(196 days)
These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.
The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.
Here's an analysis of the provided text, focusing on acceptance criteria and the study that proves the device meets them:
The provided document is a 510(k) Premarket Notification summary for the Victoreen VeriDose Diodes. This type of regulatory submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or meeting specific, independently established acceptance criteria through a comprehensive clinical study.
Therefore, the information presented does not include a detailed study proving the device meets explicit acceptance criteria in the way a clinical trial or performance study for an AI/software device would. Instead, the document lists general specifications that characterize the device's performance, implying these specifications are comparable to or meet the expected performance for such a device, and are substantially equivalent to the predicate device.
Let's break down what is available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a physical medical device (radiation detector), the "acceptance criteria" are implied by the listed general specifications of the device, which are then compared to the predicate device (ISORAD Photon Detectors) for substantial equivalence. "Reported device performance" refers to these established specifications.
| Characteristic | Acceptance Criteria (Implied by Specification) | Reported Device Performance (VeriDose Diodes) |
|---|---|---|
| Range | Expected to measure radiation dose rates within a specified range. | 2.0 cGy/minute to 1000 cGy/minute |
| Effective Detection Area | Defined physical area for radiation detection. | 2 mm² |
| Output | Nominal output signal per unit of radiation. | 1.0 nC/R nominal (all models) |
| Cable Length | Standard cable length for connection. | 2 meters |
| Optimal Build-up (Material & Thickness) | Appropriate material and thickness needed for accurate measurement for different energy levels/particles. Compare to predicate. | 1-4 MV Photon: 5 mm H2O equiv. (826 mg/cm²) - Same as Isorad Build-up 6-12 MV Photon: 15 mm H2O equiv. (1500 mg/cm²) - Same as Isorad Build-up 12-18 MV Photon: 28 mm H2O equiv. (2800 mg/cm²) - No (compared to Isorad) 18-25 MV Photon: 36 mm H2O equiv. (3600 mg/cm²) - No (compared to Isorad) 6-25 MeV Electron: 1 mm Al equiv. (275 mg/cm²) - Same as Isorad Build-up 100-662 keV Photons: Energy Compensated - No (compared to Isorad) |
| Sensitive Area Build-up Shape | Physical characteristic. | Hemispherical |
| Angular Dependence | Variation in measurement based on the angle of radiation incidence. | Less than 5% over 2π hemisphere from perpendicular incidence to 75 degrees; less than 10% from 75 to 90 degrees. |
| Linearity | Consistency of output signal proportional to dose rate. | Better than 0.3% over 2 cGy/min to 1000 cGy/min, provided that dose-per-pulse remains constant. |
| Polarity Options | Availability of different polarity versions. | Both positive and negative polarity versions available for each model. |
| Temperature Sensitivity | Change in measurement per degree Celsius. | Less than 0.3% per degree C. |
| Waterproof/Washable | Environmental resistance features. | Waterproof, washable in cold disinfectant, molded in non-hygroscopic plastic. |
| Connector Type | Standardized connection interface. | BNC coaxial connector. |
Regarding the "Study that proves the device meets the acceptance criteria":
The provided document is a 510(k) summary from 1996. For physical, non-software/AI medical devices, the demonstration of "acceptance criteria" and "proof" typically comes from bench testing and engineering validation comparing the new device's specifications to those of a predicate device, and ensuring it meets its own design specifications. The document summarizes these characteristics, implying that the necessary testing was performed to establish these specifications. However, it does not describe the detailed study methodologies or results.
Based on the prompt's request for information commonly associated with AI/software device studies, much of that information is not applicable or not provided in this type of regulatory submission for a physical device from that era.
Here's an attempt to address the remaining points, noting where information is absent or irrelevant:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable / not provided. This device is a physical radiation detector. "Test set" and "data provenance" as understood for AI/software are not relevant here. The "testing" would involve characterizing the diode's physical and electrical properties in a laboratory setting, likely under controlled radiation fields, rather than with a "data set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / not provided. As a physical sensor, there is no "ground truth" established by human experts in the way an AI algorithm needs it for image interpretation. The "truth" in this context would be physical measurements from calibrated radiation sources and established dosimetry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / not provided. Adjudication methods are used in cases where human interpretation is part of establishing ground truth (e.g., for medical images). This is not relevant for a physical radiation detection device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, not applicable. MRMC studies and the concept of "human readers improving with AI" are specific to AI-assisted diagnostic or interpretive tools. This device is a sensor used by medical professionals, not an interpretive AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance (algorithm only) is not applicable. The device itself is a "standalone" physical sensor. Its performance is based on its physical properties and electrical output, not on an algorithm. It requires a human operator and an "appropriate display device" to interpret its readings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for evaluating this device would be physical dosimetry standards and measurements obtained from highly calibrated and traceable radiation sources (e.g., using primary or secondary standard electrometers and ionization chambers). It would involve comparing the diode's output to these established physical standards under controlled laboratory conditions. This is implied by the specification data, but not explicitly documented as a "ground truth" method.
8. The sample size for the training set
- Not applicable. This device is a physical sensor, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. No training set is involved.
In summary, the provided document is a regulatory submission for a physical medical device (radiation detector) from the 1990s. The concept of "acceptance criteria" is largely met by demonstrating that the device's technical specifications are suitable for its intended use and are substantially equivalent to a predicate device. The detailed study methodologies for establishing these specifications are not included in this type of summary document, and many of the specific questions related to AI/software performance studies are not applicable to this device.
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: Exhibit "C"
K96.4785-
Premarket Notification [510(k)] Summary as required by section 807.92(c)
Date Summary was prepared:
November 21, 1996
Submitter's Name:
JUN 1 3 1997
Victoreen, Inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Contact Person:
Linda S. Morin Director of Regulatory Affairs and Quality Assurance Phone: 216-248-9300 Fax: 216-248-9301
Device Name:
Veridose Diodes
Classification Name:
Medical Charged-Particle Radiation Therapy System
Predicate Device:
ISORAD Photon Detectors that are part of the Dual Dosimetry System, Model number 37-720, 510(k) number K940660/S1
Intended Use:
(Function): The VeriDose solid state detectors are used to make relative measurements of radiation in therapeutic oncology. Silicon diode detectors have been in use for many years for the measurement of both photons and electrons used in radiation. The VeriDose is intended for the detection of ionizing radiation, it should only be used by persons who have the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation. The diodes are taped or otherwise attached to a
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patient's skin during a therapeutic oncology session where the patient is being exposed to radiation. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are more rugged and more sensitive than ionization chambers and are waterproof. They must be connected to an appropriate display device. The purpose of the diode is to measure ionizing radiation independently at various points of interest. The responsible operator should verify the characteristics of each specific detector if the exact parameter is critical to any given clinical application.
Product Description:
The product consists of a waterproof color coded molded plastic hemisphere containing the appropriate buildup material and a radiation sensitive diode attached to a coaxial cable. A BNC connector is supplied for connection to a readout device.
| Model # | Description | Color Code |
|---|---|---|
| 30-471 | VeriDose Diode, 1-4 MV Photon, (positive polarity) | Blue |
| 30-471-8000 | VeriDose Diode, 1-4 MV Photon, (negative polarity) | Blue |
| 30-472 | VeriDose Diode, 6-12 MV Photon, (positive polarity) | Yellow |
| 30-472-8000 | VeriDose Diode, 6-12 MV Photon, (negative polarity) | Yellow |
| 30-473 | VeriDose Diode, 12-18 MV Photon, (positive polarity) | Red |
| 30-473-8000 | VeriDose Diode, 12-18 MV Photon, (negative polarity) | Red |
| 30-474 | VeriDose Diode, 18-25 MV Photon, (positive polarity) | Green |
| 30-474-8000 | VeriDose Diode, 18-25 MV Photon, (negative polarity) | Green |
| 30-475 | VeriDose Diode, 6-25 MeV Electron, (positive polarity) | Silver |
| 30-475-8000 | VeriDose Diode, 6-25 MeV Electron, (negative polarity) | Silver |
| 30-476 | VeriDose Diode, Energy Compensated Photon, (positive polarity) | Black |
| 30-476-8000 | VeriDose Diode, Energy Compensated, (negative polarity) | Black |
Model no. table
GENERAL SPECIFICATIONS:
-
- Range:
2.0 cGy / minute to 1000 cGy / minute. 2 mm²
- Range:
-
- Effective Detection Area:
-
- Output, all models: 1.0 nC/R nominal
-
- Cable length:
-
2 meters
- 2
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| Range | Particle | Optimal Build-up | mg/cm2 | Same as IsoradBuild-up | Color Dot |
|---|---|---|---|---|---|
| 1-4 MV | Photon | 5 mm H2O equiv. | 826 | Yes | Blue |
| 6-12 MV | Photon | 15 mm H2O equiv. | 1500 | Yes | Yellow |
| 12-18 MV | Photon | 28 mm H2O equiv. | 2800 | No | Red |
| 18-25 MV | Photon | 36 mm H2O equiv. | 3600 | No | Green |
| 6-25 MeV | Electron | 1 mm Al equiv. | 275 | Yes | Silver |
| 100-662 keV | Photons | Energy Compensated | No | Black |
- The sensitive area buildup material is hemispherical in shape. 6.
- The angular dependence is less than 5% over the 2 pi hemisphere from 7. perpendicular incidence to 75 degrees and less than 10% from 75 to 90 degrees.
- Linearity is better than 0.3% over the range of 2 cGy / min to 1000 cGy/min 8. provided that dose-per-pulse remains constant.
- There are both positive and negative polarity versions of each. 9.
- The temperature sensitivity is less than 0.3% per degree C. 10.
- The detectors are waterproof and are washable in cold disinfectant. They are 11. molded in plastic that is non-hygroscopic.
-
- The device has a BNC coaxial connector.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 1997
Linda S. Morin Corporate Director of Regulatory Affairs and Quality Assurance Victoreen, inc. 6000 Cochran Road Cleveland, Ohio 44139-3395
Re: K964785
VeriDose Diodes Medical Charged-Particle Radiation Therapy System Dated: April 18, 1997 Received: April 25, 1995 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Morin:
We have reviewed your Section SIOR) notification of intent to market the device referenced above and we have decemined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 disgnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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 entiled, "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/dsmamain.html".
Sincerely yours,
William Y
Lillian Yin, Ph.D. 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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K964785 510(k) Number:
Veridose Diodes Device Name:
Indications for Use:
These diodes are used to provide dose verification and quality assurance for paţients undergoing radiation therapy.
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Harild A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use _
1794 ประเทศ
or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.