CARDIA-CATH by MILLAR INSTRUMENTS, INC.

The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.

AI/ML Overview

The medical device in question is the Millar Instruments Cardia-Cath, a Pressure-Volume (PV) Catheter Transducer. The provided text outlines the acceptance criteria and corresponding study results for this device, primarily focusing on verification testing, biocompatibility, sterility, and accelerated aging, demonstrating its substantial equivalence to a legally marketed predicate device (Millar model SPC-550).

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Verification Testing (BP-22)	- Catheters must meet the same specifications as the legally marketed predicate device as defined in its IFU. - Compliance with BP-22 standard requirements. - Temperature Error Band at Zero Pressure: ≤ 3.24 mmHg (for predicate device). - Sensitivity Error Band: ≤ 3.16% (for predicate device).	- All tested catheters met the testing requirements and complied with BP-22 standard requirements. - Deviation 1: Temperature Error Band at Zero Pressure relaxed to 3.5 mmHg. - Deviation 2: Sensitivity Error Band relaxed to 3.5%. - The modified device IFU includes the new (relaxed) values to ensure end-users obtain the same level of data accuracy.
Transportation Testing	- Compliance with ASTM D4169-08 standards for fully packaged finished product. - Samples must pass all tests including bubble leak and packaging integrity. - No impact on device functionality (safety and effectiveness) after transportation testing.	- Samples passed all tests including bubble leak test and packaging integrity, as per DDL report No: 1009057 Rev. A. - Functionality testing (Millar reference VRP-2010-0423-01 VAL-180) confirmed no impact on device functionality, safety, and effectiveness.
Biocompatibility (ISO 10993-1)	- Requirements for External communicating device, circulating blood, contact duration A-Limited (<24hrs): Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Systemic toxicity (acute), and Haemocompatibility. - Statistical similarity to the predicate device (Model SPC-550).	- Nelson Labs analysis determined that the Cardia-Cath (modified device) was statistically similar, and therefore substantially equivalent, to the predicate (legally marketed) device, Model SPC-550 for all tests: Modified ASTM Hemolysis (Direct Contact Method), Partial Thromboplastin time (PTT) test, MEM Elution, Complement Activation Test, ISO Acute Systemic Injection Test, Rabbit Pyrogen Test (Material Mediated)- ISO, ISO Intracutaneous Reactivity Test, Thrombogenicity Study in Dogs ISO, ISO Guinea Pig Maximization Sensitization Test.
Sterility	- Method: EtO-Overkill, validated per ANSI/AAMI ISO 11135. - Sterility Assurance Level (SAL): ≥ 10⁻⁶. - Pyrogen Free: Limulus Amebocyte Lysate test (LAL) should not show significant interference with lysate gel formation. - Residuals: Ethylene Oxide (EO) < 10mg, Ethylene Chlorohydrin < 5mg (per ANSI/AAMI/ISO 10993-7). - EtO breathable materials (Tyvek) for sterilant penetration and maintenance of sterility.	- Sterility method EtO-Overkill validated per ANSI/AAMI ISO 11135. - Actual SAL: 3.33 times more than 10⁻⁶ (meeting the requirement). - LAL test showed no significant interference with lysate gel formation, indicating pyrogen-free status. - Maximum EO residuals: 0.3096mg (<10mg). - Maximum Ethylene Chlorohydrin residuals: 0.1079mg (<5mg). - Packaging uses EtO Breathable materials (Tyvek).
Accelerated Aging	- 2-year accelerated aging test per ASTM F1980-07. - Device must pass test criteria after accelerated aging. - Substantial equivalence to the predicate device (Model SPC-550) after aging.	- A 2-year accelerated aging test was performed by DDL. - The tested samples were inspected by Millar, and the Cardia-Cath passed the test criteria and maintained substantial equivalence to the predicate device, Model SPC-550.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each test set (e.g., number of catheters tested for BP-22, transportation, or accelerated aging, or the number of samples for biocompatibility). It mentions:

"Selected samples of the modified catheters were tested to the same specification..." for verification testing.
"Samples" were tested for transportation testing.
"Samples of the legally marketed device and the modified device were sent to Nelson Laboratories" for biocompatibility.
The accelerated aging test was performed on "the actual modified device. Cardia-Cath."

Data Provenance: The studies appear to be prospective verification and validation tests conducted by Millar Instruments, DDL (for transportation and accelerated aging), and Nelson Labs (for biocompatibility). The testing was for a modified device (Cardia-Cath) to establish its substantial equivalence to a legally marketed predicate device (Millar model SPC-550). The country of origin of the data is implied to be primarily the United States, given the involved organizations (Millar Instruments in Houston, TX; Nelson Labs; DDL; FDA submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of information is generally not applicable to the non-clinical bench and lab testing described in the document. The "ground truth" here is defined by established international standards (ISO 14971, ISO 10993-1, ISO 11135, ASTM D4169-08, ASTM F1980-07) and internal specifications of the manufacturer, rather than expert consensus on clinical findings.

However, the document states:

"The final report [for verification testing] has been reviewed and approved by qualified individuals."
Biocompatibility testing was performed "following GLP requirements" by Nelson Labs, an accredited laboratory.

This indicates that experts with relevant qualifications (e.g., engineers for verification testing, toxicologists/biologists for biocompatibility) would have been involved in the design, execution, and review of these tests. Specific numbers and detailed qualifications are not provided.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient data by multiple human readers. This document describes non-clinical performance testing (bench testing, lab analysis, physical testing) against predefined technical specifications and standards. Therefore, an adjudication method for a test set in the conventional sense is not applicable. The "adjudication" is inherent in the objective measurements and pass/fail criteria of the specified tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes non-clinical performance and safety testing (bench, lab, and physical tests) of a medical device against established standards and a predicate device. It does not involve human readers interpreting cases, nor does it assess the effect of AI assistance on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

The device described is a physical catheter transducer, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable here. The performance described is inherent to the physical device itself.

7. The Type of Ground Truth Used

The ground truth for the various tests is defined by:

Industry Standards: ISO 14971:2007 (Risk Management), ISO 10993-1 (Biocompatibility), ISO 11135 (Sterilization), ASTM D4169-08 (Transportation), ASTM F1980-07 (Accelerated Aging).
Predicate Device Specifications: The "same specification as the legally marketed device as defined in its IFU" for general performance, and specific values for parameters like Temperature Error Band and Sensitivity Error Band of the predicate device (SPC-550).
Regulatory Limits: Maximum permissible levels for EO and Ethylene Chlorohydrin residuals per ANSI/AAMI/ISO 10993-7.
Objective Measurements: Directly measured parameters against these standards and specifications (e.g., pressure readings, percentage errors, biological responses, SAL values).

8. The Sample Size for the Training Set

The concept of a "training set" and "training data" is applicable to machine learning or AI models. Since this document describes a physical medical device and its non-clinical verification and validation testing, there is no training set in the context of AI/ML.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for an AI/ML model, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Millar, a company that specializes in sensors, systems, and solutions. The logo features the company name in a bold, sans-serif font, with the tagline "SENSORS.SYSTEMS.SOLUTIONS." written in a smaller font below. To the right of the company name is a square graphic composed of smaller squares, with a jagged line running through it.

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6001-A Gulf Freeway Houston, TX 77023 Phone 832-667-7000 Fax 832-667-7015 www.millarinstruments.com

510(k) Summary:

510(k) Number: K112323

Organization No: 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 No: 1625382 .
. Operations: Specification Developer and Manufacturer of Mikro-Tip Catheter Transducers and Accessories for Clinical and Research purposes.

purposes.

Contact Name: Fatma Ali .
Contact Title: Director of Regulatory Affairs and Quality Assurance ●
Devices Name: Cardia-Cath, Pressure Volume Catheter Transducer .
Common Name/Model: Cardia-Cath ●

Image /page/0/Figure/18 description: The image shows a black and white picture of a cable. The cable is connected to a cylindrical object on the left side of the image. The cable is bent into a circular shape, and the end of the cable is curled.

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Image /page/1/Picture/0 description: The image shows the logo for Millar, a company that specializes in sensors, systems, and solutions. The logo features the word "Millar" in a bold, sans-serif font, with a small square grid above the word. The grid has a design inside of it. Below the word "Millar" is the tagline "SENSORS.SYSTEMS.SOLUTIONS."

6001-A Gulf Freeway Houston, TX 77023 Phone 832-667-7000 Fax 832-667-7015 www.millarinstruments.com

Classification: Transducer, Pressure, Catheter Tip .
Catheter Tip Pressure Transducer ◆ Regulation:
Regulation Number: 21 CFR 870-2870
Product Code : DXO .
Review Panel: Cardiovascular .
- Device description: The Cath-Cath-Catheter is a disposable/single use, sterile pressure-volume catheter transducer that combines one or two pressure transducers and a series of electrodes mounted at various locations along the distal segment of the catheter body. It terminates in one electrical connection at the proximal end.
. Intended use: Cardia-Cath catheter is used to monitor combined pressure and electrical impedance (volume) in the cardiovascular system.
. Labeling: Labeling consists of IFU (P/N: 004-2181) and packaging label (P/N: CS-320-7251).
Risk Management
- Risk management report, project Code: 1-30-20, Project Name: Cardia o Cath
  - Report Summary:
    - . Risk management has been conducted in accordance with ISO 14971:2007 to evaluate the modifications with regard to introduction of any new risk. Risk of using new configuration of the connector, off-the-shelf electrode material, and methodology of mounting the electrodes have been identified as unknown risk and shall be verified. Therefore, verification testing has been conducted. The following summary showed that the modified device passed all verification testing and it is substantially equivalent to the Millar legally marketed device, model SPC-550.
. Verification testing and acceptance criteria
- Test Reports o
  - BP-22 Verification test report reference VRP-2010-0423-02 VAL-. 181. The report shows successful execution of the predetermined test protocol addressing the requirements of the standard and following systematic procedures, SOP-2624, Design Verification Procedure and SOP-2626, Protocol and Report Writing.
    - . Selected samples of the modified catheters were tested to the same specification as the legally marketed device as defined in its IFU. All catheters met the testing

112323

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Image /page/2/Picture/0 description: The image shows the logo for Millar, a company that specializes in sensors, systems, and solutions. The logo features the word "Millar" in a bold, serif font, with the tagline "SENSORS.SYSTEMS.SOLUTIONS." underneath in a smaller font. To the right of the word "Millar" is a square graphic with a geometric design.

6001-A Gulf Freeway Houston, TX 77023 Phone 832-667-7000 Fax 832-667-7015 www.millarinstruments.com

requirements and complied with BP-22 standard requirements. Two deviations from the legally marketed device specifications have been identified. These deviations have no impact on safety or efficacy. These deviations are:

Temperature Error Band at Zero Pressure relaxed o from 3.24 mmHg to 3.5 mmHG.
Sensitivity Error Band" relaxed from 3.16% to o 3.5%.

The modified device IFU includes the new values for the end user to be able to obtain same level of data accuracy. The final report has been reviewed and approved by qualified individuals.

Transportation testing was performed on the fully packaged finished product of the modified device, Cardia-Cath by DDL. The test was performed in accordance with ASTM D4169-08. Samples passed all tests including bubble leak test and packaging integrity. DDL report No: 1009057 Rev. A is available for review. Then the catheters were tested for functionality to ensure no impact on the device functionality (safety and effectiveness) from transportation testing. This verification test was performed in accordance with Millar reference VRP-2010-0423-01 VAL-180.
Biocompatibility 트
- . Biocompatibility testing was performed through Nelson Labs. Testing included all requirements per ISO 10993-1 for External communication device, circulating blood, contact duration A-Limited (<24hrs), which includes Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Systemic toxicity (acute), and Haemocompatibility. Samples of the legally marketed device and the modified device were sent to Nelson Laboratories to perform the required tests following GLP requirements. Nelson Labs analysis determined that the Cardia-Cath (modified device) was statistically similar, and therefore substantially equivalent, to the predicate (legally marketed) device, Model SPC-550. Test reports are available for FDA review, if required. The test reports are:
  - o Modified ASTM Hemolysis (Direct Contact Method) GLP Report # 538955
  - Partial Thromboplastin time (PTT) test GLP Report o # 538954
  - MEM Elution GLP Report # 538949 o
  - Complement Activation Test GLP Report # 538956 o
  - ISO Acute Systemic Injection Test GLP Report # 538952

PROPRIETARY INFORMATION - MILLAR INSTRUMENTS, INC. NOT TO BE REPRODUCED OR DISCLOSED TO OTHER WITHOUT PRIOR WRITTEN APPROVAL

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.K112323
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Image /page/3/Picture/1 description: The image shows the logo for Millar, a company that provides sensors, systems, and solutions. The logo features the word "Millar" in a bold, sans-serif font, with the words "SENSORS.SYSTEMS.SOLUTIONS." underneath in a smaller font. To the right of the word "Millar" is a square grid with a mountain-like shape in the middle.

Phone 832-667-7000 Fax 832-667-7015 www.millarinstruments.com 6001-A Gulf Freeway Houston, TX 77023

Rabbit Pyrogen Test (Material Mediated)- ISO GLP o Report # 538953
ISO Interacutaneous Reactivity Test GLP Report # o 238951
Thrombogenicity Study in Dogs ISO GLP Report o # 538957
o ISO Guinea Pig Maximization Sensitization Test GLP Report # 538950
I Sterility
- Method: EtO-Overkill .
- Validation of sterilization per ANSI/AAMI ISO 11135 .
- Test report, Sterility test report # MI-0010 dated 04/20/11 .
- Actual Sterility assurance level (SAL): 3.33 times more than what is required to achieve sterility (1/10° )
- . Limulus Amebocyte Lysate test (LAL) for Pyrogen Free showed that the test article didn't significantly interfere with the lysate gel formation.
- Packaging description: .
  - O Sterilant penetration and maintenance of sterility:
    - · EtO Breathable materials (Tyvek)
- Residuals: �
  - o Maximum level of residuals of EO 0.3096mg (<10mg)
  - o Maximum level of Ethylene Cholorhydrin 0.1079mg (<5mg)
  - o Per ANSI/AAMI/ISO 10993-7, Ethylene Glycol residuals are not included
Accelerated aging (expiration date) 대
- Reference Validation Report # VP-2010-0630-01, VAL-. 188, DHF820-0263, a 2-year accelerated aging test was performed by DDL on the actual modified device. Cardia-Cath. Cardia-Cath was subjected to accelerated aging testing in accordance with ASTM F1980-07; Guide for Accelerated Aging of Sterile Medical Device Packages. The test started on May 25, 2011 and was complete on August 08, 2011 (75 days). The tested samples were returned to Millar on August 10, 2011. Millar inspected the packages and the functionality of the Cardia-Cath. The result showed that Cardia-Cath passed the test criteria and is substantially equivalent to the predicate device, Model SPC-550.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 8 2011

Millar Instruments, Inc. c/o Ms. Fatma M. Ali Director Regulatory Affairs and Quality Assurance 6001-A Gulf Freeway . Houston, TX 77023

Re: K112323

Trade/Device Name: Cardia-Cath Regulatory Number: 21 CFR 870.2870 Regulation Name: Catheter Tip Pressure Transducer Regulatory Class: II (two) Product Code: 74 DXO Dated: September 15, 2011 Received: September 20, 2011

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 M. 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 (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.lda.gov/AboutFDA/CentersOffices/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/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 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,

Bram D. Zuckerman, M.D.
Director

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and . Radiological Health

Enclosure

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Image /page/6/Picture/0 description: The image shows the logo for Millar, a company that provides sensors, systems, and solutions. The logo features the company name in a bold, serif font, with a small square graphic above the name. The words "SENSORS.SYSTEMS.SOLUTION" are printed in a smaller, sans-serif font below the name. The logo is simple and professional, and it conveys the company's focus on technology and innovation.

www.millarinstruments.com Phone 832-667-7000 Fax 832-667-7015 6001-A Gulf Freeway Houston, TX 77023

Statement of indications for use 1.

к | 2323 510(k) Number:

Cardia-Cath, Pressure-Volume (PV) Catheter Device Name:

Indications for use: Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system

(Division Sign-Off)
Division of Cardiovascular Devices

Division of Čardiovascular Devices

510(k) Number_

PROPRIETARY INFORMATION - MILLAR INSTRUMENTS, INC.
WITHOUT PRIOR WRITTEN APPROVAL

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).