PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2

K092458 · Isoray Medical, Inc. · KXK · Aug 28, 2009 · Radiology

Device Facts

• Record ID: K092458
• Device Name: PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2
• Applicant: Isoray Medical, Inc.
• Product Code: KXK · Radiology
• Decision Date: Aug 28, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Proxcelan Implant Devices consist of Cesium-131 brachytherapy seeds combined with bioabsorbable spacers; preloaded into bioabsorbable hollow strands or 18-gauge needles. Designed for placement on body surfaces, into body cavities, or directly into tissue to deliver localized nuclear radiation for malignant disease treatment. Seeds/spacers arranged in precise patterns per physician/medical physicist treatment plan to maintain specific seed separation distances. Used in clinical settings by medical professionals. Benefits include targeted radiation delivery to tumors. Safety ensured via leak testing, contamination testing, apparent activity verification, and sterility testing.

Clinical Evidence

Bench testing only. No clinical data presented. Safety and effectiveness are supported by product release specifications including leak testing, external contamination testing, apparent activity verification, and sterility testing, all conforming to established design specifications.

Technological Characteristics

Cesium-131 brachytherapy seeds; bioabsorbable spacers; bioabsorbable sleeves (strands); 18-gauge brachytherapy needles. Biocompatible materials. Single-use. Radiation source: Cesium-131. No software or electronic components.

Indications for Use

Indicated for patients with malignant disease (e.g., head, neck, brain, breast, lung, prostate, eye) requiring surface, interstitial, or intracavity radiation therapy for radiosensitive tumors. Used as primary treatment, adjunct to external beam radiation/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

• IsoRay Proxcelan™ (Cesium-131) Implant Devices (K062384)

Submission Summary (Full Text)

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## 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: [e-mail]
- 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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K092458
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- 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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## 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 [phone] or [phone] 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:

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.

| Prescription Use | X |
|------------------------|---|
| (Per 21 CFR § 801.109) | |

OR

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