Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites, after excision of primory tumore after excision of primary tumors.

Device Description

The Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.

AI/ML Overview

This document is a 510(k) Summary and an FDA clearance letter for a medical device called Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared device, not to present a new clinical study proving effectiveness. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device in a clinical setting, nor does it report on such performance for this submission. The device is a brachytherapy source, and its effectiveness is related to its physical characteristics and how it's used in treatment, not a diagnostic or AI-driven performance metric.

However, the document does mention "release specifications" for finished products to ensure safety and effectiveness. These are internal manufacturing and quality control criteria, not clinical performance metrics.

Acceptance Criteria (Internal)	Reported Device Performance (Internal)
Meet all required release specifications (e.g., leak testing for external contamination, apparent activity, labeling).	All finished products are tested and must meet all required release specifications before distribution.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This submission is for demonstrating substantial equivalence based on material and structural changes to an existing device, not a clinical effectiveness study requiring a test set of patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As above, this is not a clinical effectiveness study.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a brachytherapy seed, not an AI-driven image analysis tool or a diagnostic aid requiring human reader interpretation studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.

7. The Type of Ground Truth Used

Not applicable for clinical performance. For manufacturing release, the "ground truth" would be established by validated test methods demonstrating that the device meets its design specifications (e.g., activity levels, leak integrity).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device and Approval:

Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands
Manufacturer: IsoRay Medical, Inc.
Intended Use: Single-use prescription devices for interstitial, surface, and intracavity brachytherapy for malignant disease (e.g., head and neck, brain, breast, lung, prostate, eye). Can be used as primary treatment or with other modalities.
Nature of Submission: 510(k) clearance for a modification to a previously cleared device (K062384). The modification is the addition of a preloaded flexible braided strand instead of a rigid hollow tubular strand.
Basis for Equivalence: Substantial equivalence to the IsoRay Proxcelan™ (Cesium-131) Implant Devices (K062384). The technical characteristics are essentially the same (Cesium-131 brachytherapy seeds), with the change being the flexible braided sleeve. All materials are biocompatible and used in similar marketed devices.
Safety and Effectiveness (as stated in the document): Ensured through internal testing of all finished products to meet required release specifications (e.g., leak testing, apparent activity, labeling) as defined by written and approved procedures conforming to product design specifications. This refers to manufacturing quality control, not clinical study results.
FDA Decision: Substantially equivalent.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features an atom symbol to the left of the company name. The word "MEDICAL" is written in smaller letters below "IsoRay".

1092136

AUG 0 7 2009

3.0 Section C: 510(k) Summary Required by 21 CFR § 807.92

3.1 Submitter: IsoRay Medical, Inc.
3.2 Address: 350 Hills Street, Suite 106 Richland, WA 99354-5411
3.3 Telephone and Fax Numbers: 509-375-1202 (Fax) 509-375-3473
3.4 Contact Person: Fredric Swindler fswindler@isoray.com
Date of preparation of this Summary: 07/10/09 3.5
Device Name, Regulatory and Classification Information: 3.6
- Trade Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 --3.6.1 Cs-131 Preloaded Braided Strands
- 3.6.2 Common Name: Preloaded Brachytherapy Seeds
Classification Name: Radionuclide Brachytherapy Source (Per 21CFR 3.7 8892.5730)
Marketed device to which equivalence is claimed: The Proxcelan (Cesium-3.8 131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands that are the subject of this submission are substantially equivalent to the IsoRay Proxcelan™ (Cesium-131) Implant Devices as described in 510(k) No. K062384 (SE 11/09/2006).
Product Description: The Proxcelan (Cesium-131) Implant Devices, Model PL-5 3.9 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.

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Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features a stylized atom symbol on the left, followed by the text "IsoRay" in a bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller, sans-serif font. The overall design is simple and professional.

Statement of intended use compared to the currently marketed predicate 3.10 device: Proxcelan (Cesium-131) Implant Devices, Model PL-5 - Cs-131 Preloaded Braided Strands are single use prescription devices that are 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. This is identical to the legally marketed predicate devices, the IsoRay Proxcelan (Cesium-131) Implant Devices as described in 510(k) No. K062384 (SE 11/09/2006).
Statement of Technological Characteristics: The technical characteristics 3.11 consist of cesium-131 brachytherapy seeds that are preloaded into braided bioabsorbable sleeves (strands). All materials used in the construction of the Proxcelan (Cesium-131) Implant Devices are biocompatible and currently used in similar marketed devices that are in wide clinical application. The difference between the currently marketed Proxcelan (Cesium-131) Implant Devices and the proposed modification is the addition of a preloaded flexible braided stand instead of the current rigid hollow tubular strand.
Safety and Effectiveness: To ensure that the devices are safe and effective, all 3.12 finished products are tested and must meet all required release specifications before distribution. The testing required for release specifications
tech to the county of the testing required for release includes, but is not limited to leak testing for external contamination, apparent activity, but is not himmed labeling. The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands is detailed in the Device Master Record.

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Image /page/2/Picture/0 description: The image shows a partial logo of the Department of Health and Human Services. The logo features a stylized human figure with outstretched arms, and the text "DEPA" is visible to the right of the figure. The image is black and white and appears to be a close-up of the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration · 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Fredric G. Swindler Vice President Regulatory Affairs and Quality Assurance IsoRay Medical, Inc. 350 Hills St., Suite 106 RICHLAND WA 99354-5411

AUG 0 7 2009

Re: K092136

Trade/Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 - Cs-131 Preloaded Braided Strands Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: July 10, 2009 Received: July 15, 2009

Dear Mr. Swindler:

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); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.0 Section B

Indications for Use

510(k) Number:

f092136

Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands

Indications for Use:

Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites,
after excision of primory tumore after excision of primary tumors.

Prescription Use × (Per 21 CFR § 801.109)

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulut Leun

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 10(k) Number

Page 4 of 32

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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.