I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

• K Number: K992963
• Device Name: I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
• Manufacturer: INTERNATIONAL ISOTOPES, INC.
• Date Cleared: 1999-09-21 ( 19 days)
• Product Code: KXK
• Regulation Number: 892.5730

Intended Use

I3RAD 1351 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Device Description

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

Predicate Devices

K914825/A,K914281,K972271

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a radioactive seed for brachytherapy and does not mention any AI or ML components.

Therapeutic

Yes
The device delivers radiation therapy for treating various tumors, which is a therapeutic intervention.

Diagnostic

No

This device, I3RAD 1351 Seeds, is described as being used for "permanent interstitial implantation in selected localized tumors" for treatment, not for diagnosing them. It uses radioactive beads to treat tumors.

SaMD (Software as a Medical Device)

No

The device description explicitly states it uses "1251 beads encapsulated in a titanium tube," which are physical components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states that the device is for "permanent interstitial implantation in selected localized tumors." This describes a therapeutic device used within the body to treat disease.
• Device Description: The description of the device as "125I beads encapsulated in a titanium tube" further supports its use as an implantable therapeutic device.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing samples like blood, urine, tissue, etc.

Therefore, the I3RAD 125I Seeds are a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

I3RAD 1351 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Product codes

90 KXK

Device Description

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

EndoSeed, 510(k) number K914825/A, Amersham Model 6711, K914281, Mentor IoGOLD, K972271

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

K992963

SEP 2 1 1999

510(k) Summary International Isotopes , Inc. International Isotopes Inc. I3RAD 1251 Seed

I. General Information on Submitter:

Name:	International Isotopes, Inc.
Address:	3100 Jim Christal Road
Denton, TX 76207
Phone:	[phone]
Fax:	[phone]

Name of Contact Person:	Rebecca Ellis
	International Isotopes, Inc.
Phone:	[phone] ext. 124
Fax:	[phone]

Date Summary Prepared: 31 August 1999

• II. General Information on Device International Isotopes Inc. I3RAD 125I Seed Product Name:
  Classification Name:

Source, Radionuclide, Brachytherapy, 21 C.F.R. § 892.5730

• III. Predicate Devices:
  EndoSeed, 510(k) number K914825/A

Amersham Model 6711, K914281

Mentor IoGOLD, K972271

1

Description of the Device: IV.

The I3RAD. 1251 Seeds use 1251 beads encapsulated in a titanium tube.

• Intended Use: V.
  I3RAD 1251 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring tumors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

Technological Characteristics of Device Compared to Predicate Device: VI.

The I3RAD 1251 Seed uses the same type of encapsulation of 125T as predicate devices. The range of activity is similar to other devices. There are no biocompatibility or other safety and effectiveness differences between this device and other predicate devices.

VII. Substantial Equivalence

The I3RAD 125 Seed has been tested for safety and biocompatibility by standard tests used for radionuclide devices and found to safe and effective and substantially equivalent to other predicate devices.

2

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 1 1999

Ms. Rebecca L. Ellis Manager, Quality & Regulatory Affairs International Isotopes, Inc. 3100 Jim Christal Road Denton, TX 76207

Re:

K992963 13RAD 125I Brachytherapy Seed Dated: August 31, 1999 Received: September 2, 1999 Regulatory Class: II (TWO) Product Code: 90 KXK 21 CFR 892.5730

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 prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been redassified 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 practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), 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 equivalent determination 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 notification submission does not affect any oblication you might have under sections 531 through 542 of the Act for devices under the Electronic Product 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 Compliance at [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 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Dear Ms. Ellis:

Enclosure

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INDICATION FOR USE FORM

Page 【 of I

510 (k) Number (if known):

International Isotopes Inc. I3RAD 125I Seed Device Name:

Indications for Use:

I3RAD 1351 Seeds with activities from 0.1 to 1.0 mCi are indicated for permanent interstitial implantation in selected localized tumors. They can be used either as primary treatment (such as prostate cancer or unresectable tumors) or treatment of residual disease after excision of the primary tumor or recurring turnors. They may also be used at completion of external beam radiation therapy. Tumors of the head, neck, lung, pancreas, breast, prostate (early stages), and other accessible tumors are commonly treated.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K992963

| Prescription Use

(Per 21 CFR 801.1091	X	OR	Over-The-Counter Use
	(Optional Format 1-2-96)

I3RAD 125I Brachytherapy Seed1 Brachytherapy Seed I3RAD ' International Isotopes, Inc.

31 August 1999

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