(90 days)
Not Found
No
The description focuses on digital image capture, storage, and transfer, with no mention of AI or ML for image analysis, interpretation, or other functions.
No
The device is described as a digital capture system for recording surgical images and videos, not for treating or diagnosing medical conditions.
No
The device is described as a system for capturing, storing, and transferring intra-operative images and video, primarily for archival and presentation purposes. It does not mention any function for analyzing images to provide medical insights, diagnosis, or assist in diagnosing conditions.
No
The device description explicitly mentions hardware components such as a capture unit, camera head, foot switch, keyboard, internal hard disk drive, and connections for video outputs and removable storage media.
Based on the provided information, the Dyonics Vision 635 Digital Capture System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "digitally capture intra-operative still and motion images" for "long term archival, retrieval or printing". This describes a system for documenting surgical procedures, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on capturing and storing video and images from surgical procedures. It connects to devices with standard video outputs, which are typically surgical cameras or endoscopes, not devices that analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), performing diagnostic tests, or providing diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Dyonics Vision 635 does not fit this description.
N/A
Intended Use / Indications for Use
The Dyonics Vision 635 Digital Capture System is used in the operating room to digitally capture intra-operative still and motion images using the camera head, the foot switch, the front panel of the capture unit or the keyboard. Images are then stored in one of several standard image file formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, GCJ
Device Description
The Dyonics Vision 635 Digital Capture System (DV 635) is designed to provide surgeons the ability to capture still images and motion video during surgical procedures in various file formats for archival and presentation purposes. The DV 635 connects to any device with standard video outputs via standard video connections, and provides video throughput to video monitors, and other video peripheral devices. The DV 635 utilizes an external keyboard for input of basic patient and case information, and to set the system configuration. To capture images, the DV 635 utilizes user inputs from front panel switches, camera head buttons, the keyboard or optional footswitch. Images and motion video clips are stored on an internal hard disk drive, and later transferred to a removable storage media, including CD-R and ZIP™ disks, or to an network drive or printer via a Ethernet connection. The DV 635 may also print images directly to a postscript printer via a print server.
Mentions image processing
Yes
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
surgeons / operating room
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
SECTION B: ADMINISTRATIVE INFORMATION
l. 510(k) Summary Dyonics Vision 635 Digital Capture System Date Prepared:
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
Submitter A.
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810
Company Contact B.
Steven Jackson Manager, Regulatory Affairs Smith & Nephew, Inc. Endoscopy Division 3600 NW 138th St. Oklahoma City, OK 73134 Phone (405) 936-3085 Fax (405) 936-3059
C. Device Name
Dyonics Vision 635 Digital Capture System Trade Name: Common Name: Picture Archiving and Communications System (PACS) Classification Name: Image Processing System Class II, per 21 CFR 892.2050 Classification: Product Code: LLZ
D. Predicate Device
Fotomaster™ Hamilton Thorn Research 100 Cummings Center Suite 102-C Beverly, MA 01915
Substantial Equivalence - K000380, May 3, 2000
E. Description of Device
The Dyonics Vision 635 Digital Capture System (DV 635) is designed to provide surgeons the ability to capture still images and motion video during surgical procedures in various file formats for archival and presentation purposes. The DV 635 connects to any device with standard video outputs via standard video connections, and provides video throughput to video monitors, and other video peripheral devices. The DV 635 utilizes an external keyboard for input of basic patient and case
Dyonics Vision 635 Digital Capture System Page 11 of 227
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information, and to set the system configuration. To capture images, the DV 635 utilizes user inputs from front panel switches, camera head buttons, the keyboard or optional footswitch. Images and motion video clips are stored on an internal hard disk drive, and later transferred to a removable storage media, including CD-R and ZIP™ disks, or to an network drive or printer via a Ethernet connection. The DV 635 may also print images directly to a postscript printer via a print server.
F. Intended Use
The Dyonics Vision 635 Digital Capture System is used in the operating room to digitally capture intra-operative still and motion images using the camera head, the foot switch, the front panel of the capture unit or the keyboard. Images are then stored in one of several standard image file formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.
G. Comparison of Technological Characteristics
The Dyonics Vision 635 Digital Capture System (DV 635) is equivalent to the Hamilton Thorn Research Fotomaster™ in that both process, digitize, store, and save images obtained during surgical procedures using remote triggers and use standard publicly available JPEG image compression algorithms from the independent JPEG Group's software library.
The DV 635 can also store generate images in bitmap, DICOM and postscript formats, and motion video clips MPEG1 and MPEG2 formats . The DV 635 can also connect directly to a network via an Ethernet connection and download stored images to a network storage device or networked printer or may be connected to a local printer via a local print server. These changes do not impact the safety or efficacy of the device.
Steve Jack 6-20-01
Steven Jackson Manager, Regulatory Affairs
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2001
Mr. Steven Jackson Manager, Regulatory Affairs Smith & Nephew. Inc. Endoscopy Division 3600 NW 138th Street Oklahoma City, Oklahoma 73134
Re: K011944
Trade/Device Name: Dyonics Vision 635 Digital Capture System Regulation Number: 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: GCJ Dated: June 20, 2001 Received: June 21, 2001
Dear Mr. Jackson:
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. Steven Jackson
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 premated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionaly 21 011 - 11 - 11 - 11 - 11 - 11 - 11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 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). 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,
Susan Walker, us
Celia M. Witten, Ph.D., M.D.
Dir
Div
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO11944 510(k) Number : Unknown
Device Name : Dyonics Vision 635 Digital Capture System
Indications for Use :
The Dyonics Vision 635 Digital Capture System is indicated to be used in the operating the from to digitally I he Dyonce Vision 055 Digital Capture Bystein is marcase witch, the front switch, the front panel of the front panel of the fi capture unit or the keyboard. Images are then stored in one of several standard image file formats on capture unit of the Keyodate. Thinges are there to the receivel, retrieval or printing using third party image application software.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Zl
Division Sign Off
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K011944
(Optional Format 3-10-98)
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