(29 days)
Not Found
Yes
The device description explicitly states "voice control," which is a common application of AI/ML technology for speech recognition and processing.
No.
The device's function is to provide voice control for other surgical devices and simplify their settings, not directly treat a medical condition.
No
The device is described as a "computer-driven system" that provides "voice control for ancillary devices" and simplifies "control of medical device settings." Its function is to manage and control other surgical equipment, not to diagnose conditions or analyze patient data.
No
The device description explicitly states it is a "computer-driven system" and its function is to offer "voice control for ancillary devices." While it provides a software interface for controlling other devices, the description implies a hardware component (the computer system itself) is part of the device. It is not solely software running on existing, general-purpose hardware.
Based on the provided information, the HERMES® O.R. Control Center and Port Expander 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, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- HERMES Function: The HERMES O.R. Control Center is described as a computer-driven system that provides voice control for ancillary medical devices used during surgical procedures. Its purpose is to simplify the control of surgical equipment settings, not to analyze biological specimens.
- Intended Use: The intended use clearly states its application in various endoscopic surgeries and its interaction with other surgical devices. It does not mention any analysis of patient samples.
Therefore, the HERMES O.R. Control Center falls under the category of surgical equipment control systems, not in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FXTM Electrosurgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics® Power Shaver. It can be 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 cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES O.R. Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
Product codes
GCJ
Device Description
The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices.
The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
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
Users of the HERMES O.R. Control Center 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)
The HERMES O.R. Control Center has been tested to the following standards:
- IEC 601-1 International Standard for Medical Electrical Equipment
- IEC 601-1 Amendment 1 International Standard for Medical Electrical Equipment
- IEC 601-2-18 International Standard for Medical Electrical Equipment
- UL 2601-1 Underwriters Laboratory
- CAN/CSA-C22.2 No. 601.1 Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1
- EN55022/A1 Conducted Emission
- EN55022/A1 Radiated Emission
- EN61000-4-2 Electrostatic Discharge
- EN61000-4-3 and EN50140 RF Immunity
- EN61000-4-4 EFT/Bursts Immunity
- EN61000-4-5 Surge Immunity
- EN61000-4-6 Conducted Immunity
- EN60601-1 International Standard for Medical Electrical Equipment
- EN60601-1-1 General Requirements for Safety – Collateral Standard
- EN 60601-1-2 Emissions and Immunity Test Measurements
- VA-24734 CMI System Functional Testing
- CP-15345 CMI Software Verification and Validation
- VA-19795 CMI Environmental Testing
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.
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
K030240
CONFIDENTIAL
HERMES® O.R. Control Center 510(k) Summary
FEB 2 1 2003
In accordance with 21 CFR section 807.92 Computer Motion, Inc. (CMI) is submitting the following 510(k) Summary:
- Submitter Information Computer Motion, Inc. 130-B Cremona Drive Goleta, CA 93117
Contact: Cathy Stupak, Ph.D.
- Name of Device:
| Proprietary Name: | Modification to HERMES® O.R. Control Center |
|---|---|
| Common Name: | HERMES |
| Product Code: | GCJ |
| Classification Name: | Laparoscope for Use in General and Plastic Surgery |
| Regulation Number: | 876.1500 |
| Regulation Class: | Class II. |
- 3)This device is substantially equivalent to the HERMES O.R. Control Center, K973700, and the more recent 510(k) for HERMES control of the Skytron Stellar Series O.R. Lights, K024294.
-
- The HERMES O.R. Control Center is a computer-driven system whose basic function is to offer the surgeon the additional option of voice control for ancillary devices.
The intent of the HERMES O.R. Control Center is to allow for simplified and more direct control of medical device settings by the physician, thereby eliminating the necessity of using the various interfaces existing on ancillary devices, or relying on verbal communications between the surgeon and other personnel in the operating room in order to adjust the surgical equipment.
-
- The HERMES® O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HR (HERMES-Ready™), Valleylab Force FX™ Electro-surgical Unit, Smith & Nephew Dyonics® Access 15 Arthroscopic Fluid Irrigation System, Smith & Nephew Dyonics® Vision 635 Digital Image Management System, , Skytron Stellar Series O.R. Lights, and Smith & Nephew Dyonics® Power Shaver. It can be used in general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy where a laparoscope/endoscope is indicated for use. A few examples of the more common
1
endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thoracoscopic 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 in indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the HERMES O.R Control Center are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.
| Test | Title |
|---|---|
| IEC 601-1 | International Standard for Medical |
| Electrical Equipment | |
| IEC 601-1 Amendment 1 | International Standard for Medical |
| Electrical Equipment | |
| IEC 601-2-18 | International Standard for Medical |
| Electrical Equipment | |
| UL 2601-1 | Underwriters Laboratory |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1, |
| General Requirements for Safety, | |
| General Instructions Part 1 | |
| EN55022/A1 | Conducted Emission |
| EN55022/A1 | Radiated Emission |
| EN61000-4-2 | Electrostatic Discharge |
| EN61000-4-3 and EN50140 | RF Immunity |
| EN61000-4-4 | EFT/Bursts Immunity |
| EN61000-4-5 | Surge Immunity |
| EN61000-4-6 | Conducted Immunity |
| EN60601-1 | International Standard for Medical |
| Electrical Equipment | |
| EN60601-1-1 | General Requirements for Safety – |
| Collateral Standard | |
| EN 60601-1-2 | Emissions and Immunity Test |
| Measurements | |
| VA-24734 | CMI System Functional Testing |
| CP-15345 | CMI Software Verification and |
| Validation | |
| VA-19795 | CMI Environmental Testing |
- The HERMES O.R. Control Center has been tested to the following standards:
2
Image /page/2/Picture/1 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 a human face in profile, with three overlapping profiles creating a sense of depth and dimension. The face is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
FEB 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Computer Motion, Inc. Cathy Stupak, Ph.D. Regulatory Specialist 130 Cremona Drive, Suite B Goleta, California 93117
Re: K030240
Trade/Device Name: Modification to HERMES® O.R. Control Center Regulation Number: 876.1500 Regulation Name: Laparoscope for use in general and plastic surgery Regulatory Class: Class II Product Code: GCJ Dated: January 22, 2003 Received: January 23, 2003
Dear Dr. Stupak:
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.
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 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
3
Page 2 - Dr. Cathy Stupak
Page 2 - Dr. Cathy Stupak
(21 CFR Part 807): labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely vours.
-miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION FOR USE STATEMENT
510(k) Number (if known): _