VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS

K033371 · Varian Medical Systems · JAQ · Dec 24, 2003 · Radiology

Device Facts

• Record ID: K033371
• Device Name: VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
• Applicant: Varian Medical Systems
• Product Code: JAQ · Radiology
• Decision Date: Dec 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5700
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The applicators will be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.

Device Story

Intracavitary brachytherapy applicators designed for use with VariSource High Dose Rate (HDR) afterloaders; used to deliver radiation therapy for gynecological and rectal cancers. Applicators inserted into body cavities (cervix, vagina, rectum) to position radioactive sources. Sets include cervix, vaginal, segmented cylinder, stump, shielded, and segmented cervix applicators; some models feature titanium components for CT/MRI compatibility. Used in clinical settings by medical professionals. Benefits include localized tumor irradiation and anatomical adaptation via segmented construction. Output is the physical guidance of radiation sources to target tissue.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material similarity to predicate devices.

Technological Characteristics

Intracavitary applicators for HDR afterloaders; materials equivalent to predicate; includes titanium components in specific models for CT/MRI compatibility; segmented construction for anatomical adaptation; non-powered mechanical devices.

Indications for Use

Indicated for patients requiring intracavitary brachytherapy for the treatment of cancerous gynecological and rectal tumors. 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

• GammaMed Plus High Dose Rate Afterloader System applicators (K983436)

Submission Summary (Full Text)

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DEC 2 4 2003

K033371

V
me

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

# 510(k) Summary

The following information is provided following the format of 21 CFR 807.92 for the Intracavitary Brachytherapy Applicators

| 1) Submitter: | Varian Medical Systems, Inc.<br>3100 Hansen Way/ MS E-110<br>Palo Alto, California 94304 |
|-----------------|------------------------------------------------------------------------------------------|
| Contact Person: | Vy Tran, Director, Corporate Regulatory Affairs |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Email: | [e-mail] |
| Date Prepared: | October 16, 2003 |

- Intracavitary BrachyTherapy Applicators Device Name: 2) 11-00404 Cervix Applicator Set; 11-00414 Vaginal Applicator Set; 11-00415 Segmented Cylinder Set; 11-00416 Stump Applicator Set; 11-00438 Shielded Applicator Set; 11-00454 Segmented Cervix Applicator Set
- Intracavitary Brachytherapy Applicators Common Name:

#### Predicate Device 3) GammaMed Plus High Dose Rate Afterloader System Name: applicators, K 983436

- The applicator sets in this submission are designed to be used Description: 4) with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors. The Intracavitary applicators are designed to be inserted into a body cavity.
- Six intracavitary applicator sets are included in this submission. Intended Use: 5) The intended use of each applicator is described below.

### 11-00404 Cervix Applicator Set

Cervix Applicator set is designed for use in medical intracavitary brachytherapy for treatment of cancerous gynological tumors. It is suitable (combined) irradiation of the vagina and the endometrium. It is also to irradiate the uterus, vaginal stump or rectum. The maximum implantation time for this applicator is 2 days.

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K 633371

p2 of 2

# 11-00414 Vaginal Applicator Set

Vaginal Applicator Set is developed for intracavitary brachytherapy to treat cancer of the vagina or rectum. The maximum implantation time for this applicator is 30 days.

### 11-00415 Segmented Cylinder Set

Segmented Cylinder Set is developed to treat cancer of the vagina and the vaginal stump. It is also suitable to treat rectal cancer. The applicator set is MR and CT compatible. The maximum implantation time for this applicator is 2 days.

## 11-00416 Stump Applicator Set

Stump Applicator Set is developed for post-operative irradiation of the vaginal stump. The flexible applicator probe has a connector made of titanium, so that position checks can be made using CT or MRI. The maximum implantation time for this applicator is 30 days.

# 11-00438 Shielded Applicator Set

Shielded Applicator Set is developed to treat cancer of the vagina or rectum where partial shielding is required. The maximum implantation time for this applicator is 2 days.

# 11-00454 Segmented Cervix Applicator Set

Segmented Cervix Applicator Set is developed to irradiate the cervix, the vagina and the vaginal stump. The applicator set is MR and CT compatible. The cylinder segments can be used with cervical sleeves (Smit), flexible intra-uterine probes or without intra-uterine probes. The segmented construction of the applicator allows an individual adaptation to the patient's anatomy. The maximum implantation time for the Segmented Cervix Applicator is 7 days.

#### Technological 6) Considerations:

The applicators are identical or equivalent to the predicate devices in materials.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 2 4 2003

Ms. Vy Tran Director, Corporate Regulatory Affairs VARIAN Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K033371

Trade/Device Name: Intracavitary Brachy Therapy Applicators Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: October 16, 2003 Received: October 21, 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 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); 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 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 the 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" (21CFR Part 807,97) you may obtain. 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. Brogdor 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):

- Device Name: Intracavitary BrachyTherapy Applicators 11-00404 Cervix Applicator Set; 11-00414 Vaginal Applicator Set; 11-00415 Segmented Cylinder Set: 11-00416 Stump Applicator Set; 11-00438 Shielded Applicator Set; 11-00454 Segmented Cervix Applicator Set)
#### Indications for use:

The applicators will be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

David h. Aezom

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