(239 days)
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No
The summary explicitly states the device is a "data gathering device" and does not mention any AI, ML, or advanced image processing techniques beyond basic tomographic image reconstruction. There is no mention of training or test sets for AI/ML models.
No
The device is described as a "data gathering device" that allows simulators to process data into tomographic images and is explicitly stated as "not a diagnostic tool." There is no mention of it being used for treatment or therapeutic purposes.
No
The text explicitly states: "The SLS-CT is not a diagnostic tool."
No
The description explicitly states the SLS-CT System is a "passive add-on option" to existing hardware (Radiotherapy Simulators) and is a "data gathering device," implying it includes hardware components to interface with and gather data from the simulator.
Based on the provided information, the SLS-CT is not an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" and "Device Description" sections both explicitly state: "The SLS-CT is not a diagnostic tool."
- Function: The device is described as a "data gathering device" that allows existing Radiographic Simulators to process data into tomographic images. Its role is to facilitate image creation, not to perform a diagnostic test on a biological sample.
- Context: It's an add-on to Radiotherapy Simulators, which are used for planning radiation treatment, not for in vitro diagnostic testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SLS-CT does not fit this description.
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
The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
Mentions image processing
The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images.
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)
Modular testing of the hardware and software has been performed to the specifications. A hazard analysis of the hardware and software was performed by both Philips Medical Systems and BIR with safeguards instituted. Stringent software and hardware design and quality assurance procedures were adhered to. Stringent system verification and validation testing was performed per documented procedures during two Beta tests, with Beta Test 1 being performed at Philips Medical Systems and Beta Test 2 in a clinical setting. In-house verification and validation was performed by BIR.
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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§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
"SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION"
for the BIO-IMAGING RESEARCH SLS-CT System 510(k) PREMARKET NOTIFICATION
"This 510(k) Summary of Safety and Effectiveness Information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990."
Ronald Baker
Donald Barham Regulatory Affairs Manager Bio-Imaging Research, Inc. 425 Barclay Blvd Lincolnshire, IL 60069
2/26/96
Date
The SLS-CT System manufactured by Bio-Imaging Research (BIR) is a passive add-on option to Philips Medical Systems, Inc.'s existing, legally marketed, Radiotherapy Simulators. The SLS-CT does not control the Simulator x-ray and mechanical functions. The SLS-CT is a data gathering device that allows the Radiographic Simulators to process data into tomographic images. The SLS-CT is not a diagnostic tool.
The SLS-CT System complies with voluntary standards IEC601, UL 2601, and CSA 601. The SLS-CT software was developed utilizing the IEEE Software Engineering Standard as a model.
System and software requirements specifications were developed in concert with Philips Medical Systems. Modular testing of the hardware and software has been performed to the specifications. A hazard analysis of the hardware and software was performed by both Philips Medical Systems and BIR with safeguards instituted. Stringent software and hardware design and quality assurance procedures were adhered to. Stringent system verification and validation testing was performed per documented procedures during two Beta tests, with Beta Test 1 being performed at Philips Medical Systems and Beta Test 2 in a clinical setting. In-house verification and validation was performed by BIR. Operator, System Validation and Maintenance, and Service Manuals, along with Customer Acceptance Test Schedule documents provide the user with clear and concise information thus ensuring the safe and effective operation of the system.
BIR's manufacturing facility strictly adheres to and believes in the FDA's Good Manufacturing Practices. BIR's Quality System is certified to ISO9001 for the design, manufacturing, and service of medical imaging equipment.