XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM

K071233 · Kub Technologies, Inc. · MWP · Jun 20, 2007 · Radiology

Device Facts

• Record ID: K071233
• Device Name: XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
• Applicant: Kub Technologies, Inc.
• Product Code: MWP · Radiology
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

Device Story

XPERT Specimen Radiography System (XPERT 40) is a self-contained, shielded cabinet X-ray system for imaging surgically excised and needle core biopsies. Device uses small focal spot X-ray source and adjustable sample positioning to provide variable magnification, high-resolution, and high-contrast images. System supports radiographic film (up to 10x12") or digital imaging via DICOM-compliant detectors (up to 8x10"). Operated by clinical staff in a medical setting; device does not expose patients to radiation. System includes PC with DICOM-compliant software and LCD monitor for image display. Clinicians use output to verify that correct tissue has been excised, facilitating rapid intraoperative or post-biopsy assessment.

Clinical Evidence

Bench testing only. The device underwent electrical safety testing, radiation safety testing, and software validation testing to confirm performance requirements were met.

Technological Characteristics

Shielded cabinet X-ray system; small focal spot X-ray source; adjustable sample positioning; supports radiographic film or digital detectors (DICOM-compliant); PC-based workstation with LCD monitor; software-based image acquisition and display.

Indications for Use

Indicated for rapid verification of excised tissue specimens from various anatomical regions during biopsy procedures.

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

• piXarray by Biotics (K052433)
• Dx-50 by Faxitron (K061361)
• MX 20 by Faxitron (K953404)

Submission Summary (Full Text)

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

btec

Ko 71233

GUN 2 0 2007

# 510 (k) Summary

Date Prepared [21 CFR 807.92(a)(1)} 4/30/07

#### Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary on behalf of KUB Technologies, Inc.

Contact: Joseph Azary 543 Long Hill Avenue Shelton, CT 06484 Tel: [phone] Fax: [phone].

Manufacturer: KUB Technologies, Inc. 1317 Mill Plain Road, Unit A Fairfield, CT 06824 FDA Establishment Registration# Pending

#### Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

The device trade names are:

- > XPERT Specimen Radiography System
- > XPERT 40

Specimen X-Ray System / Cabinet Class II, Product Code MWP, 21 CFR 892.1680

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#### Predicate Device [21 CFR 807.92(a)(3)]

- piXarray by Biotics K052433 ்
- Dx-50 by Faxitron K061361 0
- MX 20 by Faxitron K953404 (the product formerly owned by Micro Focus Imaging) 0

### Description of the Device [21 CFR 807.92(a)(4)]

The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size.

With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies.

The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.

#### Intended Use [21 CFR 807.92(a)(5)]

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

#### Technological Characteristics [21 CFR 807.92(a)(6)]

The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics.

#### Performance Data [21 CFR 807.92(b)(1)]

The subject device has been subjected to and passed electrical and radiation safety requirements, as well software validation testing.

#### Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

KUB Technologies, Inc. % Mr. Joseph M. Azary Official Correspondent Azary Technologies, LLC 543 Long Hill Avenue SHELTON CT 06484

Re: K071233

Trade/Device Name: Kubtec XPERT 40 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: April 30, 2007 Received: May 3, 2007

JUN 2 0 200

#### Dear Mr. Azary:

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 shows a logo for the FDA Centennial, which took place from 1906-2006. The logo is circular and contains the letters "FDA" in the center. Below the letters, the word "Centennial" is written. Below that are three stars. Below the logo, the words "Protecting and Promoting Public Health" are written in a decorative font.

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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/cdrl/industry/support/index.html.

Sincerely yours.

Nancy Chogdon

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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## Indications for Use

(07/233 510(k) Number (if known):

Device Name: Kubtec XPERT 40

Indications For Use:

Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Humphrey

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

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