(84 days)
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
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.
The provided text describes a 510(k) summary for the DPD-12PC Direct Patient Dosemeter. According to the document, the device is a modification of a predicate device (DPD-3 and DPD-510) and is intended for in-vivo dosimetry in radiation therapy and quality control measurements of therapeutic radiation devices.
Here's an analysis of the acceptance criteria and the study as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria in a numerical or statistical format, nor does it provide specific reported device performance metrics against such criteria. Instead, it relies on a comparison to a predicate device and compliance with established standards.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Similar operational characteristics to predicate device (DPD-3) | "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." |
| Safety against electrical hazards | "Scanditronix Medical adheres to recognized and established industry practice, and all devices are subject to final performance testing." |
| Conformance with IEC 601-1 standards for electrical isolation and leakage current | "The Scanditronix Medical DPD-12PC is designed for conformance with IEC 601-1 standards for electrical isolation and leakage current" |
| Meets electrical performance standards for CSA and UL | "and meets electrical performance standards for CSA and UL." |
| Semiconductor detectors fulfill IEC-601-2-9 standard | "all semiconductor detectors fulfills the IEC-601-2-9 standard." |
| Electromagnetic compatibility according to IEC 601-1-2 | "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." |
| Performance as good as or better than predicate device (DPD-3) | "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." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a "test set" in the context of clinical data or patient samples. The tests performed were non-clinical, focusing on engineering specifications and comparison to a predicate device. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
No ground truth established by experts for a test set is mentioned, as no clinical testing or performance evaluation against specific clinical outcomes was conducted. The evaluation primarily relied on engineering standards and comparison with a predicate device.
4. Adjudication Method for the Test Set:
Not applicable, as no test set requiring expert adjudication for ground truth was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "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."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is not an algorithm or AI system. It is a physical medical device (direct patient dosemeter). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance was evaluated through non-clinical technical tests comparing it to its predicate.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was adherence to established industry practices, international standards (IEC 601-1, IEC 601-2-9, IEC 601-1-2), and observed operational characteristics of a legally marketed predicate device (DPD-3). There was no ground truth derived from expert consensus, pathology, or outcomes data as no clinical testing was performed.
8. The Sample Size for the Training Set:
Not applicable. The device is not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
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 ABStålgatan 14,S-754 50 UppsalaSweden |
|---|---|
| Contact persons: | Lars Göran Larsson+46 18 18 08 52orEva Larsten+46 18 18 07 88 |
| Date of preparation: | 26-Feb-1999 |
| (2) Trade name of device: | DPD-12PC |
| Common name: | Direct Patient Dosemeter |
| Classification name: | (Accessory to) Radionuclide radiation therapysystem, §892,5750; X-ray radiation therapysystem, §892,5900; and Medical charged-particleradiation therapy system, §892.5050. |
| (3) Identification of predicatemarketed device: | DPD-3 (Scanditronix Medical AB),FDA K9420921, 510(k) July 1994,DPD-510 (Scanditronix Medical AB)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
{1}------------------------------------------------
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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle.
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 (301) 594-4613. 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"(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 (800) 638-2041 or (301) 443-6597, 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
{3}------------------------------------------------
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
§ 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.