Interstrand 125 & Interstrand 103, Model Numbers 1251S and 1031S

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K011155 ↗

FDA Product Code

KXK

Device Class

Class II

Regulation

21 CFR Part 892.5730

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Ez-Pak

  Class II

  FDA 510(k) K041702 Active Cleared 16 Jul 2004

• Optistrand, Model 1032S

  Class II

  FDA 510(k) K043336 Active Cleared 21 Jan 2005

• What are the Interstrand 125 and Interstrand 103 (Model Numbers 1251S and 1031S) used for in clinical practice?

  These devices are designed specifically for brachytherapy, a form of internal radiation therapy where radioactive sources are placed directly into or near a tumor to deliver precise, localized radiation doses. They are intended for use in radiology procedures where controlled delivery of radionuclides is required, such as in the treatment of gynecological, prostate, or other cancers where targeted radiation is critical.

• Are the Interstrand 125 and 103 single-use or reusable, and what does that mean for my workflow?

  The Interstrand 125 and 103 (Model Numbers 1251S and 1031S) are single-use devices, meaning each unit is intended for one-time clinical use only. This design eliminates the need for reprocessing, reducing the risk of contamination or cross-infection while simplifying inventory management and ensuring consistent performance per the manufacturer’s specifications.

• What storage conditions should I follow for the Interstrand 125 and 103 to maintain their integrity?

  While the provided data does not specify exact storage conditions, as brachytherapy radionuclide sources, these devices are typically stored in a controlled, radiation-safe environment with restricted access. They should be kept in their original packaging until use, protected from physical damage, and handled only by trained personnel familiar with radiation safety protocols. Always refer to the manufacturer’s instructions for facility-specific guidelines.

• How do I know which model (1251S or 1031S) is right for my procedure, and are there size variations?

  The Interstrand 125 and Interstrand 103 (Model Numbers 1251S and 1031S) are differentiated by their radioactive source strength and application-specific design, but the data does not provide explicit size or activity-level details. The choice depends on the clinical protocol, tumor type, and radiation dose requirements, which should be determined in consultation with a radiation oncologist or brachytherapy specialist. Contact Ibt, Inc. for model-specific technical data or application guidance.

• What regulatory pathway was followed for FDA clearance of these devices, and how does that affect their use?

  The Interstrand 125 and 103 received FDA 510(k) clearance under K-number K011155 with a substantially equivalent (SESE) determination, meaning they were deemed comparable to a legally marketed predicate device in terms of technology and safety. This clearance falls under the brachytherapy source category (regulation number 892.5730) and was reviewed by the Radiology (RA) Advisory Committee. Clinically, this ensures they meet FDA standards for precision radiation delivery in controlled settings, but their use must comply with all current radiation safety and licensing regulations.