I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401

K992963 · International Isotopes, Inc. · KXK · Sep 21, 1999 · Radiology

Device Facts

• Record ID: K992963
• Device Name: I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401
• Applicant: International Isotopes, Inc.
• Product Code: KXK · Radiology
• Decision Date: Sep 21, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

I3RAD 125I Seeds consist of radioactive iodine-125 beads encapsulated within titanium tubes. Device functions as brachytherapy source for permanent interstitial implantation. Physician implants seeds directly into localized tumors (e.g., prostate, lung, breast, head/neck) to deliver localized radiation therapy. Used as primary treatment, for residual disease, or following external beam radiation. Provides continuous low-dose radiation to tumor site; benefits patient by targeting malignant tissue while minimizing exposure to surrounding healthy structures.

Clinical Evidence

Bench testing only. Safety and biocompatibility verified through standard testing protocols for radionuclide brachytherapy devices.

Technological Characteristics

Radioactive iodine-125 beads encapsulated in titanium tubes. Permanent interstitial implant. Activity range 0.1 to 1.0 mCi. No electronic components or software.

Indications for Use

Indicated for patients with localized tumors, including prostate cancer, unresectable tumors, residual disease, or recurring tumors. Applicable to head, neck, lung, pancreas, breast, and other accessible tumors. Used for permanent interstitial implantation.

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

• EndoSeed (K914825/A)
• Amersham Model 6711 (K914281)
• Mentor IoGOLD (K972271)

Submission Summary (Full Text)

{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<br>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.

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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<br>(Per 21 CFR 801.1091 | <div style="text-align:center;">X</div> | 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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