VERT-X

K061873 · Direx Systems Corp. · OXO · Aug 18, 2006 · Radiology

Device Facts

• Record ID: K061873
• Device Name: VERT-X
• Applicant: Direx Systems Corp.
• Product Code: OXO · Radiology
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

Device Story

Vert-X is a compact, mobile fluoroscopic system for general fluoroscopic imaging. The device acquires, processes, displays, and stores x-ray images for diagnostic purposes. It is intended for use in clinical settings where mobile fluoroscopy is required. Healthcare providers use the displayed images to assist in clinical diagnosis. The device benefits patients by providing portable, real-time imaging capabilities.

Clinical Evidence

No clinical tests were performed.

Technological Characteristics

Mobile fluoroscopic x-ray system. Complies with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-1-4, ISO 14971, and FDA CDRH 21 CFR 1020.30/1020.32 standards.

Indications for Use

Indicated for fluoroscopic examination of patients requiring mobile x-ray imaging.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression 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

• Direx 3Dscope (K053640)

Submission Summary (Full Text)

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## Section 5: 510(k) Summary

[Submitted pursuant to 21 CFR 807.92(a). All data included in this document are accurate and complete to the best of DSC's knowledge.]

### 1. Submitter Information

AUG 1 8 2006

Kanga

| Submitter: | | Direx Systems Corporation<br>437 Turnpike Street<br>Canton<br>MA 02021 |
|--------------------------------------|--|------------------------------------------------------------------------|
| Telephone:<br>Fax:<br>Contact Person | | [phone]<br>[phone]<br>Larisa Gershtein<br>QA Manager |
| Contact Person e-mail address: | | [e-mail] |
| 2. Device | | |
| Trade/Proprietary Name: | | Vert-X |
| Classification Name: | | System, x-ray, fluoroscopic, image-intensified |
| Regulation Number: | | 21 CFR 892.1650 |
| Regulatory Class: | | Class II (special controls) |
| Product code: | | 90 JAA |
| Panel: | | Radiology |

#### 3. Predicate Devices

Direx 3Dscope (K053640)

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#### 4. Intended Use:

Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

#### 5. Description

Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.

#### 6. Clinical Tests

No clinical tests were performed

#### 7. Performance Testing

Vert-X was tested according to the following standards: IEC 60601-1 (1998) + A1(1991) + A2(1995) IEC 60601-1-1 (2000) IEC 60601-1-2 (2001) + A1 (2004) IEC 60601-1-3 (1994) IEC 60601-2-7 (1998) IEC 60601-1-4 (1996) + A1 (1999) ISO 14971 (2000) FDA CDRH 21CFR 1020.30 FDA CDRH 21CFR 1020.32

#### 6. Substantial Equivalence

Vert-X is meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness, of the Company's predicate device, 3Dscope.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 8 2006

Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021

Re: K061873

Trade/Device Name: Vert-X Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: June 27, 2006 Received: July 3, 2006

Dear Ms. Gershtein:

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 either class II (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "PA" in a bold, sans-serif font in the center. Above the letters "PA" are the numbers "1906 - 2006". Below the letters "PA" is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".

Protecting and Promoting Public Health

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Page 2 -

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.

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Nancy Cbrogdon
Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is in black and white, with the word "Direx" in large, bold letters. Below the word "Direx" is a horizontal line, and below that is the text "Systems Corp." in smaller letters. The logo is simple and modern, and it is likely used to represent the company in a variety of contexts.

# Section 4: Indications for Use Statement

# Indications for Use STATEMENT

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:

Vert-X

Indications for Use:

Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

Prescription Use __ _ _ _ (Per 21 CFR § 801.109) OR

Over the Counter Use

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

David A. Syverson

(Division Sign-O Division of Reproductive, and Radiological Devic 510(k) Number

437 Turnpike Street • Canton, MA 02021 Phone: [phone] ♦ Fax: [phone] e - mail p r o m o @ @ d i r e x u s a . c o m