ACCU-SOURCE

K051753 · Oncology Systems, Inc. · JAQ · Mar 29, 2006 · Radiology

Device Facts

• Record ID: K051753
• Device Name: ACCU-SOURCE
• Applicant: Oncology Systems, Inc.
• Product Code: JAQ · Radiology
• Decision Date: Mar 29, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ACCU-SOURCE™ remote controlled high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.

Device Story

Accu-Source™ is a remote afterloading system for High Dose Rate (HDR) Brachytherapy. It utilizes a radioactive source (Ir192 or Yb169) housed in a tungsten-shielded safe. The system includes an operator console and a remote afterloading device. Encoders and motors, controlled by software, drive the source from the safe through channels to the patient to deliver a predetermined radiation dose. The system features 24 channels, supports up to 1200 dwell points, and includes an integrated radiation monitor and emergency manual retraction. It is operated by clinical staff in a controlled environment. The output is the precise positioning of the radioactive source to treat target tissue. The system includes battery backup and an uninterruptible power supply to ensure treatment data is maintained during power failures. Clinical benefit is the targeted delivery of radiation for cancer treatment while minimizing radiation exposure to staff through remote operation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Remote afterloading brachytherapy system. Materials: Tungsten shielding. Energy source: Radioactive isotopes (Ir192, Yb169). Connectivity: Standalone operator console with PC. Software: Windows XP-based control system. Features: 24 channels, 1200 dwell points, integrated radiation monitor, emergency manual retraction, battery backup. Source positioning accuracy: +/- 0.5mm.

Indications for Use

Indicated for treatment of cancer and other lesions via intracavitary, interstitial, intralumenal, intraoperative, endobronchial, and surface applicator irradiation. Prescription use only.

Regulatory Classification

Identification

A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Predicate Devices

• Nucletron-Oldeft Corporation Microselectron-HDR Version 2 (K953946)

Submission Summary (Full Text)

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MAR 2 9 2006

K051753

### 510(k) Summary

Submitter: Oncology Systems, Inc.

Address: 206 N. Randolph Street, Suite 300 Champaign, IL 61820

Phone number: [phone]

Fax number: [phone]

Contact Person: Jennifer Williams

Date Prepared: May 27, 2005

Trade Name: Accu-Source™

Common Name: Remote Control High Dose Rate Afterloading Brachytherapy Device

Classification name: Remote Controlled Radionuclide System, 90 JAQ, Regulation 21 CFR క్ర892.5700.

Substantial Equivalence claimed to:

- 1. Nucletron-Oldeft Corporation K953946 Microselectron-HDR Version 2

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Kos1753

### Description:

The Accu-Source™ is a remote afterloading system for High Dose Rate Brachytherapy. The system is designed to deliver a predetermined dose of radiation to organs and tissue via a radioactive source.

The ACCU-SOURCE™ system includes an operator console and a remote afterloading device. The ACCU-SOURCE™ system has a tungsten shielded storage safe which houses a radioactive source when the system is not in use. There are encoders and motors used in conjunction with electronic circuitry that drive the source and keep track of its position. A battery is used for back-up power and an uninterruptible power supply is also integrated into the ACCU-SOURCE™ system to charge the battery backup subsystem.

### Intended Use:

The ACCU-SOURCE™ remote controlled high dose rate afterloading brachytherapy system is intended for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.

Technical Specifications:

Comparison Table Substantial Equivalent Device

The ACCU-SOURCE™ system is comparable to:

- Nucletron MicroSelectron HDR Version 2 .

| FEATURE<br>Device | Nucletron<br>Micro-Selectron | Oncology Systems, Inc.<br>ACCU-SOURCETM | |
|------------------------------------------------------------------------------|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use | Remote<br>Afterloading<br>Brachytherapy unit<br>for interstitial,<br>intracavity,<br>intralumenal,<br>including bronchial,<br>intraoperative, and<br>surface applicator<br>treatments | The ACCU-SOURCE remote<br>control high dose rate<br>brachytherapy system is<br>intended for the treatment of<br>cancer and other lesions by<br>intracavity, interstitial,<br>intralumenal, intraoperative,<br>endobronchial and surface<br>applicator irradiation<br>treatments |
| | Base Area | | |
| | Height | Variable | 101cm |
| | Weight | 150 lbs | 180 lbs |
| | Transportable | V2 only | Yes |
| | Power Supply | 110 VAC | 110 VAC/220 VAC |
| | Mobile | Yes | Yes |
| | Nucletron<br>Micro-Selectron | Oncology Systems, Inc.<br>ACCU-SOURCE TM | |
| HDR | Yes | Yes | |
| Number of<br>Channels | 18 | 24 | |
| Shielding | Tungsten | Tungsten | |
| Maximum Activity of<br>Shielding | 10 Ci | 12 Ci | |
| Maximum<br>Treatment Activity | 10 Ci | 12 Ci | |
| Maximum exposure<br>rate a XX distance<br>containing the<br>maximum activity | At 10cm =<br>>2mR/h | Inner vault: > 100mR/h at<br>20cm<br>Outer vault: >2mR/h at 10cm | |
| Dwell positions per<br>channel | 48 | Up to 100 dwell points per<br>channel not to exceed 1200<br>dwell points (Ex. 24 channels<br>w/ 50 dwell points each or 12<br>channels w/100 dwell points<br>each) | |
| Total Channels | 18 | 24 | |
| Contains radiation<br>monitor | Optional | Yes, Included | |
| Device Control OS<br>Software | Windows | Windows XP | |
| Treatment Data<br>maintained during<br>power failure | Yes | Yes | |
| Simulator (Dummy)<br>Source | Yes | Yes | |
| Verification of<br>Channel Length by<br>direct measurement | By direct<br>measurements | Yes<br>By direct measurements | |
| Source Positioning | Distal to proximal | Distal to proximal | |
| Maximum Source<br>Position error over<br>treatment length (+/-<br>.5mm) | 1mm | .5 mm | |
| Emergency<br>container for the<br>source included | Optional | Yes, Included | |
| Response to<br>Emergency signal | Automatic<br>Retraction of<br>Source | Automatic Retraction of<br>Source | |
| Emergency manual | Yes | Yes | |
| | | Nucletron<br>Micro-Selectron | Oncology Systems, Inc.<br>ACCU-SOURCE TM |
| Source | Isotope | Ir192 | Ir192 |
| | | | |
| | Maximum Activity | 10 Ci | 12 Ci for Ir192 |
| | | | |
| | Maximum<br>Treatment Activity | 10 Ci | 12 Ci for Ir192 |
| | | | |
| | Capsule<br>Dimensions | 4.5mm length by<br>.9mm width | 4.5mm length by .9mm width<br>for Ir192 and 6.9 mm length by<br>1.17 mm width for Yb169 |
| | | | |
| | Active dimensions | 3.6mm length by<br>.65mm width | 3.6mm length by .65mm width<br>for Ir192 and 5.4mm length by<br>.8mm width for Yb169 |
| | Source extension<br>length | 150cm | 160cm |
| Operator Console | Operating console<br>with personal<br>computer | Yes | Yes |
| | Keyswitch Control | Yes | Yes |
| | Operating Voltage | 110/220 VAC | 110/220 VAC |

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## KOSI753

the state of the state of the states and

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:

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three wavy lines, resembling a bird or a symbol representing health and human services.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Jennifer Williams Official Correspondent Oncology Systems, Inc. 206 N. Randolph Street, Suite 300 CHAMPAIN IL 61820

Re: K051753

MAR 2 9 2006

Trade/Device Name: ACCU-SOURCE Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ

Dated: February 16, 2006 Received: February 21, 2006

Dear Ms. Williams:

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 (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, 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 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); 200d manufacturing practice requirements as set forth in the quality systems (05) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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.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" (21 CFR 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/cdrh/industrv/support/index.html

Sincerely yours.

T. Nancy C. Brigdon

Naney C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices ()fice of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Accu-Source™

Indications for Use:

The Accu-Source™ remote control high dose rate afterloading brachytherapy system is indicated for the treatment of cancer and other lesions by intracavitary, interstitial, intralumenal, intraoperative, endobronchial and surface applicator irradiation treatments.

| (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) |
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| Concurrence of CDRH, Office of Device Evaluation (ODE) |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
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| | <img alt="Signature" src="signature.png"/> |
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| (Division Sign-Off) | |
| Division of Reproductive, Abdominal,<br>and Radiological Devices | |
| 510(k) Number | K051753 |