(38 days)
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 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 is a device that allows for voice control of ancillary medical devices during surgical procedures. The 510(k) summary provides information on the device's adherence to various engineering and safety standards, but it does not include a study proving device performance against specific clinical acceptance criteria in terms of AI accuracy or effectiveness.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various standards the device was tested against. These are primarily safety, electrical, and software validation standards, not performance metrics related to diagnostic accuracy or clinical outcomes often seen in AI/ML medical devices. Therefore, the "reported device performance" in relation to clinical acceptance criteria is not applicable or provided in this context.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 601-1 (and Amendment 1) | Met the standard for Medical Electrical Equipment |
| IEC 601-2-18 | Met the standard for Medical Electrical Equipment |
| UL 2601-1 | Met the Underwriters Laboratory standard |
| CAN/CSA-C22.2 No. 601.1 | Met the Canadian standard for Medical Electrical Equipment |
| EN55022/A1 (Conducted Emission) | Met the standard for Conducted Emission |
| EN55022/A1 (Radiated Emission) | Met the standard for Radiated Emission |
| EN61000-4-2 (Electrostatic Discharge) | Met the standard for Electrostatic Discharge |
| EN61000-4-3 and EN50140 (RF Immunity) | Met the standard for RF Immunity |
| EN61000-4-4 (EFT/Bursts Immunity) | Met the standard for EFT/Bursts Immunity |
| EN61000-4-5 (Surge Immunity) | Met the standard for Surge Immunity |
| EN61000-4-6 (Conducted Immunity) | Met the standard for Conducted Immunity |
| EN60601-1 (International Standard) | Met the standard for Medical Electrical Equipment |
| EN60601-1-1 (Collateral Standard) | Met the General Requirements for Safety |
| EN60601-1-2 (Emissions and Immunity Test) | Met the Emissions and Immunity Test Measurements |
| VA-24772 (CMI System Functional Testing) | Met internal functional testing requirements |
| CP-15345 (CMI Software Verification and Validation) | Met internal software verification and validation requirements |
| VA-19795 (CMI Environmental Testing) | Met internal environmental testing requirements |
Note: This submission primarily focuses on electrical safety, electromagnetic compatibility, and software validation for a device that provides voice control functionality. It is not an AI/ML device in the modern sense that interprets data for diagnostic or predictive purposes, and therefore, typical AI acceptance criteria like sensitivity, specificity, or AUC based on clinical data are not present.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a clinical "test set" for performance evaluation in the context of diagnostic or predictive AI. The testing mentioned refers to technical standards compliance (functional, environmental, software). Therefore, information on sample size, data provenance, or retrospective/prospective nature of a clinical test set is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As there is no clinical "test set" for evaluating diagnostic or predictive performance, there is no information on experts establishing ground truth. The device's function is voice control, and ground truth would relate to the accuracy of voice command recognition and execution, which would be covered under functional testing (VA-24772).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set for diagnostic/predictive performance is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The HERMES O.R. Control Center is a voice-controlled interface for surgical equipment, not an AI system designed to assist human "readers" (e.g., radiologists interpreting images). The purpose is to streamline control, not to improve diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a "human-in-the-loop" device by its very nature, as it responds to voice commands from a surgeon. Therefore, a standalone (algorithm only) performance, in the context of interpretation, is not applicable. Its standalone performance would be its ability to accurately recognize and execute commanded actions, which would fall under functional testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional aspects of the device, the ground truth would likely be the correct understanding and execution of voice commands by the system, as verified during "CMI System Functional Testing" (VA-24772) and "CMI Software Verification and Validation" (CP-15345). This is not a clinical ground truth like pathology or outcomes data, but rather a technical ground truth related to functional correctness.
8. The sample size for the training set
This device, in this submission, is not described as an AI/ML device that undergoes "training" on a dataset in the modern sense (e.g., for image recognition or predictive analytics). It's a control system with voice recognition. The "training" for such a system typically involves developing and refining the voice recognition algorithms against a collection of voice commands, but the document does not specify a training set size or methodology.
9. How the ground truth for the training set was established
Given the absence of a described "training set" as understood in current AI/ML contexts, there is no information on how ground truth for a training set was established. For voice recognition, ground truth would usually involve correctly transcribed speech paired with the associated intended action, but these details are not provided in the 510(k) summary.
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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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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 MedicalElectrical Equipment |
| IEC 601-1 Amendment 1 | International Standard for MedicalElectrical Equipment |
| IEC 601-2-18 | International Standard for MedicalElectrical 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 MedicalElectrical Equipment |
| EN60601-1-1 | General Requirements for Safety -Collateral Standard |
| EN60601-1-2 | Emissions and Immunity TestMeasurements |
| VA-24772 | CMI System Functional Testing |
| CP-15345 | CMI Software Verification andValidation |
| VA-19795 | CMI Environmental Testing |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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.