RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS

K083645 · 5 Star Medical, Inc. · MQB · Feb 24, 2009 · Radiology

Device Facts

• Record ID: K083645
• Device Name: RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS
• Applicant: 5 Star Medical, Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 24, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Device Story

RadStar DDR Digital Imaging System comprises solid-state X-ray imager and Windows-based viewing software. Designed for integration into complete X-ray systems by qualified service personnel. Captures X-ray signals, converting them into high-quality digital images in under 5 seconds. Operated by qualified medical personnel in clinical settings. Output displayed on computer monitor for diagnostic review by physicians to inform clinical decision-making. Replaces traditional film/screen systems, offering digital workflow benefits.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Solid-state X-ray imager (flat panel/digital imager). Windows-based software for image viewing. Designed for integration into stationary X-ray systems. Operates across wide range of X-ray dose settings.

Indications for Use

Indicated for generating radiographic images of human anatomy for general purpose diagnostic procedures. Contraindicated when, in the judgment of the physician, procedures are contrary to the patient's best interest. Not for mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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

• Canon CXDI-60G (K081648)
• Varian PaxScan 4030 (K024147)

Submission Summary (Full Text)

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

K083645
Traditional 510(k)

.

. "

:

## RadStar

---

## SECTION 5. 510(K) SUMMARY

| Submission Correspondent: | 5-Star Medical, Inc. |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone] |
| | Email: [e-mail] |
| | Contact: Terry L. Ancar |
| | FEB 2 4 2009 |
| Submission Sponsor: | 5-Star Medical, Inc. |
| | 11515 Prosperous Dr. |
| | Odessa, FL. 33556 |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | Contact: Terry L. Ancar |
| Date summary prepared: | October 30, 2008 |
| Device trade name: | RadStar Digital Imaging System |
| Device common name: | Solid State X-ray Imager (Flat Panel/Digital Imager) |
| Device classification name: | MQB at 21 CFR Part 892.1650 |
| Legally marketed devices to which the device is substantially equivalent: | K081648 |
| | Canon CXDI-60G |
| | K024147 |
| | Varian PaxScan 4030 |
| Description of the device: | The RadStar Digital Imaging System consists of two components, a solid state x-ray imager and software for viewing the captured images on a Windows-based computer. The device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. The RadStar Digital Imaging System will display high quality images in less than 5 seconds over a wide range of X-Ray dose settings. |

・

.

:

.

.

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

f

: · ·

·

·

| Intended use of the device: | The RadStar DDR Digital Imaging System is intended for use in<br>generating radiographic images of human anatomy. This device is<br>intended to replace film/screen systems in all general purpose<br>diagnostic procedures. The device is intended for incorporation into<br>a complete x-ray system by qualified x-ray service personnel. This<br>device is not intended for mammography applications. This device<br>is intended for use by qualified medical personnel and is<br>contraindicated when, in the judgment of the physician, procedures<br>would be contrary to the best interest of the patient. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>characteristics: | The technological characteristics between the predicate and proposed<br>devices are identical. There is no difference in fundamental scientific<br>technology. |
| Conclusions: | There are no significant differences between the RadStar Digital Imaging<br>System and the predicate devices and therefore, the RadStar Digital<br>Imaging System does not raise any questions regarding safety and<br>effectiveness. |
| | The RadStar Digital Imaging System, as designed, is as safe and effective<br>as the predicate device, and the device is determined to be substantially<br>equivalent to the referenced predicate device currently on the market. |

. ·

l

.

.

.

.

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

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized depiction of a human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

5 Star Medical, Inc. % Mr. Terry L. Ancar President Porta Vision Medical P.O. Box 641606 KENNER LA 70065

AUG 2 3 2013

Re: K083645

Trade/Device Name: RadStar DDR Digital Imaging System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 12, 2009 Received: January 21, 2009

Dear Mr. Ancar:

This letter corrects our substantially equivalent letter of February 24, 2009.

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## SECTION 4. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

Indications for Use:

is83645

RadStar DDR Digital Imaging System

The RadStar DDR Digital Imaging System is intended for use in generating radiographic images of human anatomy. This device is intended to replace film/screen systems in all general purpose diagnostic procedures. This device is intended for incorporation into a complete x-ray system by qualified x-ray service personnel. This device is not intended for mammography applications. This device is intended for use by qualified medical personnel and is contraindicated when, in the judgment of the physician, procedures would be contrary to the best interest of the patient.

Prescription Use × (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulk Pein

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

5-Star Medical