PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE

K060636 · C.R. Bard, Inc. · KXK · Apr 19, 2006 · Radiology

Device Facts

• Record ID: K060636
• Device Name: PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE
• Applicant: C.R. Bard, Inc.
• Product Code: KXK · Radiology
• Decision Date: Apr 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics: . Localized, . Unresectable, . Low to moderate radiosensitivity. The tumors may be of the following types: . Superficial; . Intrathoracic; . Intra-abdominal; . Lung, pancreas, prostate, head and neck; . Residual following external beam or excision of primary tumor; . Recurrent.

Device Story

Palladium-103 Seed Implant Kits consist of pre-manufactured TheraSeed® Palladium-103 brachytherapy seeds packaged in various sterile and non-sterile configurations. Device functions as a radioactive source for interstitial brachytherapy; seeds are implanted directly into tumor tissue to deliver localized radiation. Used by clinicians in clinical settings for treatment of localized, unresectable, or recurrent tumors. Device provides targeted radiation therapy; intended to treat malignancy while sparing surrounding healthy tissue. No change to seed technology or operation compared to predicate.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarity to legally marketed predicate devices.

Technological Characteristics

Palladium-103 radionuclide brachytherapy source. Seeds are identical to those cleared under K010283. Packaging configurations are identical to those cleared under K043246. Device is a passive radioactive implant.

Indications for Use

Indicated for patients with localized, unresectable, low to moderate radiosensitivity tumors, including superficial, intrathoracic, intra-abdominal, lung, pancreas, prostate, head and neck tumors, as well as residual or recurrent tumors.

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

• TheraSeed® Palladium-103 Implants (K010283)
• BrachySource® Brachytherapy Seed Implants (K043246)

Submission Summary (Full Text)

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K060636

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

APR 1 9 2006

Image /page/0/Picture/3 description: The image shows the word "BARD" in a stylized, bold font. The letters are thick and have a rounded appearance. The "A" in "BARD" is designed with a unique shape, resembling a triangle with a horizontal line across the middle. The overall design of the word gives it a modern and distinctive look.

# 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:

Contact Person's Fax:

Date of Preparation:

| Submitter's Name: | C. R. Bard, Inc. | |
|------------------------------------|--------------------------|--|
| | Bard Urological Division | |
| Address: | 13183 Harland Dr. | |
| | Covington, GA 30014 | |
| Contact Person: | Julie J. Bassett | |
| Contact Person's Telephone Number: | 678-342-4921 | |

#### B. DEVICE NAME:

| Trade Name(s): | Palladium-103 Seed Implant Kits |
|-----------------------|----------------------------------------------------------------|
| Common/Usual Name: | Brachytherapy seed implants |
| Classification Names: | 90KXK - Source, Brachytherapy, Radionuclide<br>21 CFR 892.5730 |

770-788-5517

March 9, 2006

#### C. PREDICATE DEVICE NAME:

Trade Name(s): TheraSeed® Palladium-103 Implants and BrachySource® Brachytherapy Seed Implants

#### D. DEVICE DESCRIPTION:

The Pd-103 Seed Implant Kits will be offered using TheraSeed® Palladium-103 Implants, which are produced and marketed commercially by Theragenics, Inc. under the 510(k) K010283. There is no change to the seeds produced by Theragenics and marketed under the name TheraSeed® Palladium-103 devices. These seeds will be packaged in various sterile and non-sterile configurations. These configurations are the same as the predicate described in K043246.

The principles of operation and fundamental scientific technology have not changed. Reference K043246 and K010283 for a detailed description.

TheraSeed® is a registered trademark of Theragenics Corporation®

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# E. INTENDED USE:

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:

- . Localized,
- Unresectable,
- Low to moderate radiosensitivity.

The tumors may be of the following types:

- . Superficial;
- . Intrathoracic;
- . Intra-abdominal;
- 트 Lung, pancreas, prostate, head and neck;
- . Residual following external beam or excision of primary tumor;
- . Recurrent.

The intended use has not changed from Theragenics 510(k), K010283.

## ﺎﻧﺎ TECHNOLOGICAL CHARACTERISTICS SUMMARY:

The subject device, Palladium-103 Implant Kits, has the same intended use, design and fundamental scientific technology as the predicate devices.

# G. PERFORMANCE DATA SUMMARY:

The appropriate testing for the Palladium-103 Seed Implant Kits was conducted.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

APR 1 9 2006

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

Re: K060636

Trade/Device Name: Palladium-103 Seed Implant Kits Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: March 9, 2006 Received: March 10, 2006

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 (Premarket Approval), 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of a rison 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.

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 promated 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:

| 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 807.97). 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/cdrh/industry/support/index.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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C.R. Bard, Inc., Bard Urological Division Palladium-103 Seed Implant Kits Premarket Notification [510(k)]

1.3 Indications for Use Statement

510(k) Number (if known):

Device Name: Palladium-103 Seed Implant Kits_

Indications for Use:

TheraSeed® Palladium-103 Implants are indicated for tumors with any of the following characteristics:

- . Localized,
- l Unresectable,
- Low to moderate radiosensitivity. 트

The tumors may be of the following types:

- l Superficial:
- . Intrathoracic;
- 일 Intra-abdominal;
- 1 Lung, pancreas, prostate, head and neck;
- 발 Residual following external beam or excision of primary tumor;
- 지 Recurrent.

| Prescription Use | X |
|-----------------------------|---|
| (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)

David A. Segrim

(Division Sign-Off) V
Division of Reproductive, Abdominal,
anır Radiological Devices K060636

(Recommended Format 11/13/2003)

TheraSeed® is a registered trademark of Theragenics Corporation®.