10 CURIE IRDIUM 192, CSN00100-192

K991571 · Alpha-Omega Services, Inc. · KXK · Feb 22, 2000 · Radiology

Device Facts

• Record ID: K991571
• Device Name: 10 CURIE IRDIUM 192, CSN00100-192
• Applicant: Alpha-Omega Services, Inc.
• Product Code: KXK · Radiology
• Decision Date: Feb 22, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device. Prescription Device. Federal Law (US) restricts this device to sale by or on the order of a physician.

Device Story

Device is a hermetically sealed Iridium-192 radionuclide brachytherapy source (Model CSN0010-192) for use with Nucletron Microselection HDR afterloader systems. Input is radioactive Iridium-192 seed; output is nuclear radiation for therapeutic treatment. Device consists of stainless steel 316LVM capsule (1.1mm diameter) welded to 7x7 stranded stainless steel cable (2000mm length). Used in clinical oncology settings; operated by trained, licensed personnel (physicians/technicians) within established irradiation equipment installations. Device delivers radiation to target tissue/cavity; clinical decision-making relies on physician-directed treatment planning. Benefits include precise delivery of radiation therapy for cancer treatment.

Clinical Evidence

Bench testing only. No clinical data provided. Comparison based on physical specifications, material biocompatibility, and performance testing (50,000 transfer cycles).

Technological Characteristics

Radionuclide brachytherapy source; Ir-192 radioisotope; stainless steel 316LVM capsule; 1.1mm diameter; 2000mm cable length; 7x7 stranded cable; laser/TIG welding; 9-13 Ci activity at shipping; 75-day half-life.

Indications for Use

Indicated for patients requiring brachytherapy; source placed on body surface, in body cavity, or in tissue for radiation therapy. Used as active source for Nucletron Microselection HDR afterloader. Prescription only.

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

• Nucletron Microselection Source (K864210)

Submission Summary (Full Text)

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Section 2 Summary 510(k)

The following is a Summary of the Alpha-Omega Services, Inc., 10 Curie IR-92 Brachytherapy Source for Nucletron Microselection device.

| Applicant | Alpha-Omega Services, Inc.<br>9156 Rose Street<br>Bellflower, California 90706<br>[phone]<br>[phone] Fax |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Manufacturing Facility | Alpha-Omega Services, Inc.<br>1282 Big Woods and Starks Rd.<br>Edgerly, LA 70668<br>[phone] |
| Contact Person | Bruce Hedger, President and RSO |
| Classification Name | Radionuclide Brachytherapy Source. |
| Common/Usual Name | 10 Curie IR-92 Brachytherapy Source for Nucletron<br>Afterloader device. |
| Proprietary Name | 10 Curie Iridium 192 Source, Model CSN0010-192. |
| Establishment Registration Number | 2022694 California, Louisiana registration has been sent in. |
| Classification | 21 CFR 892.5730, Class II, Product Code: JAQ |
| Special Controls | Product will comply with the nuclear regulatory requirements<br>for the State of Louisiana NRC and US NRC. |
| Substantial Equivalence | K864210 Nucletron Microselection Source. |

## General Information

The contents of this premarket notification summary will demonstrate the substantial equivalence of the subject device, 10 Curie IR-92 Brachytherapy Source for Nucletron Afterloader device. The substantial equivalence will be based on the following features of the device:

- . Indications
- Physical Size .
- Radioisotope .
- . Radiation activity

The Alpha-Omega Services, Inc., 10 Curie Iridium 192 Source, Model CSN0010-192 device is a hermetically sealed radionuclide brachytherapy source indicated for, to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

The source is made of a stainless steel capsule with an outer diameter of approximately 1.1mm. A hole is drilled through the center of the capsule to a depth of the ir 192 seed. The closed end of the capsule is welded to a 1.1 mm diameter 7 X 7 stranded stainless steel cable. On the opposite end, a solid connector is welded in the same manner to the free end of the cable A Ir 192 seed is inserted into the open end of the capsule. The Ir 192 seed is secured by welding the open end of the capsule. The post-weld length of capsule is approximately 4.5 mm in length

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and overall length of the finished source cable assembly is approximately 2000 mm. These physical specifications are the source for the Nucletron Microselection HDR device.

The following table compares indications statement for Alpha-Omega Services, Inc., 10 Curie IR-92 Brachytherapy Source for Nucletron Microselection HDR device and the predicate device.

| 10 Curie IR-92 Brachytherapy Source for | IR-192 (K864210), Nucletron Microselection |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nucletron Afterloader device | Predicate Device |
| A high specific activity radionuclide<br>brachytherapy source to be placed onto a body<br>surface or into a body cavity or tissue as a<br>source of nuclear radiation for therapy. Device<br>is the active source for a Nucletron<br>Microselection Device. | A high specific activity radionuclide<br>brachytherapy source to be placed onto a body<br>surface or into a body cavity or tissue as a<br>source of nuclear radiation for therapy. Device<br>is the active source for an Nucletron<br>Microselection |

Based on the intent of the indications statement for the subject device, the Alpha-Omega Services, Inc., 10 Curie IR-92 Brachytherapy Source for Nucletron Afterloader device, is substantially equivalent to the predicate device with respect to its indications.

The following table compares the physical size. materials of construction, and the radioisotope for the subject device and predicate device.

| Feature Description | 10 Curie Iridium 192 Source, Model<br>CSN0010-192 for Nucletron<br>Microselection device | IIR-192 (K864210), Nucletron<br>Microselection<br>Predicate Device |
|-----------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Diameter | 1.1 mm | 1.1 mm |
| Length | 2000 mm ± 5% | 2000 mm ± 5% |
| Cable Type | 7X7 Stranded | 7X7 Stranded |
| Material | Stainless steel 316LVM | Stainless steel 316LVM |
| Seal Method | Laser / Tig Welding | Laser Welding |
| Radioisotope | IR - 192 Seed 3.5 mm | IR - 192 Seed 3.5 mm |
| Tested transfers cycles | 50,000 | 20,000 |
| Recommended cycles | 5,000 | 5,000 |
| Radioactive half life | 75 days | 75 days |
| Apparent Activity<br>Levels | 9 - 13 Ci at time of shipping | 9 - 13 Ci at time of shipping |

## LIMITATIONS AND/ OR OTHER CONSIDERATIONS OF USE

- The source cable shall be distributed in the United States to persons specifically 1. licensed by the United States NRC or an agreement state.
- 2. The source cable shall be distributed internationally to users with approval from local competent authorities.
- 3. The source cable shall be leak tested at six (6) month intervals using techniques capable of detecting 0.005 microcuries of removable contamination.
- Handling, storage, use, transfer and disposal will be determined by the licensing 4. authority. The sealed source must be installed and transferred by experienced, trained and licensed personnel only using adequate handling procedures.
- ક. The licensee shall not cut, splice or altar the source cable in any way.
- To be used as an active source cable for the Nucletron Oldelft Microselectron HDR 6.

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Afterloader at existing irradiation equipment installations. The licensee shall strictly abide by all requirements of the customer's license and applicable requirements of the U.S.N.R.C., agreement state or international competent authorities in which the authorized work is performed

## External Radiation Levels

The following are radiation dose rates for a 10 curie source

| Distance (in cm) | Dose Rate (mr/hr) |
|------------------|-------------------|
| 1 | 48,000,000 |
| 25 | 76,800 |
| 50 | 19,200 |
| 100 | 4,800 |

These values are for health physics ONLY and not for clinical use.

Based on the dimensions of the subject device being the same as the predicate device, the body tissue contacting materials being made of a known biocompatible material, stainless steel, and both devices using IR-192 as the radionuclide, the subject device, Alpha-Omega Services, Inc., 10 Curie Indium 192 Source, Model CSN0010-192 for use with Nucletron Microselection HDR device is substantially equivalent to the predicate device with respect to features and indications.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2000

Alpha-Omega Services, Inc. C/O J. Harvey Knauss Delphi Consulting Group 11874 South Evelyn Circle Houston, TX 77071

Re:

K991571 10 Curie Iridium 192 Source, Model CSN0010-192 Dated: January 18, 2000 Received: January 19, 2000 Regulatory class: II 21 CFR 892.5730/Procode: 90 KXK

Dear Mr. Knauss:

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 II (Special Controls) or 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 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

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510(k) Number K 991571

10 Curie Iridium 192 Source, Model CSN0010-192 Device Name:

- Indications for use: A high specific activity radionuclide brachytherapy source to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. Device is the active source for a Nucletron Microselection Device.
Prescription Device. Federal Law (US) restricts this device to dale by or on the order of a physician.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991571

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

(Optional Format 1-2-96)

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