AIDA WITH DICOM AND HL7 INTERFACE

K043324 · KARL STORZ Endoscopy-America, Inc. · FET · Apr 4, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043324
• Device Name: AIDA WITH DICOM AND HL7 INTERFACE
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Apr 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis. It is also a Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA system the Storz Application Manager software (SAM) enables the selection and integrations of AIDA functions with various compatible applications, such as Karl Storz’s Storz Communication Bus (SCB) or other third party image capturing devices.

Device Story

AIDA is a Windows-based software system for capturing, archiving, and documenting surgical images, video, and audio. Used in ORs and nurses' stations by qualified personnel; integrates with hospital PACS via DICOM and HIS via HL7. Features Storz Application Manager (SAM) for integration with Storz Communication Bus (SCB) or third-party capture devices. Provides documentation and reference viewing; output is for clinical reference only, not primary diagnosis. Benefits include streamlined surgical documentation and data management.

Clinical Evidence

No clinical data. Safety and effectiveness established via risk analysis, software verification, and validation testing.

Technological Characteristics

Windows-based software; DICOM and HL7 connectivity; integrates with SCB and third-party capture devices. Includes built-in screen prompts, alarms, and error messages. Risk management via hazard analysis and software verification/validation.

Indications for Use

Indicated for use by qualified personnel in OR and Nurses Station for capturing, archiving, and documenting surgical still/video images, audio sequences, and patient data. Not for primary diagnosis.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• SIENET MagicWeb and Magic Link I (K973131)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Karl Storz Endoscopy – America, Inc.
Mr. Paul S. Lee
Senior Regulatory Affairs Specialist
600 Corporate Pointe
Culver City, CA 90230

JUL 27 2015

Re: K043324
Trade/Device Name: AIDA with DICOM and HL7 interface
Regulation Number: 21 CFR § 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FET, LLZ
Dated (Date on orig SE ltr): March 1, 2005
Received (Date on orig SE ltr): March 16, 2005

Dear Mr. Lee,

This letter corrects our substantially equivalent letter of April 4, 2005.

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

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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 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] 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" (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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D.
Director
Division of Reproductive, Gastro-Renal, and Urological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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# Indication for Use Form

510(k) Number (if known): Not yet assigned- K043324

Device Name: AIDA with DICOM and HL7 interface

## Indications for Use:

This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.

It is also a Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA system the Storz Application Manager software (SAM) enables the selection and integrations of AIDA functions with various compatible applications, such as Karl Storz’s Storz Communication Bus (SCB) or other third party image capturing devices.

Prescription Use: ☑ (Per 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)

Confidential

Nancy C. Bogdon
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K043324

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K043324
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APR - 4 2005

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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 is accurate and complete to the best of KSEA’s knowledge.

## Applicant:

Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
[phone]

**Establishment Number:** 2020550

## Contact:

Paul S. Lee
Senior Regulatory Affairs Specialist
Telephone [phone]
Telecopier [phone]

## Device Identification / Classification:

- Trade Name: AIDA/DICOM/HL7
- Classification Name: Picture Archiving and Communications System
- Classification Panel: Reproductive, Abdominal, Radiological Devices
- CFR Section: 21CFR892.2050
- Device Class: Class II
- Product Code: LIZ

## Indication:

This software is intended for use by qualified personnel in the Operating Room and Nurses Station. The Advanced Image and Data Archiving System (AIDA) is a Windows® based still/video image capturing, archiving, documentation system and recording of audio sequences and patient data during a procedure. It allows capture and annotation of the

Confidential

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K043324
Page 2 of 2

surgical procedure for documentation purposes. Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis.

It is also a Windows® based solution to communicate with other picture archival communication systems (PACS) using DICOM and with Hospital Information Systems (HIS) using the HL7 standard. Also as a part of the AIDA system the Storz Application Manager software (SAM) enables the selection and integrations of AIDA functions with various compatible applications, such as Karl Storz’s Storz Communication Bus (SCB) or other third party image capturing devices.

## Device Description:

The Karl Storz AIDA/DICOM/HL7 is an image capturing device with DICOM viewer which communicates with the Hospital Information System via HL7 protocol.

## Substantial Equivalence:

The Karl Storz AIDA/DICOM/HL7 is substantially equivalent to the predicate device (SIENET MagicWeb and Magic Link I: K973131) since the basic features and intended uses are the same. The minor differences between the Karl Storz AIDA/DICOM/HL7 and the predicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.

## General Safety and Effectiveness Concerns:

Built in screen prompts, alarms, error messages and warnings ensure safe and effective use of the AIDA/DICOM/HL7 software. Risk management is ensured via risk analyses, which are used to identify potential hazards. These hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical and radiation hazards, KSEA adheres to recognized and established industrial practice and standards.

Signed: 

Paul Lee
Senior Regulatory Affairs Specialist

Confidential