(54 days)
Not Found
No
The summary describes a central control unit for medical equipment, focusing on hardware and software for centralized control and user interface. There is no mention of AI, ML, image processing, or data analysis that would typically indicate the presence of AI/ML technology.
No
The device is a central control unit for other medical equipment, not a therapeutic device itself. It facilitates therapeutic procedures but does not directly provide therapy.
No
The device is described as a central control unit for compatible medical equipment during diagnostic and therapeutic procedures, but it does not perform diagnostic functions itself. It facilitates the control of other devices, some of which may be diagnostic.
No
The device description explicitly states that the system consists of "KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300)". This indicates the device includes specific hardware components beyond just software.
Based on the provided information, the KARL STORZ OR1™ SCB CONTROL is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures." This describes a system for managing and controlling medical devices used on a patient, not for examining specimens from a patient.
- Device Description: The description focuses on hardware and software for controlling other medical devices via cables and a touchscreen interface. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, performing tests on biological samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The KARL STORZ OR1™ SCB CONTROL's function is entirely focused on managing the operation of other medical equipment used in a clinical setting.
N/A
Intended Use / Indications for Use
The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
Product codes
ODA, FET
Device Description
The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101).
The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.
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
The KARL STORZ OR1 SCB CONTROL is intended to be used only in healthcare facilities/hospitals.
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
Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical verification testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
Key Metrics
Not Found
Predicate Device(s)
KSEA SCB-RUI K994348
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
October 3, 2023
Karl Storz SE & Co. KG Thomas Ostrowski Senior Regulatory Affairs Specialist Dr.-Karl-Storz-StraBe 34 Tuttlingen, Baden-Wurttemberg 78532 Germany
Re: K232406
Trade/Device Name: Karl Storz Or1™ Scb Control (wu300) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODA, FET Dated: August 9, 2023 Received: August 10, 2023
Dear Thomas Ostrowski:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.10.03
09:36:25 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Indications for Use (Describe)
The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Ostrowski
Senior Regulatory Affairs Specialist
Phone: +1 (508) 248-2420
E-mail: Thomas.Ostrowski@karlstorz.com |
| Date of Preparation: | August 9, 2023 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ OR1™ SCB CONTROL
Classification Name: Endoscopic Central Control Unit |
| Regulatory Class: | II |
| Product Code: | ODA, FET |
| Regulation: | 876.1500 |
| Predicate Device(s): | Primary Predicate Device: KSEA SCB-RUI K994348
The predicate device has not been subject to a design-related recall. |
1. Device Description
The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101).
The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.
5
Image /page/5/Picture/0 description: The image is a logo for STORZ. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" also written in blue. The logo is simple and professional.
The cables used to transfer data and commands between the OR1 SCB CONTROL and the connected medical devices include the following:
- . 20040076: RJ-45 Network Cable for Ethernet connection
- 20090370: SCB Cable (2 feet) ●
- 20090170: SCB Cable (3 feet)
- 20090270: SCB Cable (16 feet) ●
- 20090470: SCB Cable (25 feet) ●
- 20090870: SCB Cable (121 feet) ●
Software Description
The KARL STORZ OR1™ SCB CONTROL software is used to display and enable central control of the parameters of both the SCB equipment connected to the KARL STORZ OR1™ SCB CONTROL and the equipment from other manufacturers intended for this purpose. Information in the form of data and commands are exchanged between the various hardware components of the system via the software main application which processes and distributes data through various sublevel applications to achieve central control and display of controls.
Clinician control of the OR1™ SCB CONTROL occurs via touchscreen monitor where users enter touch commands. These inputs are communicated to the OR1™ SCB CONTROL hardware CPU which determines the appropriate reaction of the system. The CPU formulates the commands and communicates via corresponding protocol to the appropriate device. When the device receives these inputs, it updates its values accordingly and sends back confirmation of the actual values to the CPU which processes and instructs the user interface display to update accordingly.
Environment of Use
The KARL STORZ OR1 SCB CONTROL is intended to be used only in healthcare facilities/hospitals.
2. Indications for Use
The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
3. Comparison of Technological Characteristics with the Predicate Device(s)
At a high level, the subject and predicate devices are based on the following same technological elements:
- Windows operating system O
- Commercial grade CPU technology O
- SCB communication protocol O
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Image /page/6/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
-
Touchscreen user interface O
The following technological differences exist between the subject and predicate devices: -
Compatibility with additional medical equipment via serial cable and o additional communication protocol
-
Operating System update O
-
Graphical User Interface layout, menu and navigational updates O
-
CPU hardware specifications (i.e. processor speed, memory) O
4. Non-Clinical Performance Data
The following non-clinical performance data were provided in support of the substantial equivalence determination.
Electrical Safety and Electromagnetic Compatibility (EMC)
The system complies with the following standards:
- o ANSI/AAMI ES60601-1:2005/(R)2012, and A1:2012, C1:2009(R2012) and A2:2010(R)2012
- o IEC 60601-1-2:2014
- IEC 60601-1-6:2010 + AMD1:2013
Software Life Cycle Processes
The system complies with the following standard:
- IEC 62304:2006 + A1:2015 O
Software Verification and Validation Testing
The system complies with the following guidance:
- Guidance for the Content of Premarket Submissions for Software Contained o in Medical Devices
5. Clinical Performance Data
Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical verification testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
6. Conclusion
The conclusions drawn from the non-clinical performance data demonstrated that the subject device is as safe as and as effective as the predicate device. As such, we concluded that the substantial equivalence of the subject and the predicate device has been met, and the differences between the subject and the predicate device do not raise new questions of safety or effectiveness.