(84 days)
K9420921, K925133
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
No
The device is used to monitor radiation dosage and for quality control of therapeutic radiation devices, meaning it measures and assesses, but does not directly deliver or perform therapy.
No
The device monitors radiation dosage during radiotherapy and performs quality control measurements of therapeutic radiation devices. While it measures a physical parameter (radiation dosage), it doesn't diagnose a patient's medical condition or disease.
No
The device description explicitly lists hardware components including an electrometer, display unit (personal computer), semiconductor detectors, detector support, extension cable, and communication cable.
Based on the provided information, the DPD-12PC Direct Patient Dosemeter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor radiation dosage to a patient during radiotherapy procedure" and "for quality control measurements of therapeutic radiation devices." This involves measuring radiation within or on the patient's body during treatment, or measuring the output of a radiation device.
- Device Description: The device uses semiconductor detectors and an electrometer to measure radiation. This is consistent with in vivo dosimetry or quality control for radiation therapy equipment.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment. The DPD-12PC does not perform this function. It measures radiation directly related to the treatment process.
- Predicate Device: The predicate device, DPD-3, is described as being used for "In Vivo Dosimetry in radiation therapy." This further supports the device's function as an in-vivo measurement tool, not an in-vitro diagnostic.
Therefore, the DPD-12PC is a device used for in vivo dosimetry and quality control in radiation therapy, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / 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.
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
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
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.
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
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical tests: 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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K9420921, K925133
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
Stålgatan 14,
S-754 50 Uppsala
Sweden |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact persons: | Lars Göran Larsson
+46 18 18 08 52
or
Eva 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 therapy
system, §892,5750; X-ray radiation therapy
system, §892,5900; and Medical charged-particle
radiation therapy system, §892.5050. |
| (3) Identification of predicate
marketed 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