SMD-Sr90-DA Radionuclide Brachytherapy Source

K163206 · Salutaris Medical Devices, Inc. · KXK · Dec 15, 2016 · Radiology

Device Facts

• Record ID: K163206
• Device Name: SMD-Sr90-DA Radionuclide Brachytherapy Source
• Applicant: Salutaris Medical Devices, Inc.
• Product Code: KXK · Radiology
• Decision Date: Dec 15, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

Device Story

SMD-Sr90-DA is a radionuclide brachytherapy source containing Strontium-90; designed for episcleral brachytherapy. Device functions as a radiation source within a manual brachytherapy applicator system. Used by ophthalmologists or radiation oncologists in clinical settings to deliver localized beta radiation to ocular tissues. Provides therapeutic radiation dose to target area; intended to treat specific ocular conditions. No automated processing or software components involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radionuclide brachytherapy source containing Strontium-90. Designed for integration into manual brachytherapy applicator systems. Class II device under 21 CFR 892.5730. No software, electronics, or connectivity features.

Indications for Use

Indicated for episcleral brachytherapy in patients requiring localized radiation treatment to the eye.

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

December 15, 2016

Salutaris Medical Devices, Inc. % Laurence Marsteller, M.D. CEO 4340 N Campbell Avenue, Suite 266 TUCSON AZ 85718

Re: K163206

Trade/Device Name: SMD-Sr90-DA Radionuclide Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: November 9, 2016 Received: November 15, 2016

Dear Dr. Marsteller:

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 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.

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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/Resourcesfor You/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.

Michael D'Hara

For

Robert Ochs, Ph.D. 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) K163206

#### Device Name

SMD-Sr90-DA Radionuclide Brachytherapy Source

Indications for Use (Describe)

The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy.

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

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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