(118 days)
StorM-Base 2.0 is intended to be used by physicians and other qualified medical personnel for the documentation, communication, display, printing and storage of medical diagnostic data in the field of Lithotripsy. When installed with a Storm-Touch system, it is also an image archiving system based on the DICOM standard capable of capturing and annotating lithotripsy procedures for documentation purposes. Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis.
The Strorz StorM-Base 2.0 is a Windows XP based software application that stores patient data, examination results including the number, type and location of stones, treatment images and data. The application may be installed on a standalone PC or on the StroM-Touch MODULITH Lithotripter (K070579). When installed on the StroM-Touch MODULITH Lithotripter, the system can acquire the images and treatment data directly from the lithotripter via an import function and be networked to the Storz Controller Buss.
The Karl Storz Endoscopy StorM-Base 2.0 is a software application intended for documentation, communication, display, printing, and storage of medical diagnostic data in lithotripsy. It is explicitly stated that "Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis."
Given this intended use, the submission primarily focuses on software verification and validation, compliance with standards (DICOM), and comparison to a predicate device regarding similar technical characteristics and safety. There are no clinical performance acceptance criteria or studies involving human readers or ground truth for diagnostic accuracy, as the device is not intended for primary diagnosis.
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to diagnostic accuracy, nor can I answer questions about sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, or standalone performance. The document only addresses the software's functional and safety aspects.
Here's a summary of the information available based on the provided text, primarily focusing on the software's development and validation:
1. Table of Acceptance Criteria and Reported Device Performance (Operational and Safety Focus):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with software verification and validation methods | Developed in compliance with software verification and validation methods. |
| Implementation of appropriate risk control measures | Appropriate risk control measures identified and implemented through a risk management process meeting ISO 14971. |
| Proper implementation of requirements | Verification and validation testing performed to ensure requirements are properly implemented. |
| Compliance with DICOM standard | Verified to be in compliance with the DICOM standard. |
| System functionality (storage, display, printing, etc.) | Technical characteristics similar to predicate (Windows-based, stores patient info, complies with HL7/DICOM, archives data, imports/distributes images). |
| No manipulation of original PACS or HIS data | Does not manipulate original PACS or HIS data. |
| Images not for diagnostic use | Stored images are not intended for diagnostic use. |
Since the device is not intended for primary diagnosis, the following points address what is NOT applicable or available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable as no clinical diagnostic performance study was conducted or reported. The "test set" would refer to software validation tests, not clinical data sets for diagnostic accuracy.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there is no ground truth for diagnostic accuracy established for this device's intended use.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. The device is not an AI for diagnostic assistance.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for diagnostic performance. The device is a data management system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic accuracy. Ground truth for software validation would be based on functional requirements.
- The sample size for the training set: Not applicable as this is not a machine learning or AI device requiring a "training set" in the context of diagnostic data.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
MAR 1 8 2010
510(k) Summary of Safety and Efficacy
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.
| Date Prepared | 3-05-2010 |
|---|---|
| Applicant: | Karl Storz Endoscopy of America, Inc.2151 Grand AveEl Segundo, CA 90245 |
| Contact: | Leigh SpotténRegulatory Affairs Manager(424) 218-8738Email: lspotten@ksea.com |
| Device Identification/ Classification | StorM-Base 2.0System, Image Processing, Radiological892.2050Class II |
| Indication: | StorM-Base 2.0 is intended to be used by physicians and otherqualified medical personnel for the documentation, communication,display, printing and storage of medical diagnostic data in the field ofLithotripsy. When installed with a Storm-Touch system, it is also animage archiving system based on the DICOM standard capable ofcapturing and annotating lithotripsy procedures for documentationpurposes. Images imported and distributed by StorM-Base 2.0 are forviewing and reference purposes only and are not intended for primarydiagnosis. |
| Device Description: | The Strorz StorM-Base 2.0 is a Windows XP based softwareapplication that stores patient data, examination results including thenumber, type and location of stones, treatment images and data. Theapplication may be installed on a standalone PC or on the StroM-TouchMODULITH Lithotripter (K070579). When installed on the StroM-Touch MODULITH Lithotripter, the system can acquire the imagesand treatment data directly from the lithotripter via an import function |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font.
Predicate Devices The Storz StorM-Base 2.0 is substantially equivalent to the Storz AIDA with DICOM and HL7 interface (K043324) Technical The proposed device and the predicate are Windows® based software Characteristics communication systems, deployed on a standalone PC or networked. intended to be used by Health Professionals, are accessories to the hospital information system (HIS), store patient information, comply with the HL7 and DICOM standards, require password login and authorization, store and archive data locally, import and distribute images. The proposed device and the predicate do not manipulate original PACS or HIS data and the stored images are not intended for diagnostic use. Summary of Non-The Storz StorM-Base 2.0 has been developed in compliance with software verification and validation methods. Appropriate risk control Clinical Testing measures have been identified and implemented through a risk management process that meets the requirements of ISO 14971. Verification and validation testing has been performed to ensure that requirements have been properly implemented. The device has been verified to be in compliance with the DICOM standard. Substantial The basic technology, design and intended use is similar to predicate device and raise no new issues of safety and effectiveness. The minor Equivalence: differences between the StorM-Base 2.0 and predicate devices have no effect on the performance, function or intended use of the devices
and be networked to the Storz Controller Buss.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is stylized with thick, black lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
Ms. Leigh Spotten Regulatory Affairs Manager Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245
MAR 1 8 2010
Re: K093603
Trade/Device Name: StorM-Base 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 5, 2010 Received: March 8, 2010
Dear Ms. Spotten:
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
{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,
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indication For Use
510(k) Number (if known):
Device Name: StorM-Base 2.0
Indications For Use:
StorM-Base 2.0 is intended to be used by physicians and other qualified medical personnel for the documentation, communication, display, printing and storage of medical diagnostic data in the field of Lithotripsy. When installed with a Storm-Touch system, it is also an image archiving system based on the DICOM standard capable of capturing and annotating lithotripsy procedures for documentation purposes. Images imported and distributed by StorM-Base 2.0 are for viewing and reference purposes only and are not intended for primary diagnosis.
Prescription Use X (Part 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) () ()
Conference of
(Division Sign Off)
(Division Sign-Off) Division of Radiological Device Office of In Vitro Diagnostic Devices
510K K093603
14
§ 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).