ISOSEED PD-103

K993552 · Bebig Isotopentechnik GmbH · KXK · Mar 31, 2000 · Radiology

Device Facts

• Record ID: K993552
• Device Name: ISOSEED PD-103
• Applicant: Bebig Isotopentechnik GmbH
• Product Code: KXK · Radiology
• Decision Date: Mar 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

Device Story

BEBIG IsoSeeds® Pd-103 are cylindrical, sealed brachytherapy sources containing Pd-103 radioactivity; used for localized tumor treatment. Sources consist of metallic Pd-103 deposited within a porous ceramic tube, encased in a titanium capsule, and sealed via laser weld. A gold wire serves as a radiopaque marker. Sources are provided non-sterile and require sterilization before use. Clinicians implant these sources in close proximity to or within tumors to deliver localized radiation therapy. The device provides a therapeutic benefit by targeting malignant tissue while minimizing exposure to surrounding healthy structures.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, adherence to international standards for sealed radioactive sources (ISO 2919, ISO 9978, ANSI/HPS N43.6-1997), and quality system compliance.

Technological Characteristics

Cylindrical sealed source, 4.5 mm length, 0.8 mm diameter. Materials: Titanium (ASTM F67-95 grade 2) capsule, porous ceramic core, gold wire radiopaque marker. Energy source: Pd-103 radionuclide (half-life 16.97 days). Sterilization: Steam sterilization required. Standards: ISO 2919, ISO 9978, ANSI/HPS N43.6-1997, DIN EN 25426.

Indications for Use

Indicated for treatment of selected localized tumors, including superficial, intraabdominal, and intrathoracic tumors (e.g., head, neck, lung, pancreas, prostate). May be used alone or in combination with external beam radiation.

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

• UroMed Brachytherapy Iodine-103 Source (K982226)
• Theragenics Modified Palladium Seed (K874787)

Submission Summary (Full Text)

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

K993552

# HAR 3 1 2006

# 510(k) Summary of Safety and Effectiveness

#### BEBIG IsoSeeds® Pd-103

#### Company Name

BEBIG Isotopentechnik und Umweltdiagnostik GmbH Robert Rössle Str. 10 13125 Berlin, Germany

#### Official Contact

Sven Langer Regulatory Affairs

#### Device Name

| Proprietary Name: | BEBIG IsoSeeds® Pd-103 |
|----------------------|---------------------------------------------------|
| Common Name: | Brachytherapy Palladium-103 Sources |
| Classification Name: | 21 CFR 892.5730 Radionuclide Brachytherapy Source |

## Predicate Devices used for Substantial Equivalence

| Device | Premarket # |
|----------------------------------------|-------------|
| UroMed Brachytherapy Iodine-103 Source | K982226 |
| Theragenics Modified Palladium Seed | K874787 |

## Intended Use

The BEBIG IsoSeeds® Pd-103 are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

#### Indications for use

The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intraabdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.

#### Description

The BEBIG IsoSeeds® Pd-103 are cylindrical sealead sources containing Pd-103 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium being closed at one end and sealed by a laser weld at the other end in a final step. The metallic palladium-103 is deposited within a porous ceramic tube. A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold wire.

Palladium seeds have a half live of 16,97 days and are available in a range of activity levels. The BEBIG IsoSeeds® Pd-103 are provided non-sterile and must be sterilized prior to use.

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

#### Summary of Standards Achieved

Medizinproduktegesetz (German Law concerning medical devices)

Directive 90/385/EEC for active implants

DIN EN 1441 Medical devices- Risk analysis

DIN EN 25426 Sealed radioactive sources - Classification, requirements, test methods

ISO 2919 sealed radioactive sources - General requirements and classifications

ISO 9978: 1992(E), Radiation Protection-Sealed radioactive sources- Leakage test Methods

ANSI/HPS N43.6-1997-Sealed Radioactive Sources Classification

ASTM Standard for Titanium: F67-95 rev. 95 grade 2

DIN EN 554 Sterilization of medical devices - Validation and routine control of steam sterilization

DIN EN 980 Graphic Symbols used for labeling of medical devices

DIN EN 1041 Terminology, symbols and information associated with medical devices

DIN EN 25430 Radiation safety labeling

ISO 90001: Quality Management Systems

ISO 46001: Medical devices quality system

FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practice.

DIN EN 6804 Radiation safety regulations for handling sealed radiation sources

DIN EN 25407 Shielding from ionizing radiation

DIN EN 25422 Storing of radioactive devices - Protection from radiation fire and theft

DIN EN 25425 Radionuclide labs - Design, radiation safety and fire protection

#### Summary

In Summary, the BEBIG IsoSeeds® Pd-103 are substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to predicate devices with respect to its performance, safety, and effectiveness.

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

#### Certificates 10.

- TÜV Certificate for quality system according to 46001
- Certificate of ISO-Classification with protocol

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three horizontal lines curving upwards, resembling a bird in flight or a symbolic representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 1 2000

Dear Mr. Langer:

Sven Langer Regulatory Affairs BEBIG Isotopentechnik und Unweltdiagnostik GMBH Robert-Rossle/Str.10 D-13125 Berlin-Buch, Germany

Re:

K993552 IsoSeed Pd-103 Dated: January 10, 2000 Received: January 19, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 pror 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). 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Aproval), 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 895. A substantially equivalion assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you micht have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance at [phone]. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

1 of 1 510(k) Premarket Notification Indication for Use BEBIG Brachytherapy Palladium-103 Sources

510(k) Number (if known): K

Device Name: BEBIG IsoSeed® Pd-103

Indications for Use:

The BEBIG Pd-103 Radionuclide Brachtherapy Sources are indicated for the treatment of The DEDIS I a 105 rainers. These sources are commonly used to treat superficial, intrasereotico roundou tumors. There box. Tumors of the head, neck, lung, pancreas and prostate aboommal and marations may be used alone, or in combination with external beam radiation.

Elvin A. Segears
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) ivumber .

Prescription Use _ (Per 21 CFR 801.109)