(90 days)
Not Found
No
The description focuses solely on image acquisition, digitization, and storage, with no mention of AI/ML capabilities for analysis or processing.
No.
The device is used for digitizing and storing images from surgical proceedings; it does not directly treat or diagnose diseases.
No
The device is described as an "acquisition unit for digitizing and storing images" generated during surgical proceedings. Its sole stated purpose is to capture and store images and video; there is no mention of analysis, interpretation, or diagnosis based on these images.
No
The device description explicitly mentions hardware components such as a hard disk drive, USB I/O for keyboard, mouse, and printer, video outputs, serial outputs, network connectivity, and the ability to store data to removable media (DVD, CD-R). This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to acquire, digitize, and store images generated during surgical procedures. This is focused on capturing and managing visual information from within the body during surgery, not on analyzing biological samples (like blood, urine, tissue) outside the body to diagnose or monitor a condition.
- Device Description: The description reinforces the intended use by detailing how it captures video and still images from surgical imaging devices and stores them. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely related to image capture and storage during a surgical procedure.
N/A
Intended Use / Indications for Use
Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.
Product codes
LLZ
Device Description
The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).
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
Surgeons / Surgical proceedings
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)
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K011944 Dyonics Vision 635 Digital Capture System Model, Smith & Nephew, Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape on the left, followed by the word "Camtronics" in a bold, sans-serif font. Below "Camtronics" are the words "MEDICAL SYSTEMS" in a smaller, sans-serif font. The logo is black and white.
'JUL 1 7 2002
510(k) Summary
Date prepared: April 12, 2002
Name of contact person: Scott Pease
Device trade name: Surgery Image Recorder
Common name: Endoscope and accessories
Classification name: Endoscope and accessories
Predicate substantially equivalent devices: K011944 Dyonics Vision 635 Digital Capture System Model, Smith & Nephew, Inc.
Device description and intended use: The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).
Predicate device specifications comparison:
| | Principal Device
Camtronics Medical Systems
Surgery Image Recorder
(SIR) | Predicate Device
Smith & Nephew, Inc.
Dyonics Vision 635 Digital
Capture System Model
(K011944) |
|-------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Computer/operating
system | PC Based hardware and
operating system | PC Based hardware and operating
system |
| User interface | PC-type Mini-keyboard | Keyboard; optional footswitch |
| Video input | RGB, YC, or composite input | RGB; S-Video, AUX Input |
| Video output | RGBS via DB9; S-Video via 4
pin DIN; VGA via DB15 | RGB; S-Video |
| Video format | Interlaced NTSC/PAL video | NTSC and PAL |
| Compression type and
ratio | JPEG and MPEG4 | MPEG1 and MPEG2 |
| Storage Devices | Internal hard drive; CD/DVD
Recorder/Reader | Internal hard drive; CD-R; ZIP
TM disk |
| Output capabilities | Fast Ethernet; DICOM | Fast Ethernet; DICOM |
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Substantial equivalence summary: The Camtronics Surgery Image Recorder (SIR) is comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Camtronics is the same as that of the predicate device "Dyonics Vision 635 Digital Capture System" marketed by Smith &b Nephew, Inc... No new safety or effectiveness issues are raised with the Camtronics SIR. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the symbol. The logo is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2002
Camtronics, Ltd. Scott Pease Director. Quality Assurance and Regulatory Affairs 900 Walnut Ridge Drive, P. O. Box 950 Hartland, Wisconsin 53029
Re: K021236 Trade Name: Surgery Image Recorder Regulatory Class: II Product Code: LLZ Dated: April 12, 2002 Received: April 18, 2002
Dear Mr. Pease:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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.
2
Page 2 - Mr. Scott Pease
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" (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,
Mark n Melkersen
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
3
| Ver/ 3 - 4/24/96 | Page 1 of 1 |
|---|---|
| Applicant: | Camtronics Medical Systems |
| 510(k) Number (if known): | K021236 |
| Device Name: | Surgery Image Recorder |
Indications For Use:
Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021236 |
|---|---|
| --------------- | --------- |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
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