DPD-12PCC

K990734 · Scanditronix Medical AB · IYE · May 28, 1999 · Radiology

Device Facts

• Record ID: K990734
• Device Name: DPD-12PCC
• Applicant: Scanditronix Medical AB
• Product Code: IYE · Radiology
• Decision Date: May 28, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Indications for Use

The DPD-12PC Direct Patient Dosemeter is designed to be used to monitor radiation dosage during treatment. The DPD-12PC can also be used for quality control measurement of therapeutic radiation devices. The DPD-12PC provides multi-channel dose or dose-rate measurements utilising up to 12 semiconductor detectors. The device function is accessed by using the keyboard on the user interface personal computer. Measured parameters may be stores in the personal computer.

Device Story

DPD-12PC is an in vivo dosimetry system for radiation therapy; modification of DPD-3. System comprises 12-channel electrometer, personal computer (PC) display unit, semiconductor detectors, detector support, and cabling. Detectors placed on patient to monitor radiation dose/dose-rate during treatment; also used for quality control of radiation therapy equipment. PC interface allows user to initiate measurements via keyboard and store data. Used in clinical radiation therapy settings by trained personnel. Provides real-time dose monitoring to ensure treatment accuracy and patient safety.

Clinical Evidence

No clinical testing was performed. The device is a quality assurance tool for radiation treatment and is not directly involved in the delivery of therapeutic radiation. Evidence is based on bench testing of operational parameters and electrical/electromagnetic safety compliance.

Technological Characteristics

12-channel electrometer; semiconductor detectors; PC-based user interface. Electrical safety: IEC 601-1; Electromagnetic compatibility: IEC 601-1-2; Detector standard: IEC 601-2-9. Connectivity: PC-based data storage and control.

Indications for Use

Indicated for monitoring radiation dosage to patients during radiotherapy procedures and for quality control measurements of therapeutic radiation devices. Prescription use only.

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

• DPD-3 (Scanditronix Medical AB) (K9420921)
• DPD-510 (Scanditronix Medical AB) (K925133)

Submission Summary (Full Text)

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## CONFIDENTIAL

90734 MAY 2 8

(a)

$$\mathbf{510(k)}\text{ Summary}$$

This summery is submitted in compliance with 21 CFR 807.92

| (1) Submitted by: | Scanditronix Medical AB<br>Stålgatan 14,<br>S-754 50 Uppsala<br>Sweden |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact persons: | Lars Göran Larsson<br>[phone]<br>or<br>Eva Larsten<br>[phone] |
| Date of preparation: | 26-Feb-1999 |
| (2) Trade name of device: | DPD-12PC |
| Common name: | Direct Patient Dosemeter |
| Classification name: | (Accessory to) Radionuclide radiation therapy<br>system, §892,5750; X-ray radiation therapy<br>system, §892,5900; and Medical charged-particle<br>radiation therapy system, §892.5050. |
| (3) Identification of predicate<br>marketed device: | DPD-3 (Scanditronix Medical AB),<br>FDA K9420921, 510(k) July 1994,<br>DPD-510 (Scanditronix Medical AB)<br>FDA K925133, 510(k) Jan.1993. |

## Description of the devise: (4)

The Scanditronix Medical DPD-12PC, Direct Patient Dosemeter is a device modification of DPD-3, Direct Patient Dosemeter, FDA K9420921, 510(k) July 1994 used for In Vivo Dosimetry in radiation therapy. It consists of a 12 channel electrometer, display unit (personal computer) semiconductor detectors, detector support, extension cable, communication cable.

- Intended uses: (5)
The DPD-12PC Direct Patient Dosemeter is designed to be used to monitor radiation dosage during treatment. The DPD-12PC can also be used for quality control measurement of therapeutic radiation devices. The DPD-12PC provides multi-channel dose or dose-rate measurements utilising up to 12 semiconductor detectors. The device function is

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CONFIDENTIAL

Section 6

accessed by using the keyboard on the user interface personal computer. Measured parameters may be stores in the personal computer.

- Technological comparison: (6)
The Scanditronix Medical's DPD-12PC, Direct Patient Dosemeter is a device modification of the predicate device Scanditronix Medical's DPD-3. Both devices are using the same technology.

- Non-Clinical tests: (1) (b)
Comparison of operational characteristics for the Scanditronix Medical DPD-12-PC and the predicate product show similar results that are suitable for their intended purpose. To minimize potential electrical hazards, Scanditronix Medical adheres to recognized and established industry practice, and all devices are subject to final performance testing. The Scanditronix Medical DPD-12PC is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current and meets electrical performance standards for CSA and UL. In addition, all semiconductor detectors fulfills the IEC-601-2-9 standard.

The electrometer of Scanditronix Medical DPD-12PC has been tested and found to fulfil the requirements concerning electromagnetic compatibility according to the standard IEC 601-1-2 .

- (2) Clinical tests:
Due to the fact that the system is a quality assurance device in radiation treatment (In Vivo Dosimetry) not directly involved in the delivery of the treatment radiation, no clinical testing was performed.

- (3) Test conclusions:
Testing of operational parameters indicates that the DPD-12PC is safe, it fulfils the intended use and performs as well as or better than the previously released DPD-3.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 1999

Ms. Eva Larsten Quality Manager Scanditronix Medical AB Stalgatan 14 S-754 50 Uppsala SWEDEN

Re: K990734

DPD-12PC Direct Patient Dosemeter Dated: April 26, 1999 Received: April 29, 1999 Regulatory Class: Il 21 CFR 892.5050, 892.5750, 892.5900 Procode: 90 IYE

Dear Ms. Larston:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controis 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 III (Special Controls) or dass 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K990734/ S01/

Device Name:

DPD-12PC Direct Patient Dosemeter

Indications for Use:

The DPD-12PC Direct Patient Dosemeter is used

- to monitor radiation dosage to a patient during radiotherapy procedure
- for quality control measurements of therapeutic radiation devices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Ingram

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 990734 510(k) Number

Prescription Use_V (Per 21 CFR 801.109) (Optional Format 1-2-96)

OR

Over-The -Counter Use__

99-02-09/EL