(56 days)
Not Found
No
The description focuses on displaying vital signs and the hardware components, with no mention of AI/ML algorithms for data analysis or interpretation.
No
The device is a data viewer, displaying patient vital signs. It does not actively treat or diagnose a disease or condition.
No
The device is a data viewer, displaying vital signs that are already collected by a separate patient monitor. It does not perform any diagnostic function itself.
No
The device description explicitly lists hardware components such as an LCD display unit, non-prescription safety glasses, a control box with signal converter and battery, a base station, and a battery charger.
No, this device 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 MD-6W Wireless Critical Data Viewer is designed to display patient vital signs that are already being monitored by a separate patient monitor. It does not perform any tests on biological samples.
- Intended Use: The intended use is to provide a medical specialist with a continuous view of vital signs during procedures like surgery. This is a display and communication function, not a diagnostic test.
The device is a display and communication tool for existing vital sign data, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to vital signs of a patient undergoing surgery.
Product codes
GCJ
Device Description
The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate 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
medical specialist
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)
The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device.
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
KD42923
DEC 17 2004
510(k) Summary for MD-6W Wireless Critical Data Viewer
1. SPONSOR
The MicroOptical Corporation 33 Southwest Park Westwood, MA
| Contact Person: | Paul Zavracky, Ph.D., President |
|---|---|
| Telephone: | 781-326-8111 |
Date Prepared: October 20, 2004
2. DEVICE NAME
| Proprietary Name: | MD-6W Wireless Critical Data Viewer |
|---|---|
| Common/Usual Name: | Head-mounted display system |
| Classification Information: |
Head-mounted display systems have been classified as Class II devices under the following classification name:
| Name | Product Code | 21 CFR Ref. | Panel |
|---|---|---|---|
| Laparoscope and accessories | GCJ | 876.1500 | General Surgery |
3. PREDICATE DEVICES
The MD-6W Wireless Critical Data Viewer is substantially equivalent to MicroOptical's MD-6 Critical Data Viewer, 510(k) No. K040244.
4. DEVICE DESCRIPTION
The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger.
1
ഗ് INTENDED USE
The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to vital signs of a patient undergoing surgery.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The MD-6W Wireless Critical Data Viewer is similar to the predicate device in terms of indication, display format, field of view, and focal range.
7 PERFORMANCE TESTING
The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white and has a simple, official design.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
The MicroOptical Corporation c/o Mr. Daniel J. Dillon Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K042923
Trade/Device Name: MD-6W Wireless Critical Data Viewer Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 20, 2004 Received: October 20, 2004
Dear Mr. Dillon:
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.
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Page 2 - Mr. Daniel J. Dillon
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 (240) 276-0115. 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 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
Indications for Use
510(k) Number (if known):
MD-6W Wireless Critical Data Viewer Device Name:
Indications for Use:
The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K042723
October 20, 2004
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