RTLX

K992392 · Infimed, Inc. · MUH · Mar 31, 2000 · Dental

Device Facts

• Record ID: K992392
• Device Name: RTLX
• Applicant: Infimed, Inc.
• Product Code: MUH · Dental
• Decision Date: Mar 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.

Device Story

RTLX is a digital dental X-ray system providing real-time, full-motion radiographs; intended for use by dentists in clinical settings. System inputs include X-ray signals captured via an intra-oral CCD sensor with a scintillator. The device processes these signals through an image processor and displays them on a personal computer at up to 24 fps. Features include real-time image display, window/level adjustment, and forward/reverse/still playback. The system provides immediate visual feedback during operative treatment, assisting clinicians in monitoring instrument positioning within internal structures. This real-time capability aims to reduce patient X-ray exposure and chair time. Output is viewed by the clinician on a monitor; hard copies of individual frames can be printed. The device is designed for user-friendly sensor placement and video control.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Extraoral X-ray source (70kV/100μA); intra-oral CCD sensor with scintillator (20.1 x 30.1 mm). Image processing via personal computer. Connectivity: PC-based. Disinfection: Cold sterilization (3.4% glutaraldehyde) and disposable low-density polyethylene sheaths injected with ethyl/methyl acrylate.

Indications for Use

Indicated for dental patients requiring real-time intra-oral X-ray imaging during operative procedures to visualize internal structures and instrument positioning.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• Panoramic HDLX (K943532)
• Schick Technologies CDR (K933455)
• Trophy Radiologie RVG-S (K881133)

Submission Summary (Full Text)

{0}------------------------------------------------

K992392

## 510(K) Summary

Date Prepared: June 7, 1999 Name of Contact Person: Ralph J. Flatau Address: InfiMed, Inc 121 Metropolitan Drive Liverpool NY 13088 Phone: [phone] x224 Fax: [phone]

Device trade name: RTLX Common name: Digital Imaging System Classification Name: Extraoral source x-ray system ( as per 872.1800)

### Device Description:

RTLX, for "Real-Time, Low-Intensity X-ray" is the first X-ray imaging system that provides capabilities for instant, full motion, digital radiographs designed specifically for the dental imaging marketplace. RTLX provides capabilities for X-ray generation, radiograph capture, image storage, and image display at up to 24 fps. The full motion, digital radiographs enhance a clinicians ability for "point-and-view" radiographs reducing patient X-ray exposure and time in the chair and improving speed and accuracy for procedure performance. Product appearance and mechanical structure is designed to provide a user friendly system for sensor placement and video control. In addition, printouts can be made of individual video frames.

The RTLX includes an X-ray source and X-ray sensor assembly for generation and acquisition of X-ray signals. Additionally, power and X-ray control electronics are provided, and an image processor is utilized for radiograph acquisition, processing, and display. Mechanical design emphasizes appearance and functionality. Switches, LEDs, and a printer are provided for user input and feedback.

#### Intended Use:

The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.

#### Conclusions drawn from comparison:

The RTLX performs the same functions in the same environment as the predicate devices. The RTLX uses the same sensor technology as the Schick Technologies and the Trophy Radioligie systems and has the same real time image functionality and generator specifications as that of the HDLX system. There are some new features offered with the RTLX, but these are built on the same basic functionality offered by the three predicate devices listed and raise no new questions of efficacy or substantial risk.

{1}------------------------------------------------

| Feature/System | Panoramic RTLX | Panoramic HDLX | Schick<br>Technologies CDR | Trophy Radiologie<br>RVG-S |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | N/A | K943532 | K933455 | K881133 |
| X-ray Energy Source | 70kV/ 100μA | 70kV/ 100μA | N/A (X-ray source<br>dependent) | N/A (X-ray source<br>dependent) |
| Image Acquisition speed<br>( maximum) | 24 frames/second | 30 frames/second | N/A (Still Frames only) | N/A (Still Frames only) |
| Display image resolution | 128x160 @ 24fps -<br>256x320 @ 6 fps | 768 x 494 | N/Available | N/Available |
| Sensor Sizes | 20.1 x 30.1 mm | 18 mm diameter | 25.2 x 36.5 mm<br>19.2 x 34.6 mm<br>14.7 x 20.9 mm | 18.2 x 27.5 |
| X-ray Image Acquisition<br>Device | CCD Sensor with<br>Scintillator | Image Intensifier with<br>CCD Camera | CCD Sensor with<br>Scintillator | CCD, fiberoptics and<br>scintillator. |
| Sensor Type | Intraoral Sensor | Intraoral Sensor | Intraoral Sensor | Intraoral Sensor |
| X-ray Source | Extraoral | Extraoral | Extraoral | Extraoral |
| "Window / level"<br>features | Yes | Yes | Yes | Yes |
| Forward / Reverse / Still<br>capability | Yes | Yes (Via attached VCR) | Still only | Still only |
| Hard copy Capability | Yes | Yes | Yes | Yes |
| Image Processor/Data<br>Storage | Personal Computer | Personal Computer | Optional Personal<br>Computer | Personal Computer |
| Disinfection /<br>Sterilization | Cold Sterilization and<br>Disposable sheaths.<br><br>Cold sterilization using<br>3.4% gluteraldehde<br><br>Sheath constructed of<br>low density polyethelene<br>injected with ethyl /<br>methyl acrylate by Banta<br>Healthcare Group | Not Specified | Cold Sterilization and<br>Disposable sheaths<br><br>Sheath constructed of<br>low density polyethelene<br>injected with ethyl /<br>methyl acrylate by Banta<br>Healthcare Group<br>(formerly Ling Products<br>(Applied Technology) | Cold Sterilization and<br>Disposable sheaths.<br><br>Cold sterilization using<br>3.4% gluteraldehde<br><br>Sheath constructed of<br>low density polyethylene<br>injected with ethyl /<br>methyl acrylate by Banta<br>Healthcare Group<br>(formerly Ling Products) |

Serjo

.

.

.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2000

Ralph J. Flatau Quality Assurance Manager InfiMed, Inc. 121 Metropolitan Drive Liverpool, NY 13088

Re:

K992392 InfiMed RTLX Extraoral Dental System Dated: January 19, 2000 Received: January 21, 2000 Regulatory class: II 21 CFR 872.1800/Procode: 90 MUH

Dear Mr. Flatau:

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 pror 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 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 equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory action. In the 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 question 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 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/odrh/dsmamain.html".

Sincerely yours,

David G. Satin, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

{3}------------------------------------------------

# Indication for Use

510(K) Number ( if known): 99 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

Device Name: RTLX

Indication for Use:

The RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.

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

Concurrence of CDRH, Office of Device Evaluation ( DOE)

Prescription Use

Or

Over the counter Use _

Per 21 CFR 801.109

( Optional format 1-2-96)

David A. Seymon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number