PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 by ISORAY MEDICAL, INC.

Proxcelan™ (Cesium-131) Implant Devices 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 primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment for residual disease after excision of primary tumors.

Device Description

The Proxcelan (Cesium-131) Implant Devices are single use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows: PL-1 Cs-131 Preloaded Strands, PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles, PL-3 - Cs131 Preloaded 18 Gauge Needles.

AI/ML Overview

The provided text is a 510(k) summary for the Proxcelan™ (Cesium-131) Implant Devices, primarily focusing on its substantial equivalence to a previously marketed device (K062384) and general safety and effectiveness.

It does NOT contain specific information about detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, or standalone performance).

The text primarily describes:

Device Description: What the Proxcelan (Cesium-131) Implant Devices are (preloaded strands or needles with Cesium-131 seeds and bioabsorbable spacers).
Intended Use/Indications for Use: Treatment of malignant disease in various body sites, used as primary treatment or in conjunction with other modalities.
Technological Characteristics: Cesium-131 seeds, bioabsorbable spacers, preloaded into needles/strands. Mentions a change in copolymer formulation from the predicate device.
Safety and Effectiveness (General Statement): States that "all finished products are tested and must meet all requires release specifications before distribution." This includes leak testing, external contamination, apparent activity, sterility, and labeling, defined by written and approved procedures conforming to product design specifications. It refers to a "Device Master Record" for details.

Based on the provided text, I cannot complete the requested information for acceptance criteria and the study that proves the device meets them because the document does not contain this level of detail.

However, I can extract what is explicitly stated regarding safety and effectiveness testing, which implies general acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance (as stated in document)
General Requirement	"meet all requires release specifications before distribution"
Leak Testing	Tested and must meet specifications
External Contamination	Tested and must meet specifications
Apparent Activity	Tested and must meet specifications
Sterility	Tested and must meet specifications
Labeling	Tested and must meet specifications

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided in the text. The document only states "all finished products are tested," implying a manufacturing quality control process rather than a specific clinical or performance study with a defined test set sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. The described testing relates to manufacturing quality control (e.g., leak testing, sterility), not clinical performance requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication methods are typically for studies interpreting complex data, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is a brachytherapy implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is a brachytherapy implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated for the "release specifications" testing. For manufacturing quality control, ground truth would likely be internal quality standards, calibrated measurement instruments, and predefined tolerances for physical and radioactive properties (e.g., a known standard for activity measurement, absence of microbial growth for sterility).

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable / Not provided. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for IsoRay Medical. The logo features a stylized atom symbol on the left, followed by the company name in bold, sans-serif font. Below "IsoRay" is the word "MEDICAL" in a smaller font size.

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

AUG 2 8 2009

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
Fredric Swindler 3.4 Contact Person: fswindler@isoray.com
3.5 Date of preparation of this Summary: 08/07/09
Device Name, Regulatory and Classification Information: 3.6
- Trade Name: Proxcelan™ (Cesium-131) Implant Devices: 3.6.1
  - PL-1 Cs-131 Preloaded Strands ●
  - PL-2 Cs-131 Preloaded Strands in 18 Gauge Needles ●
  - PL-3 - Cs-131 Preloaded 18 Gauge Needles
- 3.6.2 Common Name: Preloaded Brachytherapy Seeds
3.7 Classification Name: Radionuclide Brachytherapy Source (Per 21CFR 8892.5730)
3.8 Marketed device to which equivalence is claimed: The Proxcelan (Cesium-131) Implant Devices 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 are single 3.9 use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows:
- PL-1 Cs-131 Preloaded Strands: Proxcelan PL-1 Cs-131 Strands 3.9.1 consist of a series of Cesium-131 Brachytherapy Seeds and bioabsorbable spacers held in place within a hollow bioabsorbable sleeve (strand). The seeds and spacers 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.

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Image /page/1/Picture/0 description: The image shows the logo for IsoRay Medical. The logo consists of an atom-like symbol on the left, followed by the words "IsoRay" in large, bold letters. Below "IsoRay" is the word "MEDICAL" in smaller letters. The logo is black and white.

K092458
Page 2 of 2

3.9.2 PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles: The PL-2 -Cs-131 Preloaded Strands in 18 Gauge Needles consist of a hollow strand containing Cesium131 Brachytherapy Seeds and spacers as described above that are preloaded into 18 gauge brachytherapy seeding needles. As with PL-1 above, the seeds and spacers 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.
3.9.3 PL-3 - Cs131 Preloaded 18 Gauge Needles: The PL-3 - Cs-131 Preloaded 18 Gauge Needles consist of a standard 18 gauge brachytherapy needle to which seeds and spacers 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. (These seeds and spacers are not contained in a strand as described for PL-1 and PL-2 above.)
3.10 Statement of intended use compared to the currently marketed predicate device: Proxcelan (Cesium-131) Implant Devices 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).
3.11 Statement of Technological Characteristics: The technical characteristics consist of cesium-131 brachytherapy seeds with bioabsorbable spaces that are preloaded into 18 gauge brachytherapy needles and/or 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 differences between the currently marketed Proxcelan (Cesium-131) Implant Devices and the proposed modification are a change in the formulation of the copolvmer.
3.12 Safety and Effectiveness: To ensure that the devices are safe and effective, all finished products are tested and must meet all requires release specifications before distribution. The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, and 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 is detailed in the Device Master Record.

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Image /page/2/Picture/0 description: The image shows a logo with three thick, curved lines stacked on top of each other, resembling a stylized bird in flight. To the left of the lines, there is a partial circular shape with text arranged along its curve. The text is small and difficult to read, but it appears to be part of the logo's official branding.

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

AUG 2 8 2009

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

Re: K092458

Trade/Device Name: Proxcelan™ (Cesium-131) Implant Devices, Multiple Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: August 7, 2009 Received: August 11, 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 (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 (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.

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/CDRHOffices/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: K092485 K092458

Device Name: Proxcelan (Cesium-131) Implant Devices, Multiple

Indications for Use:

Prescription Use	X
(Per 21 CFR § 801.109)

Over-The-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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.