(99 days)
Not Found
No
The document describes a pressure catheter with a sensor that produces an electrical output signal directly proportional to pressure. There is no mention of AI, ML, or any processing of the signal beyond direct measurement.
No
The device is intended for "medical research and diagnostic purposes" and "to measure cardiovascular, intracompartmental, and airway pressures," not to treat a condition.
Yes
The product explicitly states its intended use for "diagnostic purposes" and indicates it "measure[s] cardiovascular, intracompartmental, and airway pressures in the human body," which are diagnostic functions.
No
The device description explicitly states it is a "single-use catheter" with a "pressure sensor mounted at the distal tip" and a "proximal end terminates in a connector," indicating it is a physical hardware device, not software only.
Based on the provided text, the Mikro-Cath Pressure Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
- Mikro-Cath Function: The description clearly states the Mikro-Cath is a catheter intended to measure pressures in the human body (cardiovascular, intracompartmental, and airway pressures). This is an in vivo measurement, meaning it's performed inside the body.
Therefore, the Mikro-Cath Pressure Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is 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).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 10, 2017
Millar, Inc. % Allison Komiyama Principal Consultant Acknowledge Regulatory Strategies 2834 Hawthorn St. San Diego, California 92104
Re: K163376
Trade/Device Name: Mikro-Cath Pressure Catheter, Model 825-0101 Regulation Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: Class II Product Code: DXO Dated: February 6, 2017 Received: February 9, 2017
Dear Allison Komiyama:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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.
Mude Jellman
for
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K163376
Device Name
Mikro-Cath Pressure Catheter, Model 825-0101
Indications for Use (Describe)
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short term limited body contact ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda. hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/1 description: The image shows the word "Millar" in a light gray sans-serif font. To the right of the word is a stylized butterfly or flower-like graphic with three petals or wings. The top petal is a gradient of orange and yellow, the middle petal is a gradient of purple and pink, and the bottom petal is a gradient of purple and pink. The overall design is clean and modern.
510(k) Summary
510(k) Summary K163376
DATE PREPARED
February 6, 2017
MANUFACTURER AND 510(k) OWNER
Millar, Inc. 6001-A Gulf Freeway, Houston, TX 77023, USA Telephone: (832) 667-7000 (713) 714-8498 Fax: Official Contact: Jaqueline Jean-Baptiste, Director of RA/QA
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 Email: akomiyama@acknowledge-rs.com
PROPRIETARY NAME OF SUBJECT DEVICE
Mikro-Cath Pressure Catheter, Model 825-0101
COMMON NAME Transducer, Pressure, Catheter Tip
DEVICE CLASSIFICATION
Catheter tip pressure transducer (21 CFR 870.2870, Product Code DXO, Class II)
PREMARKET REVIEW
ODE/DCD/CDDB Cardiovascular Panel
INDICATIONS FOR USE
The Mikro-Cath Pressure Catheter is a single-use catheter intended to be used for medical research and diagnostic purposes. The catheter is indicated to measure cardiovascular, intracompartmental, and airway pressures in the human body. The catheter is used as a minimally invasive device under short term limited body contact (