The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair. It may be used as an adjunctive tool in the detection of intraoperative endoleaks.

Device Description

The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure Wireless AAA Pressure Measurement System includes:

The CardioMEMS EndoSure Sensor with radio-opaque markings (implant)
A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure Sensor)
CardioMEMS EndoSure Interrogator

AI/ML Overview

This 510(k) summary for the CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System primarily focuses on its equivalence to a predicate device and does not contain detailed acceptance criteria or a dedicated study section with the specifics requested. The document emphasizes safety and general performance.

However, based on the provided text, here's an attempt to extract and infer the information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	"Testing has shown the EndoSure Wireless AAA Pressure Measurement System to be biocompatible..."
MRI Safety	"...MRI safe..."
Compatibility with ultrasound	"...compatible with ultrasound..."
Compatibility with pacemakers	"...compatible with... pacemakers..."
Compatibility with defibrillators	"...compatible with... defibrillators."
Functionality per specifications	"Bench and clinical testing confirm that the device functions per its specifications..."
Substantial Equivalence to Predicate Device	"...is substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated. The document mentions "Bench and clinical testing" but does not quantify the number of cases or patients in these tests.
Data Provenance: Not explicitly stated beyond "Bench and clinical testing." There is no mention of country of origin or whether studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not applicable or not stated. The performance data section does not describe the establishment of a "ground truth" using expert consensus for the device's primary function of pressure measurement. The device directly measures pressure. For substantial equivalence, it's compared against a predicate, which implies its measurements are compared against an established method or device, not necessarily expert interpretation in the typical sense of diagnostic imaging.
Qualifications of Experts: Not applicable or not stated.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not stated. The context of adjudication, typically seen in studies where multiple readers interpret data and discrepancies need resolution, is not present here. The device's primary function is direct pressure measurement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned. The device directly measures pressure, rather than providing interpretative images or data that human readers would then analyze. The mention of its use as an "adjunctive tool in the detection of intraoperative endoleaks" could imply human interpretation, but no MRMC study details are provided.
Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study involving human readers and AI assistance is described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, implicitly. The device itself is described as measuring pressure and displaying data. The statement "Bench and clinical testing confirm that the device functions per its specifications" suggests standalone performance was evaluated. The device's "Technological Characteristics Summary" details how it remotely interrogates the sensor, records resonant frequency, and converts it to a pressure measurement, implying an automated, standalone process for acquiring the primary data.

7. The Type of Ground Truth Used

Type of Ground Truth: For the primary function of pressure measurement, the ground truth would inherently be established by direct comparison to a known, calibrated pressure standard (for bench testing) and/or comparison to other established clinical pressure measurement methods (for clinical testing). The text states it "functions per its specifications and is substantially equivalent to the predicate device," implying the predicate device's performance serves as a reference.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable or not stated. This device is a pressure sensor system, not a machine learning or AI algorithm that typically requires a discrete training set. Its functionality is based on physical principles (LC circuit, resonant frequency) rather than learned patterns from data.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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510(k) Summary

A. Submitter's Information

Submitter's Name: CardioMEMS. Inc. Submitter's Address: 75 Fifth St, NW Suite 440 Atlanta, GA 30308

OCT 1 2 2006

Contact Person:	Carol Vierling
Telephone Number:	(404) 920-6712
Fax Number:	(404) 885-9974

Date of Preparation: October 3, 2006

B. Trade Name: CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System
Common Name: Pressure Sensor System

Classification Name: Implantable Intra-aneurysm Pressure Measurement System

C. Predicate Devices: CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System

D. Device Description
The CardioMEMS EndoSure Wireless AAA Pressure Measurement System is designed to monitor pressure within the sac of a repaired aneurysm during endovascular stent graft placement. The CardioMEMS EndoSure Wireless AAA Pressure Measurement System includes:
The CardioMEMS EndoSure Sensor with radio-opaque markings (implant) -
A sterile Delivery System (pre-loaded with the CardioMEMS EndoSure | Sensor)
। CardioMEMS EndoSure Interrogator

E. Intended Use:

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F. Technological Characteristics Summary

The EndoSure Sensor is implanted in the AAA sac during the time of stent graft deployment and is left in place in the excluded portion of the aneurysm as a permanent implant. The main body of the EndoSure Sensor is manufactured from fused silica coated in silicone. A nitinol basket surrounds the EndoSure Sensor body. Radiopaque marker bands at each end of the EndoSure Sensor body allow visualization of the device under fluoroscopy.

Coils inside the EndoSure Sensor are aligned in such a way to form a capacitor (defined as an electric circuit element used to store charge temporarily, consisting in general of two metallic plates separated and insulated from each other by a dielectric). At the same time, two metal spirals form an inductor component of a miniature electrical circuit (LC circuit). It is possible to magnetically couple to the EndoSure Sensor and induce a current in the circuit. This allows for wireless communication with the device and the ability to operate it without the need for an internal source of energy such as a battery. Thus, if the EndoSure Sensor is located within the sac of an aortic aneurysm, the pressure within the sac can be determined in a simple, noninvasive procedure by remotely interrogating the EndoSure Sensor, recording the resonant frequency and converting this value to a pressure measurement.

The EndoSure Sensor is interrogated using the antenna of the EndoSure Interrogator. The antenna is placed over the patient's abdomen in the area of the EndoSure Sensor. Once the signal is acquired, a pressure waveform and numerical pressure data are displayed on the touch-screen. A printout of the data and waveform is generated from a thermal printer which is incorporated in the EndoSure Interrogator.

G. Performance Data

Testing has shown the EndoSure Wireless AAA Pressure Measurement System to be biocompatible, MRI safe, as well as compatible with ultrasound, pacemakers and defibrillators. Bench and clinical testing confirm that the device functions per its specifications and is substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 2 2006

Ms. Carol Vierling Vice President, Regulatory and Clinical Affairs Cardiomems, Inc. 75 Fifth St., NW, Suite 440 Atlanta, GA 30308

Re: K061046

Trade/Device Name: CardioMEMS EndoSure AAA Pressure Measurement System Regulation Number: 21 CFR 870.2855 Regulation Name: Implantable Aneurysm Pressure Sensor Regulatory Class: Class II (Two) Product Code: NOH Dated: August 2, 2006 Received: August 4, 2006

Dear Ms. Vierling:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Carol Vierling

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Donna R. Mc James

ABram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K061046

Device Name:

CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System

Indications for Use:

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------------------------------------------------------------------------------------------------------------------------------------------IF NEEDED)

er R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number

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.