MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM

K081859 · Sicel Technologies, Inc. · IYE · Aug 4, 2008 · Radiology

Device Facts

• Record ID: K081859
• Device Name: MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
• Applicant: Sicel Technologies, Inc.
• Product Code: IYE · Radiology
• Decision Date: Aug 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2

Intended Use

The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.

Device Story

OneDose Patient Dosimetry System measures radiation dose during radiotherapy. System components: disposable, single-use, pre-calibrated MOSFET-based dosimeters; battery-powered handheld reader; reader calibration test strip; download software. Operation: dosimeters zeroed in reader, adhered to patient skin via medical-grade adhesive; post-radiotherapy, dosimeters removed, re-inserted into reader for dose readout/reporting. Records stored on dosimeter and reader memory. Used in clinical radiotherapy settings by healthcare professionals. Software allows reader programming and report generation. Benefits include accurate patient-specific dose monitoring.

Clinical Evidence

Bench testing only. Verification and validation testing demonstrated that the modified device met pre-determined acceptance criteria based on performance specifications and performed as well as the predicate device.

Technological Characteristics

MOSFET (metal oxide semiconductor field effect transistor) sensing mechanism. Components include disposable dosimeters, handheld battery-powered reader, and download software. Features include integrated build-up cap option, medical-grade adhesive, and non-wired form factor. Connectivity via reader download software for reporting. Technical changes include dosimeter encapsulant, circuit board components, passivation layer, and grommet edging.

Indications for Use

Indicated for patients undergoing radiotherapy applications to measure radiation dose.

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

• OneDose Patient Dosimetry System (K040687)

Submission Summary (Full Text)

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## AUG - 4 2008 081855

### Attachment 5 - 510(k) Summary of Safety and Effectiveness

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: Suzanne Schwaller, Regulatory Affairs Associate Phone: [phone] ext. 363 Fax: [phone]

#### Prepared: June 27, 2008

| Common or Usual<br>Name: | Radiation Dosimeter |
|--------------------------|---------------------------------------------------------------------------------------------|
| Proprietary Name: | OneDose Patient Dosimetry System |
| Classification Name: | Accelerator, Linear, Medical |
| Manufactured By: | Sicel Technologies, Inc.<br>3800 Gateway Centre Blvd.<br>Suite 308<br>Morrisville, NC 27560 |
| | Phone: [phone]<br>Fax: [phone] |

#### Predicate Device(s):

Sicel Technologies, Inc. K040687 OneDose Patient Dosimetry System

#### Device Description:

The OneDose Patient Dosimetry System consists of the following components and accessories: (1) disposable, single use, pre-calibrated radiation dosiments, (2) a hand held, battery powered reader, (3) a reader calibration test strip and

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(4) reader download software. The dosimeters use a MOSFET, metal oxide semiconductor field effect transistor as a sensing mechanism. The dosimeters are inserted into the Reader and zeroed, then positioned onto a patient. The dosimeters are small and have no wires. They have a medical grade adhesive and liner on the back. The liner is removed and the adhesive side of the dosimeter is adhered to the patient. Following radiotherapy, the dosimeters are removed from the patient, re-inserted into the Reader, and the patient's dose is read and reported by the Reader. The patient's records are stored on the dosimeter for future reference and in the Reader's memory.

#### Intended Use:

The OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy application.

#### Comparison with Predicate Device:

The intended use of this OneDose Patient Dosimetry System is identical to the predicate device, the OneDose Patient Dosimetry System as cleared in K040687.

The technological features of the OneDose Patient Dosimetry System are the same as the predicate including the use of MOSFET technology, the calibration method, the dose range for a single dose, the energy types measured, and the method of adhesion to the skin. 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 a dosimeter version with an integrated build-up cap, and the addition of a download software option which allows programming of the reader and creating of predefined reports. There are multiple material changes including minor changes to the dosimeter encapsulant, circuit board components and passivation laver and an addition of a grommet edging to the keypad connector. Minor changes dimensions were also implemented. Details of the substantial equivalence comparison are provided.

Furthermore, verification and validation testing provided information sufficient to determine that the modifications did not have an effect on safety or effectiveness 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Suzanne M. Schwaller Regulatory Affairs Associate Sicel Technologies, Inc. 3800 Gateway Centre Blyd., Suite 308 MORRISVILLE NC 27560

#### AUG - 4 2008

Re: K081859

Trade/Device Name: OneDose Patient Dosimetry System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 30, 2008 Received: July 1, 2008

Dear Ms. Schwaller:

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 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 (QS) regulation (21 CFR Part 820); and if applicable, the associa product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1050.

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 legally marketed predicate device results in a classification for your device of your device to resur 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 Comminations) problem 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) | 240-276-0120 |
| 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, release contact CDRH Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. 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 reportain 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) 633-241 or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html U

Sincerely yours,

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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# Attachment 6 - Intended Use Statement

510(k) Number (if known): K022859

Device Name: OneDose Patient Dosimetry System

Intended Use:

The One Pattent Dosimeter System is intended to measure a patient's dose during
radiotherapy applications. This intended use thas not changed as a result of the modifications.

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Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use (Per 21 C.F.R. 801.109

The Counter Us

(Optional Format

Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Nümber

chnologies, Inc. One Dose Patient Dosimetry System Special 510(k) Jun 2001: