(872 days)
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No
The summary describes a physical medical device (a dilating sheath) and its intended use for tissue dilation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No
The device is described as a "Flexible Dilating Sheath" intended for dilation of tissue, which is a procedural tool rather than a device for treating a disease or condition.
No
The device is described as a "Flexible Dilating Sheath" intended for "percutaneous dilation of tissue." Dilation is a therapeutic procedure, not a diagnostic one. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description explicitly states it is a "Flexible Dilating Sheath" and describes its physical components and materials, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Description: The description clearly states the device is a "Flexible Dilating Sheath" intended for "percutaneous dilation of tissue surrounding indwelling catheters or foreign objects." This is a device used within the body to physically manipulate tissue.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or any diagnostic function based on laboratory analysis.
This device is a surgical or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
"intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects."
Product codes (comma separated list FDA assigned to the subject device)
74DRE
Device Description
"The Flexible Dilating Sheath is intended for percutaneous dilation of tissue surrounding indwelling catheters or foreign objects. The device is supplied sterile and is intended for one-time use. Reasonable assurance of biocompatibility of the materials comprising the Flexible Dilating Sheath is provided by their established history of use in medical product manufacturing. Results of toxicity testing also provide reasonable assurance of biocompatibility, with the results showing the material to meet the test requirements"
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.
"predicate dilating sheaths manufactured by Cook Pacemaker Corporation."
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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§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
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