ONE DIMENSIONAL WATER PHANTOM, WP 1D

K032594 · Wellhofer Dosimetrie · IYE · Sep 5, 2003 · Radiology

Device Facts

• Record ID: K032594
• Device Name: ONE DIMENSIONAL WATER PHANTOM, WP 1D
• Applicant: Wellhofer Dosimetrie
• Product Code: IYE · Radiology
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision one-dimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.

Device Story

WP 1D is a clinical reference dosimetry phantom; consists of PMMA (Perspex) cubic water tank with 1D precision servomechanism. Used by medical physicists/dosimetrists to position radiation detectors at specific depths for radiation therapy calibration. Two versions: Manual (self-locking hand crank with battery-powered position indicator) and SCU (motorized with electronic servo control unit/remote control). Device enables accurate detector placement for dosimetric protocols (e.g., AAPM TG-51, IAEA TRS-398). Output is physical positioning of sensors; assists clinicians in verifying radiation beam characteristics; ensures accurate dose delivery for patient safety.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: PMMA (Perspex) water tank. Sensing/Actuation: 1D precision servomechanism; manual hand crank or motor/potentiometer drive. Energy: Battery-powered position indicator (manual version) or electronic servo control unit (SCU). Form factor: Cubic tank with vertical guide rail. Connectivity: None.

Indications for Use

Indicated for use by experienced professionals for positioning radiation detectors in water or air to facilitate dosimetric measurements according to protocols like AAPM TG-51 or IAEA TRS-398.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Water Phantom MT-150 (MEDTEC Inc.)
• Motorized Depth Dose Apparatus (MEDTEC Inc.) (K943199)

Submission Summary (Full Text)

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K032594

# 2 - 5 2003

#### I. 510(k) SUMMARY

This summary is submitted in compliance with 21 CFR \$807.92

| Submitted by: | Scanditronix / Wellhofer |
|----------------------|------------------------------------------------------------------|
| | Bahnhofstrasse 5 |
| | 90592 Schwarzenbruck ( Germany ) |
| | Phone: [phone] |
| | FAX: [phone] |
| Contact Person: | Martin Arold |
| Date Prepared: | February 1, 2003 |
| Proprietary Name: | WP ID |
| Common Name: | Clinical Reference Dosimetry Phantom |
| Classification Name: | Accelerator, linear, medical, §892.5050 |
| Predicate Device: | Water Phantom MT-150 (MEDTEC Inc.) |
| | Motorized Depth Dose Apparatus (MEDTEC Inc.) K943199, 12/07/1994 |

#### (1) Description of the Device:

The Clinical Reference Dosimetry Phantom WP 1D comprises a one-dimensional precision servomechanism attached to a Perspex (PMMA) water tank. Various radiation detectors can be positioned along a vertical guide rail in different depths according to the application needs.

The "Manual Version" consists of the basic phantom, equipped with a self-locking hand crank to move the detector. That hand crank is coupled to a battery powered, reset-able position indicator that displays the depth.

The "SCU Version" consists of the basic phantom, equipped with a motor/potentiometer device to move the detector. An electronic servo control unit (SCU) consisting of a handheld Remote Control and a Motor Control unit is used to position the detector to a user definable or stored depth.

#### (2) Intended use:

The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision one-dimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.

#### (3) Technological comparison:

The WP 1D is a clinical Reference Dosimetry System similar to the MEDTEC Inc. Depth Dose Apparatus, K943199, 12/07/1994.

Both devices consist of an acrylic water tank equipped with a one-dimensional scanning mechanic to position various radiation sensors in different water depths.

Both scan mechanics may be driven manually or motor controlled.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with three lines representing its wings. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP - 5 2003

Wellhöfer Dosimetrie % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K032594

Trade/Device Name: One Dimensional Water Phantom, Model WP-1D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 IYE Dated: August 8, 2003

Received: August 22, 2003

Dear Mr. Preiss:

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

Enclosure

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### II. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

(not known)

WP ID

Kp32594

Indications For Use:

The Clinical Reference Dosimetry Phantom WP 1D is used to position various radiation detectors in water or air. It consists of a cubic tank and a precision onedimensional hand crank or motor driven servo. By design it is suitable to act as a phantom according to various dosimetric protocols (e.g. AAPM's TG-51 or IAEA's TRS-398). The device is intended to be used by experienced professionals entrusted with dosimetric functions only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109)

O R

Over-The-Counter Use_

Nansy C. Brogdon
(Division Sign-Off)

Divisi and Radiological Devic 510(k) Number