(24 days)
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No
The summary does not mention AI, ML, or related terms, nor does it describe functionalities typically associated with AI/ML in medical devices (like image analysis or predictive modeling).
No
The device is used for measuring pressure and detecting endoleaks, which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is intended for "measuring intrasac pressure" and "may be used as an adjunctive tool in the detection of intraoperative endoleaks," which are functions consistent with diagnosing a condition.
No
The device description is not found, but the name "CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System" strongly suggests a hardware component (14F catheter, wireless system) for pressure measurement, not just software.
Based on the provided information, the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and assist in detecting intraoperative endoleaks. This is a measurement taken in vivo (within the living body) during a surgical procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The CardioMEMS system is a device used directly on the patient during surgery to measure a physiological parameter (pressure) within the body. This falls under the category of a medical device used for monitoring or measurement in vivo, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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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
abdominal aortic aneurysm (AAA)
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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§ 870.2855 Implantable Intra-aneurysm Pressure Measurement System.
(a)
Identification. Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.
0
INDICATIONS FOR USE
510(k) Number (if known): K070680
CardioMEMS EndoSure™ s2 14F Wireless AAA Device Name: Pressure Measurement System
Indications for Use:
The CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.
______________________________________________________________________________________________________________________________________________________________________________ Prescription Use X (Part 21 CRF 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE---- CONTINUE ON ANOTHER PAGE IF NEEDED)
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