(181 days)
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No
The summary describes a pressure measurement system with a sensor, delivery system, and interrogator. There is no mention of AI, ML, or any algorithms that would process data in a way indicative of AI/ML. The performance studies focus on equivalence and functionality, not AI/ML performance metrics.
No
Explanation: The device is described as an "adjunctive tool in the detection of intraoperative endoleaks" and for "monitoring pressure," which indicates a diagnostic or monitoring function rather than directly treating a disease or condition.
Yes
The device is used to measure intrasac pressure during AAA repair and aids in detecting endoleaks, which is a diagnostic function.
No
The device description explicitly lists hardware components: a sensor (implant), a delivery system, and an interrogator.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The CardioMEMS EndoSure system measures pressure within the sac of a repaired aneurysm inside the patient's body (in vivo). It does not analyze specimens taken from the body.
- Intended Use: The intended use is to measure pressure during a surgical procedure (endovascular repair) and assist in detecting endoleaks during that procedure. This is a direct measurement within the body, not an analysis of a sample.
Therefore, the CardioMEMS EndoSure Wireless AAA Pressure Measurement System is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NOH
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
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) sac
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)
Bench and clinical testing confirm that the device functions per its specifications and is substantially equivalent to the predicate device.
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.
CardioMEMS EndoSure™ Wireless AAA Pressure Measurement System
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.
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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
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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:
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.
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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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized caduceus, a symbol often associated with healthcare, with three horizontal lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
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:
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.
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