(52 days)
Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel. Sentinella 102 may be used intraoperatively if a protective sheath is used. Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.
Sentinella 102 is a portable gamma camera system including a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays. The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.
This is a submission for a 510(k) premarket notification for a medical device called Sentinella 102, a portable gamma camera system. The submission aims to demonstrate substantial equivalence to predicate devices, namely the LumaGEM™ Scintillation Camera (K993813) and Anzai eZ-Scope AN Portable Gamma Camera (K022342).
The core of the submission relies on comparing technical specifications and performance characteristics of the Sentinella 102 with the predicate devices. The document tables these comparisons, highlighting similarities and providing justifications for any differences.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define "acceptance criteria" in a typical quantitative pass/fail format for a clinical study with a specified statistical power. Instead, the "acceptance criteria" in this context are demonstrating substantial equivalence to the predicate devices across various technical specifications and functional aspects. The performance of Sentinella 102 is reported as part of a comparative table against two predicate devices.
The table below summarizes the reported performance of the Sentinella 102 and implicitly its "acceptance criteria" through comparison with predicate devices. The "Justification of Substantially Equivalence" column serves as the explanation for how Sentinella 102 meets the implicit acceptance criteria by being equivalent or improved without compromising safety and effectiveness.
| Feature | Sentinella 102 Performance | Justification of Substantially Equivalence (Acceptance Criteria Met) |
|---|---|---|
| Indications for Use | Mobile gamma camera system for imaging radionuclide distribution in the human body by photon detection, interpreted by qualified personnel. May be used intraoperatively (with sheath) or at patient's bedside/ER/ICU. | Same as predicates. implicitly accepted by matching predicate's indications. |
| Target Population | Same as predicates | Same as predicates. implicitly accepted. |
| Anatomical Sites | Same as predicates | Same as predicates. implicitly accepted. |
| Where Used | Same as predicates | Same as predicates. implicitly accepted. |
| Personnel | Same as predicates | Same as predicates. implicitly accepted. |
| Energy Used/Delivered | Same as predicates | Same as predicates. implicitly accepted. |
| Human Factors | Mobile ergonomic arm and cart, highly adaptable. User autonomous screens with touch-screen. Plug and play. Two screens for simultaneous viewing by surgeon and physician. | Substantially equivalent, allows positioning on interest area. Simultaneous display is an improvement without compromising equivalence. |
| Design | Ergonomic cart, articulated arm with laser positioning (635nm, 4mW, Class IIIR), handheld gamma camera, 2 pinhole and 1 divergent collimator, 2x 19" screens (one touch), PC, mouse, keyboard, software, QC kit. | Laser positioning system helps locate points more precisely (improvement). Laser risk mitigated by low power, labeled warning, and activation only by user, thus not adding appreciable safety concerns. Quality control kit is an improvement. |
| Computer Specifications | PC with Intel Core Duo, 1024 MB RAM, 80 GB HDD, Windows XP. | No substantial difference noted; assumed equivalent in function. |
| Display LCD Specification | Screen size: 19", Resolution: 1280 x 1024. | Equivalent to or better than predicate (LumaGEM 15" screen, 800x600 resolution). |
| Patient Database Management | Stores patient and intervention info, uses standard SQL (PostgreSQL), local HDD with automatic backups, can be LAN-accessed (not configured by default). Based on Microsoft ADO.net. | Structure different but functioning similar to LumaGEM. Allows patient/visit registration and image display. Accessible locally or via LAN. Based on Microsoft ADO.net, equivalent to DAO. Considered equivalent. |
| Arm Vertical Movement | 65 cm | Range greater than LumaGEM (50.8 cm), allowing precise location. Considered an improvement/equivalent. |
| Electrical Safety and EMC | Compliance with EN 60601-1, UL 60601-1, EN 60601-1-2. | Complies with FDA-recognized standards. Considered equivalent regarding safety. |
| Compatibility with Environment | Compliance with DIRECTIVE 2002/96/EC (WEEE). | Same as predicates or environmentally conscious; considered equivalent. |
| Sterility | Not sterile, not to be sterilized by user. Cleaning standard procedure. Can be used intraoperatively with sterile cover. | Same as predicates. implicitly accepted. |
| Planar Imaging / Tomography | Planar: Yes, Tomography: No | Planar imaging capability matches LumaGEM. Anzai offers tomography, but Sentinella 102 still offers planar imaging like LumaGEM, thus equivalence is claimed based on LumaGEM's capabilities. |
| Energy Range | 50-200 keVs | Covers major radionuclides (Tc, Co, Ba, Am, Gd) commonly used in surgery. Deemed equivalent despite numerical differences from predicates (LumaGEM: 30-300 keVs, Anzai: 71-364 keVs). |
| Energy Resolution | 15.9 % | Although numerically larger than predicates (LumaGEM: 5%, Anzai: 7%), the energy window is about 10% per NEMA, resulting in detection of same events as predicates. Considered functionally equivalent. |
| Crystal Technology | Continuous CsI (Na) | Has less electronic noise, better performance in spatial resolution and sensitivity compared to pixelized CZT of predicates. Considered an improvement without compromising equivalence. |
| Intrinsic Spatial Resolution | 1.8 mm | Difference from predicates (2 mm) is not appreciable. Considered equivalent. |
| Spatial Resolution | Green collimator: 5.4mm @ 3cm, 7.3mm @ 5cm; Blue collimator: 8.2mm @ 3cm, 11.1mm @ 5cm; Grey divergent collimator: 6.3mm@ 3cm, 8.2mm @ 5cm. | Values are within the same range as predicates, although dependent on collimator type. Considered equivalent. |
| Sensitivity (cpm/uCi) | Green collimator: ~300 @ 3cm, 110 @ 5cm, 38 @ 10cm; Blue collimator: ~600 @ 3cm, 233 @ 5cm, 87 @ 10cm; Grey divergent collimator: 104 @ 5cm, 72 @ 10cm. | Values are within the same range as predicates, although dependent on collimator type and distance. Considered equivalent. |
| Flood Field Uniformity | 5 % | Equivalent with predicates (LumaGEM: |
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).