The Karl Storz AIDA HD Connect is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nurses Station. The Advanced Image and Data Archiving (AIDA) HD Connect is a Windows based archiving and documentation software for still images, video and audio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure in both SD and HD for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.

Device Description

The Karl Storz AIDA HD Connect is a Windows based archiving and documentation software. The unit may include a DVD drive or Blu-Ray drive and an optional integrated SmartScreen. The unit has several types of inputs and outputs to accommodate SD and HD still image capture and video recording, audio recording, image and video display, and peripherals.

AI/ML Overview

The Karl Storz AIDA HD Connect is an archiving and documentation software intended for capturing and annotating still images, video, and audio sequences, and patient data during diagnostic or therapeutic procedures. It is explicitly stated that "Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis."

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety: Device meets electrical safety standards.	Electrical safety testing performed in accordance with IEC 60601-1.
EMC: Device meets electromagnetic compatibility standards.	EMC testing performed in accordance with IEC 60601-1-2.
Performance: Device meets product requirement specifications and is fit for its intended use.	"Performance testing was conducted to verify that the device meets the product requirement specifications and is fit for its intended use." The results demonstrated "that the characteristics of the Karl Storz AIDA HD Connect are substantially equivalent to the predicates in terms of performance."
Substantial Equivalence: Differences from predicate device do not raise new issues of safety and effectiveness.	"Design control activities, including risk analysis and verification testing, demonstrate that the differences between AIDA HD Connect and the predicate do not raise any new issues of safety and effectiveness." The device is "substantially equivalent to the unmodified predicate device as it has the same intended use and utilizes the same fundamental scientific technology to perform that intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The provided text does not contain information about a specific test set of medical data (e.g., patient images, videos). The performance testing described refers to verification testing against product requirements and substantial equivalence to a predicate device, rather than a clinical study evaluating diagnostic accuracy from a specific dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable or not provided. Since the device is not intended for primary diagnosis and the testing described focuses on engineering and regulatory compliance (electrical safety, EMC, functional performance), there wouldn't be a need for experts to establish diagnostic ground truth in the context of this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable or not provided for the same reasons as point 3.

5. 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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an archiving and documentation system, not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its intended use or regulatory submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone performance study as typically understood for diagnostic AI algorithms was not done. The performance testing focused on verifying the device's technical specifications and its functional equivalence to a predicate device, not on standalone diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The type of "ground truth" for the performance testing described was primarily product requirement specifications and compliance with established engineering and regulatory standards (e.g., IEC 60601-1 for electrical safety). There was no "ground truth" related to medical disease states or patient outcomes, as the device is not for diagnosis.

8. The sample size for the training set:

This information is not applicable or not provided. The device is described as software for archiving and documentation, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable or not provided for the same reasons as point 8.

Summary

{0}------------------------------------------------

KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, California 90245 Toll Free 800 421 0837 Fax 800 321 1304

AUG 2 9 2011

K103308

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document are accurate and complete to the best of KSEA's knowledge.

Submitter:	Karl Storz Endoscopy-America, Inc.2151 E. Grand AvenueEl Segundo, CA 90245-5017Phone: (424) 218-8381Fax: (424) 218-8519
Contact Person:	Crystal Dizol HaganRegulatory Affairs SpecialistEmail: chagan@ksea.com
Date Prepared:	November 8, 2010
Device Trade Name:	Karl Storz AIDA HD Connect
Common Name:	PACS (Picture Archiving and Communications System)
Classification Name:	Picture archiving and communications system.
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ

Predicate Device(s): Karl Storz: AIDA Compact II (K052159)

Device Description:

Intended Use:

{1}------------------------------------------------

Technological Characteristics:

The primary difference between the Karl Storz AIDA HD Connect and the predicate device is the updating of the grabber board to perform image/video/sound capture and to provide capture in High Definition.

Non-Clinical Performance Data:

Performance testing was conducted to verify that the device meets the product requirement specifications and is fit for its intended use. Electrical safety and EMC testing were performed in accordance with IEC 60601-1 and 60601-1-2. The results of performance testing demonstrate that the characteristics of the Karl Storz AIDA HD Connect are substantially equivalent to the predicates in terms of performance.

Determination of Substantial Equivalence:

The Karl Storz AIDA HD Connect is substantially equivalent to the predicate device. As the Karl Storz AIDA HD Connect is a modified version ("update") of the predicate device, differences in performance and technology were implemented as improvements. Design control activities, including risk analysis and verification testing, demonstrate that the differences between AIDA HD Connect and the predicate do not raise any new issues of safety and effectiveness. The Karl Storz AIDA HD Connect is substantially equivalent to the unmodified predicate device as it has the same intended use and utilizes the same fundamental scientific technology to perform that intended use.

Conclusions:

The Karl Storz AIDA HD Connect is substantially equivalent to the identified predicate device and does not raise any new issues of safety and efficacy.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a circular seal or logo. It features the emblem of the U.S. Department of Health & Human Services. The emblem is a stylized representation of a bird or eagle in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half of the circle.

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

Karl Storz Endoscopy-America, Inc. % Ms. Crystal Dizol Hagan Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc 2151 E. Grand Avenue EL SEGUNDO CA 90245-5017

AUG 2 9 2011

Re: K103308

Trade/Device Name: Karl Storz AIDA HD Connect Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2011 Received: August 19, 2011

Dear Ms. Hagan:

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 of

{3}------------------------------------------------

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.

Mary S Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): Not yet assigned

Device Name: Karl Storz AIDA HD Connect

Indications for Use: The Karl Storz AIDA HD Connect is intended for use by qualified personnel in the Doctor's Office, Operating Room and Nurses Station. The Advanced Image and Data Archiving (AIDA) HD Connect is a Windows based archiving and documentation software for still images, video and audio sequences and patient data recording during a diagnostic or therapeutic procedure. It allows capture and annotation of the surgical procedure in both SD and HD for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primarv diagnosis.

Prescription Use:
(21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use: (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

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).