(151 days)
No
The description focuses on voice control for device settings, which is typically implemented using speech recognition technology, not necessarily AI/ML in the context of complex data analysis or pattern recognition for clinical decision support or image processing. The lack of mentions of AI/ML terms, image processing, or training/test data descriptions further supports this.
No
The device, HERMES OR Control Center, is described as a "Voice Control system" designed to simplify the control of other medical devices (camera and light source) during surgery, rather than directly treating a condition or disease.
No
The device description states its function is to offer voice control for surgical equipment settings, simplifying operation rather than providing diagnostic information.
No
The device description explicitly states it is a "computer-driven system" and a "Voice Control system," implying the presence of hardware components beyond just software. It controls physical devices (Stryker Endoscopy 882 Camera and Quantum 5000 Light Source), which requires a hardware interface.
Based on the provided information, the HERMES OR Control Center is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- HERMES OR Control Center Function: The HERMES OR Control Center is a voice control system designed to adjust the settings of endoscopic cameras and light sources during surgical procedures. It facilitates the surgeon's interaction with the equipment used for visualization inside the body.
- Intended Use: The intended use clearly states it's for use with endoscopic equipment in various surgical procedures, not for analyzing biological specimens.
- Device Description: The description focuses on its function as a voice control interface for surgical equipment.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, the HERMES OR Control Center is a surgical accessory or control system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the HERMES OR Control Center is a Voice Control system whose function is to allow for simplified and direct control of Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings by the surgeon, thereby eliminating the necessity of using multiple input interfaces now common in the operating room, or relying upon verbal communications between the surgeon and other personnel in the OR in order to adjust Stryker Endoscopy 882 Camera and Quantum 5000 Light Source.
The HERMES OR Control Center and the Stryker Endoscopy 882 Camera and Quantum 5000 Light Source are indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this systems could be used are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cheleeystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
Product codes
GCJ
Device Description
The HERMES Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.
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 users of the HERMES OR Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
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)
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
La973700
Premarket Notification 510(k) Safety and Effectiveness Summary 13.
HERMES OR Control Center System 510(k) Summary
In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.
1) Submitter Information
FEB 2 4 1998
Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 9505 1 (408) 567-2179 Contact: Carlos Gonzalez Prepared September 17, 1997
and
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117 805-685-3729 Contact: Douglas Bueschel Prepared: September 17, 1997
- Name of Device:
Proprietary Name: HERMES Operating Room Control Center and Accessories Common Name is HERMES Classification Name: Laparoscope, General & Plastic Surgery
-
- The HERMES Operating Room Control Center is a computer-driven system whose basic function is offer the additional option for surgeon selection of attachment device parameter settings utilizing voice control.
The intended use of the HERMES OR Control Center is a Voice Control system whose function is to allow for simplified and direct control of Stryker Endoscopy 882 Camera and Quantum 5000 Light Source settings by the surgeon, thereby eliminating the necessity of using multiple input interfaces now common in the operating room, or relying upon verbal communications between the surgeon and other personnel in the OR in order to adjust Stryker Endoscopy 882 Camera and Quantum 5000 Light Source.
1
The HERMES OR Control Center and the Stryker Endoscopy 882 Camera and Quantum 5000 Light Source are indicated for use in general thoracoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this systems could be used are laparoscopic cholecystectomy, laparoscopic hernia repair. laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectory, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES OR Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
- The HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.
- IEC 601-1 Second Edition 1988 International Standard for Medical Electrical Equipment ●
- IEC 601-1 Amendment 1 1991 International Standard for Medical Electrical Equipment
- IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment .
- . UL 2601-1
- EMC Directive European Union 89/336/EEC .
- CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 .
- HERMES System Functional Test Requirements .
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Douglas P. Bueschel FEB 2 4 1998 Director, Regulatory Affairs and Quality Assurance Computer Motion, Inc. 130-B Cremona Drive Goleta, California 93117
K973700 Re : Hermes Operating Room Control Center Trade Name: Requlatory Class: II Product Code: GCJ Dated: January 2, 1998 Received: January 5, 1998
Dear Mr. Bueschel:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of ... Federal Regulations, Title 21, Parts 800 to 895. substantially equivalent determination assumes compliance withousers w the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Bueschel
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page of
510(k) Number (if known): K973700
Device Name: Hermes Operating Room Control Center
Indications For Use:
র্ব. Indications For Use
The HERMES OR Control Center is indicated for use with Stryker Endoscopy 882 Camera and Quantum 5000 Light Source that is used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cheleeystectomy, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic & thorascopic anterior spinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES ORCC are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
(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 General Restorative Devices | K973700 |
| 510(k) Number |
| Prescription Use (Per 21 CFR 801.109) | |
|---|---|
| --------------------------------------- | -- |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
(Optional Format 1-2-96)