ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501

K991526 · Imagyn Medical Technologies, Inc. · KXK · Jun 17, 1999 · Radiology

Device Facts

• Record ID: K991526
• Device Name: ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
• Applicant: Imagyn Medical Technologies, Inc.
• Product Code: KXK · Radiology
• Decision Date: Jun 17, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi, are indicated for permanent interstitial implantation of selected localized tumors. They are to be used either as primary treatment (such as prostate cancer or unresectable tumors) or as treatment of residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

Device Story

Imagyn isoSTAR™ I-125 Interstitial Seed (Model IS-12501) is a brachytherapy device for permanent interstitial implantation. Device consists of 131 spheres encapsulated in a titanium tube. Emits radiation for treatment of localized tumors (e.g., prostate, head, neck, lung, pancreas). Used by clinicians for primary treatment or residual/recurring disease management. Provides localized radiation therapy to tumor sites.

Clinical Evidence

Bench testing only. Safety and biocompatibility verified via standard tests for radionuclide devices.

Technological Characteristics

Titanium tube encapsulation of 131 spheres containing I-125. Activity range 0.1 to 1.0 mCi. Radionuclide brachytherapy source.

Indications for Use

Indicated for permanent interstitial implantation in patients with localized tumors, including prostate cancer, unresectable tumors, or residual/recurring tumors of the head, neck, lung, pancreas, and other accessible sites.

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

• Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500 (K982421)
• EndoSeed (K914825/A)
• Amersham Model 6711 (K914281)
• Mentor IoGOLD (K972271)

Submission Summary (Full Text)

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

K991526

JUN 17 1999

# 510(k) Summary Imagyn Technologies Imagyn 125I Seed

- General Information on Submitter: I.

| Name: | Imagyn Medical Technologies<br>10005 Muirlands, Suite G<br>Irvine, CA 92618 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | |
| Phone: | 949-465-1710 |
| Fax: | 949-465-1718 |
| Name of Contact Person: | Cheryl Blake, Vice President Regulatory Affairs and<br>Corporate Quality Assurance<br>Imagyn Medical Technologies<br>3050 Redhill Ave.<br>Costa Mesa, CA 92626 |
| Phone: | 949-708-7748 |
| Fax: | 949-708-7795 |

April 30, 1999 Date Summary Prepared:

- II. General Information on Device Product Name: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501 Source, Radionuclide, Brachytherapy, 21 C.F.R. 892.5730 Classification Name:
- III. Predicate Devices: Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12500, K982421

EndoSeed, 510(k) number K914825/A

Amersham Model 6711, K914281

Mentor IoGOLD, K972271

- IV. Description of the Device:

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

## Mentor loGOLD, K972271

#### IV. Description of the Device:

The Imagen isoSTARTM I-125 Interstitial Seed, Model IS-12501 uses 131 spheres encapsulated in a titanium tube.

- V. Intended Use:
The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, with activities from 0.1 to 1.0 mCi, are indicated for permanent interstitial implantation of selected localized tumors. They are to be used either as primary treatment (such as prostate cancer or unresectable tumors) or as treatment of residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, prostate (early stages), and other accessible tumors are commonly treated.

- VI. Technological Characteristics of Device Compared to Predicate Device:
The Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, uses the same type of encapsulation of 1251 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 Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, 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}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 17 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Debra A. Rinderer Regulatory Affairs Specialist Imagyn Medical Technologies, Inc. 3050 Redhill Avenue Costa Mesa, California 92626

K991526 Re:

Isostar I-125 Interstitial Seeds, Model IS-12501 Dated: June 8, 1999 Received: June 9, 1999 Regulatory Class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Rinderer:

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 reclassified 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 (Special Controls) or dass 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 requlatory 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 obligation 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

Enclosure

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

#### INDICATION FOR USE FORM

| Page | 1 | of |
|------|---|----|
|------|---|----|

l

510 (k) Number (if known):

Imagyn isoSTARTM I-125 Interstitial Seed. Model IS-12501 Device Name:

Indications for Use:

Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501, 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 for residual disease after excision of the primary tumor or recurring tumors. Tumors of the head, neck, lung, pancreas, 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)

Prescription Use
(Per 21 CFR 801.109)
OR
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991526

Imagyn isoSTAR™ I-125 Interstitial Seed, Model IS-12501 4/30/1999 Imagyn

Page 9

Over-The-Counter Use