(255 days)
Not Found
No
The document describes an interface module for remote control of an energy platform, with no mention of AI or ML capabilities.
No
This device is an interface module that enables remote control of another device (COVIDIEN ForceTriad Energy Platform), it does not directly provide therapy itself.
No
The device is described as an interface module that integrates an energy platform into a control system, allowing for remote settings adjustment. Its function is to facilitate control of another device, not to perform diagnosis or provide diagnostic information.
No
The device is described as an "Interface Module" and an "accessory" that integrates a third-party device. While it involves software for control, the description implies a physical component (a module) is required for the integration into the SCB network. The performance studies mention "software verification and validation testing" but also the device being "installed into the SCB control device," suggesting a hardware interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an interface module for integrating and remotely controlling an energy platform (used for surgical procedures). This is not a diagnostic purpose.
- Device Description: The description reinforces that it's an accessory for integration and remote control of a surgical energy platform.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on the device's ability to interface and control the energy platform, not on diagnostic accuracy or performance.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is related to controlling a surgical tool, not performing in vitro diagnostics.
N/A
Intended Use / Indications for Use
The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
Product codes (comma separated list FDA assigned to the subject device)
ODA
Device Description
The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.
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)
The Karl Storz SCB/Covidien ForceTriad Interface Module demonstrated performance equivalence by software verification and validation testing, in which the device was installed into the SCB control device and the system's ability to interface with the Covidien ForceTriad Energy Platform was tested. The performance of the Karl Storz SCB/Covidien Force Triad Interface Module was found to be substantially equivalent to the predicate Karl Storz SCB/ConMed ESU Interface Module.
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.
Karl Storz SCB/ConMed ESU Interface Module (K080410)
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
1211165 PG. 1/2
510(k) SUMMARY
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 are accurate and complete to the best of KSEA's knowledge.
| Submitter: | Karl Storz Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo, CA 90245-5017
Phone: (424) 218-8381
Fax: (424) 218-8519 | JAN - 6 201 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Crystal Hagan
Regulatory Affairs Specialist
Email: chagan@ksea.com | |
| Date Prepared: | April 25, 2011 | |
| Device Trade Name: | Karl Storz SCB/Covidien ForceTriad Interface Module | |
| Common Name: | Endoscope and/or accessories | |
| Classification Name: | Endoscopic central control unit | |
| Regulation Number: | 21 CFR 876.1500 | |
| Product Code: | ODA | |
Predicate Device(s): Karl Storz SCB/ConMed ESU Interface Module (K080410)
Device Description:
The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.
Intended Use:
The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB me RARE STORE OOD OOMGER Poloo mad intentato we the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
Technological Characteristics:
The "module" is an accessory which is installed and housed within a Karl Storz SCB contraction was a The Through is an accessory while in Cantrol device is connected is connected the Covidien ForceTriad Energy Platform via an RS232 connection. Once installed, the Kan Storz SCB/Covidien ForceTriad Interface Module allows the user interface of the ForceTriad Energy Platform to be displayed Porce mad Interiace Moune another the ason intention of the Covidien can be renotely adjusted via the SCB-RUI. For a summary of technological characteristics of the Karl Storz SCB/Covidien ForceTriad Interface Module as compared to the predicate device, please refer to the attached substantial equivalence table.
1
Image /page/1/Picture/0 description: The image shows the logo for STORZ KARL STORZ ENDOSKOPE. The word "STORZ" is written in large, bold letters with a circular design in the middle of the "O". Below the word "STORZ", the words "KARL STORZ ENDOSKOPE" are written in smaller letters. The background of the image is grainy and appears to be a black and white photograph.
KIII65 AG. 2/2
Software Testing;
The Karl Storz SCB/Covidien ForceTriad Interface Module demonstrated performance equivalence by software verification and validation testing, in which the device was installed into the SCB control device and the system's ability to interface with the Covidien ForceTriad Energy Platform was tested. The performance of the Karl Storz SCB/Covidien Force Triad Interface Module was found to be substantially equivalent to the predicate Karl Storz SCB/ConMed ESU Interface Module.
Determination of Substantial Equivalence:
The Karl Storz SCB/Covidien ForceTriad Interface Module is substantially equivalent to the predicate device, as both devices have the same intended use and basic design. The differences between the SCB/Covidien ForceTriad Interface Module and the predicate device are minor and raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.
Conclusions:
The Karl Storz Scalp Dura Retractor is substantially equivalent to the identified predicate devices and does not raise any new issues of safety and efficacy.
Att: Substantial Equivalence Table for Karl Storz SCB/Covidien ForceTriad Interface Module
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The bird is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 1 0903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Ankit Shah Regulatory Affairs Associate Karl Storz Endoscopy-America, Inc. 2151 E. Grand Avenue EL SEGUNDO CA 90245
JAN - 6 - 2012
Re: K111165
Trade/Device Name: Karl Storz SCB/Covidien Force Triad Interface Module Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated: December 8, 2011 Received: December 9, 2011
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the devices we nave leviewed your bection of the device is substantially equivalent (for the indications felerenced above und nave actionship and and and and interstant devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce prior to May 20, 1776, the encordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approvisions of the general controls provisions of the Act. The You may, merelore, market the device, basjon to morements for annual registration, listing of general controls provisions of the rist labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Please note: CDICT does not ovaluation must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), and If your device is classified (sec above) ... Existing major regulations affecting your device can be it may be subject to additional controllations, Title 21, Parts 800 to 898. In addition, FDA may found in the Code of I casia stoganian your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualler of a sacomines with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemination administered by other Federal agencies. You must of any Pederal statutes and regulacions annlinited to registration and listing of median of media comply with all the Act STEquilements, morading, occaso mainer reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Joa atti.il/www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part now the regulations 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 Tou thay 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/MedicalDevices/ResourcesforYowIndustry/default.htm.
Sincerely yours;
Benjamin K. Fisher, Ph.D., Director
Benjam R. Fisher, Ph.D., Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KIIII65
INDICATIONS FOR USE
510(k) Number (if known): Not yot assigned
Karl Storz SCB/Covidien ForceTriad Interface Module Device Name:
Indications for Use: The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
Prescription Use: X (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)
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices K111165
510(k) Number
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