DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100

K071399 · Sicel Technologies, Inc. · LHN · Jun 20, 2007 · Radiology

Device Facts

• Record ID: K071399
• Device Name: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
• Applicant: Sicel Technologies, Inc.
• Product Code: LHN · Radiology
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

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. 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 Story

DVS is an implantable radiation dosimeter system used in radiotherapy. Components include: implantable MOSFET dosimeter, insertion tool, reader system (wand/base station), and data system (software/database). The dosimeter is implanted percutaneously prior to therapy. During treatment, the reader wand powers the dosimeter via electromagnetic energy; the dosimeter transmits threshold voltage readings representing radiation dose. The system is radioopaque, allowing CT-based point-of-interest identification. Data is stored in a server-based database for multi-user access. Clinicians use the Plan and Review software to compare measured fractional and cumulative doses against prescribed treatment plans. This enables real-time validation of radiation delivery, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Verification and validation testing performed based on risk analysis to confirm performance specifications and safety of modifications, including 3T MRI compatibility and sterilization validation.

Technological Characteristics

Implantable MOSFET dosimeter; electromagnetic power transfer; radioopaque for CT visualization. System includes reader wand, base station, and server-based software. Software manages dose data, calibration files, and reporting. No primary material changes from predicate.

Indications for Use

Indicated for breast and prostate cancer patients undergoing photon beam radiation therapy to measure in vivo radiation dose at tumor periphery, tumor bed, or surrounding tissues for treatment planning validation.

Regulatory Classification

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.

Predicate Devices

• DVS, Dose Verification System (K052118)
• DVS, Dose Verification System (K061051)

Submission Summary (Full Text)

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510(k) Summary

K07/399

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

JUN 2 0 2007

Contact: Tammy B. Carrea, Director Regulatory Affairs Phone: [phone] ext. 225 Fax:

Prepared: May 17, 2007

| Common or Usual<br>Name: | Patient Radiation Dosimeter |
|--------------------------|--------------------------------------------------------------------------------------------------|
| Proprietary Name: | DVS, Dose Verification System |
| Classification Name: | System, Radiation Therapy, Charged-Particle, Medical<br>Dosimeter, Ionizing Radiation, Implanted |
| Manufactured By: | Sicel Technologies, Inc.<br>3800 Gateway Centre Blvd.<br>Suite 308<br>Morrisville, NC 27560 |
| | Phone: [phone]<br>Fax: [phone] |

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Predicate Device(s):

Sicel Technologies, Inc. K052118, K061051 DVS, Dose Verification System

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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Comparison with Predicate Device:

The intended use of this SICEL DVS is identical to the predicate device, the DVS Dose Verification System in K052118 and K061051. The indications for use of the SICEL DVS also are the same.

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. The principle of operation is the same as the predicate. The primary difference between the predicate device and the modified device is the change in the accuracy specification, the addition of 3T MRI safety testing, and the change in sterilization process. There are no primary material changes. Minor changes in packaging, dimensions, and software were also implemented. 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).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Ms. Tammy B. Carrea Vice President Regulatory Affairs Sicel Technologies. Inc. 3800 Gateway Centre Blvd., Suite 308 MORRISVILLE NC 27560

Re: K071399

Trade/Device 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: May 17, 2007 Received: May 22, 2007

## 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, 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 Noss netic Act (Act) that do not require approval of a premarket approval application (PMA). You cossin 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 adultervition.

If your device is classified (see above) into either class II (Special Controls) or class 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 898. In addition FIFA may publish further announcements concerning your device in the Federal Register.

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Promoting and Promoting Public Health

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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 (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 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology). | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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): Ko71399

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.

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| 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)

Hulu Remerma

(Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number