(28 days)
Indicated for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue. It does not make a diagnosis and is not an endoscopic tool. Not for pediatric use.
superDimension is proposing that the inReach™ Planning Laptop, with its current software be approved to be used either as a stand-alone for performing bronchoscopy planning, as currently approved (K081379, June 11, 2008) or for CT-Viewing, or with the other system components in places outside of the endoscopy room.
There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved.
This 510(k) summary explains that the submission K062386 is for a minor modification to an already approved device (inReach™ Planning Laptop, K081379). The proposed modification is to allow the device to be used as a stand-alone unit for bronchoscopy planning and CT-viewing, or with other system components, outside of the endoscopy room.
Crucially, the document states: "There are no modifications proposed to the software, firmware, firmware, product design or specifications, or manufacturing processes as currently approved." and "No changes are being made to the hardware or intended use, or technological characteristics of the current marketed device."
Therefore, based on the provided text, there are no new acceptance criteria or new studies conducted to prove the device meets new criteria because the device itself and its performance characteristics are not changing. The provided text indicates that the original performance data and studies from the predicate device (K081379) are considered sufficient.
Here's a breakdown of the requested information, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no new modifications to the software, hardware, or performance are being made, no new acceptance criteria or performance data for this specific 510(k) submission (K062386) are presented. The document relies on the previous approval (K081379).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
2. Sample Size for the Test Set and Data Provenance:
No new test set was used for this submission (K062386). The changes are administrative regarding usage context, not performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no new test set was used.
4. Adjudication Method for the Test Set:
Not applicable, as no new test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted for this submission (K062386). The document explicitly states: "Clinical tests were not required to validate the changes to the inReach System to include the Planning Laptop."
6. Standalone Performance Study:
No new standalone performance study was conducted for this submission (K062386). The device's performance, whether standalone or integrated, is considered unchanged from its previous approval.
7. Type of Ground Truth Used:
Not applicable, as no new performance studies were conducted for this submission.
8. Sample Size for the Training Set:
Not applicable, as no new training was performed for the device's algorithmic components (since the software is unchanged).
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no new training was performed for the device's algorithmic components (since the software is unchanged).
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).