(293 days)
Not Found
No
The summary describes a software for archiving and documenting medical images and data. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on capture, annotation, and storage.
No
The device is described as archiving and documentation software for still images, video, and audio sequences, and patient data recording. It captures and annotates surgical procedures for documentation, viewing, and reference purposes, explicitly stating that images are not intended for primary diagnosis. This functionality supports documentation rather than direct treatment or diagnosis.
No
The intended use statement explicitly states, "Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis."
No
The device description explicitly states that the unit "may include a DVD drive or Blu-Ray drive and an optional integrated SmartScreen" and has "several types of inputs and outputs," indicating the presence of hardware components beyond just software.
Based on the provided information, the Karl Storz AIDA HD Connect is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the images captured and distributed are for "viewing and reference purposes and are not intended for primary diagnosis." IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on archiving and documentation of images and video from diagnostic or therapeutic procedures. It doesn't mention any analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
The device is a medical device used for documentation and archiving of images and video captured during medical procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 primary diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Not Found
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
qualified personnel in the Doctor's Office, Operating Room and Nurses Station.
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)
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.
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.
Not Found
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).
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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
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 Avenue
El Segundo, CA 90245-5017
Phone: (424) 218-8381
Fax: (424) 218-8519 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Crystal Dizol Hagan
Regulatory Affairs Specialist
Email: 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:
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.
Intended 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 primary diagnosis.
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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.
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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
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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
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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
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