(182 days)
The Storz SLX-F2 Storm Touch® software allows remote control / display communication between Storz Communication Buss® (SCB) network computer and SLX-F2 System® via a graphic user interface with a touch panel LCD screen. The SLX-F2 Storm Touch® interface communication software permits additional remote control and adjustment of the third party device through Storm Touch®.
The new Storm Touch® software allows remote control / display / communication between the SCB system and SLX-F2 System via a graphic user interface with a touch panel LCD screen. The main function of the Storm Touch® graphical user interface is to support the doctor by displaying SLX-F2 control panel System including its x-ray parameters during lithotripsy treatment or surgery. This SCB Storm Touch® communication software does not add any new clinical function to the SLX-F2 and third party devices. Storm Touch® has the same graphic user interface principle as our original SCB graphic interface software. Storm Touch® is installed as an optional software in the SCB computer which is located in the OR suite. SLX -F2 connects to the SCB system by a specific Buss Connectors in the SCB computer with a designated cable. The SCB Storm Touch® interface communication software also permits additional remote control and adjustment of the third party device. All third party devices that are connected to the SCB Storm Touch may still be controlled by the original device overwriting the SCB control. In case the additional remote control is not required, control of the device still remains with the device itself. The SCB Storm Touch® software allows additional optional control / communication of the third party device with the SCB.
The provided text is a 510(k) summary for the Storz SLX-F2 Storm Touch® device. It focuses on the device's function as a remote control/display interface for an extracorporeal shock wave lithotripter (SLX-F2 System®) and its substantial equivalence to predicate devices, rather than a study demonstrating clinical performance or meeting specific acceptance criteria for a new medical function.
Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this document. The submission is primarily about demonstrating that the software does not add new clinical function and is substantially equivalent to existing devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. This 510(k) summary does not define specific "acceptance criteria" for clinical performance or present a study with quantitative performance metrics for the Storm Touch® software itself. Its acceptance is based on demonstrating substantial equivalence to predicate devices because it does not introduce new clinical functions, but rather enhances user interface and remote control capabilities.
2. Sample size used for the test set and the data provenance
No test set for clinical performance is described. The device is a software interface, and the submission emphasizes that "This SCB Storm Touch® communication software does not add any new clinical function to the SLX-F2 and third party devices." Therefore, no patient data or specific clinical test set is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth for a clinical test set is established or mentioned, as the device doesn't introduce new clinical functions requiring such validation.
4. Adjudication method for the test set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This device is not an AI or imaging interpretation system, and no MRMC study or AI-assisted improvement is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is explicitly a "remote control / display / communication" interface to assist human operators (doctors) with an existing lithotripsy system. It is not an algorithm performing a standalone task.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of clinical performance data. The "ground truth" implicitly relied upon here is that the SLX-F2 System® (the lithotripter it controls) is already a legally marketed and established device, and the new software merely provides an alternative interface for its existing functions.
8. The sample size for the training set
Not applicable. The document describes a software interface, not a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or machine learning components.
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AUG 3 0 2007
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 DriveCulver City, CA 90230(310) 338-8100 |
|---|---|
| Contact: | Paul S. LeeSenior Regulatory Affairs SpecialistTelephone +1-310-410-2769Telecopier +1-310-410-5519E-mail: plee@ksea.com |
| Device Identification: | Common Name: Extracorporeal Shock Wave LithotripterTrade Name: Storz SLX-F2 Storm Touch® |
| Indication: | The Storz SLX-F2 Storm Touch® software allows remotecontrol / display communication between Storz CommunicationBuss® (SCB) network computer and SLX-F2 System® via agraphic user interface with a touch panel LCD screen. TheSLX-F2 Storm Touch® interface communication softwarepermits additional remote control and adjustment of the thirdparty device through Storm Touch®. |
| Device Description: | The new Storm Touch® software allows remote control /display / communication between the SCB system and SLX-F2System via a graphic user interface with a touch panel LCDscreen. The main function of the Storm Touch® graphical userinterface is to support the doctor by displaying SLX-F2 controlpanel System including its x-ray parameters during lithotripsytreatment or surgery. This SCB Storm Touch® communicationsoftware does not add any new clinical function to the SLX-F2and third party devices. Storm Touch® has the same graphicuser interface principle as our original SCB graphic interfacesoftware. |
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Image /page/1/Picture/0 description: The image shows a handwritten note with some illegible words. The writing appears to be in black ink on a white background. The handwriting is cursive and difficult to read due to the image quality and the style of writing. The note seems to contain a few short lines of text.
Storm Touch® is installed as an optional software in the SCB computer which is located in the OR suite. SLX -F2 connects to the SCB system by a specific Buss Connectors in the SCB computer with a designated cable.
The SCB Storm Touch® interface communication software also permits additional remote control and adjustment of the third party device. All third party devices that are connected to the SCB Storm Touch may still be controlled by the original device overwriting the SCB control. In case the additional remote control is not required, control of the device still remains with the device itself. The SCB Storm Touch® software allows additional optional control / communication of the third party device with the SCB.
Substantial Equivalence: The Storz Medical SLX-F2 Storm Touch is substantially equivalent to predicate devices since the basic technology and design are similar. The intended usage is similar to predicate devices and raise no new issues of safety and effectiveness. The minor differences between the Storz Medical Storz SLX-F2 Storm Touch® and predicate devices have no effect on the performance, function or intended use of the devices.
Signature:__
Paul Lee Senior Regulatory Affairs Specialist
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
AUG 3 0 2007
Mr. Paul S. Lee Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Drive CULVER CITY CA 90230
Re: K070579
Trade/Device Name: Storz SLX-F2 Storm Touch® Regulation Number: 21 CFR §876.5990 Regulation Name: Extracorporeal shock wave lithotripter Regulatory Class: II Product Code: LNS Dated: July 27, 2007 Received: July 31, 2007
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.
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Protecting and Promoting Public Health
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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.
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
Storz SLX-F2 Storm Touch®
Indications for Use:
SLX-F2 Storm Touch® software allows remote control / display The Storz communication between Storz Communication Buss® (SCB) network computer and SLX-F2 System® via a graphic user interface with a touch panel LCD screen. The SLX-F2 Storm Touch® interface communication software permits additional remote control and adjustment of the third party device through Storm Touch®
Prescription Use: (Per 21 CFR 801.Subpart D) OR Over-The-Counter Use: (21 CFR 801 Subpart C)
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Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)