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 (<24 hours).

Device Description

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. A pressure sensor is mounted at the distal tip of the catheter. The proximal end terminates in a connector. The sensor produces an electrical output signal which varies in direct proportion to the magnitude of sense pressure or sound.

AI/ML Overview

The provided text is a 510(k) summary for the Millar Mikro-Cath Pressure Catheter, Model 825-0101. This type of submission to the FDA is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria through a clinical study.

Therefore, the document does not contain the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, or expert adjudication.

Specifically, the document states:

"No FDA performance standards have been established for the Mikro-Cath Pressure Catheter."
"No additional testing was provided in this submission in order to demonstrate substantial equivalence."
"Millar believes that the Mikro-Cath Pressure Catheter is substantially equivalent to the predicate devices based on the information summarized here: The subject device has identical design and dimensions, and uses similar or identical materials as the device cleared in K093111. The patient contacting materials, mechanical characteristics, and electrical characteristics of the subject device have not changed from the predicate device cleared in K093111."

This means the submission relies on the proven safety and performance of the predicate device (K093111) and asserts that the new device is essentially the same in design, materials, and characteristics, and therefore does not require new testing to establish its safety and effectiveness.

To directly answer your questions based solely on the provided text:

A table of acceptance criteria and the reported device performance: Not available. The submission doesn't report performance against specific acceptance criteria.
Sample sized used for the test set and the data provenance: Not applicable. No new test set data was provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set data or ground truth establishment was conducted for this submission.
Adjudication method for the test set: Not applicable. No new test set data was provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a pressure catheter, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a pressure catheter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No new ground truth for performance evaluation was established for this submission.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a medical device that measures pressure, not a clinical study report for an AI or diagnostic imaging device. Therefore, it does not contain the information requested regarding acceptance criteria and performance data from a study.

Summary

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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

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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)

Type of Use (Select one or both, as applicable)

XPrescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

DEVICE DESCRIPTION

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. A pressure sensor is mounted at the distal tip of the catheter. The proximal end terminates in a connector. The sensor produces

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Image /page/4/Picture/1 description: The image shows the logo for Millar. The logo consists of the word "Millar" in a gray, sans-serif font, positioned to the left of a stylized butterfly or flower-like graphic. The graphic has three petals or wings, colored in shades of orange, yellow, and purple. The overall design is clean and modern.

510(k) Summary

an electrical output signal which varies in direct proportion to the magnitude of sense pressure or sound.

PREDICATE DEVICE IDENTIFICATION

The Mikro-Cath Pressure Catheter is substantially equivalent to the following predicates:

510(k)Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K093111	Mikro-Cath / Millar Instruments, Inc.	✓
K061573	Transpac III Disposable Straight Pressure Transducer (DSPT) / Hospira, Inc.
K830909	Mikro-Tip Catheter Pressure Transducer / Millar Instruments, Inc.

SUMMARY OF NON-CLINICAL AND CLINICAL TESTING

No FDA performance standards have been established for the Mikro-Cath Pressure Catheter. No additional testing was provided in this submission in order to demonstrate substantial equivalence.

EQUIVALENCE TO PREDICATE DEVICES

Millar believes that the Mikro-Cath Pressure Catheter is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has identical design and dimensions, and uses similar or identical materials as the device cleared in K093111. The patient contacting materials, mechanical characteristics, and electrical characteristics of the subject device have not changed from the predicate device cleared in K093111. The subject device has the same or similar indications for use as the devices cleared in K093111, K061573, and K830909.

CONCLUSION

The Mikro-Cath Pressure Catheter is considered substantially equivalent to the predicate devices based on identical technological characteristics. While the subject device has expanded indications (i.e. it may be used to measure intracompartmental and airway pressure), the subject device does not raise new issues of safety or efficacy compared to the predicate devices.

Regulation Number and Section

§ 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).