BEBIG ISOSEED I-125

K033781 · Bebig Isotopen-Und Medizintechnik GmbH · KXK · Dec 30, 2003 · Radiology

Device Facts

• Record ID: K033781
• Device Name: BEBIG ISOSEED I-125
• Applicant: Bebig Isotopen-Und Medizintechnik GmbH
• Product Code: KXK · Radiology
• Decision Date: Dec 30, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.

Device Story

BEBIG IsoSeed I-125 is a cylindrical sealed brachytherapy source; 4.5 mm length; 0.8 mm diameter. Contains iodine-125 radioactivity deposited as silver iodide (AgI) within a porous ceramic tube; gold alloy radiopaque marker included for x-ray visualization. Titanium capsule laser-welded at ends. Device emits characteristic photons and electrons; titanium wall absorbs electrons. Used for permanent or temporary interstitial/intracavitary radiation therapy for localized tumors. Provided non-sterile; requires sterilization before clinical use. Physician-operated in clinical settings to deliver localized radiation dose directly to tumor site; provides targeted cancer treatment while sparing surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design identity to the predicate device.

Technological Characteristics

Titanium capsule (ASTM F67-00); porous ceramic internal matrix; gold alloy radiopaque marker. Sealed radioactive source (I-125). Dimensions: 4.5 mm x 0.8 mm. Sterilization required by user. Complies with ISO 2919 and ISO 9978.

Indications for Use

Indicated for treatment of selected localized tumors, including superficial, intra-abdominal, intrathoracic, head, neck, lung, pancreas, and prostate tumors. May be used alone or 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

• BEBIG Brachytherapy Iodine-125 Source (K021343)

Submission Summary (Full Text)

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DEC 3 0 2003

# 510(k) Summary of Safety and Effectiveness

BEBIG brachytherapy 1-125 source

p 1/2

Kø33781

December 01, 2003

### Company Name

BEBIG Isotopen- and Medizintechnik GmbH Robert Rössle Str. 10 13125 Berlin, Germany phone: ++49 30 94 10 84-0

#### Official Contact

Sven Langer Regulatory Affairs

#### Device Name

| Proprietary Name: | BEBIG IsoSeed 1-125 |
|----------------------|--------------------------------------------------------|
| Common Name: | Brachytherapy iodine-125 source |
| Classification Name: | 21 CFR 892.5730 Radionuclide Brachytherapy Source, KXK |

## Predicate Devices used for Substantial Equivalence

| Device | Premarket # |
|---------------------------------------|-------------|
| BEBIG Brachytherapy Iodine-125 Source | K 021343 |

### Intended Use

The BEBIG I-125 sources 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 brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. These sources are commonly used to treat superficial, intra-abdominal 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 I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). 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 alloy.

I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the 1-125 source absorbs the electrons.

The BEBIG I-125 sources are available in a range of activity levels. The most commonly used source activity levels for permanent implants are 0.2-0.6 mCi, other source strengths, in particular for temporary applications, are available according to customer specific order. The sources are provided non-sterile and must be sterilized before use.

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The manufacturer will adhere to the following regulations and standards:

FDA Quality System Regulation 21 CFR Part 820 Good Manufacturing Practices

ISO 9001 Quality Management Systems

ISO 13485: Medical devices quality system

ASTM Standard for Titanium: F67-00

ISO 2919 sealed radioactive sources - General requirements and classifications

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

# Comparison to predicate device

The BEBIG brachytherapy J-125 source is identical with the BEBIG brachytherapy I-125 source as cleared by K 021343.

### Summary

In Summary, the BEBIG brachytherapy I-125 source is substantially equivalent to a legally marketed device. Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 3 0 2003

Mr. Sven Langer Regulatory Affairs BEBIG Isotopen- und Medizintechnic Gmbh Robert-Rossle-StraBe 10 D-13125 Berlin GERMANY

Re: K033781 Trade/Device Name: BEBIG IsoSeed I-125 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: Class II Product Code: 90-KXK Dated: December 1, 2003 Received: December 4, 2003

Dear Mr. Langer:

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) I ms letter will and in you to organ finding of substantial equivalence of your device to a legally premarket notication: "The PPP intemsgssification 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 ac 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 Addition of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding Other of Obmphanes at (2015-2210) (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small mornation on your response 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. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

Ky33781/

510(k) Number (if known):

Device Name: BEBIG brachytherapy iodine-125 source (IsoSeed I-125)

Indications for Use:

The BEBIG brachtherapy I-125 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.

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

Over-The -Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﻠﻤﺴﺎ

Nancy Brogdon

| (Division Sign-Off) | |
|--------------------------------------|---------|
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |
| 510(k) Number | K033781 |

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