(20 days)
Not Found
No
The description focuses on image capture, storage, and transfer, with no mention of AI or ML for analysis or processing.
No
The device is used for capturing and managing images and video during surgery, which is for documentation and presentation, not for treating or diagnosing a condition.
No
The device is intended to capture and store images and video during surgical procedures for archival and presentation purposes, not for diagnosing medical conditions.
No
The device description explicitly mentions hardware components such as an internal hard disk drive, external keyboard, front panel switches, and connections for video outputs and peripheral devices. It is a system that includes both hardware and software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "To capture intraoperative still and motion images." This describes a function related to image acquisition and management during surgery, not a diagnostic test performed on biological samples in vitro.
- Device Description: The description details a system for capturing, storing, and transferring surgical images and video. It focuses on video connections, storage media, and user interfaces for image capture. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The information does not include any elements typically associated with IVDs, such as:
- Analysis of biological specimens (blood, tissue, etc.)
- Detection or measurement of analytes
- Providing diagnostic information about a patient's health status based on laboratory testing.
The device is clearly designed for image management within a surgical setting, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Dyonics Vision 635 Image Management System - HERNES™-Ready is designed to be used to capture intraoperative still and motion images using the camera head, the optional footswitch, the front panel of the system, the keyboard, or with optional voice-activated of touch panel control via HERMES. Images are then stored in one of several standard image formats on transportable media or to an Ethernet network for long term archival, retrieval or printing using third party image application software.
To capture intraoperative still and motion images.
Product codes
GCJ
Device Description
The Dyonics Vision 635 Image Management 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, optional footswitch, or optional voiceactivated or touch panel central control via HERMES™. 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 a 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
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)
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
510(k) Summary Dyonics Vision 635 Image Management System
Page 1 of 2
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Submitter
Smith & Nephew, Inc., Endoscopy Division 160 Dascomb Rd. Andover, MA 01810
OCT 0 3 2002
B. Company Contact
Steven Jackson Manager, Regulatory Affairs Smith & Nephew, Inc. Endoscopy Division 3600 NW 138" St. Oklahoma City, OK 73134 Phone - (405) 936-3085 Fax - (405) 936-3059
C. Device Name
| Trade Name: | Dyonics Vision 635 Image Management System |
|---|---|
| Common Name: | Dyonics Vision 635 Image Management System |
| Classification Name: | Picture Archiving and Communications System |
D. Predicate Devices
The Smith & Nephew Dyonics Vision 635 Image Management System is substantially equivalent in design, materials, function and intended use to the following devices in commercial distribution: Dyonics Vision 635 Image Management System, K011944, Sept. 19. 2001.
Description of Device E.
The Dyonics Vision 635 Image Management 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, optional footswitch, or optional voiceactivated or touch panel central control via HERMES™. 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 Image Management System - HERNES™-Ready is designed to be used to capture intraoperative still and motion images using the camera head, the optional
1
footswitch, the front panel of the system, the keyboard, or with optional voice-activated of touch panel control via HERMES. Images are then stored in one of several standard image 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
Dyonics Vision 635 Image Management System has the same technological characteristics as the predicate device identified above.
The Dyonics Vision 635 Image Management System has been tested and found compliant with the following domestic and international standards:
- · UL2601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety
- · IEC 60601-1: Standard for Medical Electrical Equipment, Part 1: General Requirements for Safety + Amendment 1 + Amendment 2
- · IEC 60601-1-1: Medical Electrical Equipment General Requirements for Safety 1. Collateral Standard: Safety Requirements for Medical Electrical Systems
- · IEC 60601-1-2: Medical Electrical Equipment General Requirements for Safety 2. Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- · CAN/CSA C22.2 No. 601.1-M90 Medical Electrical Equipment General Requirements for Safety: A National Standard for Canada.
Stinfort
Steven Jackson Manager, Regulatory Affairs
9-12-02
CO210
Date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest feathers or wings. The bird faces to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 03 2002
Smith & Nephew, Inc. Steven Jackson Manager, Regulatory Affairs Endoscopy Division 3600 Northwest 13801 Street Oklahoma City, Oklahoma 73134
Re: K023053
Trade/Device Name: Dyonics Vision 635 Image Management System Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: September 10, 2002 Received: September 13, 2002
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 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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" (21 CFR 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,
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 Statement | |
|---|---|
| 510(k) Number | |
| (if known) | |
| Device Name | Dyonics Vision 635 Image Management System |
| Indications for Use | To capture intraoperative still and motion images. |
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF
NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K023053 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
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