The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized tumors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra-thoracic tumors. Tumors of the head, neck, lung, pancreas and prostate (early stages) are commonly treated.

The Brachytherapy Source Device, with total apparent activities greater than 1.01mCi, is indicated for interstitial treatment of tumors which have the following characteristics; unresectable, localized, and moderate radiosensitivity. These seeds may be used for selected radiation applications as temporary implants.

The Brachytherapy Source Device is indicated to treat residual tumors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.

Device Description

The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.

AI/ML Overview

Here's an analysis of the provided text regarding the Brachytherapy Source Device, Model 9011.

It's important to note that this document is a 510(k) summary for a medical device, specifically a brachytherapy source. Brachytherapy sources are physical objects that emit radiation for cancer treatment, not a diagnostic AI/ML algorithm. Therefore, many of the requested categories related to AI/ML software performance (like effect size of AI assistance, MRMC studies, ground truth establishment for training, etc.) are not applicable to this type of device. The acceptance criteria and "studies" are focused on the physical characteristics and safety of the radiation source itself, not its diagnostic accuracy or AI performance.

Acceptance Criteria and Device Performance (Brachytherapy Source Device, Model 9011)

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Predicate OncoSeed, Model 6711)	Reported Device Performance (Brachytherapy Source Device, Model 9011)
Seeds
Regulatory Status	K914281 (Cleared)	Subject Application
Capsule Material	Titanium, type A-40	Titanium, type A-40
Capsule Length	4.20 - 4.90mm (0.165 - 0.193in)	4.20 - 4.90mm (0.165 - 0.193in)
Capsule Wall Thickness	0.051 - 0.0635mm (0.002 - 0.0025in)	0.051 - 0.0635mm (0.002 - 0.0025in)
Capsule Diameter	0.77 - 0.96mm (0.031 - 0.38in)	0.48 - 0.67mm (0.019 - 0.026in) (Modified)
Carrier Substrate	99.9% silver	99.9% silver
Carrier Length	2.74 - 2.85mm (0.108 - 0.112in)	2.74 - 2.85mm (0.108 - 0.112in)
Carrier Diameter	0.48 - 0.53mm (0.019 - 0.021in)	0.27 - 0.33mm (0.011 - 0.013in) (Modified)
Isotope	Iodine I-125	Iodine I-125
Sterilization	Not sterile (User sterilized)	Not sterile (User Sterilized)
Other Performance
Sealed Source Integrity	Met ISO 2919 requirements	Tested according to ISO 2919 for sealed sources
Activity Measurement	-	Obtained from NIST Report (Air-Kerma rate measurements)
Design Validation	-	Prototype sources manufactured and assessed against predetermined criteria for Design Verification and Design Validation

Note on Acceptance Criteria: For a 510(k) submission, "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means the new device should be as safe and effective as the predicate, often by meeting the same or equivalent engineering specifications and performance standards. In this case, the predicate's characteristics serve as the de facto acceptance criteria that the new device aims to match or justify deviations from. The substantial equivalence is based on the argument that the modified characteristics (smaller diameter) do not raise new questions of safety or effectiveness, especially since other critical parameters (like capsule material, isotope, length ranges) remained the same.

2. Sample Size for Test Set and Data Provenance

The document does not specify a "test set" in the context of an AI/ML algorithm or a study involving patient data. This is a physical medical device. The "testing" involved:

Physical Prototypes: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." The exact number of prototypes is not specified.
Sealed Source Testing: The device was tested according to ISO 2919, which is a standard for sealed radioactive sources. This likely involves a series of physical tests (e.g., temperature cycling, external pressure, impact, vibration, puncture) on a sample of devices to ensure their integrity. The sample size for these specific tests is not explicitly stated in the 510(k) summary, but ISO standards typically define sample requirements.
Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This refers to calibration and measurement standards from the U.S. National Institute of Standards and Technology.

Data Provenance: Not applicable in the context of patient data as this is a physical device safety and performance evaluation. The provenance of the testing (e.g., "NIST Report") is mentioned, indicating U.S. national standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device, not a diagnostic imaging or AI algorithm that relies on expert interpretation of data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient cases requiring expert adjudication.

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

No. This type of study is relevant to diagnostic imaging devices or AI algorithms where human readers interpret medical images. It is not applicable to a radioactive implantable seed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical brachytherapy source, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, international standards (ISO 2919), and national metrology standards (NIST).

Device Specifications: The stated dimensions, materials, and isotope are the design "ground truth."
Performance Standards: Compliance with ISO 2919 for sealed source integrity ensures the physical safety and containment of the radioactive material.
Radioactivity Calibration: NIST reports provide the "ground truth" for the accurate measurement of the device's radioactive output (Air-Kerma rate), which is critical for safe and effective dosimetry in patient treatment.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this physical medical device.

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

Not applicable. There is no "training set" for this physical medical device.

Summary of the Study Proving Acceptance Criteria:

The "study" proving the device meets acceptance criteria consists of non-clinical testing focused on the physical and radiological properties of the brachytherapy source.

ISO 2919 Testing: The device underwent testing "according to ISO 2919 for sealed sources." This standard specifies the classification of sealed radioactive sources based on their safety requirements and defines a series of environmental and mechanical tests (e.g., temperature, external pressure, impact, vibration, puncture) designed to demonstrate that the source will maintain its integrity and containment of radioactive material under normal and accident conditions. Meeting this standard indicates the physical robustness and safety of the sealed source.
NIST Report for Activity Measurements: "Activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements)." This confirms that the radioactive output of the device (Iodine-125) has been accurately measured and calibrated to national standards as verified by the National Institute of Standards and Technology. Accurate activity measurement is fundamental for physicians to calculate appropriate treatment dosages for patients.
Design Verification and Design Validation: "Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation." This process ensures that the manufactured device meets its design specifications (verification) and fulfills its intended use requirements (validation). This typically involves comparing actual prototype performance against the established design requirements and user needs.

These non-clinical tests demonstrate that the Brachytherapy Source Device, Model 9011, is physically safe, robust, and accurately characterized in terms of its radioactive output, thereby establishing its substantial equivalence to the predicate device despite minor dimensional changes.

Summary

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K081066

MAY 15 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The following 510(k) Summary of Safety and Effectiveness is prepared and provided in accordance with the requirements of 21 CFR 807.92 as amended under the Safe Medical Devices Act of 1990 (SMDA).

Submitter's Information

Company Name:	Medi-Physics, Inc DBA GE Healthcare
Address:	101 Carnegie CenterPrinceton, NJ 08540-6231
Contact Name:	David RisleyDirector, US Regulatory Co-ordination GroupRegulatory Affairs
Phone Number:	609-514-6489

April 3, 2008 Summary Prepared Date:

Subject Device Information

Trade Name:	Brachytherapy Source Device
Model:	9011
Common Name:	Radionuclide Brachytherapy Source
Class:	II
Classification:	21 CFR 892.5730	Product Code: 90-IWI
Predicate Devices	Legally marketed devices to which equivalence is claimed.
1. Trade Name:	OncoSeed™ (Iodine-125 seeds)
Common Name:	Radionuclide Brachytherapy Source
Class:	II
Classification:	21 CFR 892.5730	Product Code: 90-KXK
Cleared 510(k) No.:	K914281, FDA Cleared on November 22, 1991
Submitted by:	Medi-Physics Inc, dba GE Healthcare

. . . .

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Description of Device

The Brachytherapy Source Device, Model 9011, is a welded titanium capsule containing Iodine-125 adsorbed onto a silver rod.

Intended Use

The Brachytherapy Source Device, with apparent activities between 0.19mCi and 1.01mCi, is indicated for permanent interstitial implantation of selected localized turnors which are of low to moderate radiosensitivity. They may be used either as primary treatment (such as for prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor. Seeds in this apparent activity range may be used to treat superficial, intra-abdominal, and intra thoracic tumors. Tumors of the head, neck, lung, pancreas, and prostate (early stages) are commonly treated.

The Brachytherapy Source Device is indicated to treat residual turnors concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy. In addition, recurrent tumors may be implanted with seeds.

When comparing the Intended Use and Indications for Use of the predicate OncoSeed, Model 6711, device, the Intended Use and Indications for Use of the subject device, Brachytherapy Source Device, Model 9011, has not changed.

Technological Characteristics

The following modifications have been incorporated in the subject device -- Brachytherapy Source Device, Model 9011, when compared to predicate device, OncoSeed, Model 6711:

ModifiedCharacteristics	Brachytherapy Source DeviceModel 9011(Subject Device)	OncoSeed, Model 6711(Predicate Device)
Seeds
Regulatory Status	Subject Application	K914281
Capsule Material	Titanium, type A-40	Titanium, type A-40
Capsule Length	4.20 - 4.90mm (0.165 - 0.193in)	4.20 - 4.90mm (0.165 - 0.193in
Capsule WallThickness	0.051 - 0.0635mm (0.002 -0.0025in)	0.051 - 0.0635mm (0.002 -0.0025in)
Capsule Diameter	0.48 - 0.67mm (0.019 - 0.026in)	0.77-0.96mm (0.031 - 0.38in)
Carrier Substrate	99.9% silver	99.9% silver
Carrier Length	2.74 - 2.85mm (0.108 - 0.112in)	2.74-2.85mm (0.108 - 0.112in)
Carrier Diameter	0.27 - 0.33mm (0.011 - 0.013in)	0.48 - 0.53mm (0.019 - 0.021in)
Isotope	Iodine I-125	Iodine I-125
Sterilization	Not sterile (User Sterilized)	Not sterile (User sterilized)

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Changes have only been made to the diameter of the capsule and carrier substrate diameter. All other technological characteristics of the subject seed remain unchanged compared to the predicate OncoSeed, Model 6711, 510(k) #K914281.

Nonclinical Test Data

The Brachytherapy Source Device, Model 9011, has been tested according to ISO 2919 for sealed sources, (test report section E) and activity measurements have been obtained from NIST Report (Report of Air-Kerma rate measurements) (see section F). In addition, Prototype sources have been manufactured and assessed against predetermined criteria for Design Verification and Design Validation (Declaration of Conformity Attachment 1).

Conclusion:

Upon reviewing the safety and effectiveness information provided in this submission and comparing the intended use, indications for use, method of use, the non-clinical test data and other technological characteristics, it can be concluded that the subject seed is substantially equivalent to the predicate OncoSeed, Model 6711, cleared under 510(k) # K914281.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 5 2008

Mr. David Risley Director, US Regulatory Co-ordination Group Medi-Physics, Inc. dba GE Healthcare 101 Carnegie Center PRINCETON NJ 08540

Re: K081066

Trade/Device Name: Brachytherapy Source Device, Model 9011 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: IWG and KXK Dated: April 14, 2008 Received: April 17, 2008

Dear Mr. Risley:

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.

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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.

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 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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy 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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EXHIBIT-2

Indications for Use Form

Page 1 of 1

长081066 510(k) Number (if known): _

Device Name:

Brachytherapy Source Device, Model 9011

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division S Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use _

ﻝ

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.