(299 days)
No
The summary mentions a "speech recognition engine" as an optional component, which can be implemented using various techniques, including traditional signal processing or machine learning. However, the summary does not explicitly state that AI or ML is used for this or any other function. The focus is on centralized control and status display, which are typical functions of integrated operating room systems. The predicate devices also appear to be similar control systems without explicit mention of AI/ML.
No.
The device is a control system for other medical devices in an operating room, not a device that directly treats a medical condition.
No
This device is a control system for other medical devices in the operating room, not a device that diagnoses medical conditions. Its function is to centralize control and display status of compatible equipment.
No
The device description explicitly lists multiple hardware components as part of the primary system and optional components, including a Medical Device Controller, Medical Device Hub, Touch Panel Interfaces, Ethernet Router, AVB network hub, AVB Power Supply, wireless microphone, and display controller. This indicates it is a system with significant hardware components, not solely software.
Based on the provided information, the Smith & Nephew Control Digital Operating Room System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "centralized control of these devices and display of device status" of "compatible endoscopic and surgical equipment." This describes a system that manages and controls other medical devices used during a surgical procedure, not a device that performs tests on samples taken from the body (which is the core function of an IVD).
- Device Description: The description details a computer-based system with components like controllers, hubs, touch panels, and networking equipment. This aligns with a system designed for control and display, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), performing tests, or providing diagnostic information based on such analysis.
Therefore, the Smith & Nephew Control Digital Operating Room System is a surgical control system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.
Product codes
GCJ
Device Description
The proposed Smith & Nephew Control Digital Operating Room System is a computer based system that enables centralized status display and control of multiple medical and non-medical devices through touch panel activation or through an optional voice recognition feature. The primary system consists of a Medical Device Controller, Medical Device Hub, Primary Touch Panel Interface (TPI-P), Surgical Touch Panel Interface (TPI-S), Ethernet Router and AVB network hub and AVB Power Supply. Optional components include: speech recognition engine, a wireless microphone for speech recognition, a wireless touch screen interface that can be bagged and placed in the sterile field, a display controller which allows device settings and conditions to be displayed on the surgeon's monitor
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
surgeon and O.R. staff.
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 performance testing conducted on the Smith & Nephew Control Digital. Operating Room System demonstrates substantial equivalence to the Olympus EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System. cleared in K022393 based on equivalent performance outcomes of centralized and remote control of medical devices in the O.R. The Smith & Nephew Control Digital Operating Room System conforms to the following voluntary standards: IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1988) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1) IEC 60601-1-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, Safety Requirements for Medical Electrical Systems (1992) + Amendment 1 (1995), (2000) IEC 60601-1-2 (2001-09) 2nd Edition Medical Electrical Equipment - Part I: General Requirements for Safety; Electromagnetic Compatibility - Requirements & Tests (2001) UL 60601-1 (2003): Medical Electrical Equipment - Part 1: General Requirements for Safety CAN/CSA 22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1990) + Supplement No. 1-94 (1994)
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
975 749 1000 973 749 1599 Fax www.smith-nephow.com
NOV 2 3 2005
We are smith&nephew
K050209
SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.
Smith & Nephew Control Digital Operating Room System
Date Prepared: January 27, 2005
A. Submitter's Name:
Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover, MA 01810
B. Company Contact
Janice Haselton Regulatory Affairs Specialist Phone: (978) 749-1494 Fax: (978) 749-1443
C. Device Name
| Trade Name: | Smith & Nephew Control Digital Operating Room System |
|---|---|
| Common Name: | Endoscopes and accessories, Arthroscopes, Electrosurgical |
| cutting and coagulation device and accessories | |
| Classification Name: | General and Plastic Surgery, Orthopedic, |
| Gastroenterology/Urology |
D. Predicate Devices
The Smith & Nephew Control Digital Operating Room System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Olympus EndoALPHA
1
Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393.
Description of Device E.
The proposed Smith & Nephew Control Digital Operating Room System is a computer based system that enables centralized status display and control of multiple medical and non-medical devices through touch panel activation or through an optional voice recognition feature. The primary system consists of a Medical Device Controller, Medical Device Hub, Primary Touch Panel Interface (TPI-P), Surgical Touch Panel Interface (TPI-S), Ethernet Router and AVB network hub and AVB Power Supply.
Optional components include:
- speech recognition engine ●
- a wireless microphone for speech recognition .
- a wireless touch screen interface that can be bagged and placed in the . sterile field
- . a display controller which allows device settings and conditions to be displayed on the surgeon's monitor
F. Intended Use
The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.
G. Comparison of Technological Characteristics
The Smith & Nephew Control Digital Operating Room System is substantially equivalent to the Olympus EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System, cleared in K022393 based on the following similarities:
- a central controller which monitors and controls various medical devices .
- a centralized control panel which displays various medical devices used in . the operating room
- remote control of various medical devices via a touch screen panel ●
- . voice activation and control of various medical devices used in the operating room
H. Summary Performance Data
The performance testing conducted on the Smith & Nephew Control Digital. Operating Room System demonstrates substantial equivalence to the Olympus
2
EndoALPHA Integrated Endosurgery System, cleared in K981993, HERMES Operating Room Control Center, cleared in K990691, and the Sidne™ System. cleared in K022393 based on equivalent performance outcomes of centralized and remote control of medical devices in the O.R.
The Smith & Nephew Control Digital Operating Room System conforms to the following voluntary standards:
IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1988) + Amendment 1 (1991) + Amendment 2 (1995) (UL 2601-1)
IEC 60601-1-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, Safety Requirements for Medical Electrical Systems (1992) + Amendment 1 (1995), (2000)
IEC 60601-1-2 (2001-09) 2nd Edition Medical Electrical Equipment - Part I: General Requirements for Safety; Electromagnetic Compatibility - Requirements & Tests (2001)
UL 60601-1 (2003): Medical Electrical Equipment - Part 1: General Requirements for Safety
CAN/CSA 22.2 No. 601.1 Medical Electrical Equipment - Part 1: General Requirements for Safety (1990) + Supplement No. 1-94 (1994)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is presented in black and white.
NOV 2 3 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Janice Haselton, Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 150 Minuteman Road Andover, Massachusetts 01810
Re: K050209
K030207
Trade/Device Name: Smith & Nephew Control Digital Operating Room System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 17, 2005 Received: October 18, 2005
Dear Ms. Haselton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreatinent date of the Medical Device Amendments, or to conninered print to May 20, 1978, are excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic recry there the device, subject to the general controls provisions of the Act. The 1 ou may, mereleve, mains of the Act include requirements for annual registration, listing of general controls profice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 can be found in the concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I Dr o toseantes over device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualify of trol provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Ms. Janice Haselton
This letter will allow you to begin marketing your device as described in your Section 510(k) This ictier will anow you to ough finding of substantial equivalence of your device to a legally premarket notification "The 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 11 you desire specific daries in (240) 276-0115 . Also, please note the regulation entitled, Contact the Ories of Companisemarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kaubere Invelun
Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
1050209
Device Name: __ The Smith & Nephew Control Digital Operating Room System__
Indications For Use:
The Smith & Nephew Control Digital Operating Room System is indicated for use with compatible endoscopic and surgical equipment for centralized control of these devices and display of device status. The control system provides centralized touch panel and voice control of medical devices for use by the surgeon and O.R. staff.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ------
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buehler MXM
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K050209