(182 days)
Not Found
Not Found
No
The description focuses on remote control and display of existing device parameters via a graphical user interface, with no mention of AI or ML concepts, data analysis for learning, or performance metrics typically associated with AI/ML.
No.
The device is described as software for remote control and display of medical equipment (specifically an x-ray system used during lithotripsy or surgery), but it does not perform any direct therapeutic action itself. It acts as an interface.
No
Explanation: The device description states that the software "does not add any new clinical function to the SLX-F2 and third party devices" and is primarily for remote control, display, and communication of existing parameters. It does not mention any diagnostic capabilities or functions that would lead to a medical diagnosis.
No
The device is described as software that allows remote control and display communication between existing hardware systems (SCB network computer and SLX-F2 System). While it is software, its function is to interface with and control hardware components (SLX-F2 System and third-party devices), making it an integral part of a larger hardware system rather than a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Storz SLX-F2 Storm Touch® software is described as a remote control and display interface for a lithotripsy system (SLX-F2 System®) and potentially other third-party devices. It facilitates communication and control within an operating room setting.
- Lack of Specimen Analysis: There is no mention of this device collecting, preparing, or analyzing any biological specimens from a patient. Its function is related to controlling and displaying information from medical equipment used during a procedure.
Therefore, the device's intended use and description clearly indicate it is a control and interface system for medical equipment, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
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®.
Product codes
LNS
Device Description
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.
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
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”)
0
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 Drive
Culver City, CA 90230
(310) 338-8100 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paul S. Lee
Senior Regulatory Affairs Specialist
Telephone +1-310-410-2769
Telecopier +1-310-410-5519
E-mail: plee@ksea.com |
| Device Identification: | Common Name: Extracorporeal Shock Wave Lithotripter
Trade Name: Storz SLX-F2 Storm Touch® |
| Indication: | 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®. |
| Device Description: | 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. |
1
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
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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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.
Image /page/2/Picture/10 description: The image is a circular logo for the FDA Centennial, celebrating 100 years from 1906 to 2006. The letters FDA are in the center of the logo in a stylized font. The word "Centennial" is written below the letters FDA.
Protecting and Promoting Public Health
3
Page 2 -
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
4
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)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
High Ridge Asset Management
High Ridge Special Credit Opportunities Fund III, L.P.
High Ridge Special Credit Opportunities Fund III Offshore, L.P.
High Ridge Special Credit Opportunities Fund III (Cayman), L.P.
High Ridge Special Credit Opportunities Fund III (Parallel), L.P.
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number