ACU007S

K092522 · Oncology Systems, Inc. · KXK · Nov 20, 2009 · Radiology

Device Facts

• Record ID: K092522
• Device Name: ACU007S
• Applicant: Oncology Systems, Inc.
• Product Code: KXK · Radiology
• Decision Date: Nov 20, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of Oncology Systems, Inc. Model ACU-007S Brachytherapy Source is for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

Device Story

Model ACU-007S is a singly-encapsulated Iridium-192 brachytherapy source; consists of a solid radioactive pellet sealed in a stainless steel capsule attached to a cable. Device functions as a component of the Oncology Systems, Inc. AccuSource 1000 remote afterloader system. Operated by trained clinicians in a clinical setting to deliver temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation. The afterloader manipulates the source to the target site to treat localized tumors. Output is ionizing radiation; used to destroy malignant tissue. Benefits include precise, localized radiation delivery for cancer treatment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Singly-encapsulated Iridium-192 radioactive source; stainless steel capsule; cable attachment. Energy source: Iridium-192 photon emission. Designed for use with remote afterloader systems. No software or electronic components integral to the source assembly itself.

Indications for Use

Indicated for temporary interstitial, intracavitary, intraluminal, intraoperative, or surface application to treat localized tumors in patients requiring high dose rate brachytherapy. Applicable anatomical sites include cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast, and for sarcomas and intraoperative radiation therapy. May be used concurrently with or following external beam radiation or chemotherapy.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• Source Production and Equipment Company Model M-19 (K052947)

Submission Summary (Full Text)

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K092522

Image /page/0/Picture/1 description: The image shows the logo for Oncology Systems. The logo consists of a four-circle design on the left, with three of the circles patterned and one solid black. To the right of the circles, the words "Oncology Systems" are written in a bold, sans-serif font, with "Oncology" on the top line and "Systems" on the bottom line.

206 N. Randolph Street, Suite 301 Champaign, IL 61820

NOV 2 0 2009

## Section 5 510(k) Summary

## Section 807.92(a)

| (1) Submitter | Oncology Systems, Inc. | Tel: | 217-355-4460 |
|---------------|---------------------------------|------|--------------------------------------------------------------|
| | 206 N. Randolph Suite 301 | Fax: | 217-355-4470 |
| | Champaign, IL 61820 | | |
| | Establishment Registration No.: | | SBD096102 |
| | Contact Person: | | Jennifer Williams |
| | | | FDA Official Regulatory Correspondent |
| | | | e-mail: [e-mail] |
| | Date Summary Prepared: | | 03/27/09 |
| (2) | Device Name: | | ACU-007S |
| | Common or Usual Name: | | Brachytherapy Source Assembly |
| | Classification Name: | | Source Wire, Iridium Radioactive (21CFR 892.5730;PC;IWA;KXK) |
| | Proprietary Name: | | Oncology Systems, Inc. Model ACU-007S |

- Legally Marketed Predicate Devices: (3)
Source Production and Equipment Company Model M-19, 510(k) number K052947 dated 19 April 2006

- Description of Oncology Systems, Inc. Model ACU-007S 199ridium Brachytherapy Source: (4)
Oncology Systems, Inc. Model ACU-007S is a singly-encapsulated 1921ridium Brachytherapy Source. It consists of a single solid radioactive 192 ridium pellet sealed in a stainless steel capsule that is attached to a cable. Its purpose is to permit manipulation by the Oncology Systems, Inc AccuSource 1000 remote afterloader system for the treatment of cancer and other lesions.

- Intended Use (5)
The intended use of Oncology Systems, Inc. Model ACU-007S Brachytherapy Source is for the treatment of cancer and other lesions by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.

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Image /page/1/Picture/0 description: The image shows the logo for Oncology Systems. The logo consists of four circles on the left, three of which are patterned and one of which is solid black. To the right of the circles is the text "ONCOLOGY SYSTEMS" in a sans-serif font. The word "ONCOLOGY" is above the word "SYSTEMS".

206 N. Randolph Street, Suite 301 Champaign, IL 61820

Technological Characteristics: (6)

Oncology Systems, Inc, Model ACU-007S 19eridium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source, the Source Production and Equipment Company Model M-19 (K052947) that utilizes photons from 182 ridium. See Sections 12.1 Comparison Table with Predicate Device (Similarities and Differences) and section 12.2 Product Information for Predicate Device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Jennifer Williams Official Regulatory Correspondent Oncology Systems, Inc. 206 N. Randolph Street, Suite 301 CHAMPAIGN IL 61820

NOV 2 0 2009

Re: K092522

Trade/Device Name: Oncology Systems, Inc. Model ACU-007S 192 Iridium Brachytherapy Source

Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 13, 2009 Received: August 31, 2009

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 (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 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); medical device reporting of medical

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Enclosure

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Image /page/4/Picture/0 description: The image shows the logo for Oncology Systems. The logo consists of four circles arranged in a square pattern on the left side. To the right of the circles, the words "ONCOLOGY SYSTEMS" are written in a bold, sans-serif font.

206 N. Randolph Street, Suite 301 Champaign, IL 61820

510(k) Number (if known): _

Device Name: Oncology Systems, Inc. Model ACU-007S 19eridium Brachytherapy Source

Indications for Use:

Oncology Systems Model ACU-007S Source Assembly, with an individual activity up to 12Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.

This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, or chemotherapy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X | OR |
|----------------------------|---|----|
| (Per 21 CFR 801 Subpart D) | | |

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(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices

| 510(k) Number | K092522 |
|---------------|---------|
|---------------|---------|

Over-The-Counter Use _ (Per 21 CFR 801 Subpart C)

(Optional Format 1-2-96)