitch editing, and image enhancement tools (brightness, contrast, sharpness). Connectivity via LAN with DICOM interface. Developed in accordance with IEC 62304 (software life-cycle) and ISO 14971 (risk management).

Indications for Use

Indicated for post-capture positioning and joining of individual medical images to produce a composite image for 2D review.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Cedara I-Soft View (K022881)

Reference Devices

Carestream Health Inc DR Long Length Imaging Software (K130567)

Related Devices

K130567 — DR LONG LENGTH IMAGING SOFTWARE · Carestream Health, Inc. · Jun 11, 2013
K032546 — HOLOGIC DR IMAGEPRO · Hologic, Inc. · Oct 16, 2003
K973233 — IMAGE FUSION AND REVIEW SYSTEM · Adac Laboratories · Nov 25, 1997
K160579 — Xmaru View V1 and Xmaru PACS, Medical Image Processing Software · Rayence Co., Ltd. · Apr 8, 2016
K210066 — ImagePilot · Konica Minolta, Inc. · May 6, 2021

Submission Summary (Full Text)

{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) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 | {4}------------------------------------------------ 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. {5}------------------------------------------------ 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) | {6}------------------------------------------------ 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. {7}------------------------------------------------ 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 {8}------------------------------------------------ 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.