(96 days)
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.
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.
Here's an analysis of the provided text regarding the Mikro-Cath device, outlining acceptance criteria and studies:
I. Acceptance Criteria and Reported Device Performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized standards. It does not explicitly state numerical acceptance criteria for a single performance metric with a corresponding reported device performance value in a table format. Instead, it indicates that the device's performance "maintain[s] the same levels of safety and effectiveness as the predicate devices currently in commercial distribution" by complying with applicable standards.
Therefore, the table below reflects this approach:
| Acceptance Criterion (Standard) | Reported Device Performance (Compliance Claim) |
|---|---|
| Performance Testing (AAMI ANSI BP22:1994 (R) 2006) | "The performance [tooling] and therefore maintain the same levels of safety and effectiveness as the predicate devices currently in commercial distribution." (Implicitly, the device meets the performance requirements of this standard.) |
| Biocompatibility (ISO 10993-1:2003) | "Biocompatibility testing in accordance with ISO 10993-1:2003" (Implies compliance with the standard.) |
| Sterility Validation (ISO 11135-1:2007) | "Sterility validation testing in accordance with ISO 11135-1:2007" (Implies compliance with the standard.) |
| Electromagnetic Compatibility (EN 60601-1-2:2007) | "EMC testing in accordance with EN 60601-1-2:2007" (Implies compliance with the standard.) |
| Packaging Accelerating/Aging (ASTM F 1980 & ISO 11607) | "Packaging Accelerating/Aging testing in accordance with ASTM F 1980 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) and ISO 11607 (Packaging for Terminally Sterilized Medical Devices)." (Implies compliance with the standards.) |
II. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical tests (e.g., biocompatibility, sterility, EMC, packaging, performance testing to AAMI ANSI BP22). It does not mention specific clinical trials or a test set of patient data in the context of device performance to measure hemodynamic cardiac pressures. The performance testing refers to compliance with safety and effectiveness standards, likely through bench testing, rather than a clinical dataset.
Therefore, this information is not available in the provided text.
III. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical test set of patient data is described, there is no mention of experts establishing ground truth for such a set. The expertise involved would be in conducting and interpreting the non-clinical tests according to the cited standards.
Therefore, this information is not available in the provided text.
IV. Adjudication Method for the Test Set
As no clinical test set requiring adjudication is described, this information is not applicable and not available in the provided text.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study, which typically evaluates human reader performance with and without AI assistance, is not mentioned in the provided document. The device in question is a physical catheter transducer, not an AI or imaging diagnostic tool.
Therefore, this information is not applicable and not available in the provided text.
VI. Standalone (Algorithm Only) Performance Study
The Mikro-Cath is a physical medical device, specifically a catheter tip pressure transducer. It is not an algorithm or AI system. Therefore, a standalone algorithm-only performance study is not applicable to this device.
Therefore, this information is not applicable and not available in the provided text.
VII. Type of Ground Truth Used
For the non-clinical performance testing (e.g., to AAMI ANSI BP22), the ground truth would be the physical measurements and specifications defined by the standard itself, obtained through laboratory or bench testing. For biocompatibility, it would be the results of in vitro and in vivo biological tests as defined by ISO 10993. For sterility, it would be the microbiological test results demonstrating a sterility assurance level as defined by ISO 11135.
There is no mention of ground truth based on expert consensus, pathology, or outcomes data in the context of clinical performance, as no clinical study is described.
VIII. Sample Size for the Training Set
The device is a physical catheter, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable. The manufacturing and design process would follow established engineering principles and quality systems rather than data-driven training.
Therefore, this information is not applicable and not available in the provided text.
IX. How the Ground Truth for the Training Set Was Established
As the device is not an AI/ML model, the concept of establishing ground truth for a training set is not applicable.
Therefore, this information is not applicable and not available in the provided 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
§ 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).