SMD Sr90-1 Radionuclide Brachytherapy Source

K142701 · Salutaris Medical Devices, Inc. · KXK · Dec 19, 2014 · Radiology

Device Facts

• Record ID: K142701
• Device Name: SMD Sr90-1 Radionuclide Brachytherapy Source
• Applicant: Salutaris Medical Devices, Inc.
• Product Code: KXK · Radiology
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths. The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system.

Device Story

SMD Sr90-1 Radionuclide Brachytherapy Source is a radioactive source designed for episcleral brachytherapy; used for treatment of ocular tumors and benign growths. Device functions as a component within a manual brachytherapy applicator system. It delivers localized beta radiation to target tissue. Operated by specialized clinicians (e.g., ophthalmologists/oncologists) in clinical settings. Output is ionizing radiation; intended to destroy or inhibit growth of pathological tissue. Benefits include targeted radiation delivery to ocular structures while minimizing exposure to surrounding healthy tissue.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use consistent with established radionuclide brachytherapy sources.

Technological Characteristics

Radionuclide brachytherapy source containing Strontium-90 (Sr90). Form factor designed for integration into manual episcleral brachytherapy applicator systems. Operates via emission of beta radiation for localized therapeutic effect. Class II device under 21 CFR 892.5730.

Indications for Use

Indicated for episcleral brachytherapy of tumors and benign growths in patients requiring localized radiation therapy.

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.

Submission Summary (Full Text)

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

Salutaris Medical Devices, Inc. % Laurence Marsteller CEO 4330 N Campbell Ave, Suite 250 Tucson, Arizona 85718

April 24, 2015

Re: K142701 Trade/Device Name: Smd Sr90-1 Radionuclide Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide Brachytherapy Source Regulatory Class: Class II Product Code: KXK Dated: December 3, 2014 Received: December 5, 2014

Dear Laurence Marsteller,

This letter corrects our substantially equivalent letter of December 19, 2014.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K142701

Device Name

SMD Sr90-1 Radionuclide Brachytherapy Source

Indications for Use (Describe)

The SMD Sr90-1 Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy of tumors and benign growths.

The SMD Sr90-1 RBS device is intended for use within a manual brachytherapy applicator system.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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