(8 days)
Not Found
No
The description focuses on the device being a display system for viewing images from other equipment. There is no mention of any processing or analysis of the images using AI/ML.
No.
The device is a monitor system used to display images from other medical equipment and radiographic images for reference. It does not provide any therapy itself.
No.
Explanation: The device is a monitor system that displays images from other medical equipment. Its intended use states "display radiographic images for reference only" and "The system can also be used to display reference quality (not for diagnosis) radiographic images," explicitly stating it is not for diagnosis.
No
The device description explicitly states it is a "flat screen display" and mentions "input connector" and "display," indicating it is a hardware device.
Based on the provided information, the Hill-Rom PrimaView Monitor System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The PrimaView Monitor System is described as a display system for viewing images generated by endoscopic, laparoscopic, or similar equipment during surgical procedures. It also displays radiographic images for reference.
- Lack of Sample Analysis: The device does not analyze biological samples. It simply displays images generated by other medical devices.
- Intended Use: The intended use is to provide a visual display for clinicians during procedures, not to perform diagnostic tests on patient samples.
Therefore, the device's function and intended use clearly fall outside the scope of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hill-Rom PrimaView Mouitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.
Product codes
FET
Device Description
The Hill-Rom PrimaView Monitor System is considered and accessory item to an endoscopic or laproscopic system (not supplied by Hill-Rom) in that it provides a means to view images generated by an endoscopic or laparoscopic camera and their associated components. The PrimaView flat screen display is mounted in the operating room or other area of a medical facility where endoscopic or similar procedures are done. Output video signals from the camera and processing unit are fed into the appropriate input connector of the PrimaView System. The signal is then routed to the display for presentation to the clinician. The system can also be used to display reference quality (not for diagnosis) radiographic images
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
endoscopic, laproscopic or similar equipment, radiographic images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, operating room or other area of a medical facility where endoscopic or similar procedures are done
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Compliance to all or applicable parts of IEC, EN, CISPR, UL and CSA standards (IEC 601-1-2, EN 60601-1 and -2, EN 61000-4-3,4,5, CISPR 11, UL 2601-1 and CSA C22.2 601.1-M90) will be confirmed through design testing and documented. Documentation will be retained in the design and development file as part of the Design History File (DHF).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/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 eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
2 7 2015 ..............................................................................................................................................................................
Hill-Rom, Inc. Ms. Chantel Carson Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062
K013709 Trade/Device Name: Hill-Rom Prima View Monitoring System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated (Date on orig SE ltr): November 6, 2001 Received (Date on orig SE Itr): November 8, 2001
Dear Ms. Carson,
Re:
This letter corrects our substantially equivalent letter of November 16, 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
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 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
"Indications for Use Statement"
NOV 1 6 2001
510(k) Number (if known): _ KO13709
Device Name: Hill-Rom PrimaView Monitoring System
Indications For Use:
The Hill-Rom PrimaView Mouitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF REQUIRED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Or
Prescription Use: (21 CFR 801.109)
Over-The Counter Use: ________________________________________________________________________________________________________________________________________________________
Susan Walk
(Division Si -n-Off) (Division Sisti-chil)
Division of --- reral, Restorative
Division of Devices Division of " 16.15."
and Neurok 21. al Devices
Neuro
510(k) Number K013709
510(k)5a
3
K013 709
Image /page/3/Picture/1 description: The image shows the logo for Hill-Rom, a Hillenbrand Industry. The text "Hill-Rom" is in a bold, sans-serif font, with a slightly distressed or textured appearance. Below the main logo, in a smaller font, is the text "A HILLENBRAND INDUSTRY", indicating that Hill-Rom is part of the Hillenbrand group of companies.
510(k) Summary Date: September 12, 2001
NOV 1 6 2001
-
- Establishment Information:
| Submitter: | Hill-Rom
A Hillenbrand Industry
1069 State Route 46 East
Batesville, IN 47006-9167 |
|------------------|---------------------------------------------------------------------------------------------|
| Registration #: | 1824206 (Owner/Operator)
1836145 (Manufacturing Site) |
| Contact Name: | Timothy M. Davis |
| Contact Phone #: | 812-931-3825 or 1-800-445-2114 (x-13825) |
| Contact Fax #: | 812-934-1675 |
-
- General Device Information:
| Common Name: | Video Display (No Audio) |
|---|---|
| Trade Name: | Hill-Rom PrimaView Monitor System |
| Classification Name: | Endoscope and accessories |
| Classification Number: | 876.1500 (accessory item - monitor) |
| Device Classification: | Class II |
| Performance Std: | Performance Standards for this device have not been established under section 514 of the FD&C Act. |
-
- Substantial Equivalence: Hill-Rom PrimaView Monitor System is substantially equivalent in the intended use (display video images) to the Sony Trinitron Color Video Monitor PVM-1343MD cleared under 510(k) number K885042.
-
- Technology Differences: The primary difference between the predicate device and the Hill-Rom PrimaView Monitor System is that the display on the Sony Trinitron Monitor is CRT based and the PrimaView uses LCD flat screen technology. The Sony system also is a portable device (stand-alone), whereas the PrimaView is a fixed surgical mounted display that uses interconnecting hardware and circuitry to route the video signal. However both devices are designed to accept various types of signals (analog and digital) from Endoscopic, Laproscopic or other similar sources for display.
-
- Device Description: The Hill-Rom PrimaView Monitor System is considered and accessory item to an endoscopic or laproscopic system (not supplied by Hill-Rom) in that it provides a means to view images generated by an endoscopic or laparoscopic camera and their associated components. The PrimaView flat screen display is mounted in the operating room or other area of a medical facility where endoscopic or similar procedures are done. Output video signals from the camera and processing unit are fed into the appropriate input connector of the PrimaView System. The signal
1069 STATE ROUTE 46E, BATESVILLE, INDUNA 47006-9167 12-934-7777 Telefox International: 112-934-1191 Telefox Domestic: 812-93-4189
4
is then routed to the display for presentation to the clinician. The system can also be used to display reference quality (not for diagnosis) radiographic images
-
- Intended Use: The Hill-Rom PrimaView Monitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laparoscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.
-
- Performance Data: Compliance to all or applicable parts of IEC, EN, CISPR, UL and CSA standards (IEC 601-1-2, EN 60601-1 and -2, EN 61000-4-3,4,5, CISPR 11, UL 2601-1 and CSA C22.2 601.1-M90) will be confirmed through design testing and documented. Documentation will be retained in the design and development file as part of the Design History File (DHF).
-
- Conclusion: The Hill-Rom PrimaView Monitor System is designed to be safe and effective for its intended use. Verification and Validation Testing will be completed prior to commercial distribution.