(29 days)
The Nurse's Assistant® is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The Nurse's Assistant® is intended to be used to turn on and off, and adjust certain settings of, endoscopic and surgical cameras, electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 Insufflator, surgical lamps, operating room ("O.R.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radios and CD players.
The Nurse's Assistant® is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic and thorascopic anteriorspinal 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 is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
The Nurse's Assistant is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The document describes the ConMed Integrated Systems' Nurse's Assistant® O.R. Control System, a programmable controller that offers a simplified remote user interface and real-time display of settings for various surgical equipment. The device is intended to turn on, turn off, and adjust settings of endoscopic and surgical cameras, electrosurgical generators, laparoscopic insufflators, surgical lamps, operating room lights, and to operate digital documentation products, VCRs, video monitors, video printers, radios, and CD players.
Here's an analysis of the provided information, framed by your request for acceptance criteria and study details:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific quantitative acceptance criteria (e.g., performance metrics like accuracy, sensitivity, or specificity for a particular function) nor does it report the device's performance against such criteria in a clinical or analytical study.
Instead, the document focuses on compliance with safety standards as its primary method for demonstrating acceptable performance and substantial equivalence. The "acceptance criteria" can be inferred as the successful completion of these listed safety tests, which inherently imply the product is functioning as intended and safely.
If we interpret "acceptance criteria" as meeting safety standards and "reported device performance" as the successful completion of these tests, a table would look like this:
| Acceptance Criterion (Test Standard) | Reported Device Performance |
|---|---|
| IEC 601-1 | Tested to standard |
| IEC 601-1 Amendment 1 | Tested to standard |
| IEC 601-2-18 | Tested to standard |
| EN 60601-1 | Tested to standard |
| EN 60601-1-1 | Tested to standard |
| EN 60601-1-2 (2001) | Tested to standard |
| CAN/CSA C22.2 601.1-M90 | Tested to standard |
| UL 2601-1, 2nd Ed. | Tested to standard |
| EN 55011 (Conducted Emissions) | Tested to standard |
| EN 55011 (Radiated Emissions) | Tested to standard |
| IEC 61000-4-2 (Electrostatic Discharge) | Tested to standard |
| IEC 61000-4-3 (Radio Frequency Electromagnetic Fields) | Tested to standard |
| IEC 61000-4-4 (Fast Transients Common Mode) | Tested to standard |
| IEC 61000-4-5 (High Energy Surge) | Tested to standard |
| IEC 61000-4-6 (Conducted Immunity) | Tested to standard |
Explanation: The document explicitly states, "The Nurse's Assistant® O.R. Control System has been tested to the following standards:" followed by the list above. The implied "performance" is that the device successfully met the requirements of each standard.
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" in the traditional sense of patient data. The testing performed was related to electrical safety and electromagnetic compatibility standards. Therefore, concepts like "sample size" for patient data, "country of origin," or "retrospective/prospective" are not applicable here. The testing was likely conducted in a laboratory environment on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the type of testing described (safety and EMC standards). "Ground truth" in this context would be whether the device passed or failed a specific engineering test, which is determined by test engineers and equipment, not by medical experts establishing a "ground truth" on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies for interpretation of results by multiple experts. The testing described is against engineering standards.
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 Nurse's Assistant® O.R. Control System is a control interface for surgical equipment, not an AI-powered diagnostic or assistive tool for human readers/clinicians, so an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an O.R. control system that relies on a "human-in-the-loop" (the O.R. staff) to operate it. It is not an autonomous algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the requirements and specifications defined by the various international and national safety and EMC standards (e.g., IEC 601-1, UL 2601-1, EN 55011). The device was tested to ensure it met these pre-defined engineering and safety "truths."
8. The sample size for the training set
Not applicable. The Nurse's Assistant® O.R. Control System is a hardware and software control system, not an AI/ML algorithm that requires a "training set" of data in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set."
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with its wings and tail feathers represented by thick, curved lines. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ConMed Intergrated Systems Mr. C. Jeff Lipps Director of Regulatory Affairs 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006
JUL 2 7 2015
Re: K031979
Trade/Device Name: ConMed Integrated Systems' Nurse's Assistant® O.R. Control System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ, FET, FSY, HET, HIF, GEI and LMC Dated (Date on orig SE ltr): June 25, 2003 Received (Date on orig SE ltr): June 26, 2003
Dear Mr. Lipps,
This letter corrects our substantially equivalent letter of July 25, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
{1}------------------------------------------------
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
XIV. INDICATIONS FOR USE STATEMENT
510(k) Number: K031979
Device Name:
Modification to ConMed Integrated Systems' Nurse's Assistant® O.R. Control System
Indications for Use:
The Nurse's Assistant® is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
The Nurse's Assistant® is intended to be used to turn on and off, and adjust certain settings of, endoscopic and surgical cameras, electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 Insufflator, surgical lamps, operating room ("O.R.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radios and CD players.
The Nurse's Assistant® is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectorny, laparoscopic and thorascopic anteriorspinal 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 is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
(Per 21 C.F.R. 801.109)
(Optional Formal 1-2-96)
ConMed Integrated Systems Nurse's Assistant Special 510/k) Notification
{3}------------------------------------------------
03/979
Confidential
JUL 25 2003 XIII. 510(K) SUMMARY
Modified Nurse's Assistant® O.R. Control System
In accordance with 21 CFR section 807.92, ConMed Integrated Systems is submitting the following 510(k) summary:
1) Date Submitted
June 25, 2003
2) Submitter Information
ConMed Integrated Systems 1815 NW 169th Place, Suite 4020 Beaverton, OR 97006 Contact: C. Jeff Lipps, BS/MBA, Dir. of RA (503) 614-1106 ext. 1206 Phone Fax (503) 614-1109
3) Name of Device
| Proprietary Name: | Nurse's Assistant® O.R. Control System |
|---|---|
| Common Name: | Surgical Control Center |
| Classification Names: | Surgical Lamp, 878.4580Endoscope and accessories, 876.1500Gynecologic laparoscope and accessories, 884.1720Laparoscopic insufflator, 884.1730Electrosurgical cutting and coagulation deviceand accessories, 878.4400Medical image hardcopy device, 892.2040 |
| Product Codes: | FSY, GCJ, FET, KOG, HET, HIF, GEI, LMC |
| Classification Panel: | General & Plastic Surgery |
| Device Class: | Class II |
1 of 3
ConMed Integrated Systems Nurse's Assistant Special 510(k) Notification
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the text "Ko3/1979 Confidential". The text is written in black ink on a white background. The word "Confidential" is written in a smaller font size than the other text.
510(k) Summary - Modified Nurse's Assistant® O.R. Control System
Page 2
4) Predicate Devices
This device is substantially equivalent to the ConMed Integrated Systems' Nurse's Assistant®O.R. Control System (K010754), Modification to Olympus' Integrated Endosurgery System EndoALPHA (K022270), and Modification to Computer Motion's HERMES Operatir g Room Control Center (K030240).
5) Device Description
The Nurse's Assistant is a programmable controller operated through a touch screen GUI that offers professional O.R. staff a simplified remote user interface and a real time display of settings for the devices attached to the system thereby eliminating the necessity for using the various control panels on diverse surgical equipment.
6) Intended Use
The Nurse's Assistant is intended to be used to turn on and off, and adjust certain settings of, endoscopic and surgical cameras, electrosurgical generators such as the ConMed System 5000 ESU, laparoscopic insufflators such as the Linvatec GS1002 Insufflator, surgical lamps, operating room ("O.H.") lights, and operate digital documentation products, VCR's, video monitors, video printers, radics and CD players.
7) Indications for Use:
The Nurse's Assistant® is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, nasopharyngoscopy, ear endoscopy, and sinuscopy. A few examples of the more common surgical procedures where this system could be used are laparoscopic cholecystectorny, laparoscopic hernia repair, laparoscopic appendectorny, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anteriorspinal fusion, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectorny, pleurodesis, internal mammary artery dissection for coronary antery bypass, coronary artery bypass grafting where endoscopic visualization Is indicated, examination of the evacuated cardiac chamber during performance of valve replacement, arthroscopic meniscus repair, anterior cruciate ligament repair and associated procedures.
ConMed Integrated Systems Nurse's Assistant Special 510{k} Notification 27
2 of 3
{5}------------------------------------------------
Ko31979
Confidential
510(k) Summary – Modified Nurse's Assistant® O.R. Control System
Page 3
8) Applied Safety Standards:
The Nurse's Assistant®O.R. Control System has been tested to the following standards:
| Test | Title |
|---|---|
| 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 |
| EN 60601-1 | International Standard for Medical ElectricalEquipment |
| EN 60601-1-1 | General Requirements for Safety - CollateralStandard |
| EN 60601-1-2 (2001) | International Standard for Medical ElectricalEquipment, Electro Magnetic Compatibility(EMC) |
| CAN/CSA C22.2 601.1-M90 | Medical Electrical Equipment - Part 1: GeneralRequirements for Safety, General InstructionNo. 1; Supplement 1; 1994 R(1997) |
| UL 2601-1, 2nd Ed. | UL Standard for Safety Medical ElectricalEquipment, Part 1: General Requirements forSafety, 2nd Ed. |
| EN 55011 | Conducted Emissions |
| EN 55011 | Radiated Emissions |
| IEC 61000-4-2 | Electrostatic Discharge |
| IEC 61000-4-3 | Radio Frequency Electromagnetic Fields |
| IEC 61000-4-4 | Fast Transients Common Mode |
| IEC 61000-4-5 | High Energy Surge |
| IEC 61000-4-6 | Conducted Immunity |
28
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.