(72 days)
Not Found
No
The summary describes a basic endoscopic imaging system with light source, camera, and monitor, and explicitly states that AI, DNN, or ML were not found in the description.
No
The device is described as providing illumination, camera use, and image display/storage for diagnostic procedures, which are functions that support a medical procedure rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the system is designed to "display and store medical images obtained during endoscopic surgical or diagnostic procedures," explicitly mentioning diagnostic procedures.
No
The device description explicitly states it includes hardware components: a light source, camera, and LCD monitor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for delivering illumination, providing camera use, and displaying/storing images obtained during endoscopic surgical or diagnostic procedures. This involves direct interaction with the patient's body (via the endoscope) and visualizing internal structures.
- Device Description: The description confirms it's a light source, camera, and monitor for capturing images during these procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples taken from the body to aid in diagnosis or monitoring. This device is for visualizing the inside of the body directly.
N/A
Intended Use / Indications for Use
The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures
Product codes
GCJ
Device Description
The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.
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
The View MD Office System has been tested to conform to IEC 60601-1 and IEC 61000-3-2 / -3, 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11.
Key Metrics
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
JUL 19 2007
13 510(k) Summary of Safety and Effec
Submitter: | |
---|---|
Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
Division name (if applicable): | N.A. |
Street address: | 353 Corporate Woods Parkway |
City: | Vernon Hills |
State/Province: | Illinois |
Country: | USA |
ZIP / Postal Code: | IL 60061 |
Contact name: | Mr. Robert L. Casarsa |
Contact title: | Quality Assurance Manager |
Date of Preparation: | 04. May 2007 |
FDA establishment registration number: | 14 184 79 |
Phone number (include area code): | ( 847 ) 913 1113 |
FAX number (include area code): | ( 847 ) 913 0924 |
Product Information:
Trade name: | View MD Office System |
---|---|
Model number: | 41066.5540 |
Common name: | Light Source / Camera / Monitor |
Classification name: | Light Source |
Information on devices to which substantial equivalence is claimed:
510(k) Number | Trade or proprietary or model name | Manufacturer |
---|---|---|
1. K010033 | 1. Light Projector 4251.007 and Endocam Light 5551.107 with Camera Heads 5551.961 (NTSC) and 5551.901 (PAL) | 1. Richard Wolf |
2. K022490 | 2. KSEA Medi Pack | 2. Karl Storz |
3. Pre-enactment | 3. Light source 4008, 4046, 4246 | 3. Richard Wolf |
4. K950502 | 4. CCD Endocam Office 5501 | 4. Richard Wolf |
1.0 Description
2
The View MD Office System is a 50 watt light source, 1 CCD camera, and LCD Monitor with image capture combined into a compact unit.
2.0 Intended Use
The View MD Office System is designed to deliver illumination, provide camera use, and display and store images obtained during endoscopic surgical or diagnostic procedures.
1
3.0 Technological Characteristics
- There are no new technological characteristics when the sum of the separate components are compared to the combination device with the exception of the ability to store images on a USB Memory Stick.
4.0 Substantial Equivalence
The View MD Office System is substantially equivalent to separated devices currently sold by Richard Wolf , as well as, the Medi Pack device (K022490) sold by Karl Storz.
5.0 Performance Data
The View MD Office System has been tested to conform to IEC 60601-1 and IEC 61000-3-2 / -3, 61000-4-2 / -3 / -4 / -5 / -6 / -8 / -11.
6.0 Clinical Tests
No clinical test were performed.
7.0 Conclusions Drawn
The device is designed and tested to assure safety and effectiveness when used according to the instructions for use.
By:
Robert Lasso
Robert L. Casarsa
Date: May 4, 2007
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
JUL 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard Wolf Medical Instruments Corp. % Mr. Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, Illinois 60061-3110
Re: K071292
Trade/Device Name: "View MD Office System" 41066.5540 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 4, 2007 Received: May 8, 2007
Dear Mr. Casarsa:
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. Robert L. Casarsa
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Koziagz
Device Name: "View MD Office System" 41066.5540
510(k) Number (if known):
Indications for Use: The "The View MD Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures
ction 5 Indications for Us
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDF and Neurological De
510(k) Number K071243
Prescription use (Part 21 CFR 801 Subpart D)
and / or
Over-The Counter Use (Part 21 CFR 801 Subpart D)
Page 9 of 25 (25 pages does not include manuals, literature, etc.)