ISOSEEDS I-125

K021343 · Bebig Isotopen-Und Medizintechnik GmbH · KXK · May 20, 2002 · Radiology

Device Facts

• Record ID: K021343
• Device Name: ISOSEEDS I-125
• Applicant: Bebig Isotopen-Und Medizintechnik GmbH
• Product Code: KXK · Radiology
• Decision Date: May 20, 2002
• Decision: SESE
• Submission Type: Traditional
• 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 IsoSeeds I-125 are cylindrical sealed brachytherapy sources (4.5mm length, 0.8mm diameter) containing iodine-125 radioactivity. Iodine-125 is deposited as silver iodide (AgI) within a porous ceramic tube containing a gold alloy radiopaque marker. The titanium capsule is laser-welded at both ends. The device emits characteristic photons and electrons; the titanium wall absorbs electrons. Sources are provided nonsterile for clinical use in treating localized tumors via implantation. The device is used by clinicians to deliver localized radiation therapy to tumors, potentially benefiting patients by providing targeted treatment.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Cylindrical sealed source; titanium capsule (ASTM F67-95); iodine-125 radioactive isotope; gold alloy radiopaque marker; porous ceramic carrier. Dimensions: 4.5mm x 0.8mm. Sterilization required post-manufacture. 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

• UroMed Brachytherapy Iodine-103 Source (K982226)

Submission Summary (Full Text)

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**MAY 20 2002**

510(k) Summary of Safety and Effectiveness

# BEBIG brachytherapy I-125 source

## April 24, 2002

# 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 IsoSeeds 1-125 Common Name: Brachytherapy iodine-125 source 21 CFR 892.5730 Radionuclide Brachytherapy Source, KXK Classification Name:

## Predicate Devices used for Substantial Equivalence

| Device | Premarket # |
|----------------------------------------|-------------|
| UroMed Brachytherapy Iodine-103 Source | K982226 |

## 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 I-125 source absorbs the electrons.

The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.

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K021345
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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

EN 46001 / EN ISO 13485: Medical devices quality system

ASTM Standard for Titanium: F67-95

ISO 2919 sealed radioactive sources - General requirements and classifications ISO 9978: 1992(E) Radiation Protection-Sealed radioactive sources- Leakage test Methods

# Comparison to predicate device

The BEBIG brachytherapy I-125 source is technically identical with the UroMed Brachytherapy Iodine-103 Source

# Summary

In Summary, the BEBIG brachytherapy I-125 sources are 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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#### Public Health Service

MAY 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sven Langer Regulatory Affairs BEBIG Isotopen-und Medizintechnik GmbH Robert-Rössle-StraBe 10 D-13125 BERLIN GERMANY

Re: K021343

Trade/Device Name: BEBIG brachytherapy I-125 sources Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: April 24, 2002 Received: April 29, 2002

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 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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/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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510(k) Premarket Notification Indication for Use BEBIG brachytherapy I-125 Sources

510(k) Number (if known): K___________________________________________________________________________________________________________________________________________________

Device Name: BEBIG brachytherapy I-125 source

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, intra-abdominal and intrathoracic turnors. 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 (Per 21 CFR 801.109)

David G. Byrom

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

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