CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080

• K Number: K070680
• Device Name: CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080
• Manufacturer: CARDIOMEMS, INC.
• Date Cleared: 2007-04-05 ( 24 days)
• Product Code: NQH
• Regulation Number: 870.2855
• Type: Special
• Panel: CV
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

Device Description

Not Found

AI/ML Overview

The provided text describes the Indications for Use for the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System. It states that the device 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.

However, the provided text does not contain any information regarding the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed points requested in your prompt.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes or data provenance
3. Number and qualifications of experts
4. Adjudication method
5. MRMC study details or effect size
6. Standalone performance information
7. Type of ground truth used
8. Training set sample size
9. Method for establishing training set ground truth

To answer your request, I would need a different document, such as a 510(k) summary, clinical study report, or a detailed technical specification that describes the validation and performance testing of the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System.

Regulation Number and Section

§ 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.