RADIONUCLIDE BRACHYTHERAPY SOURCE

K093663 · C.R. Bard, Inc. · KXK · Dec 23, 2009 · Radiology

Device Facts

• Record ID: K093663
• Device Name: RADIONUCLIDE BRACHYTHERAPY SOURCE
• Applicant: C.R. Bard, Inc.
• Product Code: KXK · Radiology
• Decision Date: Dec 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal, and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual ournors following completion of a course of external radiation therapy and for recurrent tumors.

Device Story

BrachySource Seed Implants are permanent interstitial radiotherapy devices. Each implant consists of a welded titanium capsule containing Iodine-125 absorbed onto a nickel/copper coated, gold-cored aluminum wire. The device delivers localized radiation via photon emissions (27.4 keV, 31 keV x-rays, and 35.5 keV gamma) to treat tumors. The titanium wall absorbs Auger electrons. Implants are placed interstitially by clinicians to treat localized, residual, or recurrent tumors in various anatomical sites. The device provides targeted radiation therapy, potentially sparing surrounding healthy tissue compared to external beam radiation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium capsule, nickel/copper coated aluminum wire with gold core. Dimensions: 4.5mm length, 0.8mm diameter. Energy source: Iodine-125 (half-life 59.6 days) emitting x-rays and gamma radiation. Principle: Permanent interstitial radionuclide brachytherapy.

Indications for Use

Indicated for permanent interstitial treatment of localized tumors including head, neck, lung, pancreas, and early-stage prostate. Applicable for superficial, intra-abdominal, and intra-thoracic locations, as well as residual or recurrent tumors following external radiation therapy.

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

• BrachySource® Brachytherapy Seed Implants (K043246)

Submission Summary (Full Text)

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# Bard Medical Division C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30014

DEC 2 3 2009

Image /page/0/Picture/3 description: The image shows the word "BARD" in a bold, outlined font. The letters are thick and have a textured appearance, possibly due to the image being a scan or a low-resolution graphic. The word is horizontally oriented and appears to be the primary focus of the image.

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990,

### A. SUBMITTER INFORMATION:

| Submitter's-Name: | C. R. Bard, Inc. |
|-------------------|-------------------------------------------|
| | Bard Medical Division |
| Address: | 8195 Industrial Blvd. Covington, GA 30014 |

| Contact Person: | Julie Bassett |
|------------------------------------|---------------|
| Contact Person's Telephone Number: | 770-784-6375 |
| Contact Person's Fax: | 770-385-4706 |

## B. DEVICE NAME:

| Device Name: | Brachytherapy seed implants |
|-----------------------|-------------------------------------------------------------------------------------|
| Trade Name(s): | BrachySource ^® Brachytherapy Seed Implants |
| Common/Usual Name: | Brachytherapy seed implants |
| Classification Names: | 90KXK - Source, Brachytherapy, Radionuclide |
| CFR Reference: | 21 CFR 892.5730 – Radionuclide Brachytherapy<br>Source Class II |

#### C. PREDICATE DEVICE NAME:

| Trade Names: | BrachySource® Brachytherapy Seed Implants |
|--------------|-------------------------------------------|
| | K043246 |

### D. DEVICE DESCRIPTION:

480-06

BrachySource® Seed Implants consist of a welded titanium capsule containing lodine-125 absorbed onto a nickel/copper coated, gold cored aluminum wire. The implants are nominally 4.5mm long by 0.8mm in diameter.

lodine-125 has a half-life of 59.6 days and decays by electron capture with the emission of characteristic photons and Auger electrons. The principal photon emissions are 27.4 and 31 keV x-rays and a 35.5 keV gamma. The tifanium wall of the BrachySource Seed Implant absorbs the electrons.

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## E. INTENDED USE:

E

BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. BrachySource® Seed Implants may be used in superficial, intra-abdominal, and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual ournors following completion of a course of external radiation therapy and for recurrent tumors.

# TECHNOLOGICAL-CHARACTERISTICS-SUMMARY:-

The subject BrachySource® Brachytherapy Seed Implants have the same intended use, general design and fundamental scientific technology as the predicate device.

## G. PERFORMANCE DATA SUMMARY:

The appropriate bench testing to determine substantial equivalence was completed.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

DEC 2 3 2009

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

Ms. Julie Bassett Regulatory Affairs Specialist C. R. Bard, Inc. Bard Medical Division 8195 Industrial Blvd. COVINGTON GA 30014

Re: K093663

Trade/Device Name: BrachySource® Brachytherapy Seed Implants Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 23, 2009 Received: November 25, 2009

Dear Ms. Bassett:

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,

Ramona M. Mavis

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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# C.R. Bard, Inc., Bard Medical Division BrachySource® Brachytherapy Seed Implants Premarket Notification [510(k)]

## 1.4 Indications for Use Statement

510(k) Number (if known): K093663

Device Name:

Indications for Use:

BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate BrachySource® Seed Implants may be used in superficial, intra-abdominal and intra-thoracic locations. BrachySource® Seed Implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Houn M. Wher

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