(15 days)
Not Found
No
The description focuses solely on the display and video input capabilities, with no mention of AI/ML processing or analysis of the displayed data.
No
The device is described as a display system for video data or images, with no mention of treating, diagnosing, or preventing any medical condition. Its intended use is solely for displaying visual information.
No
The device is described as a display system for video data or images, not for detecting, diagnosing, or treating a disease or condition. Its function is to show visual information to the user, not to interpret or analyze it for diagnostic purposes.
No
The device description explicitly details hardware components such as a head-worn monocular display, headgear, interconnecting cable, video control electronics module, battery, power supply, belt, and battery charger.
Based on the provided information, the Nomad™ ND1000M system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "display video data or images while worn on the user's head." This describes a display device for visual information, not a device used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Device Description: The description focuses on the hardware components (display module, headgear, control electronics, power supply) and its function as a display. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic results
- Measuring analytes
- Using reagents
The device appears to be a general-purpose head-mounted display that can be connected to various video sources. Its function is to present visual information to the user, not to perform in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Nomad™ ND1000M Augmented Vision System is a monochromatic head-worn monocular display. The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head. It can be connected to any SVGA video source. The display combines the ambient environment with the displayed image (the image is superimposed over the normal field of vision). The display may be adjusted over either eve. Optionally, the display may be used in a non see-through fashion (occluded) with addition of the provided ocular cover.
The system consists of a display module, attached to headgear, that is connected via a .non-detachable interconnecting cable to a video control electronics module. The video input is connected to the video control electronics module. The device accepts power from a battery or an optional medical grade AC to DC power supply, both supplied with the device. A beit to hold the video control module and battery is provided. A rechargeable Li-Ion battery is also supplied along with a battery charger.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 0 9 2003
Microvision, Inc.
P.O. Box 3008
19910 North Creek Parkway
Bothell, Washington 98011
Nomad™ ND1000M Augmented Vision System 510(k) Submission
Image /page/0/Picture/3 description: The image shows a trefoil knot, which is the simplest non-trivial knot. It is a closed curve that is embedded in three-dimensional space and cannot be untangled to form a simple loop without cutting the knot. The trefoil knot has three crossings, which are the points where the curve crosses over itself.
MICROVISION
- 510(k) Summary
Date:
Company Name and Address
Microvision Incorporated 19910 North Creek Parkway Bothell, WA 98011
Contact Person
Karl Bylund Regulatory and Compliance Engineer Telephone: 425-415-6634
Device Trade Name
Nomad™ ND1000M Augmented Vision System
Common Name Video Monitor
Classification Name
Endoscope and Accessories
Predicate Devices
| 1) Device name: | Head Mounted Display |
|---|---|
| Manufacturer: | Vista Medical Technologies |
| 5451 Avenida Encinas, Suite A | |
| Carlsbad, CA 92008 | |
| Classification : | Class II |
| 510K Number : | K961800 |
| Regulation Number : | 876.1500 |
| Product code : | GCJ |
| 2) Device name: | i-View Personal Video Display |
| Manufacturer: | MediVision Endoscopy Incorporated |
| 1440 S. State College Boulevard, #1D | |
| Anaheim, CA 92806 | |
| Classification : | Class II |
| 510K Number : | K000669 |
| Regulation Number : | 876.1500 |
| Product code : | GCJ |
425-415-6847 phone: facsimile: 425-415-6600
website: www.mvis.com
1
Nomad™ ND1000M Augmented Vision System 510(k) Submission
Description of the Device
The Nomad™ ND1000M Augmented Vision System is a monochromatic head-worn monocular display. The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head. It can be connected to any SVGA video source. The display combines the ambient environment with the displayed image (the image is superimposed over the normal field of vision). The display may be adjusted over either eve. Optionally, the display may be used in a non see-through fashion (occluded) with addition of the provided ocular cover.
The system consists of a display module, attached to headgear, that is connected via a .non-detachable interconnecting cable to a video control electronics module. The video input is connected to the video control electronics module. The device accepts power from a battery or an optional medical grade AC to DC power supply, both supplied with the device. A beit to hold the video control module and battery is provided. A rechargeable Li-Ion battery is also supplied along with a battery charger.
Intended Use
The Nomad™ ND1000M Augmented Vision System is designed to display video data or images while worn on the user's head.
Technological Characteristics Comparison with Predicate Devices
The Nomad™ ND1000M system is similar to the Vista HMD (Head Mounted Display) which received FDA clearance on September 11, 1996 (K961800), and the MediVision i-View Personal Video Display which received FDA clearance on May 26, 2000 (K000669). An exception is that the Nomad™ ND1000M system is monochromatic while the other systems are full color. All of these devices accept video signals and display video data or images while worn on the user's head.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 9 2003
Microvision Incorporated c/o Mr. Charles Mack Engineering Team Leader Underwriters Laboratories, Inc. 2600 NW Lake Road Camas, Washington 98607-8642
Re: K030940
Trade/Device Name: Nomad™ ND1000M Augmented Vision System Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope and accessories Regulatory Class: II Product Code: GCJ Dated: March 21, 2003 Received: March 25, 2003
Dear Mr. Mack:
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 (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.
3
Page 2 - Mr. Charles Mack
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. 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" (21CFR Part 807.97) you may obtain. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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
4
Attachment 1 b Page __ of _
510(k) Number (if known): Device Name: Indications For Use:
Video Monitor
The intended use of the Nomad™ ND1000M system is to display video data or images while worn on the user's head.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Meriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number KC30940
(Optional Format 1-2-96)