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, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation 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, 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.

Device Description

The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.

AI/ML Overview

The HERMES™ O.R. Control Center is a computer-driven system for voice control of ancillary devices during endoscopic surgeries.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Standard Met)	Reported Device Performance
IEC 601-1 / EN60601-1	International Standard for Medical Electrical Equipment	Device tested to and meets this standard.
IEC 601-1 Amendment 1	International Standard for Medical Electrical Equipment	Device tested to and meets this standard.
IEC 601-2-18	International Standard for Medical Electrical Equipment	Device tested to and meets this standard.
UL 2601-1	Underwriters Laboratory Standard	Device tested to and meets this standard.
CAN/CSA-C22.2 No. 601.1	Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1	Device tested to and meets this standard.
EN55022/A1 Conducted Emission	Conducted Emission Standard	Device tested to and meets this standard.
EN55022/A1 Radiated Emission	Radiated Emission Standard	Device tested to and meets this standard.
EN61000-4-2 Electrostatic Discharge	Electrostatic Discharge Standard	Device tested to and meets this standard.
EN61000-4-3 and EN50140 RF Immunity	RF Immunity Standard	Device tested to and meets this standard.
EN61000-4-4 EFT/Bursts Immunity	EFT/Bursts Immunity Standard	Device tested to and meets this standard.
EN61000-4-5 Surge Immunity	Surge Immunity Standard	Device tested to and meets this standard.
EN61000-4-6 Conducted Immunity	Conducted Immunity Standard	Device tested to and meets this standard.
EN60601-1-1	General Requirements for Safety - Collateral Standard	Device tested to and meets this standard.
EN 60601-1-2 Emissions and Immunity Test	Emissions and Immunity Test Measurements Standard	Device tested to and meets this standard.
System Functional Testing	N/A (Implied successful operation for intended use)	Successful completion of system functional testing reported.
Software Verification and Validation	N/A (Implied successful verification and validation)	Successful completion of software verification and validation reported.
Environmental Testing	N/A (Implied successful performance under specified environmental conditions)	Successful completion of environmental testing reported.

Summary of the Study Proving Device Meets Acceptance Criteria:

The provided document describes a 510(k) submission for the HERMES™ O.R. Control Center, indicating that the device has undergone various tests to demonstrate its safety and effectiveness. The main study described is the testing of the device against a comprehensive set of international and national medical device standards, as listed in the table above. These standards cover aspects such as electrical safety, electromagnetic compatibility, and general safety requirements for medical electrical equipment.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a "test set" in the context of clinical data or images. The testing described is primarily engineering and performance-based to ensure compliance with relevant safety and performance standards. Therefore, concepts like sample size for a test set and data provenance (country of origin, retrospective/prospective) are not directly applicable to the type of testing reported for this device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable. The "ground truth" for this device's acceptance is its adherence to established engineering and safety standards, rather than a clinical diagnosis or interpretation requiring expert consensus.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing involves compliance with technical standards, not interpretation of clinical data.

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:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The HERMES™ O.R. Control Center is a voice-controlled system for ancillary devices, not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:

A "standalone" performance study in the context of an algorithm's diagnostic accuracy was not done. The device's function is to provide voice control, and its performance is evaluated based on its ability to control the integrated devices and its compliance with safety and performance standards, not as a standalone diagnostic algorithm.

7. The type of ground truth used:

The "ground truth" used for this device's acceptance is its compliance with internationally recognized and national medical electrical equipment and safety standards. This is a functional and safety ground truth, rather than a clinical ground truth like pathology, expert consensus on images, or outcomes data.

8. The sample size for the training set:

The document does not mention a "training set." The HERMES™ O.R. Control Center is a control system, not a machine learning model that requires a training set of data.

9. How the ground truth for the training set was established:

This information is not applicable as there is no mention of a training set or machine learning components in the described device.

Summary

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K022897

HERMES™ O.R. Control Center 510(k) Summary of Safety and Effectiveness

OCT 11 2002

In accordance with 21 CFR section 807.92 Computer Motion is submitting the following safety and effectiveness summary.

Submitter Information

Computer Motion, Inc. 130-B Cremona Drive Goleta, CA 93117

Contact: Cathy Stupak, Ph.D.

Name of Device:

Proprietary Name:	HERMES™ O.R. Control Center
Common Name:	HERMES
Classification Name:	Laparoscope for Use in General and Plastic Surgery
Regulation Number:	876.1500
Class:	Class II.

1. Substantially equivalent to HERMES O.R. Control Center, K973700, and the more recent 510(k), K003222, for HERMES control of the Valleylab Force FXTM Electrosurgical Unit.
1. The HERMES O.R. Control Center is a computer-driven system whose basic function is offer voice control of ancillary devices.

The HERMESTM O.R. Control Center and Port Expander is indicated for use with Stryker Endoscopy 882 Camera, Stryker Quantum 5000 Light Source, Stryker SE5 Shaver, W.O.M. 20L Insufflator, W.O.M. 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP® HERMES-Ready™, Valleylab Force FX™ Electro-surgical Unit, and Dyonics® Access 15 Arthroscopic Fluid Irrigation 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, 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,

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gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists.

Test	Comments
IEC 601-1	International Standard for Medical ElectricalEquipment
IEC 601-1 Amendment 1	International Standard for Medical ElectricalEquipment
IEC 601-2-18	International Standard for Medical ElectricalEquipment
UL 2601-1	Underwriters Laboratory
CAN/CSA-C22.2 No. 601.1	Medical Electrical Equipment Part 1, GeneralRequirements for Safety, General InstructionsPart 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 ElectricalEquipment
EN60601-1-1	General Requirements for Safety -CollateralStandard
EN 60601-1-2	Emissions and Immunity TestMeasurements
N/A	System Functional Testing
N/A	Software Verification and Validation
N/A	Environmental Testing

1. The HERMES O.R. Control Center has been tested to the following standards:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

11 2002

Computer Motion, Inc. Cathy Stupak, Ph.D. Regulatory Specialist 130 Cremona Drive, Suite B Goleta, California 93117

Re: K022897

Trade/Device Name: Modification to Hermes Operating Room Control Center Regulation Number: 876.1500 Regulation Name: Laparoscope for use in general and plastic surgery Regulatory Class: Class II Product Code: GCJ Dated: October 1, 2002 Received: October 2, 2002

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 (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 – Dr. Cathy Stupak

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR 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.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ra 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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CONFIDENTIAL

INDICATION FOR USE STATEMENT

510(k) Number (if known):

HERMES O.R. Control Center Device Name:

(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)

Over-the-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of General, Restorative and Neurological Devices

510(k) Number	K022897
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000024

Regulation Number and Section

§ 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.