InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS™InstaRISPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fully-integrated electronic patient records.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

InstaPACS™/InstaRISPACS™ is a software application used for viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. When viewing images, users can perform adjustments of window width and level, annotation, and various image manipulations. In addition, the device can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study), providing seamless access to reports for fully-integrated electronic patient records.

InstaPACS™/InstaRISPACS™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:

. Central Server - runs the Web Server and Image Server and provide study and image data to doctors. The server includes a DICOM Gateway Application which is deployed at remote centers or hospitals. It receives images from modalities over LAN and uploads them to central server
WorkStation User at the client side can access the study list in the . browser. They can select the patient and download the images.

AI/ML Overview

The provided text is a 510(k) summary for a Picture Archiving Communications System (PACS) software, InstaPACS™/InstaRISPACS™. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical studies with performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description	Reported Device Performance/Conclusion
Substantial Equivalence	The device must demonstrate substantial equivalence to a legally marketed predicate device in terms of intended use, technological characteristics, safety, and effectiveness.	"The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices." "Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device. Therefore, InstaPACS™/InstaRISPACS™ is substantially equivalent to the predicate device."
Functional Verification	The system must perform all intended input and output functions and actions in each operational mode.	"The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the InstaPACS™InstaRISPACS™ software in each operational mode and followed the process documented in the System Validation Test Plan." "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."
Safety Risks	The device should not introduce new safety risks.	"The new device does not raise any new potential safety risks..."
Performance Equivalence	The device should perform equivalently to existing legally marketed devices.	"...is equivalent in performance to the existing legally marketed devices."
Non-Diagnostic Role	The software itself is not intended to perform diagnosis, but rather to facilitate interpretation by qualified medical professionals.	"Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
Mammography Handling (Specific)	Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.	The "Indications for Use" statement explicitly includes these conditions as part of the device's intended use and limitations. The document doesn't provide a specific "performance" against this, but rather states these as conditions of use to meet regulatory requirements, implying the device is designed to operate within these constraints.

Study Information:

The provided document describes a Nonclinical Testing approach for the InstaPACS™/InstaRISPACS™ system. This is a foundational regulatory submission that demonstrates substantial equivalence to a predicate device, rather than providing detailed clinical study results with performance metrics (like sensitivity, specificity, etc.) in the way one might expect for a diagnostic AI algorithm.

Sample size used for the test set and the data provenance:
- The document mentions "The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria." It also states, "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."
- However, no specific sample size for a "test set" of medical images or patient cases is provided. The testing appears to be centered on system functionality and software validation, not a clinical performance study with annotated data.
- Data provenance: Not explicitly stated regarding specific images used for any functional validation. The submitter is MEDDIFF Technologies Pvt. Ltd. based in Bangalore, Karnataka - India.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the study described is a nonclinical, system validation rather than a clinical performance study. The document states, "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This indicates that human experts are responsible for interpretation, but it doesn't describe their role in establishing a ground truth for testing the software's performance in a diagnostic capacity.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / not provided. The type of testing performed did not involve a clinical ground truth adjudication process.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This submission is for a PACS system, which is a tool for viewing and managing images, not an AI-assisted diagnostic algorithm in the sense that would require an MRMC study to show improved reader performance. The device's role is to display and manipulate images for human interpretation, not to provide diagnostic findings or assist with them through AI.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / not done. The device itself is a PACS system; its "performance" is in its ability to display, process, store, and communicate images reliably and without error, facilitating human interpretation. It is not an algorithm that produces a diagnostic output on its own. The document explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / not specified for clinical performance. The ground truth for the nonclinical system validation would be whether the software performs its specified functions (e.g., displaying an image correctly, performing window/level adjustments, storing data, communicating across networks) as designed, based on engineering requirements and test protocols.
The sample size for the training set:
- Not applicable / not provided. This device is a PACS software, not an AI algorithm that undergoes a "training" phase with a dataset.
How the ground truth for the training set was established:
- Not applicable / not provided. As this is not an AI algorithm requiring a training set, the concept of establishing ground truth for training is irrelevant to this submission.

Summary

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510(k) Summary of Safety

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

February 19, 2012

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Sanieev. MD and CEO MEDDIFF Technologies Pvt. Ltd. Salarpuria Palladium, 3rd floor, #2021. 100 ft Road. HAL 2ndStage Bangalore - 560 008, Karnataka - India Tel: +91-80-65350192 Fax: +91-80-66885510

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name: Common Name: Device Classification: Product Code:
InstaPACS™/InstaRISPACS™ Picture Archiving Communications System 892.2050 System, Image Processing LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

InstaPACS™/InstaRISPACS™ is substantially equivalent to:

Device Classification Name	system, image processing, radiological
510(k) Number	K080334
Device Name	InstaRAD
Applicant	MEDSPHERE TECHNOLOGIES PVT LTD.
Regulation Number	892.2050
Classification Product Code	LLZ
Decision Date	02/21/2008
Decision	substantially equivalent (SE)
Classification Advisory Committee	Radiology

Device Description: 21 CFR 807 92(a)(4)

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K120718

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manipulations. In addition, the device can be integrated with an institution's existing Hospital Information System or Radiology Information System (based on the study), providing seamless access to reports for fully-integrated electronic patient records.

InstaPACS™/InstaRISPACS™ allows multiple centers or hospitals to send their images to a central server where Radiologists can view images over Web. It consists of following components:

. Central Server - runs the Web Server and Image Server and provide study and image data to doctors. The server includes a DICOM Gateway Application which is deployed at remote centers or hospitals. It receives images from modalities over LAN and uploads them to central server
WorkStation User at the client side can access the study list in the . browser. They can select the patient and download the images.

Indications for Use: 21 CFR 807 92(a){5)

InstaPACS™InstaRISPACS ™ is a software device (DICOM Gateway Application, Enterprise Server, and Workstation) used for viewing and manipulating digital medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. InstaPACS™/instaRISPACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) based on the study of the System, providing seamless access to reports for fullyintegrated electronic patient records. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MPixel resolution and meets other technical specifications reviewed and accepted by FDA.

Technological Characteristics: 21 CFR 807 92(a)(6)

InstaPACS™/InstaRISPACS ™ device is a software product that handles digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.

Nonclinical Testing:

The complete system configuration has been assessed and tested at the factory and has passed all predetermined in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the InstaPACS™InstaRISPACS ™ software in each operational mode and followed the process documented in the System Validation Test Plan.

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Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for InstaPACS™/InstaRISPACS ™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, InstaPACS™/InstaRISPACS™ is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design, with three distinct wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

MEDDIFF Technologies Pvt. Ltd. % Mr. Carl Alletto Official Correspondent 1600 Manchester Way CORINTH TX 76210

Re: K120718

Trade/Device Name: InstaPACSTM/InstaRISPACSTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 7, 2012 Received: April 12, 2012

Dear Mr. Alletto:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K120718

Indications for Use

510(k) Number (if known):

Device Name:

InstaPACS™/InstaRISPACS™

Indications for Use:

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 In Vitro Diagnostic Devices (OIVD) (Division Sign-Off) Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K120718
Page 1 of 1

Regulation Number and Section

§ 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).