GAMMAMED 212 AND 232 SOURCE ASSEMBLY

K030745 · Varian Medical Systems · KXK · Mar 12, 2003 · Radiology

Device Facts

• Record ID: K030745
• Device Name: GAMMAMED 212 AND 232 SOURCE ASSEMBLY
• Applicant: Varian Medical Systems
• Product Code: KXK · Radiology
• Decision Date: Mar 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Gammamed Model 212 and 232 source assemblies are designed for use in medical brachytherapy applications.

Device Story

Gammamed 212 and 232 Source Assemblies are radionuclide brachytherapy sources containing Iridium-192; used in conjunction with Gammamed remote afterloaders (12i/12it for Model 212; Plus or 3/24 for Model 232). Devices deliver radiation therapy to cancerous tumors; operated by clinical staff in hospital environments. Assemblies consist of radioactive isotope source attached to cable; laser-welded construction. Output is ionizing radiation for tumor treatment; clinical decision-making relies on physician-prescribed dose plans delivered via afterloader system.

Clinical Evidence

Bench testing only.

Technological Characteristics

Radionuclide brachytherapy source; Ir-192 isotope; 370 GBq nominal activity; 0.6 mm diameter; 3.5 mm active length; 2100 mm cable length; laser-welded construction.

Indications for Use

Indicated for the treatment of cancerous tumors in hospital and medical facility settings.

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

• Gammamed 12i (K891131)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a bold, sans-serif font, with a stylized "I" that has a dot above it. Below the word "VARIAN" is the phrase "medical systems" in a smaller, sans-serif font. The logo is simple and clean, and it conveys a sense of professionalism and innovation.

K030745

Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 IISA tel [phone] www.varian.com

The following information is provided following the format of 21 CFR 807.92 for the Gammamed 212 and 232 Source Assembly

MAR 1 2 2003

| 1. Submitter: | Varian Medical Systems |
|---------------|---------------------------|
| | 3100 Hansen Way M/S H055 |
| | Palo Alto, CA 94304-1129 |
| | Contact Name: Vy Tran |
| | Phone: [phone] |
| | Fax: [phone] |
| | Email: [e-mail] |
| | Date: March 7, 2003 |

2. Device Name: Gammamed 212 and 232 Source Assembly

| Classification Name: | Radionuclide brachytherapy source |
|----------------------|--------------------------------------|
| Common/Usual Name: | Gammamed 212 and 232 Source Assembly |
| Proprietary Name: | Gammamed 212 and 232 Source Assembly |

3. Equivalent Device: Gammamed 12i, K891131

4. Device Description: The Gammamed 212 and 232 Source Assemblies are brachytherapy sources that are used in conjunction with Gammamed remote afterloaders. The Gammamed 212 Source Assembly is used in conjunction with the Gammamed 12i or 12it temote afterloader. The Gammamed 232 Source Assembly is used with either the Gammamed Plus or Gammamed 3/24 afterloader.

5. Statement of Intended Use: The Gammamed Model 212 and 232 source assemblies are designed for use in medical brachytherapy applications.

6. Comparison to substantially equivalent devices:

| Features / Products | | GAMMAMED 12i | GAMMAMED 212 | GAMMAMED 232 |
|---------------------|------------------------------|-----------------|-----------------|-----------------|
| Device | FDA approval | K891131 | Pending | Pending |
| | Isotope | Ir-192 | Ir-192 | Ir-192 |
| | Nominal Activity | 370 GBq (10 Ci) | 370 GBq (10 Ci) | 370 GBq (10 Ci) |
| | Active dimensions Ø x length | 0.6 x 4.0 mm | 0.6 x 3.5 mm | 0.6 x 3.5 mm |
| | cable length | 2100 mm | 2100 mm | 2100 mm |
| | cable diameter | 1.1 mm | 1.1 mm | 0.9 mm |
| | manufacturing process | electron beam | laser welding | laser welding |

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2003

Ms. Vy Tran Manager, Regulatory Affairs Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K030745

Trade/Device Name: Gammamed 212 and 232 Source Assembly Regulation Number: 21 CFR \$892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 7, 2003 Received: March 10, 2003

Dear Ms. Tran:

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); 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.

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This letter will allow you to begin marketing your device as described in your 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C 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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Image /page/3/Picture/0 description: The image shows the logo for Varian Medical Systems. The logo consists of the word "VARIAN" in a serif font, with a stylized "I" that resembles a person. Below the word "VARIAN" are the words "medical systems" in a smaller, sans-serif font. The logo is simple and professional, and it conveys a sense of innovation and technology.

Varian Medical Systems, Inc. 3100 Hanson Way Palo Alto, CA 94304-1038 USA tel [phone] www.varian.com

## Statement of Indications for Use

510(k) Number (if known):

K030745

Device Name:

The Gammamed Model 212 and 232 source assembly

Indications For Use:

The Gammamed Model 212 and 232 source assembly is designed to be used in conditions typically associated with hospitals and medical facilities for the treatment of cancerous tumors.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

David R. Lyman

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

510(k) Number K030745