CCD CAMERA, MODEL 9000

K990066 · Camtronics, Ltd. · LMA · Mar 17, 1999 · Radiology

Device Facts

• Record ID: K990066
• Device Name: CCD CAMERA, MODEL 9000
• Applicant: Camtronics, Ltd.
• Product Code: LMA · Radiology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2030
• Device Class: Class 2

Intended Use

This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.

Device Story

CCD video camera for digital radiography; integrates with X-ray image intensifiers in diagnostic imaging chains. Inputs: X-ray image intensifier signals. Processing: interline CCD sensor, progressive scanning, 12-bit contrast resolution (4096 gray levels), automatic gain control (AGC), automatic anti-blooming level (AAL), and automatic brightness control (ABC). Outputs: high-line interlaced video (1.0 V peak-to-peak) and RS 644 digital output. Used in clinical settings (e.g., cardiology, fluoroscopy suites) by medical professionals. Output displayed on monitors for diagnostic visualization; assists clinicians in real-time imaging and procedural guidance. Benefits: high-resolution, high-dynamic-range (66 dB) imaging for diagnostic accuracy.

Clinical Evidence

No clinical data; bench testing only. Performance data not required for determination of substantial equivalence for this device class.

Technological Characteristics

Interline CCD sensor; progressive scanning; 1024x1024 resolution; 12-bit contrast resolution; 66 dB dynamic range; 40 MHz bandwidth. Features automatic gain control (AGC), automatic anti-blooming level (AAL), and automatic brightness control (ABC). Video output: high-line interlaced (1.0 V peak-to-peak); digital output: RS 644. Internal/external synchronization. Motorized iris control.

Indications for Use

Indicated for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy, as part of diagnostic imaging chains utilizing X-ray image intensifiers.

Regulatory Classification

Identification

A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include systems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• MediCal Imaging Ltd. "Camvision 1000" (K953974)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Camtronics Medical Systems, with the date 3/17/99 written above the company name. The logo features a stylized graphic to the left of the company name. The words "MEDICAL SYSTEMS" are written in smaller letters below the company name. The logo is black and white.

## 510(k) Summary

K690066

Date prepared: January 4, 1999 Name of contact person: Robert Kriedermann Device trade name: CCD Camera Common name: CCD Video Camera Classification name: System, X-ray, Fluoroscopic, Image-intensified Predicate substantially equivalent devices: K953974 MediCal Imaging Ltd. "Camvision 1000"

Device description and intended use: This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.

## Predicate device specifications comparison:

| | Principal Device | Predicate Device |
|-----------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| | Camtronics CCD Camera | K953974 MediVision-Medical |
| | | Imaging Ltd. “Camvision 1000” |
| CCD and analog<br>circuitry | | |
| CCD type | interline | interline |
| Scanning | progressive | progressive |
| Resolution | 1024 x 1024 | 1024 x 1024 |
| Contrast resolution | 12 bit, 4096 gray levels | 10 bit, 1024 gray levels |
| Anti-blooming | automatic control, up to 100:1 | automatic control, up to 100:1 |
| TV parameters | | |
| Video output | High-line interlaced, 1.0 V peak to peak on 75 ohm | composite video RS-343A or<br>progressive scan, 50 or 60 Hz, 1.0 V<br>peak-to-peak on 75 ohm |
| Digital output | RS 644 | RS-422 AIA compatible |
| Bandwidth | 12 bit 40 MHz | input equivalent to 20 MHz, output<br>equivalent to 40 MHz |
| Dynamic range | 66 dB | 60 dB |
| Signal to noise ratio | greater than 1000:1 | 1000:1 at camera's connector |
| Gamma | adjustable or linear | adjustable, 0.45-1.0 |
| Frame rate | up to 25 or 30 frames per second | up to 25 or 30 frames per second |
| Fast frame rate | 50 or 60 frames per second at 1024 x 512. 30<br>fps at 1024 x 1024 | 50 or 60 frames per second at 1024 x<br>512 |
| X-ray and image<br>control | | |
| Internal controls | automatic gain control (AGC)<br>automatic anti-blooming level (AAL) | automatic gain control (AGC)<br>automatic anti-blooming level (AAL)<br>automatic integration control (AIC) |
| External controls | video gain select<br>horizontal scan reverse<br>vertical scan reverse<br>black level select | video gain select<br>anti-blooming level select<br>horizontal scan reverse<br>vertical scan reverse<br>black level select |
| Video<br>synchronization | internal or external | internal or external |
| Fluoroscopy control | automatic brightness control (ABC) | automatic brightness control (ABC) |
| Iris control | motorized control | automatic control |

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Image /page/1/Picture/0 description: The image shows the logo for Camtronics Medical Systems. The logo features 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, thinner font. The logo is black and white.

Page 2 Camtronics CCD Camera 510(k) Summary January 4, 1999

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 CCD Camera is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the CCD Camera is that of the predicate device "Camvision 1000", marketed by Medivision-Medical Imaging Ltd. No new safety or effectiveness issues are raised with the Camtronics CCD Camera. The substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three lines extending from the head, resembling wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

Robert Kriedermann Regulatory Specialist Camtronics, Ltd. 900 Walnut Ridge Dr. Hartland, WI 53029

Re:

K990066 CCD Camera, Model 9000 Dated: January 4, 1999 Received: January 8, 1999 Regulatory class: II 21 CFR 892.2030/Procode: 90 LMA

Dear Mr. Kriedermann:

We have reviewed your Section 510(k) 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 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). 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 dass III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Dan Letizia

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K990066 · 510(k) NUMBER (IF KNOWN) : Camtronics CCD Camera DEVICE NAME:

INDICATIONS FOR USE:

This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) ાર

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Over-The-Counter-Use (Optional Format 1-2

David G. Wagner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number