(21 days)
The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.
The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
The provided text is a 510(k) summary for the DVS (Dose Verification System) and discusses its substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, device performance metrics (other than stating "the dosimeter performance specifications are the same and have not changed"), sample sizes for testing, ground truth establishment, or clinical study designs (such as MRMC studies).
Therefore, I cannot populate the table or answer most of the questions based on the provided text.
Here is what can be inferred or stated about the information requested:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The dosimeter performance specifications are the same and have not changed." |
| Not specified | "The Reader design and performance specifications are the same and have not changed." |
| Not specified | "verification and validation testing... demonstrated that the device met pre-determined acceptance criteria based on performance specifications." (Specific criteria not provided) |
2. Sample sized used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "verification and validation testing" but does not detail the nature of the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a "ground truth" using human experts for the test set.
4. Adjudication method for the test set:
- Not specified, as no expert adjudication of a test set is mentioned.
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 MRMC comparative effectiveness study is mentioned. This device is a hardware/software system for dose verification, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This device is not an algorithm-only system. It's a physical dosimeter and reader system with accompanying software. The document states "verification and validation testing... demonstrated that the device met pre-determined acceptance criteria based on performance specifications," which implies standalone testing of the system's performance.
7. The type of ground truth used:
- The document implies that the device's measurements are validated against established physical dosimetry principles and potentially against existing clinical dose measurement standards (given its use for "verification of the prescribed dose"). However, the specific type of ground truth (e.g., gold standard phantom measurements, comparison to other validated dosimetry systems) is not explicitly detailed.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML model that requires a training set in the typical sense. It is a measurement device.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model for this device.
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510(k) Summary
K080004
pg 1 of 2
Predicate Device(s):
Sicel Technologies, Inc. K052118. K061051. K071399 DVS, Dose Verification System
JAN 2 3 2008
Device Description:
The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.
Indication for Use:
The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.
The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
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K080004
Pg. 2 of 2
Comparison with Predicate Device:
The intended use of this SICEL DVS is identical to the predicate device, the DVS Dose Verification System in K052118, K061051, and K071399. The indications for use of the SICEL DVS also are the same.
The technological features of the SICEL DVS Dosimeter are the same as the predicate including the use of MOSFET technology, the calibration method, dose range, and energy sources measured. The dosimeter performance specifications are the same and have not changed. The principle of operation is the same as the predicate. The tissue contacting materials are the same and the sterilization method is the same. The insertion tool design, materials, and sterilization are the same. The Reader design and performance specifications are the same and have not changed. The Data System is the same and has not changed.
The primary difference between the predicate device and the modified device is the change to the dosimeter's potting epoxy used to secure and position the electronics within the biocompatible glass capsule. Other changes include minor dimensional changes, minor changes to the electronics components, and minor changes to the Reader software and accompanying Operator's Manual. Details of the substantial equivalence comparison are provided.
Furthermore, verification and validation testing based on the risk analysis, provided information sufficient to determine that the modifications did not have an effect on safety or efficacy and demonstrated that the device met pre-determined acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device. The verification and validation results are provided within the 510(k).
Thus, the DVS, Dose Verification System is substantially equivalent to the DVS, Dose Verification System (K052118, K061051, K071399).
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
JAN 2 3 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tammy B. Carrea Vice President, Regulatory Affairs Sicel Technologies, Inc. 3800 Gateway Centre Boulevard, Suite 308 MORRISVILLE NC 27560
Re: K080004
Trade/Device Name: Dose Verification System Patient Dosimetry System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: NZT Dated: December 31, 2007 Received: January 2, 2008
Dear Ms. Carrea:
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, 1796, 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 such 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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0126 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: DVS, Dose Verification System
Indications for Use:
Intended Use
The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.
Indications for Use
The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.
(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 C.F.R. 801.109) | OR |
| Over-The-Counter Use ______ | |
| (Optional Format 1-2-96) | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, andRadiological Devices |
510(k) Number
§ 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.