(72 days)
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No
The 510(k) summary describes the addition of a sterilization option for an existing medical device. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance study focuses on sterilization validation, not algorithmic performance.
No
This device is a sterilization system for medical equipment, not a device used for treating medical conditions.
No
The device is described as a sterilization option for components of a medical system, not as a tool for diagnosing medical conditions.
No
The device description clearly states it is an addition of a sterilization option for components of a physical system (StealthStation™ System), indicating it is related to hardware reprocessing, not a standalone software device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- The description focuses on sterilization: The core function described is the addition of a sterilization option for components of a previously cleared system. Sterilization is a process applied to medical devices to make them safe for use, not a diagnostic test performed on biological samples.
- No mention of diagnostic testing: There is no indication that this device is used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- The validation is for sterilization: The performance study described is a validation of the sterilization process, not a study of diagnostic accuracy.
Therefore, based on the information provided, this device falls under the category of a medical device used for sterilization, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission. This sterilization option was validated by an independent laboratory in accordance with the AAMI TIR No. 12-1994, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
UCT 25 1996
SIO(K)
Summary of Safety and Effectiveness
StealthStation™ System Sterilization
- 】. Company: Surgical Navigation Technologies 530 Compton St. Broomfield, CO 80020 (303) 439-9709
- Product Name: StealthStation™ System II.
- III. This submission describes the addition of the STERRAD®* Sterilization System as a sterilization option for certain components of the StealthStation™ System which was cleared in a previous 510(k) submission. This sterilization option was validated by an independent laboratory in accordance with the AAMI TIR No. 12-1994, Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers.
*STERRAD is a registered trademark of Advanced Sterilization Products, a Division of Johnson and Johnson Medical, Inc.