DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER by SICEL TECHNOLOGIES, INC.

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.

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.

AI/ML Overview

The provided text describes a medical device, the DVS (Dose Verification System), and its regulatory submission. However, it does not contain specific information about acceptance criteria for performance, a study proving those criteria were met, or details related to an AI/ML device.

The document is a 510(k) summary for a patient radiation dosimeter. It focuses on:

Device Description: What the DVS is and how it works (MOSFET technology for in vivo radiation dose measurement).
Intended Use/Indications for Use: To verify treatment planning and radiation dose in radiation therapy, specifically for breast and prostate cancer to measure photon beam therapy.
Comparison to Predicate Device: Stating that the intended use and technological features are largely the same as a predicate device, with an additional indication for prostate cancer.
Regulatory Information: Submitter details, FDA communication, and classification.

Therefore, I cannot provide the requested information about acceptance criteria, performance study details, or AI/ML-specific metrics because these details are not present in the provided text.

To address the prompt directly with the information available:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document describes the device, its intended use, and its equivalence to a predicate device, but does not detail specific performance metrics, acceptance criteria, or results from a performance study.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document. No test set or data provenance is mentioned.

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)

This information is not provided in the document. There is no mention of experts or ground truth establishment for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document. There is no mention of adjudication or a test set.

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

This information is not provided in the document. The DVS is a patient radiation dosimeter, not an AI/ML-assisted diagnostic device. Therefore, an MRMC study related to human reader improvement with AI assistance would not be applicable to this device and is not mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. The DVS is a physical implantable device with a reader and software, not an algorithm in the sense of AI/ML. Its performance is inherent to its physical measurement capabilities.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. For a radiation dosimeter, ground truth would typically refer to a known, accurately measured radiation dose from a reference instrument. However, the document does not elaborate on how this was established for validation.

8. The sample size for the training set

This information is not provided in the document. As this device is not described as an AI/ML device, a "training set" in that context would not apply.

9. How the ground truth for the training set was established

This information is not provided in the document. (See point 8).

Summary

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JUN 1 3 2006

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87 (h).

Submitter:

Sicel Technologies, Inc. 3800 Gateway Centre Blvd. Suite 308 Morrisville, NC 27560

Contact: Tammy B. Carrea, Director Regulatory Affairs Phone: (919) 465-2236 ext. 225 Fax:

Prepared: April 14, 2006

Common or UsualName:	Patient Radiation Dosimeter
Proprietary Name:	DVS, Dose Verification System
Classification Name:	System, Radiation Therapy, Charged-Particle, Medical
Manufactured By:	Sicel Technologies, Inc.3800 Gateway Centre Blvd.Suite 308Morrisville, NC 27560
	Phone: (919) 465-2236Fax: (919) 465-0153

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Kolelosi
Page 282

Predicate Device(s):

Kobi051

Sicel Technologies, Inc. K052118 DVS, Dose Verification System

Device Description:

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 periphers, furnor bed and/or surrounding normal tissues for validation of the prescribed dose.

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Kolelosi
page 3 of 3

Comparison with Predicate Device:

K061051

The intended use of this SICEL DVS is identical to the predicate device, the DVS Dose Verification System.

The indications for use of the SICEL DVS also are the same as the predicate device except for the additional indication for prostate cancer.

The technological features of the SICEL DVS are the same as the predicate including the use of MOSFET technology, the calibration method, dose range, energy sources measured, and dose management software.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2006

Ms. Tammy B. Carrea Director. Regulatory Affairs Sicel Technologies, Inc. 3800 Gateway Centre Boulevard Suite 308 MORRISVILLE NC 27560

Re: K061051

Trade Name: DVS, Dose Verification System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: LHN and NZT Dated: April 14, 2006 Received: April 17, 2006

Dear Ms. Carrea:

This letter corrects our substantially equivalent letter of June 13, 2006.

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, 1976, 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 (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 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.

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

Image /page/3/Picture/13 description: The image is a black and white logo for the FDA Centennial. The logo is circular and contains the text "1906 - 2006" at the top. Below that is the FDA acronym in a bold font. The word "Centennial" is below the acronym. There are three stars below the word "Centennial". The text around the circle says "A Century of Protecting Your Health".

Protecting and Promoting Public Health

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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 (QS) 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 continue 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Daniel Ch. hyron

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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Kolo 1051 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)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

David R. lyons

(Division Sign-Off)

Division of Reproductive and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.