LAWRENCE CSERION, MODEL CS-1

• K Number: K030162
• Device Name: LAWRENCE CSERION, MODEL CS-1
• Manufacturer: ISORAY, INC
• Date Cleared: 2003-03-28 ( 71 days)
• Product Code: KXK
• Regulation Number: 892.5730

Intended 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 Description

The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).

Predicate Devices

K924261

Reference Devices

K914281, K010283

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a radioactive seed for brachytherapy and does not mention any AI or ML components or functionalities.

Therapeutic

Yes
The device is indicated for the treatment of malignant disease, which is a therapeutic purpose.

Diagnostic

No
The device is described as a treatment for malignant diseases using radiation, not for diagnosing them.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "small, cylindrical sealed source" containing a radionuclide, which is a physical object and 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 the device is for the "treatment of malignant disease" by delivering radiation directly to tumors. This is a therapeutic application, not a diagnostic one.
• Device Description: The device is described as a "sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131". This is a radioactive source used for brachytherapy (internal radiation therapy).
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is used to treat a disease within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

90 KXK

Device Description

The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

head and neck, brain, breast, prostate, etc.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K924261

Reference Device(s)

K914281, K010283

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

Image /page/0/Picture/0 description: The image shows the logo for ISORAY INC. The logo is in black and white, with the company name in a bold, sans-serif font. There are two horizontal lines under the company name. The logo is simple and professional.

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.
350 Hills Street, Suite 106
Richland, WA 99352
	Phone: [phone]
FAX: [phone]
Contact Person/Email:	David J. Swanberg, COO
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
sealed source which contains the low energy gamma (X-ray) emitting
radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The
nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and
patient-contacting material (titanium) are identical to predicate device(s).
Intended 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.

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)