SURGERY AND ACCESSORIES

K021236 · Camtronics, Ltd. · LLZ · Jul 17, 2002 · Radiology

Device Facts

• Record ID: K021236
• Device Name: SURGERY AND ACCESSORIES
• Applicant: Camtronics, Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.

Device Story

Surgery Image Recorder (SIR) is a PC-based acquisition unit used in surgical settings to digitize and store images and streaming video from endoscopic imaging devices. Surgeons or clinical staff operate the device to capture visual data from standard video outputs (RGB, YC, or composite). The device provides a user interface for entering patient demographics via USB keyboard/mouse and supports output to USB printers, serial devices, and network connections. Data is stored on an internal hard drive or removable media (CD/DVD). The system utilizes JPEG and MPEG4 compression. By providing a centralized digital record of surgical proceedings, the device assists healthcare providers in documentation and clinical review, potentially improving patient record management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based hardware architecture; supports RGB, YC, and composite video inputs; provides RGBS, S-Video, and VGA outputs. Connectivity includes Fast Ethernet and DICOM. Storage via internal hard drive and CD/DVD recorder. Compression formats: JPEG and MPEG4. Operates on interlaced NTSC/PAL video standards.

Indications for Use

Indicated for use as an acquisition unit for digitizing and storing images and streaming video generated during surgical procedures, including but not limited to endoscopic surgery.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Dyonics Vision 635 Digital Capture System Model (K011944)

Submission Summary (Full Text)

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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<br>Camtronics Medical Systems<br>Surgery Image Recorder<br>(SIR) | Predicate Device<br>Smith & Nephew, Inc.<br>Dyonics Vision 635 Digital<br>Capture System Model<br>(K011944) |
|-------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Computer/operating<br>system | PC Based hardware and<br>operating system | PC Based hardware and operating<br>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<br>pin DIN; VGA via DB15 | RGB; S-Video |
| Video format | Interlaced NTSC/PAL video | NTSC and PAL |
| Compression type and<br>ratio | JPEG and MPEG4 | MPEG1 and MPEG2 |
| Storage Devices | Internal hard drive; CD/DVD<br>Recorder/Reader | Internal hard drive; CD-R; ZIP<br>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.

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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.

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## 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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| 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 |
|---------------|---------|
|---------------|---------|

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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