(238 days)
No
The summary describes a system for networking and controlling existing medical equipment in the operating room, primarily through remote control interfaces like voice command and touch screen. There is no mention of AI, ML, image processing for analysis, or any performance studies related to algorithmic performance, which are typical indicators of AI/ML use in medical devices.
No
The SIOS device primarily focuses on optimizing operating room procedures through equipment control, image/data handling, and networking. It acts as a control system for other medical devices rather than directly providing a therapeutic effect on a patient. Its intended use is to manage and integrate existing medical technologies within the OR, not to deliver therapy itself.
No
The device description and intended use indicate that the SIOS product is for optimizing operating room procedures through equipment control, image and data handling, and networking capabilities, not for diagnosing medical conditions.
No
The device description explicitly states it is a "system capable of networking select medical and non-medical equipment" and "combines a number of individual functional units through a standard interface to a centralized computer control station." This indicates the device includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SIOS product is for optimizing procedures in the operating room by providing equipment control, image and data handling, and networking capabilities. This is focused on managing the surgical environment and equipment, not on analyzing biological samples or providing diagnostic information about a patient's health status.
- Device Description: The description reinforces this by explaining that the system networks and controls medical and non-medical equipment in the OR.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The SIOS system does not fit this definition.
N/A
Intended Use / Indications for Use
The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.
The SIOS product is limited to use with the following products:
- Wolf Endocam 3CCD Endocam 5507,
- Wolf Light Source Auto-CP 5131,
- Wolf Insufflator Laparo CO2 Pacu 2332, and
- Maquet OR Table ALPHAMAQUET 1150.
Product codes
ODA,KOG
Device Description
The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.
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
Operating room
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)
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.
0
JUL 2 7 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Siemens Medical Corporation Ms. Malgorzata Stanek, RAC Senior Technical Specialist 186 Wood Avenue South Iselin, NJ 08830
Re: K994231
Trade/Device Name: Siemens Integrated Operating System (SIOS) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODA Dated (Date on orig SE ltr): May 30, 2000 Received (Date on orig SE Itr): May 31, 2000
Dear Ms. Stanek,
This letter corrects our substantially equivalent letter of August 10, 2000.
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. 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
1
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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.
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 (reporting of medical 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 contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ATTACHMENT 8
INDỊCATIONS FOR USE
| 510(k) Number (if known): | K99423.1 |
|---|---|
| Device Name: | Siemens Integrated Operating System (SIOS) |
Indications For Use:
The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.
The SIOS product is limited to use with the following products:
- (1) Wolf Endocam 3CCD Endocam 5507,
- (2) Wolf Light Source Auto-CP 5131,
- (3) Wolf Insufflator Laparo CO2 Pacu 2332, and
- (4) Maquet OR Table ALPHAMAQUET 1150.
(Please do not write below this line - continue on another page if needed)
OR
Concurrence of the CDRH, Office of Device Evaluation (ODE)
ﯾﺎﮞ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺳﺎﺗﮫ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍ During
(Division Sign-Off) Division of General Restorative Devices Division or Ser K99423
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
3
ATTACHMENT 7
510(K) SUMMARY
FOR THE
SIEMENS INTEGRATED OPERATING SYSTEM (SIOS)
Submitted by:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ 08830
December 15, 1999
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
- Contact Person:
Ms. Malgorzata Stanek Phone: (732) 321-3950 Fax: (732) 321-4841
2. Device Name and Classification:
Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:
Siemens Integrated Operating System (SIOS) Endoscope and/or Accessories General Surgery 21 CFR § 876.1500 Class II 78KOG
3. Substantial Equivalence:
The Siemens Integrated Operating System is designed to control select medical equipment in the operating room (OR), allow trained medical personnel direct control of the equipment using remote control (i.e., verbal commands, hand input device), and network with hospital information systems (HIS) and picture archival communication systems (PACS).
The package is substantially equivalent to the following devices:
| Device Name | Manufacturer | FDA 510(k) Number | FDA Clearance Date |
|---|---|---|---|
| HERMESTM Operating Room | |||
| Control Center and Accessories | Computer Motion | K980787 | 7/31/98 |
| EndoALPHATM Integrated | |||
| Endosurgery System | Olympus | K981993 | 8/21/98 |
510(k) for Siemens Integrated Operating System (SIOS) Siemens Medical Systems, Inc.
4
4. Device Description:
The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.
પં Intended Use of the Device:
The SIOS product is intended to optimize procedures in the operating room by providing consistent pre-operative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.
Summary of Technological Characteristics of the Devices Compared to the ર. Predicate:
The SIOS product is substantially equivalent to HERMES TM by Computer Motion and EndoALPHA ™ by OLYMPUS. All systems enable remote control of connected devices without changing the original functionality of those devices.
Kathleen Rutherford Manager, Regulatory Submissions Siemens Medical Systems, Inc.