(29 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, 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.
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 computer-driven system designed to offer surgeons voice control for ancillary devices in the operating room. This system aims to simplify the control of medical device settings, eliminating the need for manual interfaces on various ancillary devices or verbal communication between the surgeon and other personnel.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Safety Standards (Electrical and Medical Equipment) | |
| IEC 601-1 (International Standard for Medical Electrical Equipment) | Device tested to this standard, indicating compliance with general safety requirements for medical electrical equipment. |
| IEC 601-1 Amendment 1 (International Standard for Medical Electrical Equipment) | Device tested to this standard, indicating compliance with an amendment to the general safety requirements. |
| IEC 601-2-18 (International Standard for Medical Electrical Equipment) | Device tested to this specific standard, likely related to the particular type of medical electrical equipment. |
| UL 2601-1 (Underwriters Laboratory) | Device tested to this standard, indicating compliance with UL safety requirements. |
| CAN/CSA-C22.2 No. 601.1 (Medical Electrical Equipment Part 1, General Requirements for Safety, General Instructions Part 1) | Device tested to this Canadian/CSA standard, indicating compliance with general safety requirements for medical electrical equipment. |
| EN60601-1 (International Standard for Medical Electrical Equipment) | Device tested to this European standard, indicating compliance with general safety requirements for medical electrical equipment. |
| EN60601-1-1 (General Requirements for Safety – Collateral Standard) | Device tested to this collateral standard, indicating compliance with specific safety aspects. |
| Electromagnetic Compatibility (EMC) | |
| EN55022/A1 (Conducted Emission) | Device tested for conducted emissions, indicating compliance with limits on electromagnetic interference generated and conducted through power lines. |
| EN55022/A1 (Radiated Emission) | Device tested for radiated emissions, indicating compliance with limits on electromagnetic interference generated and radiated into the environment. |
| EN61000-4-2 (Electrostatic Discharge) | Device tested for electrostatic discharge immunity, indicating its ability to withstand static electricity without malfunction. |
| EN61000-4-3 and EN50140 (RF Immunity) | Device tested for radiofrequency (RF) immunity, indicating its ability to operate correctly in the presence of RF electromagnetic fields. |
| EN61000-4-4 (EFT/Bursts Immunity) | Device tested for electrical fast transient/burst immunity, indicating its ability to withstand short-duration, high-frequency electrical bursts. |
| EN61000-4-5 (Surge Immunity) | Device tested for surge immunity, indicating its ability to withstand transient overvoltages. |
| EN61000-4-6 (Conducted Immunity) | Device tested for conducted immunity, indicating its ability to operate correctly in the presence of electromagnetic disturbances conducted through signal lines. |
| EN 60601-1-2 (Emissions and Immunity Test Measurements) | Device tested to this standard, indicating compliance with general requirements for EMC in medical electrical equipment. |
| Functional and Software Performance | |
| VA-24734 (CMI System Functional Testing) | Device underwent CMI System Functional Testing, demonstrating that the system performs its intended functions as specified. (Details of specific functions or metrics are not provided in the summary.) |
| CP-15345 (CMI Software Verification and Validation) | Device underwent CMI Software Verification and Validation, confirming that the software meets its specified requirements and is fit for its intended use. (Specific verification/validation metrics are not provided.) |
| Environmental Performance | |
| VA-19795 (CMI Environmental Testing) | Device underwent CMI Environmental Testing, demonstrating its ability to safely and effectively operate within specified environmental conditions (e.g., temperature, humidity). (Specific test parameters or results are not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not contain information regarding:
- The sample size used for any specific test set.
- The data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The 510(k) summary does not contain information about:
- The number of experts used to establish ground truth.
- The qualifications of those experts.
The tests conducted are primarily engineering and compliance-based (electrical safety, EMC, software verification, environmental testing), rather than clinical performance evaluations that would typically involve expert-established ground truth. The focus is on the device's adherence to recognized standards for safety and fundamental operation.
4. Adjudication Method for the Test Set:
Given the nature of the tests (compliance with IEC, UL, CSA, EN standards, functional testing), an adjudication method in the context of expert review for a "test set" (as might be seen in diagnostic AI) is not applicable or detailed in this summary. The tests involve quantifiable measurements against established standards, and functional checks against specification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
Based on the provided text, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. The device is an O.R. control system, not a diagnostic imaging AI that would typically undergo such a study. The "AI" component is its voice control for ancillary devices, which is assessed for functionality and safety rather than diagnostic accuracy or comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The "HERMES® O.R. Control Center" is itself a standalone system (it functions independently as a computer-driven control center). The provided tests are evaluating the performance of this system as a whole, including its software, electronics, and voice recognition capabilities. There isn't a clear distinction made between "algorithm only" performance versus "human-in-the-loop," as the device's primary function is to serve the human surgeon. Its performance is its standalone capability to interpret voice commands and control ancillary devices.
7. The Type of Ground Truth Used:
For the compliance tests (IEC, UL, CSA, EN standards), the "ground truth" is the published requirements and limits defined by those international and national standards. For CMI System Functional Testing, Software Verification and Validation, and Environmental Testing, the "ground truth" would be the detailed specifications and design requirements internally defined by Computer Motion, Inc. for the HERMES system.
8. The Sample Size for the Training Set:
The 510(k) summary does not contain information regarding a "training set" or its sample size. This type of information is typically relevant for machine learning or AI models that learn from data, which is not explicitly discussed here in that context. While the voice recognition component undoubtedly involves some form of training, details are not provided.
9. How the Ground Truth for the Training Set Was Established:
As no specific training set is discussed, the summary does not provide information on how its ground truth might have been established. For any voice recognition components, ground truth during development would likely involve carefully curated voice commands and their corresponding intended actions, possibly recorded by various speakers in different conditions, and transcribed/labeled for training purposes. However, these specifics are beyond the scope of the provided 510(k) summary.
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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 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 |
| EN 60601-1-2 | Emissions and Immunity TestMeasurements |
| VA-24734 | CMI System Functional Testing |
| CP-15345 | CMI Software Verification andValidation |
| VA-19795 | CMI Environmental Testing |
- 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 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
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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
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INDICATION FOR USE STATEMENT
510(k) Number (if known): _ << 0 3 0 2 4 0
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, 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.
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
iriam C. Provost
Division Sign-Off) Division of General, Restorative and Neurological Devices
Use $\rlap{\kern 2pt/}$10(k) Number K030240
OR Over-the-Counter U=
Prescription Use (per 21 CFR 801.109)
Over-the-Counter Use (Optional Format 1-2-96)
§ 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.