(155 days)
The Val Med Nurse's Assistant is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R.") lights, and to operate VCRs, monitors, video printers, radios, and CD players.
The Val Med 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 cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, 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 Val Med's Nurse's Assistant is a computer with a monitor and touch screen that a nurse uses in the operating room to activate and control the following equipment: (1) surgical cameras, including an endoscopic camera; (2) room or surgeons' nurses' lounge cameras ("operating room cameras"); (3) surgical lights; (4) room lights; (5) a VCR; (6) a video printer; (7) video monitor(s); (8) a radio; and (9) a CD player. Val Med's Nurse's Assistant controls one or more electrical dimmer switches, which in turn control the surgical lights.
The furnished text describes a 510(k) premarket notification for the "Val Med Corporation Nurse's Assistant O.R. Control System." This document is a regulatory submission to the FDA, asserting substantial equivalence to existing predicate devices. It does not present a study with specific acceptance criteria and performance data in the way typically found for AI/ML-driven medical devices or devices where quantitative performance metrics are critical for safety and effectiveness.
Instead, the document focuses on demonstrating that the device meets safety standards and has similar technological characteristics and intended uses as predicate devices. The "Performance Data" section specifically references compliance with recognized electrical safety and software standards, which are a form of acceptance criteria for medical devices, but not in the format of a clinical performance study.
Here's an analysis based on the information provided, highlighting why certain requested sections cannot be fulfilled based on this document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance |
|---|---|
| Control Unit: EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety 4: Collateral Standard: Programmable Electrical Medical Systems | The Nurse's Assistant's control unit meets EN 60601-1. |
| Power Supply: UL 2601-1 "U.L. Standard for Safety for Medical Electrical Equipment - General Requirements for Safety" | The Nurse's Assistant's power supply meets UL 2601-1. |
| Controlling Software: ANSI standard 1375-221 | The Nurse's Assistant's controlling software meets ANSI standard 1375-221. |
Missing Information/Not Applicable:
The document does not describe acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or other quantitative measures of how well the device performs a specific diagnostic or therapeutic function). This is because the Nurse's Assistant O.R. Control System appears to be a control interface and integration system, not a device directly performing diagnostic analysis or treatment requiring such performance metrics. Its "performance" is primarily defined by its ability to reliably control other medical equipment and adherence to safety and software standards.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided because the document describes compliance with engineering and software standards, not a clinical study on a patient population. There is no "test set" in the context of clinical data.
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 provided. Ground truth, in the context of clinical or diagnostic performance, is not applicable to the type of device and submission described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods are relevant for clinical studies establishing ground truth, which is not applicable here.
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:
This information is not provided. MRMC studies are used for evaluating diagnostic or interpretive AI systems, which this device is not. The Nurse's Assistant is an O.R. control system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. This concept is relevant for AI/ML-driven diagnostic devices. The Nurse's Assistant is a control system that integrates human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. Ground truth, in the clinical/diagnostic sense, is not applicable to this device's regulatory submission.
8. The sample size for the training set:
This information is not provided. Training sets are relevant for AI/ML models. This device is a control system, not an AI/ML diagnostic or predictive tool.
9. How the ground truth for the training set was established:
This information is not provided. Not applicable for the reasons stated above.
Summary of Device and Performance:
The Val Med Corporation Nurse's Assistant O.R. Control System is a computer-based system with a monitor and touch screen intended to control various pieces of operating room equipment, including endoscopic and surgical cameras, surgical lamps, O.R. lights, VCRs, monitors, video printers, radios, and CD players.
Its "performance" as described in this 510(k) submission is solely based on its compliance with established safety and software standards:
- EN 60601-1: General Requirements for Safety of Medical Electrical Equipment, with a specific collateral standard for Programmable Electrical Medical Systems. This ensures the electrical safety and basic functional safety of the control unit.
- UL 2601-1: U.L. Standard for Safety for Medical Electrical Equipment, ensuring the power supply meets safety requirements.
- ANSI standard 1375-221: For the controlling software, indicating adherence to a relevant software development or quality standard.
The submission demonstrates substantial equivalence to predicate devices (e.g., Computer Motion's Hermes, Olympus EndoAlpha, Karl Storz KSEA SCB-RUI) based on similar intended use, indications for use, and technological characteristics. The document does not describe any studies involving clinical performance data, patient outcomes, or expert interpretations because the device's function is to control and integrate other equipment, not to perform diagnostic or therapeutic interventions requiring such clinical performance validation.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged around the top and left side of the circle. The logo is simple and recognizable, representing the department's role in providing health and human services to the United States.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Val Med Corpration % Mr. Howard M. Holstein, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Columbia Square Washington, D.C. 20004
JUL 2 7 2015
Re: K010754
Trade/Device Name: Val Med Corporation 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 Itr): July 5, 2001 Received (Date on orig SE ltr): July 5, 2001
Dear Mr. Holstein.
This letter corrects our substantially equivalent letter of August 15, 2001.
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
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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/ReportalProblem/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
Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K 010754
Device Name:
Val Med Corp. Nurse's Assistant O.R. Control System
Indications for Use:
The Nurse's Assistant is intended to be used to turn on and off and I he Nurse's Assistants of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R.") lights, and to operate VCRs, monitors, video printers, radios, and CD players.
The Val Med Nurse's Assistant is indicated for use in general, The Val Med Narse Sigastroenterology, urology, plastic, obstetrics, cardlovascular, 2113, Sedic surgery, and general thorascoscopy, general cardiothoracic surgery, general laparoscopy, general cardiochoracio sargosy, and sinuscopy. A few examples of nasophalyngoscopy, car chaocedures where this system could be used the laparoscopic cholecystectomy, laparoscopic hernia repair, are laparoscopic choices secolor pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic laparoscopically assnodecompression fixation, wedge resection, lung anterfor Spinal rusion, doosal sympathectomy, pleurodesis, internal blogsy, plearal blopsy, dorodary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated, bypass granting where chated cardiac chamber during performance of exammation of the evacuationic meniscus repair, anterior cruciate ligament repair and associated procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
\
510(k) Number K010734
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AUG 1 5 2001
510(k) SUMMARY
Val Med's Nurse's Assistant O.R. Control System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Val Med Corp. 4800 NW Saltzman Road Portland, Oregon 97229 Telephone: (503) 614-1106 Facsimile: (503) 614-1109
| Contact Person: | Darko Spoljaric |
|---|---|
| Vice President |
Date Prepared: March 13, 2001
Name of Device and Name/Address of Sponsor
Val Med Corp. 4800 NW Saltzman Road Portland, Oregon 97229 Telephone: (503) 614-1106 Facsimile: (503) 614-1109
Common or Usual Name
Surgical Control Center
Classification Name
Accessory to a Ceiling Mounted Surgical Lamp Accessory to a Medical Image Storage Device Accessory to a Laparoscope, General & Plastic Surgery
Predicate Devices
Computer Motion's Hermes Operating Room Control Center Olympus EndoAlpha Karl Storz KSEA SCB-RUI Hill-Rom, Inc.'s BrightStar® American Sterilizer Co.'s Quantum®, SQ24
\\DC - 85034/1 - #1284147 v1
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Getinge/Castle, Inc. OptiView@, 500 series
Intended Use / Indications for Use
The Val Med Nurse's Assistant is intended to be used to turn on and off and adjust certain settings of endoscopic and surgical cameras, surgical lamps, and operating room ("O.R.") lights, and to operate VCRs, monitors, video printers, radios, and CD players.
The Val Med 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 cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, 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.
Performance Data
The Nurse's Assistant's control unit meets EN 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety 4: Collateral Standard: Programmable Electrical Medical Systems.
The Nurse's Assistant's power supply meets UL 2601-1 "U.L. Standard for Safety for Medical Electrical Equipment - General Requirements for Safety".
The Nurse's Assistant's controlling software meets ANSI standard 1375-221.
Technological Characteristics
The Val Med's Nurse's Assistant is a computer with a monitor and touch screen that a nurse uses in the operating room to activate and control the following equipment: (1) surgical cameras, including an endoscopic camera;
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(2) room or surgeons' nurses' lounge cameras ("operating room cameras"); { {3) surgical lights; (4) room lights; (5) a VCR;& (6) a video printer; (7) video monitor(s);3 (8) a radio; and (9) a CD player . . Val Med's Nurse's Assistant controls one or more electrical dimmer switches, which in turn control the surgical lights.
Substantial Equivalence
The Nurse's Assistant has the same intended use and similar indications for use and technological characteristics as its predicate, Computer Motion's Hermes Operating Room Control Center, the Olympus EndoAlpha, and the Storz KSEA SCB-RUI. In addition, the surgical lamp that is used with the Nurse's Assistant is substantially equivalent to Hill-Rom, Inc.'s BrightStar®, American Sterilizer Co.'s Quantum®, SQ240, and Getinge/Castle, Inc. OptiView©, 500 series. Therefore, the Nurse's Assistant is substantially equivalent to its predicate devices.
We believe that these monitors are accessories to medical image ମ୍ୟା communications devices. As such, theses monitors are Class I exempt from 510(k) requirements under 21 C.F.R. § 892.2020(a), which states that a "medical image communications device" provides "electronic transfer of medical images between medical devices."
We have not been able to identify any device classification regulations that li encompass operating room lights, operating room cameras, speakerphones, radios, and CD players nor have we identified any cleared devices like these products. For this reason, we believe that these products are not medical devices and the company will for make medical claims related to these components.
We believe that these surgical cameras are Class I exempt devices, under 21 1 C.F.R. § 878.4160.
We believe that the VCR is a medical image storing device under 21 C.F.R. 2 § 892.2010(a), which is, therefore, a Class I exempt storage device. Alternatively, it is not a medical device, subject to FDA regulation.
§ 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.