The Meritrans ECO Reusable Pressure Transducer is intended to be coupled with a disposable dome kit for converting hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals for invasive blood pressure monitoring when connected to a patient monitor or recording device.

The devices are intended for pediatric and adult patient populations.

Device Description

The Meritrans ECO Reusable Pressure Transducer is a non-invasive, reusable device used primarily for blood pressure monitoring. The housing assembly interfaces the pressure sensor assembly to the fluid channel of patient by coupling the transducer to the Meritrans ECO Disposable Dome. The fluid channel of patient is isolated from the pressure sensor by diaphragms. As the pressure signal of patient carried via the saline solution presses against the surface of transducer, the diaphragm is deflected, and the physiological pressure signal is transformed from the dome to the sensor of the reusable pressure transducer. Subsequently, the physiological pressure signal is transformed into electrical signal and displayed in a monitor that is connected via transducer interface cable.

The Meritrans ECO Disposable Domes are disposable diaphragm domes which are coupled with the reusable transducer for invasive blood pressure monitoring. The disposable diaphragm dome has a transparent hemispherical hollow cavity. The domes have two ports; one port of the dome has a rotating Luer Lock fitting where the patient line is connected. Another port has an adaptor for connection to a pressurized IV fluid bag or an infusion pump. The disposable diaphragm dome has a diaphragm membrane that isolates the patient's fluid-filled system from the reusable transducer. For dome models with flush devices, an integral flow/flush device provides continuous flow of fluid to maintain catheter patency during the invasive blood pressure measurements.

AI/ML Overview

The provided text describes the acceptance criteria and the studies performed to demonstrate the device's conformance, but it does not detail a study proving the device meets the acceptance criteria in the format typically used for AI/ML performance evaluation (e.g., specific metrics for accuracy, sensitivity, specificity, clinical outcome studies). Instead, it focuses on compliance with various engineering, safety, and biological standards through a battery of tests.

Here's an analysis of the provided information:

1. A table of acceptance criteria and the reported device performance

The document lists various standards that the device complies with, implying that meeting the requirements of these standards constitutes the acceptance criteria. The reported device performance is stated as "Results of the testing demonstrate that the subject devices met the acceptance criteria sufficient for their intended use." However, specific numerical performance metrics for each criterion against a defined acceptable range are not provided in this summary.

Generic Table based on the document's structure for Performance Bench Testing:

Category / Standard	Acceptance Criteria (Implied)	Reported Device Performance
Product Performances
ANSI/AAMI BP22:1994 (R)2016 (Blood pressure transducers)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
IEC 60601-1:2020 (Edition 3.2) (General safety and essential performance)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
IEC 60601-1-2:2020 (Edition 4.1) (Electromagnetic disturbances)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
IEC 60601-2-34:2011 (Edition 3.0) (Invasive blood pressure monitoring equipment)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
IEC 62366-1:2015 + Cor 1:2016 + Amd 1:2020 (Usability engineering)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 80369-7:2021 (Small-bore connectors for intravascular/hypodermic applications)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
FDA Guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices	Compliance with guidance recommendations	Met the acceptance criteria sufficient for intended use
Packaging and Transportation
EN ISO 2233:2001 (Packaging - Conditioning for testing)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ASTM D4169 - 16 (2016) (Performance Testing of Shipping Containers)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
EN ISO 11607-1:2020 (Packaging for terminally sterilized medical devices)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ASTM F1980 16 (2016) (Accelerated Aging of Sterile Barrier Systems)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
Biocompatibility (Meritrans ECO Disposable Domes)
ISO 10993-1:2018 (Biological evaluation - Risk management)	Compliance with all requirements of the standard and FDA guidance	Met the acceptance criteria sufficient for intended use (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Hemocompatibility)
ISO 10993-4:2017 (Interactions with blood)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 10993-5:2009 (In vitro cytotoxicity)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 10993-10:2021 (Skin sensitization)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 10993-11:2017 (Systemic toxicity)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 10993-12:2021 (Sample preparation and reference materials)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ISO 10993-23:2021 (Irritation)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
FDA Guidance, Use of International Standard ISO 10993-1	Compliance with guidance recommendations	Met the acceptance criteria sufficient for intended use
Sterilization / Sterility / EO residuals / Pyrogenicity (Meritrans ECO Disposable Domes)
EN ISO 11135:2014 (+ Amd 1:2018) (Ethylene oxide sterilization)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
EN ISO 10993-7:2008 (+ Cor 1:2009 + AMD 1:2019) (Ethylene Oxide sterilization residuals)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
AAMI TIR28:2016 (Product Adoption and process equivalency for ethylene oxide sterilization)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
ANSI/AAMI ST72:2019 (Bacterial endotoxins Test methods)	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
United States Pharmacopeia 43, National Formulary 38:2020 (USP), General Chapter <151> Pyrogen Test	Compliance with all requirements of the standard	Met the acceptance criteria sufficient for intended use
FDA Guidance. Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile	Compliance with guidance recommendations	Met the acceptance criteria sufficient for intended use

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document lists various standards and states that "A battery of tests was performed based on the requirements of the below FDA recognized / non-recognized consensus standards and guidance, as well as biocompatibility, sterilization, and labeling standards and guidance." However, it does not specify the sample sizes used for these tests or the data provenance (country of origin, retrospective/prospective). This information would typically be detailed in the test reports themselves, which are not included in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable in the context of this 510(k) summary. The device in question, a pressure transducer and disposable domes, is a hardware medical device with electrical and mechanical performance, biocompatibility, and sterility requirements. Its evaluation is based on engineering testing and biological assays against recognized standards, not on image interpretation or diagnostic performance with expert-established ground truth. Therefore, there are no "experts" in the sense of clinical reviewers establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the reasons stated above. Adjudication methods are relevant for studies involving human interpretation (e.g., radiologists, pathologists) where discrepancies need to be resolved to establish ground truth, typically in AI/ML performance evaluations.

5. 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

This is not applicable. The device is an extravascular blood pressure transducer, a piece of hardware for physiological monitoring. It does not involve AI assistance for human readers in any diagnostic or interpretive task.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a hardware product, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by the specified requirements and test methods outlined in the recognized consensus standards (e.g., ANSI/AAMI BP22 for blood pressure transducers, ISO 10993 for biocompatibility). These standards define acceptable performance metrics, physical properties, and biological responses. The device's performance is measured against these established technical and biological benchmarks.

8. The sample size for the training set

This is not applicable. The device is a hardware medical device, and the evaluation described is for its physical and biological performance against standards, not for a trainable AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above. There is no AI/ML training set mentioned or implied for this device's evaluation.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 17, 2023

Merit Medical Pte. Ltd. Pauline Liow Senior Regulatory Affairs Specialist 198 Yishun Avenue 7 Singapore, Singapore 768926

Re: K221782

Trade/Device Name: Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular Blood Pressure Transducer Regulatory Class: Class II Product Code: DRS Dated: June 16, 2022 Received: June 21, 2022

Dear Pauline Liow:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Aneesh S. Deoras -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2023
Indications for Use	See PRA Statement below.

510(k) Number (if known)

K221782

Device Name

Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes

Indications for Use (Describe)

The devices are intended for pediatric and adult patient populations.

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

Prescription 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."

FORM FDA 3881 (6/20)

Page 1 of 1

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5.0 510(k) Summary

	Submitter Name:	Merit Medical Singapore Pte. Ltd.
	Address:	198 Yishun Avenue 7,
		Singapore 768926
GeneralProvisions	Telephone Number:	(65) 6750-9281
	Fax Number:	(65) 6754-3961
	Contact Person:	Ms. Pauline Liow
	Date Prepared:	June 16, 2022
	Establishment Registration Number:	8020616
	Trade Name:	Meritrans ECO Reusable PressureTransducer and Meritrans ECO DisposableDomes
Subject Device	Common/Usual Name:	Reusable Pressure Transducer
	Classification Name:	Transducer, Blood-Pressure, Extravascular
	Regulatory Class:	Class II
	Product Code:	DRS
	21 CFR §:	870.2850
	Review Panel:	Cardiovascular
	Premarket Notification Predicate Device 1:
	Trade Name:	MX960 Reusable Pressure Transducer(predicate for Meritrans ECO ReusablePressure Transducer)
	Common/Usual Name:	Reusable Pressure Transducer
	Classification Name:	Transducer, Blood-Pressure, Extravascular
Predicate Device	Premarket Notification:	K961404
	Manufacturer:	Smiths Medical ASD, Inc. (see Note 1below)*Note 1: The manufacturer, Medex, Inc. statedin the 510k letter, K961404 has been acquiredby Smiths Medical.
	Premarket Notification Predicate Device 2:
	Trade Name:	LogiCal® Pressure Cartridges (disposabledomes that are configured in the LogiCal®Transducer Pressure Monitoring System)(predicate for Meritrans ECO DisposableDomes)
	Common/Usual Name:	Reusable Pressure Transducer
	Classification Name:	Transducer, Blood-Pressure, Extravascular
	Premarket Notification:	K172458
	Manufacturer:	Smiths Medical ASD, Inc.
Classification	Regulatory Class:	II
	Product Code:	DRS
	21 CFR §:	21 CFR § 870.2850
	Review Panel:	Cardiovascular
Intended Use /Indications forUse	The Meritrans ECO Reusable Pressure Transducer is intended to becoupled with a disposable dome kit for converting hemodynamic pressurewaveforms via a piezoresistive bridge circuit into electrical signals forinvasive blood pressure monitoring when connected to a patient monitoror recording device.The devices are intended for pediatric and adult patient populations.
DeviceDescription	The Meritrans ECO Reusable Pressure Transducer is a non-invasive,reusable device used primarily for blood pressure monitoring. The housingassembly interfaces the pressure sensor assembly to the fluid channel ofpatient by coupling the transducer to the Meritrans ECO DisposableDome. The fluid channel of patient is isolated from the pressure sensor bydiaphragms. As the pressure signal of patient carried via the salinesolution presses against the surface of transducer, the diaphragm isdeflected, and the physiological pressure signal is transformed from thedome to the sensor of the reusable pressure transducer. Subsequently,the physiological pressure signal is transformed into electrical signal anddisplayed in a monitor that is connected via transducer interface cable.The Meritrans ECO Disposable Domes are disposable diaphragm domeswhich are coupled with the reusable transducer for invasive bloodpressure monitoring. The disposable diaphragm dome has a transparenthemispherical hollow cavity. The domes have two ports; one port of thedome has a rotating Luer Lock fitting where the patient line is connected.Another port has an adaptor for connection to a pressurized IV fluid bagor an infusion pump. The disposable diaphragm dome has a diaphragmmembrane that isolates the patient's fluid-filled system from the reusabletransducer. For dome models with flush devices, an integral flow/flushdevice provides continuous flow of fluid to maintain catheter patencyduring the invasive blood pressure measurements.
Comparison toPredicate Device	The subject Meritrans ECO Reusable Pressure Transducer and MeritransECO Disposable Domes have the same intended use, principle ofoperation and design / technology concept as the predicate devices.Despite the slight differences in materials used or specifications, thesafety and effectiveness of the devices are equivalent since they conformto the same FDA recognized standards such as ANSI/AAMI BP22 (FDARecognition Number: 3-44), IEC 60601-1-2 (FDA Recognition Number: 19-36),IEC 60601-2-34 (FDA Recognition Number: 3-115), IEC 62366-1 (FDARecognition Number: 5-129), ISO 80369-7 (FDA Recognition Number: 5-133)and ISO 10993-1 (FDA Recognition Number: 2-258).The subject devices are substantially equivalent to the predicate device 1for transducer (K961404) and predicate device 2 for disposable domes(K172458).
Safety &Performance Data	FDA guidance and FDA recognized / non-recognized consensusstandards have been established for Transducer, Blood-Pressure,Extravascular under FDA 21 CFR § 870.2850 DRS. A battery of tests wasperformed based on the requirements of the below FDA recognized / non-recognized consensus standards and guidance, as well asbiocompatibility, sterilization, and labeling standards and guidance.Conformity to these standards demonstrates that the subject MeritransECO Reusable Pressure Transducer and Meritrans ECO DisposableDomes met the standards' established acceptance criteria applicable tothe safety and effectiveness of the device.
	Product Performances:
	• ANSI/AAMI BP22:1994 (R)2016, Blood pressure transducers [FDARecognition Number: 3-44]
	• IEC 60601-1:2020 (Edition 3.2), Medical electrical equipment - Part1: General requirements for basic safety and essential performance
	• IEC 60601-1-2:2020 (Edition 4.1), Medical electrical equipment -Part 1-2: General requirements for basic safety and essentialperformance - Collateral Standard: Electromagnetic disturbances -Requirements and tests [FDA Recognition Number: 19-36]
	• IEC 60601-2-34:2011 (Edition 3.0), Medical electrical equipment -Part 2-34: Particular requirements for the basic safety and essentialperformance of invasive blood pressure monitoring equipment [FDARecognition Number: 3-115]
	• IEC 62366-1:2015 + Cor 1:2016 + Amd 1:2020 [Equivalent to IEC62366-1:2020 (Edition 1.1 Consolidated Version)], Medical devices - Part1: Application of usability engineering to medical devices [FDARecognition Number: 5-129]
	• ISO 80369-7:2021, Small-bore connectors for liquids and gases inhealthcare applications - Part 7: Connectors for intravascular orhypodermic applications [FDA Recognition Number: 5-133]
	• FDA Guidance, Information to Support a Claim of ElectromagneticCompatibility (EMC) of Electrically-Powered Medical Devices, July11, 2016
	Packaging and Transportation:
	• EN ISO 2233:2001, Packaging - Complete, filled transport packagesand unit loads - Conditioning for testing
	• ASTM D4169 - 16 (2016), Standard Practice for PerformanceTesting of Shipping Containers and Systems [FDA RecognitionNumber: 14-499]
	• EN ISO 11607-1:2020 (Equivalent to ISO 11607-1:2019), Packaging forterminally sterilized medical devices - Part 1: Requirements formaterials, sterile barrier systems and packaging systems [FDARecognition Number: 14-530]

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· ASTM F1980 16 (2016), Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices [FDA Recognition Number: 14-4971
Biocompatibility (for Meritrans ECO Disposable Domes):
ISO 10993-1:2018. Biological evaluation of medical devices Part 1: . Evaluation and testing within a risk management process [FDA Recognition Number: 2-2581
ISO 10993-4:2017, Biological evaluation of medical devices Part 4: . Selection of tests for interactions with blood [FDA Recognition Number: 2-248]
· ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity [FDA Recognition Number: 2-245]
ISO 10993-10:2021 Biological evaluation of medical devices Part . 10: Tests for skin sensitization
ISO 10993-11:2017 Biological evaluation of medical devices Part . 11: Tests for systemic toxicity [FDA Recognition Number: 2-255]
ISO 10993-12:2021 Biological evaluation of medical devices Part . 12: Sample preparation and reference materials /FDA Recognition Number: 2-2891
ISO 10993-23:2021 Biological evaluation of medical devices Part . 23: Tests for irritation [FDA Recognition Number: 2-291]
. FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 4, 2020

Sterilization / Sterility / EO residuals / Pyrogenicity (for Meritrans ECO Disposable Domes):

. EN ISO 11135:2014 (Equivalent to ISO 11135:2014) + Amd 1:2018 -Sterilization of health-care products - Ethylene oxide -Requirements for the development, validation and Routine Control of a sterilization process for medical devices IFDA Recognition Number: 14-529]
EN ISO 10993-7:2008 + Cor 1:2009 + AMD 1:2019, Biological . Evaluation of Medical Devices – Part 7: Ethylene Oxide sterilization residuals [FDA Recognition Number: 2-275]
· AAMI TIR28:2016, Product Adoption and process equivalency for ethylene oxide sterilization
ANSI/AAMI ST72:2019. Bacterial endotoxins Test methods, routine . monitoring, and alternatives to batch testing [FDA Recognition Number: 14-541]
· United States Pharmacopeia 43, National Formulary 38:2020 (USP), General Chapter <151> Pyrogen Test
FDA Guidance. Submission and Review of Sterility Information in . Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, January 21, 2016

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Performance Bench Testing

The Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes comply with the FDA recognized / non-recognized consensus standards as outlined within this submission. Results of the testing demonstrate that the subject devices met the acceptance criteria sufficient for their intended use. The subiect devices met the following requirements from these standards:

. Blood pressure transducers requirements per ANSI/AAMI BP22:1994 (R)2016
General requirements for basic safety and essential performance of . medical electrical equipment per IEC 60601-1:2020 (Edition 3.2)
Requirements and tests relating to electromagnetic disturbances of . Medical electrical equipment per IEC 60601-1-2:2020 (Edition 4.1)
Particular requirements for the basic safety and essential . performance of invasive blood pressure monitoring equipment per IEC 60601-2-34:2011 (Edition 3.0)
Usability engineering requirements per IEC 62366-1:2015 + Cor . 1:2016 + Amd 1:2020 [Equivalent to IEC 62366-1:2020 (Edition 1.1 Consolidated Version)]
. Requirements for connectors for intravascular or hypodermic applications per ISO 80369-7:2021

Biocompatibility testing

The biocompatibility evaluation for the Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes was conducted in accordance with the FDA Guidance. Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", September 4, 2020, and International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, as recognized by FDA. The reusable pressure transducer, Meritrans ECO Reusable Pressure Transducer does not come into contact directly or indirectly with the patient's body, tissues or fluid path, therefore testing per ISO 10993 is not required. As for the Meritrans ECO Disposable Domes, testing included the following:

Cytotoxicity
. Sensitization
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity
Hemocompatibility ●

The Meritrans ECO Disposable Domes are externally communicating devices with blood path, indirect contact for a prolonged duration (> 24 hours to 30 days).

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Summary ofSubstantialEquivalence	Based on the indications for use, design, safety and performance testing the subject Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes meet the requirements of all the applicable standards including the FDA recognized / non-recognized consensus standards that are considered essential for their intended use and are substantially equivalent to the predicate device 1 for transducer: MX960 Reusable Pressure Transducer, K961404 and predicate device 2 for disposable domes: LogiCal® Pressure Cartridges (disposable domes that are configured in the LogiCal® Transducer Pressure Monitoring System) K172458.
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Summary ofSubstantialEquivalence

Based on the indications for use, design, safety and performance testing the subject Meritrans ECO Reusable Pressure Transducer and Meritrans ECO Disposable Domes meet the requirements of all the applicable standards including the FDA recognized / non-recognized consensus standards that are considered essential for their intended use and are substantially equivalent to the predicate device 1 for transducer: MX960 Reusable Pressure Transducer, K961404 and predicate device 2 for disposable domes: LogiCal® Pressure Cartridges (disposable domes that are configured in the LogiCal® Transducer Pressure Monitoring System) K172458.

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Regulation Number and Section

§ 870.2850 Extravascular blood pressure transducer.

(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).