(14 days)
Not Found
No
The description focuses on mechanical and electronic control of a phantom for radiation dosimetry, with no mention of AI or ML algorithms for data analysis, image processing, or decision support.
No.
The device is a dosimetry phantom used to position radiation detectors for quality assurance and calibration of radiation therapy equipment, not to directly treat patients.
No
The document describes a phantom used for positioning radiation detectors in water or air according to dosimetric protocols. It is a device for calibrating or verifying the accuracy of radiation delivery, not a device used to diagnose a medical condition in a patient.
No
The device description explicitly details physical components such as a cubic tank, hand crank, motor driven servo, Perspex water tank, vertical guide rail, battery powered position indicator, motor/potentiometer device, handheld Remote Control, and Motor Control unit. These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Clinical Reference Dosimetry Phantom WP 1D is used to position radiation detectors in water or air for dosimetric measurements. It is a tool for calibrating and verifying radiation therapy equipment, not for analyzing biological samples.
- Intended Use: The intended use is for experienced professionals performing dosimetric functions, which relates to measuring radiation doses, not diagnosing medical conditions.
- Lack of Biological Sample Analysis: The description does not mention any interaction with or analysis of human biological samples.
Therefore, the device falls outside the scope of an In Vitro Diagnostic device. It is a phantom used in the field of medical physics for quality assurance and calibration of radiation therapy equipment.
N/A
Intended Use / 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.
Product codes
90 IYE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
experienced professionals entrusted with dosimetric functions only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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: +49-9128-607-0 | |
| FAX: +49-9128-607-10 | |
| 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.
1
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.
2
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 | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
3
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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