Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes

K221782 · Merit Medical Pte. , Ltd. · DRS · Mar 17, 2023 · Cardiovascular

Device Facts

• Record ID: K221782
• Device Name: Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
• Applicant: Merit Medical Pte. , Ltd.
• Product Code: DRS · Cardiovascular
• Decision Date: Mar 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2850
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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 Story

Device consists of reusable pressure transducer and disposable dome kit. Input: hemodynamic pressure waveforms from patient fluid-filled system. Principle: piezoresistive bridge circuit converts pressure signal to electrical signal. Disposable dome uses diaphragm to isolate patient fluid path from reusable transducer. Dome includes Luer Lock fitting for patient line and adaptor for IV fluid/infusion pump; some models include flush device for catheter patency. Output: electrical signal transmitted to patient monitor/recording device. Used in clinical settings for invasive blood pressure monitoring. Healthcare providers view output on monitor to guide clinical decision-making regarding patient hemodynamic status.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI BP22, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, IEC 62366-1, and ISO 80369-7. Biocompatibility testing for disposable domes (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility) per ISO 10993 series. Sterilization validation per EN ISO 11135.

Technological Characteristics

Piezoresistive bridge circuit transducer; disposable diaphragm dome with Luer Lock and flush device options. Materials evaluated per ISO 10993. Standards: ANSI/AAMI BP22, IEC 60601-1, IEC 60601-1-2, IEC 60601-2-34, IEC 62366-1, ISO 80369-7, ISO 10993. Sterilization: Ethylene Oxide (EO) for disposable domes.

Indications for Use

Indicated for pediatric and adult patients requiring invasive blood pressure monitoring via hemodynamic pressure waveform conversion to electrical signals.

Regulatory Classification

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.

Predicate Devices

• MX960 Reusable Pressure Transducer (K961404)
• LogiCal® Pressure Cartridges (K172458)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

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)

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FORM FDA 3881 (6/20)

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# 5.0 510(k) Summary

| | Submitter Name: | Merit Medical Singapore Pte. Ltd. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 198 Yishun Avenue 7, |
| | | Singapore 768926 |
| General<br>Provisions | 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 Pressure<br>Transducer and Meritrans ECO Disposable<br>Domes |
| 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<br>(predicate for Meritrans ECO Reusable<br>Pressure 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 1<br>below)<br>*Note 1: The manufacturer, Medex, Inc. stated<br>in the 510k letter, K961404 has been acquired<br>by Smiths Medical. |
| | Premarket Notification Predicate Device 2: | |
| | Trade Name: | LogiCal® Pressure Cartridges (disposable<br>domes that are configured in the LogiCal®<br>Transducer Pressure Monitoring System)<br>(predicate for Meritrans ECO Disposable<br>Domes) |
| | 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 /<br>Indications for<br>Use | The Meritrans ECO Reusable Pressure Transducer is intended to be<br>coupled with a disposable dome kit for converting hemodynamic pressure<br>waveforms via a piezoresistive bridge circuit into electrical signals for<br>invasive blood pressure monitoring when connected to a patient monitor<br>or recording device.<br><br>The devices are intended for pediatric and adult patient populations. | |
| Device<br>Description | The Meritrans ECO Reusable Pressure Transducer is a non-invasive,<br>reusable device used primarily for blood pressure monitoring. The housing<br>assembly interfaces the pressure sensor assembly to the fluid channel of<br>patient by coupling the transducer to the Meritrans ECO Disposable<br>Dome. The fluid channel of patient is isolated from the pressure sensor by<br>diaphragms. As the pressure signal of patient carried via the saline<br>solution presses against the surface of transducer, the diaphragm is<br>deflected, and the physiological pressure signal is transformed from the<br>dome to the sensor of the reusable pressure transducer. Subsequently,<br>the physiological pressure signal is transformed into electrical signal and<br>displayed in a monitor that is connected via transducer interface cable.<br><br>The Meritrans ECO Disposable Domes are disposable diaphragm domes<br>which are coupled with the reusable transducer for invasive blood<br>pressure monitoring. The disposable diaphragm dome has a transparent<br>hemispherical hollow cavity. The domes have two ports; one port of the<br>dome has a rotating Luer Lock fitting where the patient line is connected.<br>Another port has an adaptor for connection to a pressurized IV fluid bag<br>or an infusion pump. The disposable diaphragm dome has a diaphragm<br>membrane that isolates the patient's fluid-filled system from the reusable<br>transducer. For dome models with flush devices, an integral flow/flush<br>device provides continuous flow of fluid to maintain catheter patency<br>during the invasive blood pressure measurements. | |
| Comparison to<br>Predicate Device | The subject Meritrans ECO Reusable Pressure Transducer and Meritrans<br>ECO Disposable Domes have the same intended use, principle of<br>operation and design / technology concept as the predicate devices.<br><br>Despite the slight differences in materials used or specifications, the<br>safety and effectiveness of the devices are equivalent since they conform<br>to the same FDA recognized standards such as ANSI/AAMI BP22 (FDA<br>Recognition Number: 3-44), IEC 60601-1-2 (FDA Recognition Number: 19-36),<br>IEC 60601-2-34 (FDA Recognition Number: 3-115), IEC 62366-1 (FDA<br>Recognition Number: 5-129), ISO 80369-7 (FDA Recognition Number: 5-133)<br>and ISO 10993-1 (FDA Recognition Number: 2-258).<br><br>The subject devices are substantially equivalent to the predicate device 1<br>for transducer (K961404) and predicate device 2 for disposable domes<br>(K172458). | |
| Safety &<br>Performance Data | FDA guidance and FDA recognized / non-recognized consensus<br>standards have been established for Transducer, Blood-Pressure,<br>Extravascular under FDA 21 CFR § 870.2850 DRS. A battery of tests was<br>performed based on the requirements of the below FDA recognized / non-<br>recognized consensus standards and guidance, as well as<br>biocompatibility, sterilization, and labeling standards and guidance.<br>Conformity to these standards demonstrates that the subject Meritrans<br>ECO Reusable Pressure Transducer and Meritrans ECO Disposable<br>Domes met the standards' established acceptance criteria applicable to<br>the safety and effectiveness of the device. | |
| | Product Performances: | |
| | • ANSI/AAMI BP22:1994 (R)2016, Blood pressure transducers [FDA<br>Recognition Number: 3-44] | |
| | • IEC 60601-1:2020 (Edition 3.2), Medical electrical equipment - Part<br>1: General requirements for basic safety and essential performance | |
| | • IEC 60601-1-2:2020 (Edition 4.1), Medical electrical equipment -<br>Part 1-2: General requirements for basic safety and essential<br>performance - Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests [FDA Recognition Number: 19-36]…