(107 days)
The Heyman Packing Applicator Set is indicated for use for treating endometrial cancer using HDR or PDR brachytherapy.
The Heyman Packing Applicator Set consists of various sized Heyman-capsules which may be connected to compatible brachytherapy afterloaders via guide tubes. The set also includes a number of associated accessories for sterilization (Cleaning Cap, Leak Stop Button, and Leak Stop Channel Marker Sets). The Heyman Packing Applicator Set is an applicator for intracavitary Brachytherapy is a form of radiotherapy using Gamma rays from a radioactive source placed at locations close to or within a tumor or other treatment area to a predefined treatment plan defines the positions and times for the source to ensure the correct dose for the treatment area. The applicator acts to guide the radioactive source to the correct location or locations for treatment. The device does not contain or consist of software/firmware. The device does not contain any biologics or drug components. The device has patient-contacting materials. The device is designed for repeated use. No parts of the system are provided sterile. The device can be steam sterilized with common parameters using pre-vacuum sterilization. The Heyman Packing Applicator Set includes patients whose cancer can be treated using HDR or PDR brachytherapy, as determined by the prescribing physician. The Heyman Packing Applicator Set is intended to be used in a healthcare or treatment facility by trained and qualified personnel.
The provided text describes a 510(k) premarket notification for a medical device called the "Heyman Packing Applicator Set (GM11004580)". This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets acceptance criteria through a separate study with specific performance metrics (like accuracy, sensitivity, specificity, etc.) that would typically apply to AI-driven or diagnostic devices.
Instead, the "acceptance criteria" here refer to the device's conformance to established engineering standards, biocompatibility, and safety, as well as its functional characteristics. The "study that proves the device meets the acceptance criteria" is primarily a series of non-clinical performance tests and adherence to consensus standards.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device and not an AI or diagnostic software, the "acceptance criteria" are not reported as statistical performance metrics like sensitivity or specificity. Instead, they relate to functional and safety attributes. The "reported device performance" refers to the confirmed characteristics after testing.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Intended for use when performing HDR or PDR brachytherapy. |
| Indications for Use | Indicated for use for treating endometrial cancer using HDR or PDR brachytherapy. |
| Biocompatibility | Meets biocompatibility requirements in compliance with ISO 10993-1 and applicable parts. |
| Magnetic Resonance (MR) Safety | MR Safe (without mandrins inserted), complies with ASTM F2503-23. (Previously MR Conditional). |
| **Cleaning, Disinfection, | |
| & Sterilization** | Device components can be effectively sterilized (steam sterilization with common parameters using pre-vacuum sterilization) and reused for the specified number of times. Labelling emphasizes proper sterilization. |
| Human Factors / Usability | Performs well as intended for the intended users, uses, and use environments (validated per IEC 62366). |
| Mechanical Integrity | Undergone formal design verification and design validation testing, demonstrating it performs as intended. |
| Material Composition | Heyman capsules: PEEK; Mandrin: Stainless Steel. Change from previous model (Titanium eliminated from capsules) shown to have no new or increased biocompatibility or safety concerns, and no impact on performance specifications. |
| Features | Simulates classic Heyman packing technique; 4mm, 6mm, 8mm capsules; mandrins stabilize during insertion; CT Compatible; Leak stop channel markers; Reusable; Steam sterilizable; Compatible with all Varian afterloader systems (including BRAVOS); Suitable for patient contact |
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.