(38 days)
No
The device description mentions "voice control" but does not use terms like AI, ML, or deep learning, nor does it describe capabilities typically associated with advanced AI/ML processing of data or images. The focus is on simplified control through voice commands, which can be achieved with traditional voice recognition technology.
No
The device is described as a control system that offers voice control for ancillary devices, aiming to simplify the control of medical device settings by the physician. It does not directly perform any therapeutic action on a patient.
No
The device description indicates its function is to provide voice control for ancillary devices and simplify the control of medical device settings, not to diagnose a condition.
No
The device description explicitly states it is a "computer-driven system" and mentions a "Port Expander" in the name, implying 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 describes the device as a control center and port expander for various surgical devices used in endoscopic procedures. It focuses on controlling and simplifying the operation of these devices during surgery.
- Device Description: The description reinforces this by explaining its function as a computer-driven system for voice control and simplified adjustment of medical device settings in the operating room.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens.
The device's function is to facilitate and control surgical procedures, not to perform diagnostic tests on biological samples.
N/A
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 System, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®R (HERMES-Ready™), Valleylab Force FX™ 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, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew InteliJET Arthroscopic Fluid Management System. 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, appendectorny, laparoscopic pelvic lymph node laparoscopic 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.
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
Smith & Nephew Dyonics® Vision 635 Digital Image Management System
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 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; IEC 601-1 Amendment 1; IEC 601-2-18; UL 2601-1; CAN/CSA-C22.2 No. 601.1; 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; EN60601-1-1; EN60601-1-2; VA-24772 (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)
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 1 1 2003
1 2003 K031720
HERMES® O.R. Control Center 510(k) Summary
In accordance with 21 CFR section 807.92 Computer Motion, Inc. (CMI) is submitting the following 510(k) Summary:
- (1) Submitter Information:
Computer Motion, Inc. 130-B Cremona Drive Goleta, CA 93117
Contact: Keith Lowrey, Manager of Regulatory Affairs
-
(2) 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 Requlation Number: 876.1500 Requlation Class: Class II. -
This device is substantially equivalent to the HERMES O.R. Control Center, (3) K973700, and the more recent 510(k) for HERMES control of the S&N Dyonics® Power Shaver, K030240.
-
The HERMES O.R. Control Center is a computer-driven system whose basic (4) 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 (5) Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, WOM 20L Insufflator System, 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, S&N Dyonics® Power Shaver (K030240), and Smith & Nephew InteliJET Arthroscopic Fluid Management System. lt 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
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1
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.
- The HERMES® O.R. Control Center has been tested to the following standards: (6)
| 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 | |
| EN60601-1-2 | Emissions and Immunity Test |
| Measurements | |
| VA-24772 | CMI System Functional Testing |
| CP-15345 | CMI Software Verification and |
| Validation | |
| VA-19795 | CMI Environmental Testing |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle with three stylized wings.
Public Health Service
JUL 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Keith Lowery Manager of Regulatory Affairs Computer Motion, Inc 130 Cremona Drive, Suite B Goleta. California 93117
Re: K031720
Trade/Device Name: Modification to Hermes O.R. Control Center Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope Regulatory Class: II Product Code: GCJ Dated: May 30, 2003 Received: June 13, 2003
Dear Mr. Lowery:
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 (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.
3
Page 2 - Mr. Keith Lowery
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. 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" (21CFR Part 807.97) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Melleusa
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):
510(k) Number (if known): K031720
Modification to HERMES® O.R. Control Center Device Name:
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 System, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, Steris Amsco Table Model SP3085, AESOP®R (HERMES-Ready™), Valleylab Force FX™ 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, S&N Dyonics® Power Shaver (K030240) and the Smith & Nephew InteliJET Arthroscopic Fluid Management System. 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, appendectorny, laparoscopic pelvic lymph node laparoscopic 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.
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
Prescription Use
(per, 21 CFR 801.109)
✓
OR
Over-the-Counter Use (Optional Format 1-2-96)
Mark A. Wilkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
00025
510(k) Number K031720