(96 days)
No
The summary describes a pressure catheter and its intended use for measuring hemodynamic pressures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies mentioned are standard for pressure measurement devices.
No
The device is described as being used for "medical research and diagnostic purposes" and to "measure hemodynamic cardiac pressures." Its function is to provide information for understanding cardiac health, not to treat or alleviate a medical condition.
Yes
The intended use explicitly states, "The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes." It further clarifies that it is used "to measure hemodynamic cardiac pressures in the human body to allow physicians to better understand cardiac health."
No
The device description explicitly states it is a "cardiovascular catheter transducer," which is a physical hardware component.
Based on the provided information, the Mikro-Cath is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Mikro-Cath's Intended Use: The Mikro-Cath is explicitly described as a device used to measure hemodynamic cardiac pressures in the human body. It is a minimally invasive device that is inserted into the cardiovascular system.
- Method of Use: The device directly interacts with the patient's internal environment (cardiovascular system) to obtain measurements. This is an in vivo application, not in vitro.
Therefore, the Mikro-Cath falls under the category of an invasive medical device used for diagnostic purposes within the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Millar Mikro-Cath will be used to measure hemodynamic cardiac pressures in the human body to allow physicians to better understand cardiovascular health. It will be used as a minimally invasive device under short term limited body contact
§ 870.2870 Catheter tip pressure transducer.
(a)
Identification. A catheter tip pressure transducer is a device incorporated into the distal end of a catheter. When placed in the bloodstream, its mechanical or electrical properties change in relation to changes in blood pressure. These changes are transmitted to accessory equipment for processing.(b)
Classification. Class II (performance standards).
0
K093111 pg 1 of 3
THE HEART QF 5EN5OR INNGVATION
Image /page/0/Picture/1 description: The image shows the logo for Millar Instruments. The logo consists of the word "Millar" in a bold, serif font, with the word "INSTRUMENTS" in a smaller, sans-serif font underneath. To the right of the word "Millar" is a small graphic of a mountain range inside of a grid.
JAN - 5 2010
2.0 510K Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.
The assigned 510(k) number is: K09311
Date: 12/02/2009
Organization Number: 211571
Establishment: Millar Instruments, Inc.
Owner Name: Huntly Millar
Address: 6001-A Gulf Freeway, Houston, TX 77023
Phone: 832-667-7000
Fax: 832-667-7001
Registration Number: 1625382
Operations: Specification Developer and Manufacturer of Mikro-Tip Catheter Transducers and Accessories for Clinical and Research purposes.
Contact: Fatma Ali, Director of Regulatory Affairs and Quality Assurance
Name of the Devices: Mikro-Cath
Common Name: Mikro-Cath
Classification Name: Transducer, Pressure, Catheter Tip
Regulation: Catheter Tip Pressure Transducer (21 CFR 870-2870)
Product Code : DXO
Device Description: The Mikro-Cath is a disposable/single use, sterile cardiovascular pressure catheter transducer for monitoring and measuring pressure anywhere in the cardiovascular system with an appropriately sized guide catheter.
6001 - 6001 Freeray Honton, Tecas 77023-5417 Peaca 832.667.700 Fax 82.667.7007 Hithin the USA 800.669.2343 weeks.com
1
K093111 pg 2 of 3
Image /page/1/Picture/1 description: The image shows the logo for Millar Instruments. The logo consists of the word "Millar" in large, bold letters, with the word "INSTRUMENTS" in smaller letters underneath. There is a small graphic above and to the right of the word "Millar". The logo is simple and professional.
Intended Use: Millar Mikro-Cath will be used to measure hemodynamic cardiac pressures in the human body to allow physicians to better understand cardiovascular health. It will be used as a minimally invasive device under short term limited body contact