BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS

K043246 · C.R. Bard, Inc. · KXK · Feb 2, 2005 · Radiology

Device Facts

• Record ID: K043246
• Device Name: BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS
• Applicant: C.R. Bard, Inc.
• Product Code: KXK · Radiology
• Decision Date: Feb 2, 2005
• Decision: SESE
• Submission Type: Traditional
• 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 tumors following external radiation therapy and for recurrent tumors.

Device Story

BrachySource® Seed Implants are permanent interstitial brachytherapy sources; consist of Iodine-125 absorbed onto nickel/copper coated, gold-cored aluminum wire; encapsulated in welded titanium. Titanium capsule absorbs Auger electrons; emits characteristic photons (27.4, 31 keV) and gamma radiation (35.5 keV) for localized tumor treatment. Used in clinical settings for permanent implantation into tumors; provides continuous radiation therapy to localized, residual, or recurrent tumor sites. Benefits include targeted radiation delivery to tumor tissue while minimizing exposure to surrounding healthy structures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Welded titanium capsule; Iodine-125 source on nickel/copper coated, gold-cored aluminum wire. Dimensions: 4.5mm length x 0.8mm diameter. Radionuclide brachytherapy source; 59.6-day half-life. Emits x-rays and gamma radiation.

Indications for Use

Indicated for permanent interstitial treatment of localized tumors (head, neck, lung, pancreas, early-stage prostate) and residual or recurrent tumors in superficial, intra-abdominal, or intra-thoracic locations.

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

• 1-125 Implant Seed, STM 1251

Submission Summary (Full Text)

{0}------------------------------------------------

K043246

BARD

## 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 Urological Division |
| Address: | 8195 Industrial Blvd. |
| | Covington, GA 30014 |
| Contact Person: | John C. Knorpp |
| Contact Person's Telephone Number: | 770-784-6451 |
| Contact Person's Fax: | 770-784-6419 |

#### B. DEVICE NAME:

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

November 22, 2004

#### C. PREDICATE DEVICE NAME:

Date of Preparation:

1-125 Implant Seed, STM 1251 Trade Name(s):

#### D. DEVICE DESCRIPTION:

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 titanium wall of the BrachySource® Seed Implant absorbs the electrons.

#### 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

{1}------------------------------------------------

in superficial, intra-abdominal and intra-thoracic locations. used ased - in - ospornals are indicated to treat residual tumors following Brachyoureee of external radiation therapy and for recurrent tumors.

### Technological Characteristics Summary: F.

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

#### Performance Data Summary: G.

The appropriate testing for the modification of the BrachySource® Seed Implant was conducted.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an image of a bird in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.

FEB - 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John C. Knorpp Sr. Regulatory Affairs Specialist Bard Urological Division C. R. Bard, Inc. 8195 Industrial Blvd. COVINGTON GA 30014

Re: K043246 Trade/Device Name: BrachySource® Brachytherapy Seed Implant Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 22, 2004 Received: November 23, 2004

Dear Mr. Knorpp:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced worre 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 the enerosate) to e enactment date of the Medical Device Amendments, or to devices that have been May 20, 1770, the characterith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that recrassmou in acoveral of a premarket approval application (PMA). You may, therefore, market the do not require approvisions 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 If you de rio is classince to such additional controls. Existing major regulations affecting your Applo rary, to may of babyer 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 I rease of advisou 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 I casur starees and rogening, 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) (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I this letter wilf anow you to begin makesing of substantial equivalence of your device to a legally premarket nothleation: "The PDF mailies sification 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 If you desire specific advice for your as root 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 Also, please note the regulation on your responsibilities under the Act from the 807.77). Tou may ooually ourers, International and Consumer Assistance at its toll-free number (800) DVNSion of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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

{4}------------------------------------------------

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

Indications for Use Statement 1.3

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K043246

Device Name: ___ BrachySource® Brachytherapy Seed Implant

Indications for Use:

BrachySource® Seed Implants are indicated for permanent interstitial treatment of selected BrachySource® Seed implants are indication in proceess, and early stage prostate. localized lumors such as. - nead and Though Tang, Particial, intra-abdominal and intracthoriaci BrachySource® Seed Implants are indicated to treat residual tumors following locations. locations. " Drachyood. Google of external radiation therapy and for recurrent turnors.

× Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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)

David R. Ingram

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

(Recommended Format 11/13/2003)