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. The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized tumors. 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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the BEBIG IsoSeed I-125:

The provided 510(k) summary does not describe a study where the device's performance was measured against specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (BEBIG Brachytherapy Iodine-125 Source, K021343).

Therefore, I cannot fill out all sections of your request as a study proving device performance against acceptance criteria was not conducted or reported in this document. The "reported device performance" in the table will reflect the general description of the device's characteristics and its intended use, rather than specific measured performance metrics.

Here's the information extracted and limitations based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define explicit "acceptance criteria" in terms of measurable performance targets for a new study. Instead, the "acceptance criteria" here are implied by the claim of substantial equivalence to the predicate device, meaning the new device should possess similar characteristics and intended use. "Reported device performance" is derived from the description of the device itself.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Description)
Device Type: Brachytherapy I-125 source	Cylindrical sealed sources containing iodine-125 radioactivity.
Material/Construction: Similar to predicate	Outer capsule: Titanium. Sealed at each end by laser weld. Iodine-125 deposited as silver iodide (AgI) within a porous ceramic tube. Radiopaque marker: Gold alloy in the center of the ceramic tube.
Dimensions: Similar to predicate	4.5 mm long, 0.8 mm in diameter.
Radioactive Isotope: Iodine-125	Contains iodine-125. Half-life of 59.46 days. Decays by electron capture with emission of characteristic photons and electrons. Titanium wall absorbs electrons.
Activity Levels: Comparable to predicate	Available in a range, commonly 0.2-0.6 mCi for permanent implants; other strengths for temporary applications available by custom order.
Sterility: Non-sterile, requiring sterilization	Provided non-sterile and must be sterilized before use.
Intended Use: For cancer treatment	Intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor.
Indications for Use: Localized tumors	Indicated for treatment of selected localized tumors (superficial, intra-abdominal, intrathoracic, head, neck, lung, pancreas, prostate). May be used alone or in combination with external beam radiation.
Safety and Effectiveness: Substantially equivalent	"Quality System Controls assure the device is substantially equivalent to the predicate device with respect to its performance, safety, and effectiveness." (This is a claim, not a measurement). Adherence to FDA Quality System Regulation 21 CFR Part 820, ISO 9001, ISO 13485, ASTM F67-00, ISO 2919, ISO 9978.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This document is a 510(k) summary demonstrating substantial equivalence to a predicate device, not a report of a new performance study with a test set of data. The "test set" implicitly refers to the characteristics of the new device itself as compared to the predicate, rather than a dataset used to evaluate its performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. No ground truth establishment by experts is described as part of this 510(k) submission. The equivalence is based on comparing device specifications and intended use.

4. Adjudication Method for the Test Set

Not applicable. No adjudication method is mentioned, as there was no "test set" in the context of a new performance study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study would be relevant for devices that interpret images or require human readers in their use. This document describes a brachytherapy source, not an AI or diagnostic imaging device involving human reader interpretation. No MRMC study was performed or reported.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This is not an AI or algorithm-based device. A standalone performance study for a medical device like this would typically involve bench testing (e.g., leakage, dimensions, activity verification) and possibly animal or clinical studies to demonstrate safety and effectiveness if substantial equivalence could not be established. The document explicitly states that the device is identical to the predicate (K021343), implying that the predicate's prior clearance and associated testing are sufficient, supported by the manufacturing quality system.

7. The Type of Ground Truth Used

Not applicable. In the context of a 510(k) leveraging substantial equivalence, the "ground truth" is effectively the established knowledge and clearance of the predicate device. The new device's specifications and manufacturing processes are compared against the predicate's known characteristics.

8. The Sample Size for the Training Set

Not applicable. Training sets are relevant for machine learning algorithms. This document does not describe the development or evaluation of such an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, no training set or machine learning algorithm is discussed.

Summary

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

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

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.

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

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.

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

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.

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

Page 2

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Addition of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

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

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

Page 1 of 1

Regulation Number and Section

§ 892.5730 Radionuclide brachytherapy source.

(a)
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.(b)
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.