LAWRENCE CSERION, MODEL CS-1

K030162 · Isoray, Inc. · KXK · Mar 28, 2003 · Radiology

Device Facts

• Record ID: K030162
• Device Name: LAWRENCE CSERION, MODEL CS-1
• Applicant: Isoray, Inc.
• Product Code: KXK · Radiology
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

Device Story

Lawrence CSERION Model CS-1 is a small, cylindrical, sealed brachytherapy source containing Cesium-131 radionuclide adsorbed onto an internal inorganic substrate. Encapsulated in welded titanium, the seed measures 4.5 mm in length and 0.8 mm in diameter. It includes a gold wire radiographic marker for visualization. The device is implanted by clinicians using needles, applicators, tubing, catheters, or expanders to deliver localized radiation to malignant tumors. By emitting low-energy gamma (X-ray) radiation, the seeds provide targeted therapy to radiosensitive tissues. The device is intended for use in clinical settings for primary treatment or as an adjunct to other modalities like chemotherapy or external beam radiation. It benefits patients by providing localized, continuous radiation dose to tumors while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and performance specifications compared to legally marketed predicate devices.

Technological Characteristics

Sealed brachytherapy source; radionuclide: Cesium-131; capsule material: welded titanium; dimensions: 4.5 mm length, 0.8 mm diameter; radiographic marker: gold wire; energy output: 29.5, 29.8, 33.6 keV; half-life: 9.69 days; implantation via standard needles/catheters.

Indications for Use

Indicated for patients with malignant disease (e.g., head, neck, brain, breast, prostate) requiring surface, interstitial, or intracavitary radiation therapy for tumors with known radiosensitivity. Used as primary treatment, adjunct to external beam radiation or chemotherapy, or for residual disease post-excision.

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

• Radioactive Cesium-131 Seeds/Sources (K924261)

Reference Devices

• K914281
• K010283

Submission Summary (Full Text)

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## 510(k) Summary

Image /page/0/Picture/3 description: The image shows a handwritten number sequence, "(030162", followed by the date "MAR 2 8 2003" printed in a bold, sans-serif font. The number sequence appears to be written with a thick marker, and the date is printed in all capital letters. The date indicates that the image was created or related to something that happened on March 28, 2003. The combination of handwritten numbers and a printed date suggests that this image could be from a document, record, or label.

| Summary Date: | January 13, 2003 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Information: | IsoRay, Inc.<br>350 Hills Street, Suite 106<br>Richland, WA 99352 |
| | Phone: [phone]<br>FAX: [phone] |
| Contact Person/Email: | David J. Swanberg, COO<br>Email: [e-mail] |
| Trade Name: | Lawrence CSERION Model CS-1 |
| Common Name: | Brachytherapy Sources (Seeds) |
| Classification Name: | Class II, 90-KXK, Brachytherapy, Radionuclide |
| Primary Predicate Device: | K924261 Radioactive Cesium-131 Seeds/Sources |
| Device Description: | The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical<br>sealed source which contains the low energy gamma (X-ray) emitting<br>radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The<br>nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and<br>patient-contacting material (titanium) are identical to predicate device(s). |
| Intended Use: | IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of<br>malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be<br>used in surface, interstitial, and intracavitary applications for tumors with known<br>radiosensitivity. The seeds may be used as a primary treatment or in conjunction<br>with other treatment modalities, such as external beam radiation therapy,<br>chemotherapy or as treatment for residual disease after excision of primary<br>tumors. |

Comparison Chart:

| Parameters for Evaluating | IsoRay, Inc. | Predicate Device(s) | | | |
|---------------------------------|------------------------------------------------------------|---------------------|------------------|------------|--|
| Substantial Equivalence | Lawrence CSERION | K924261 | K914281 | K010283 | |
| Indications for Use | Malignant Disease | Same | Same | Same | |
| Radionuclide | Cs-131 | Same | I-125 | Pd-103 | |
| Half-Life (days) | 9.69 | Same | 59.4 | 17.0 | |
| Principle Energies (keV) | 29.5. 29.8. 33.6 | Same | 27.4, 31.4, 35.5 | 20-22 | |
| Patient-Contacting Capsule: | Welded Titanium | Same | Same | Same | |
| Nominal External Length (mm) | 4.5 | Same | Same | Same | |
| Nominal External Diameter (mm) | 0.8 | Same | Same | Same | |
| Radiographic Marker | Gold Wire | Various | Silver Rod | Lead Piece | |
| Apparent Activity Range (mCi) | 0.20 to 50.0 | 0.1 to 100 | 5.0 to 40 | 0.1 to 10 | |
| External Contamination (uCi) | < 0.005 uCi | Same | Same | Same | |
| Implantation/Application Method | Needles, Applicators, Tubing<br>Catheters, Expanders, etc. | Same | Same | Same | |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David J. Swanberg Chief Operations Officer IsoRay, Inc. 350 Hills Street, Suite 106 RICHLAND WA 99352

Re: K030162

MAR 2 8 2003

Trade/Device Name: Lawrence CSERION Model CS-1 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: January 13, 2003 Received: January 16, 2003

Dear Mr. Swanberg:

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 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. 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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## Statement of Indications for Use D.

| Applicant: | IsoRay, Inc. |
|----------------|-----------------------------|
| 510(k) Number: | K030162 |
| Device Name: | Lawrence CSERION Model CS-1 |

Indications For Use (Page 1 of _1 ):

IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

or Over-The Counter Use

(Per 21 CFR 801.109)

David Ingram

Division of Reproductive, and Radiological Devi 510(k) Numbe

Page 6 of 71

Confidential Until SE Determination