(88 days)
No
The description focuses on displaying video images and converting video signals, with no mention of AI or ML processing.
No
Explanation: The device is intended to display video images, specifically to aid surgeons in viewing endoscopic procedures by providing a head-mounted display. It does not exert any direct therapeutic action on the patient.
No
The device is described as a monitor intended to display video images, specifically to assist surgeons by providing a head-mounted display for endoscopic procedures. It does not perform any analysis or interpretation of medical data for diagnosis.
No
The device description explicitly details hardware components including a monitor block, eyeglasses, cable, and controller box, which are essential for its function.
Based on the provided information, the Albacomp Personal Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "display video images while mounted on the user's head" during endoscopic procedures. This is a display technology for surgical visualization, not a test performed on biological samples.
- Device Description: The description details how the device receives and displays video signals from a video source (like an endoscope). It focuses on the optical and electronic components for image projection and viewing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended to improve the surgeon's ability to view images during a procedure, which falls under the category of surgical visualization or display systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Albacomp Personal Monitor is intended to display video images while mounted on the user's head.
Product codes
GCJ
Device Description
In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques of videoendoscopy, relates to the disconnection between instrument movements on the video monitor and the doctor's hand movements. With the displacement and axial rotation of the monitor, the doctor must re-learn the image to tissue relationship at each procedure, and witheach manipulation of the camera. With this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South to North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.
The Albacomp Personal Monitor projects a high resolution color video image that appears in the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area where the image appears; otherwise users are free to view the surrounding environment. The Albacomp Monitor provides an added convenience to surgeons compared to conventional monitors. The device enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The Albacomp Personal Monitor can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD displays require.
The Albacomp Personal Monitor is a monoscopic binocular displays with a relatively narrow field of vision. The Albacomp Personal Monitor takes standard video signals and displays them on a small TFT-LCD display that can be connected to any standard video source. The Albacomp Personal Monitor consists of a monitor block, eyeglasses, cable and controller box. The monitor block contains the display for Albacomp Personal Monitor, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD display. The LCD direct display control signals are sent through a flexible shielded cable to the displays.
The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V AC-DC adaptor with low EMI.
All components and accessories of the device are marketed as non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video signals
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
14981999
Image /page/0/Picture/1 description: The image shows the date "SEP 4 1998". The month is abbreviated to three letters. The day is a single digit, and the year is four digits.
Section 2
" 510(k)" Summary
Device Trade Name Albacomp Personal Monitor
Common/Usual Name Head Mounted Display Virtual Display Device
Classification Name Accessory to Endoscopes
Contact Person:
Julius L. Kluger Albatech, Inc. 1408 S.W. 13th Court Pompano Beach, Florida 33069 Telephone: (954) 941-8114 Fax: (954) 941-1342
Predicate Device:
Trade Name: MedVision Personal Monitor Models A & B Manufacturer: AlbaComp Computers Corp. H-8000 Szekesfehervar, Hosszuseta Ter 4 - 6 Hungary
510(k) # K961343
Summary Preparation Date: June 3, 1998
Statement of Intended Use
The Albacomp Personal Monitor is intended to display video images while mounted on the user's head.
Device Description
In endoscopic procedures the conventional video monitors are placed away from the site of the operation. As a result, the surgeon has to constantly divide his/her attention between the conventional monitor that shows the endoscopic image and the site of the operation. The remote location of the monitor and its orientation in the surgical setting have an effect on both the doctor's perception of the surgical field, and the difficulties encountered when interacting with it. Much of the difficulty encountered by a surgeon when learning the techniques of videoendoscopy, relates to the disconnection between instrument movements on the video monitor and the doctor's hand movements. With the displacement and axial rotation of the monitor, the doctor must re-learn the image to tissue relationship at each procedure, and witheach manipulation of the camera. With this decoupled image, the hand-eye coordination of the doctor suffers. For example, with a 90 degree rotation of the camera, an intended movement South to North direction, will result in a display movement in an East to West direction, presenting the doctor with a working field that is difficult to comprehend.
Pages 1 of 2
1
The Albacomp Personal Monitor projects a high resolution color video image that appears in the surgeon's line of sight in a viewing angle comparable to watching a 26" television from 2 meters (6.5 feet) away. The video image is see-around; it blocks only the area where the image appears; otherwise users are free to view the surrounding environment. The Albacomp Monitor provides an added convenience to surgeons compared to conventional monitors. The device enables the surgeon to maintain the endoscopic image in the surgeon's line of site regardless of where he/she is looking. The Albacomp Personal Monitor can receive video signals from any video source. The signals are converted in the controller unit into signals the driving electronics of LCD displays require.
The Albacomp Personal Monitor is a monoscopic binocular displays with a relatively narrow field of vision. The Albacomp Personal Monitor takes standard video signals and displays them on a small TFT-LCD display that can be connected to any standard video source. The Albacomp Personal Monitor consists of a monitor block, eyeglasses, cable and controller box. The monitor block contains the display for Albacomp Personal Monitor, a backlight and its driver for the LCD, and a system of lenses and mirrors that project the display image onto the retina of the eyes. The light beams coming from the display are reflected in two directions by dividing mirrors placed in front of the display. The monitor block has a mounting slot that fits into the vertical nose piece of the eyeglasses. The controller box contains the video input demodulator unit and the driving electronics of the LCD display. The LCD direct display control signals are sent through a flexible shielded cable to the displays.
The eyeglasses have adjustable temple pieces and each unit comes with a commercially available 9V AC-DC adaptor with low EMI.
All components and accessories of the device are marketed as non-sterile.
Device Comparison
The Albacomp Personal Monitor is substantially equivalent to the MedVision Personal monitor Models A & B. which received clearance from the FDA March 13. 1997 (K961343). The Albacomp Personal Monitor . also is substantially equivalent to the display component of Vista Medical Technologies' Head Mounted Display, which received clearance from the FDA on September 11, 1996 (K961800). The Albacomp Personal Monitor is a binocular monoscopic display with a single LCD display. The Med Vision Personal Monitor Models A & B are the virtually the same, but the MedVision also has an AMEL display available, The Vista Medical Technologies' Head Mounted Display has two AMLCDs and it is a monoscopic/ stereoscopic display. The predicate device, as well as the Albacomp Personal Monitor have relatively narrow field of view and relatively higher and apparent resolution. The predicate device and the Albacomp Personal Monitor are monoscopic displays that do not need the large virtual distance, large field of view to create the stereoscopic immersion as opposed to the Vista Medical Technologies' head mounted display. The tradeoff for the large field of view is the reduction in apparent resolution.
Safety
The Albacomp Personal Monitor is designed, manufactured and tested in compliance with IEC-601-1, IEC-601-2, and IEC 10004-3.
The eyeglasses will have polycarbonate lenses to ensure high resistance to impact and scratch.
When compared to the predicate device, the Albacomp Personal Monitor does not incorporate any significant change in intended use and technological characteristics that could affect the safety or effectiveness.
Pages 2 of 2
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three heads, depicted in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 4 1998
Albatech. Inc. c/o Sheryl S. Natelson, P.A. 4700 Sheridan Street Building J Hollywood, Florida 33021
Re: K981999 Trade Name: Albatech Personal Monitor Regulatory Class: II Product Code: GCJ Dated: June 3, 1998 Received: June 8, 1998
Dear Ms. Natelson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Sheryl S. Natelson, P.A.
This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Albatech, Inc. 1408 S.W. 13th Court Pompano Beach, Florida 33069
April 29, 1998
Section 1
Statement of Indication for Use
The Albatech Personal Monitor is intended to display video images while mounted on the user's head.
Prescription Use (Per 21CFR 801.109) (Division Sign-Off) or Division of General and Restorative Devices 510(K) Number_________________________________________________________________________________________________________________________________________________________________
boooza
(Division Sign-Off)
Division of General Restorative Devices K981797
510(k) Number