(123 days)
Not Found
No
The summary describes a standard image archiving and communication system with no mention of AI or ML capabilities.
No
The device is an "image capturing, archiving, documentation system" for viewing and reference purposes, explicitly stating that images "are not intended for primary diagnosis." It facilitates communication between systems (PACS, HIS) and integrates with other devices, but its described functions do not involve directly treating, preventing, or diagnosing disease, which would qualify it as a therapeutic device.
No
The text explicitly states: "Images captured and distributed by AIDA are for viewing and reference purposes and are not intended for primary diagnosis." This indicates it is not a diagnostic device.
No
The device description explicitly states it is an "image capturing device," which implies hardware components beyond just software. While it includes software functionalities like archiving, documentation, and communication, the core function involves hardware for image capture.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the images captured and distributed by AIDA 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. This device deals with in vivo (within the body) images captured during a procedure.
- Device Description: The description focuses on image capturing, archiving, communication with PACS and HIS, and viewing. This aligns with image management systems, not IVD testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, performing tests on samples, or providing diagnostic information based on laboratory results.
Therefore, the Karl Storz AIDA/DICOM/HL7 system, as described, functions as an image management and communication system for surgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LIZ, KOG, FET
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.
Mentions image processing
Yes
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 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)
Not Found
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
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
0
Page 1 of 2
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
(310) 338-8100 |
| ------------ | --------------------------------------------------------------------------------------------------------------- |
|---|
2020550 Establishment Number:
Paul S. Lee Contact: Senior Regulatory Affairs Specialist Telephone +1-310-410-2769 Telecopier +1-310-410-5519
Device Identification / Classification:
- AIDA/DICOM/HL7 Trade Name: .
- Classification Name: Picture Archiving and Communications System .
- Classification Panel: Reproductive, Abdominal, Radiological Devices .
- 21CFR892.2050 CFR Section .
- Class II Device Class: .
- LIZ Product Code: .
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
1
KC43324
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: ______________________________________________________________________________________________________________________________________________________________________
signature
Paul Lee Senior Regulatory Affairs Specialist
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has three lines representing its body and wings.
APR - 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe CULVER CITY CA 90230
Re: K043324
Trade/Device Name: AIDA with DICOM and HL7 interface Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Product Codes: KOG and FET Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Product Code: LLZ Regulatory Class: II Dated: March 1, 2005 Received: March 16, 2005
Dear Mr. Lee:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis leter with anow you to begin maneting of substantial equivalence of your device to a legally premarket notification. The PDA michig of oatsamments
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 Part 801), please If you desire specific advice for your devices on the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation emilion on your responsibilities under the Act from the 807.97). I ou may obtain office general missional and Consumer Assistance at its toll-free number (800) Drvision of Sillan Manufacturers, Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for Use Form
510(k) Number (if known): Not yet-assigned- KO43324
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 This sollware to intented 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 sure 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 It is also a windows® based belated to being DICOM and with Hospital Information Systems (HIS) coinmunication systems (11108) as a part of the AIDA system the Storz Application Manager asing the HD7 otandard. the selection and integrations of AIDA functions with various Software (SAM) chaolos the sereotion and " " " 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)
Nancy Brogdon
(Division Sign-off)
Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number .
Confidential