PORT CASSETTE

K032654 · Orex Computed Radiography, Ltd. · IXK · Oct 9, 2003 · Radiology

Device Facts

• Record ID: K032654
• Device Name: PORT CASSETTE
• Applicant: Orex Computed Radiography, Ltd.
• Product Code: IXK · Radiology
• Decision Date: Oct 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

Device Story

PoRT Cassette is a reusable phosphor storage screen accessory for the PcCR Digital Imaging Device; used for portal imaging in radiation therapy quality control. Input consists of radiographic images captured on the phosphor screen; the PcCR reader digitizes these images. Software on a user-provided PC displays, enhances, and stores the digital radiographs. System allows clinicians to review images for therapy verification. Benefits include filmless digital radiography workflow for radiation therapy quality control.

Clinical Evidence

Bench testing and clinical validation were performed to demonstrate that the PoRT Cassette performs according to specifications. No specific quantitative metrics (e.g., sensitivity, specificity) were provided in the summary.

Technological Characteristics

Reusable phosphor storage screen; 14" x 17" form factor. Operates as an accessory to the PcCR Digital Imaging Device (K003256). System includes image reader/digitizer and software for display, enhancement, and storage on a user-provided PC.

Indications for Use

Indicated for portal imaging (Radiation Therapy Quality Control) in patients undergoing radiation therapy.

Regulatory Classification

Identification

An electrostatic x-ray imaging system is a device intended for medical purposes that uses an electrostatic field across a semiconductive plate, a gas-filled chamber, or other similar device to convert a pattern of x-radiation into an electrostatic image and, subsequently, into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Kodak EC-L Cassette/EC-V Verification System for Portal Imaging (K960834)

Reference Devices

• PcCR Digital Imaging Devices (K003256)

Submission Summary (Full Text)

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K032654

OCT = 9 2003

# 510(k) Summary

for

## PcCR Digital Imaging Devices for X-Ray Systems

#### DATE SUMMARY PREPARED 1.

August 26, 2003

#### SUBMITTER'S NAME AND ADDRESS 2.

Orex Computed Radiography Ltd. Yoqneam "Star" Bldg. NESHED 36603 NESHER 36603 : 2 ISRAEL

#### 3. CONTACT PERSON

Moshe Shenhav Telephone: [phone] Facsimile: 011 972 4 959 1262

#### 4. DEVICE NAME

Trade/Proprietary Name: PoRT Cassette Accessory to Electrostatic X-ray imaging system Common Name: Accessory to Electrostatic X-ray imaging system Classification Name:

#### PREDICATE DEVICES ડ.

The legally marketed device to which equivalence is being claimed is: Kodak EC-L Cassette/EC-V Verification System for Portal Imaging (K960834)

#### 6. DEVICE DESCRIPTION

The PoRT Cassette is an optional cassette to be used with the PcCR Digital Imaging Devices for portal imaging. The PcCR Digital Imaging Devices are filmless systems intended for digital radiography using a phosphor storage screen which were cleared under K003256. The PcCR Digital Imaging device enables the clinician to scan or import images for display, review, or storage in a database. The PcCR device consists of reusable phosphor storage screens for recording radiographic images, an

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image reader/digitizer, and software for displaying, enhancing, and storing radiographs using a user-provided personal computer. The PoRT Cassette is optional cassette to be used with the PcCR System and is also a reusable phosphor screen. It is offered in 14" x 17" size. Other than the addition of the PoRT Cassette and a software upgrade, the PcCR Digital Imaging Device is identical to that described in K003256.

#### 7. INTENDED USE

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

### 8. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Orex Computed Radiography Ltd. bases the claim of equivalence to cited predicate devices upon similarities in intended use, technological characteristics, and operational characteristics. Bench testing and clinical validation demonstrate that the PoRT Cassette performs according to specifications.

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Image /page/2/Picture/1 description: The image shows a circular seal or logo. The seal features the symbol of the Department of Health & Human Services (HHS) in the center, which is a stylized eagle with three lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 2003

Orex Computed Radiography, Ltd. % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K032654 Trade/Device Name: PoRT Cassette

Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II Product Code: 90 IXK Dated: August 26, 2003 Received: August 28, 2003

Dear Ms. McNamara-Cullinane:

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 (PMA), it may be subject to 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.

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.

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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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

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

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510(k) Number (if known):

K032654

Device Name: PoRT Cassette

Indications for Use:

The PoRT Cassette is an accessory to the PcCR Digital Imaging Device and is indicated for portal imaging (Radiation Therapy Quality Control).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc hogdon
(Division Sign-Off)

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Orex Computed Radiography Ltd. 510(k) PcCR Digital Imaging Devices

August 26, 2003