MIKRO-CATH, MODEL 825-0101
Device Facts
| Record ID | K093111 |
|---|---|
| Device Name | MIKRO-CATH, MODEL 825-0101 |
| Applicant | Millar Instruments, Inc. |
| Product Code | DXO · Cardiovascular |
| Decision Date | Jan 5, 2010 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 870.2870 |
| Device Class | Class 2 |
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 <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
Device Story
Mikro-Cath is a disposable, sterile, catheter-tip pressure transducer; measures hemodynamic cardiac pressures within the cardiovascular system. Device inserted via femoral artery using a guiding catheter; operated by physicians in clinical settings. Transducer converts pressure signals into electrical data; processed by external control units (e.g., PCU-2000) and extension cables. Output displayed for physician interpretation to assess cardiovascular health. Benefits include minimally invasive, real-time pressure monitoring for diagnostic and research applications.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including biocompatibility, sterility, electromagnetic compatibility (EMC), and packaging/accelerated aging studies conducted in accordance with recognized standards (AAMI ANSI BP22, ISO 10993-1, ISO 11135-1, EN 60601-1-2, ASTM F 1980, ISO 11607).
Technological Characteristics
Disposable, sterile, catheter-tip pressure transducer. Materials and design equivalent to predicate VPM-10. Performance testing per AAMI ANSI BP22:1994 (R) 2006. Sterilization per ISO 11135-1:2007. EMC per EN 60601-1-2:2007. Packaging per ASTM F 1980 and ISO 11607. Connects to external control units (PCU-2000) via extension cables.
Indications for Use
Indicated for medical research and diagnostic purposes to measure hemodynamic cardiac pressures in humans. Used as a minimally invasive device for short-term (<24 hours) body contact, typically via the femoral artery with a guiding catheter.
Regulatory Classification
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.
Predicate Devices
- Millar Cardiovascular Mikro Tip Catheter Transducer Model SPC-330A (K792177)
- Millar Angiographic Catheter Model SPC-454D (K952773)
- Millar VPM-10 (Codman & Shurtleff Inc. Microsensor Intracranial Pressure Transducer) (K914479)
Reference Devices
- Millar Device Model PCU-2000 (K013205)
Related Devices
- K163376 — Mikro-Cath Pressure Catheter · Millar, Inc. · Mar 10, 2017
- K993694 — MIKRO-TIP ANGIOGRAPHIC CATHETER · Millar Instruments, Inc. · Mar 1, 2000
- K061573 — TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT · Hospira, Inc. · Sep 19, 2006
- K152472 — Disposable Pressure Transducer · Zhejiang Haisheng Medical Device Co., Ltd. · Oct 31, 2016
- K133587 — PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 · St. Jude Medical Systems AB · Dec 20, 2013
Submission Summary (Full Text)
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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
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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 <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
Comparison to the Predicate Device(s): Millar Mikro-Cath is substantially equivalent in performance and intended use to Millar Cardiovascular Mikro Tip Catheter Transducer Model SPC-330A approved device (reference Millar 510K# K792177). Mikro-Cath is a single
use sterile device. Same accessories of the predicate devices will be used for Mikro-Cath.
- M.I. P/N: 880-0129, Model PCU-2000 Control Unit with Patient O Isolation
- M.I. P/N: 850-1308, Model TEC-10D Extension Cable to TC-510 or O TCB-500
- M.I. P/N: 850-5103, Model PEC-4D Extension Cable to PCU-2000 o
- M.I. P/N: 850-5090, Model PEC-10D Extension Cable to PCU-2000 O All accessories are previously approved with Millar Device Model PCU-2000( reference 510K#: K013205)
- Millar Mikro-Cath is substantially equivalent in packaging and sterilization to Millar Angiographic Catheter single use sterile device. Model SPC-454D approved device under Millar 510K# K952773
- Millar Mikro-Cath is substantially equivalent in design and material with Millar VPM-10 (Codman & Shurtleff Inc. Microsensor Intracranial Pressure Transducer 510K # 914479.
## Discussion of Non-clinical Tests performed:
- Biocompatibility, sterility, Electromagnetic Compatibility (EMC), -Packaging Accelerating/Aging and performance testing are conducted in accordance with the applicable standards listed below for the type of testing.
- O Performance testing in accordance with AAMI ANSI BP22:1994 (R) 2006
- Biocompatibility testing in accordance with ISO 10993-1:2003 O
- Sterility validation testing in accordance with ISO 11135-1:2007 O
- EMC testing in accordance with EN 60601-1-2:2007 O
- Packaging Accelerating/Aging testing in accordance with ASTM O F 1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) and ISO 11607 (Packaging for Terminally Sterilized Medical Devices).
6001 - 6 all Freeway Houston, Texas 77023-5417 Phone 832.667.7001 Wahlo the USA 809.669.234.3
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Image /page/2/Picture/0 description: The image shows the logo for Millar Instruments. The logo consists of the word "Millar" in a bold, sans-serif font, with the word "INSTRUMENTS" in a smaller font size underneath. To the right of the word "Millar" is a small, square graphic that appears to be a stylized representation of a building or structure.
Image /page/2/Picture/1 description: The image contains handwritten text that appears to be a combination of letters and numbers. On the left side, there is a sequence that looks like "K093111". To the right of this sequence, there is another set of characters that reads "pg 305". The handwriting style is casual and somewhat uneven, suggesting it may be a quick note or label.
AT THE HEART OF SENSOR INNOVATION
#### . Conclusion:
The Millar Mikro-Cath has the same intended use as the approved devices previously marketed by Millar for Cardiovascular monitoring applications. marketed by Minar for Sarates the applicable standard AAMI ANSIBP22:1994 (R) 2006 The performance tooling and therefore maintain the same levels of safety and
effectiveness as the predicate devices currently in commercial distribution.
6001-1 Sud Foreay Housters, Te23-37223-5417 Phone S22.667.7000 Fax 32.667.7001 Withlor the USA 300.669.2343 Wilsonitations.com
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN - 5 2010
Millar Instruments, Inc. c/o Ms. Fatma Ali Director of Regulatory Affairs and Quality Assurance 6001-A Gulf Freeway Houston, TX 77023
DEPARTMENT OF HEALTH & HUMAN SERVICES
Re: K093111
Trade/Device Name: Mikro-Cath, Model 825-0101 Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II (two) Product Code: DXO Dated: December 2, 2009 Received: December 8, 2009
Dear Ms. Ali:
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 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.
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Page 2 - Ms. Fatma Ali
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
W.M.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the text "KOO13111" in a handwritten style. The characters are somewhat uneven and have a casual appearance. The text appears to be a code or identifier.
Image /page/5/Picture/1 description: The image shows the logo for Millar Instruments. The logo consists of the word "Millar" in a stylized font, with the word "INSTRUMENTS" in smaller letters underneath. There is also a small graphic to the right of the word "Millar".
### Indications for Use Statement 1.0
The Mikro-Cath is a single-use cardiovascular catheter intended to be used for medical research and diagnostic purposes. The catheter is used to measure hemodynamic cardiac pressures in the hurnan body to allow physicians to better understand cardiac health. The catheter would be used as a minimally invasive device under short term limited body contact <24 hours. The typical application will be through the femoral artery with the use of an additional guiding catheter.
| Prescription Use: | X |
|-------------------|---|
|-------------------|---|
and/or
Over-the-Counter Use: _
(Part 21CFR801 Subpart C)
A I T H E H E A R T O F 5 E N 5 O R I N K O V A T I O K *
(Part 21CFR801 Subpart D)
W.M.T.
510(k)
500 1 1 600 Freevery Houston, Terry 77023-5417 Phone 832.667.7001 Kitch the USA 800.669.2343 9488.2343 1000 100
