(67 days)
Model SPC-550
Not Found
No
The summary describes a physical catheter transducer and its performance testing, with no mention of AI or ML algorithms for data processing or analysis.
No
The device is described as a monitoring device for pressure and electrical impedance in the cardiovascular system, which is a diagnostic function, not a therapeutic one. It does not mention any function that treats or alleviates a medical condition.
Yes
The device is intended for "Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system," which involves assessing physiological parameters to provide information about the patient's health status, a function characteristic of diagnostic devices.
No
The device description explicitly states it is a "disposable/single use, sterile pressure-volume catheter transducer" which is a physical hardware device. The performance studies also describe testing of physical components like catheters and packaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system." This describes a device used within the body to measure physiological parameters directly.
- Device Description: The description details a catheter transducer that is inserted into the cardiovascular system. This is an invasive device used for direct measurement.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a patient's health.
The device described is clearly an in vivo device, meaning it is used within a living organism.
N/A
Intended Use / Indications for Use
Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system
Product codes (comma separated list FDA assigned to the subject device)
DXO, 74 DXO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
- Test Reports: 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 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 from 3.24 mmHg to 3.5 mmHG.
- Sensitivity Error Band" relaxed from 3.16% to 3.5%.
- 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 testing was performed through Nelson Labs. Testing included all requirements per ISO 10993-1 for External communication device, circulating blood, contact duration A-Limited (
§ 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/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.
- Report Summary:
- Risk management report, project Code: 1-30-20, Project Name: Cardia o Cath
- . 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
- 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.
- Test Reports o
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 ( 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