MODIFICATION TO HERMES O.R. CONTROL CENTER by COMPUTER MOTION, INC.

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 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 the Smith & Nephew 400 Insufflator. 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 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.

AI/ML Overview

The HERMES® O.R. Control Center is a computer-driven system providing voice control for ancillary devices in surgical settings.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Reported Device Performance (Compliance)
IEC 601-1 (Medical Electrical Equipment)	Compliant
IEC 601-1 Amendment 1	Compliant
IEC 601-2-18	Compliant
UL 2601-1 (Underwriters Laboratory)	Compliant
CAN/CSA-C22.2 No. 601.1 (Medical Electrical Equipment Part 1, General Requirements for Safety)	Compliant
EN55022/A1 (Conducted Emission)	Compliant
EN55022/A1 (Radiated Emission)	Compliant
EN61000-4-2 (Electrostatic Discharge)	Compliant
EN61000-4-3 and EN50140 (RF Immunity)	Compliant
EN61000-4-4 (EFT/Bursts Immunity)	Compliant
EN61000-4-5 (Surge Immunity)	Compliant
EN61000-4-6 (Conducted Immunity)	Compliant
EN60601-1 (International Standard for Medical Electrical Equipment)	Compliant
EN60601-1-1 (General Requirements for Safety - Collateral Standard)	Compliant
EN 60601-1-2 (Emissions and Immunity Test Measurements)	Compliant
VA-24772 (CMI System Functional Testing)	Completed and verified
CP-15345 (CMI Software Verification and Validation)	Completed and verified
VA-19795 (CMI Environmental Testing)	Completed and verified

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

The provided document details various engineering and safety standards (e.g., IEC, EN, UL, CAN/CSA) and internal company tests (CMI System Functional Testing, Software Verification and Validation, Environmental Testing). These types of tests typically involve controlled laboratory environments and specific test configurations, rather than human subject test sets with "data provenance" in the sense of patient data. Therefore, the concept of sample size and data provenance (country of origin, retrospective/prospective) for clinical test sets is not applicable to the data presented in this submission, as it focuses on demonstrating compliance with technical and safety standards.

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

This information is not provided in the document. The tests performed are primarily engineering and hardware/software verification and validation, which rely on defined test procedures and specifications rather than expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the types of engineering and safety tests outlined.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted, as the submission focuses on the safety and effectiveness of a control system for medical devices, not on the interpretation of medical images or data by human readers. The device aims to simplify control during surgery, not to aid in diagnostic or interpretive tasks where an MRMC study would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The submission describes device testing in terms of compliance with various technical and safety standards (e.g., electrical safety, EMC, software functionality). These demonstrate the algorithm's functionality and performance in a standalone capacity within the system's design parameters. However, it's important to note that the device's intended use is inherently with a human operator (the surgeon) in the loop, as it provides "voice control for ancillary devices" and aims to eliminate "relying on verbal communications between the surgeon and other personnel." The described tests verify the technical integrity of the standalone components. While the performance of the voice control algorithm itself would have been tested, the document does not break down specific "standalone algorithm performance" metrics separate from the broader system functional tests (e.g., VA-24772, CP-15345).

7. Type of Ground Truth Used

The ground truth for the various tests appears to be:

Established industry standards and regulations: For tests like IEC, UL, EN, and CAN/CSA, the ground truth is compliance with the specified requirements and limits defined in those standards.
System specifications and design documents: For CMI's internal functional, software, and environmental testing (VA-24772, CP-15345, VA-19795), the ground truth would be predetermined performance specifications, design requirements, and expected operational parameters of the HERMES® O.R. Control Center.

8. Sample Size for the Training Set

This information is not provided and is not applicable. The HERMES® O.R. Control Center is a control system that seems to rely on voice recognition and device integration. While a voice recognition component would historically have a training set, the submission does not detail its development or any machine learning training sets. Instead, the focus is on the safety, electrical, and functional performance of the integrated system.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable.

Summary

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K031956

1 8 2

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:

Submitter Information: (1)
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
Regulation Number:	876.1500
Regulation 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, WOM 2.0L Arthroscopy Pump, Stryker Total Performance System, Berchtold Surgical Lights, Steris Amsco Table Model SP3085, AESOP®HR (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 Smith & Nephew 400 Insufflator. 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

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K031956 2 of 2

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 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 forSafety,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
EN 60601-1-2	Emissions and Immunity TestMeasurements
VA-24772	CMI System Functional Testing
CP-15345	CMI Software Verification andValidation
VA-19795	CMI Environmental Testing

(6) The HERMES® O.R. Control Center has been tested to the following standards:

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal lines above the eagle's head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 7 2003

Mr. Keith Lowery Manager of Regulatory Affairs Computer Motion, Inc. 130-B Cremona Drive Goleta, California 93117

Re: K031956

Trade/Device Name: Modification to HERMES® O.R. Control Center Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 18, 2003 Received: July 3, 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,

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

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INDICATION FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

): K031956

Modification to 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)

Muriam C. Provost

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

510(k) Number K031956

00026

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.