(269 days)
Not Found
No
The device description focuses on the physical mechanism of pressure transduction and electrical signal conversion, with no mention of AI/ML algorithms for data processing or interpretation. The performance studies are based on standard bench testing and biocompatibility, not AI/ML model validation.
No
The device is described as a non-invasive, reusable device used for monitoring blood pressure by converting hemodynamic pressure waveforms into electrical signals for display on a patient monitor. Its intended use is for monitoring, not for providing therapy or treatment.
Yes
Explanation: The device, a Meritrans ECO Reusable Pressure Transducer, is used for "invasive blood pressure monitoring" and converts "hemodynamic pressure waveforms... into electrical signals." This process of measuring and displaying physiological data for the purpose of assessing a patient's condition falls under the definition of a diagnostic device.
No
The device description clearly outlines physical hardware components, including a reusable pressure transducer with a housing assembly, pressure sensor assembly, and a disposable dome with ports and a diaphragm membrane. The device converts physical pressure into electrical signals, indicating a hardware-based function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "invasive blood pressure monitoring" by converting physiological pressure waveforms into electrical signals. This is a direct measurement of a physiological parameter within the patient's body.
- Device Description: The description details how the device interfaces with the patient's fluid channel (blood pressure) and transforms this physical pressure into an electrical signal for display on a monitor. This is a direct physiological measurement, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) outside of the body. The device is directly connected to the patient's circulatory system for real-time pressure monitoring.
IVDs are devices intended for use in vitro for the examination of specimens, including blood, tissues, and body excretions, to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that definition.
N/A
Intended Use / Indications for 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.
Product codes
DRS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
pediatric and adult patient populations
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)
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 subject 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
| 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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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FORM FDA 3881 (6/20)
Page 1 of 1
3
5.0 510(k) Summary
| Submitter Name: | Merit Medical Singapore Pte. Ltd. | |
|---|---|---|
| Address: | 198 Yishun Avenue 7, | |
| Singapore 768926 | ||
| General | ||
| 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 | |
| Transducer and Meritrans ECO Disposable | ||
| 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 | |
| (predicate for Meritrans ECO Reusable | ||
| 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 | |
| below) | ||
| *Note 1: The manufacturer, Medex, Inc. stated | ||
| in the 510k letter, K961404 has been acquired | ||
| by Smiths Medical. | ||
| Premarket Notification Predicate Device 2: | ||
| Trade Name: | LogiCal® Pressure Cartridges (disposable | |
| domes that are configured in the LogiCal® | ||
| Transducer Pressure Monitoring System) | ||
| (predicate for Meritrans ECO Disposable | ||
| 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 / | ||
| Indications for | ||
| 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
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. | |
| Comparison to
Predicate Device | The subject Meritrans ECO Reusable Pressure Transducer and Meritrans
ECO Disposable Domes have the same intended use, principle of
operation and design / technology concept as the predicate devices.
Despite the slight differences in materials used or specifications, the
safety and effectiveness of the devices are equivalent since they conform
to the same FDA recognized standards such as ANSI/AAMI BP22 (FDA
Recognition Number: 3-44), IEC 60601-1-2 (FDA Recognition Number: 19-36),
IEC 60601-2-34 (FDA Recognition Number: 3-115), IEC 62366-1 (FDA
Recognition 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 1
for transducer (K961404) and predicate device 2 for disposable domes
(K172458). | |
| Safety &
Performance Data | FDA guidance and FDA recognized / non-recognized consensus
standards have been established for Transducer, Blood-Pressure,
Extravascular under FDA 21 CFR § 870.2850 DRS. 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.
Conformity to these standards demonstrates that the subject Meritrans
ECO Reusable Pressure Transducer and Meritrans ECO Disposable
Domes met the standards' established acceptance criteria applicable to
the safety and effectiveness of the device. | |
| | Product Performances: | |
| | • ANSI/AAMI BP22:1994 (R)2016, Blood pressure transducers [FDA
Recognition Number: 3-44] | |
| | • IEC 60601-1:2020 (Edition 3.2), Medical electrical equipment - Part
1: 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 essential
performance - 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 essential
performance of invasive blood pressure monitoring equipment [FDA
Recognition Number: 3-115] | |
| | • IEC 62366-1:2015 + Cor 1:2016 + Amd 1:2020 [Equivalent to IEC
62366-1:2020 (Edition 1.1 Consolidated Version)], Medical devices - Part
1: Application of usability engineering to medical devices [FDA
Recognition Number: 5-129] | |
| | • ISO 80369-7:2021, Small-bore connectors for liquids and gases in
healthcare applications - Part 7: Connectors for intravascular or
hypodermic applications [FDA Recognition Number: 5-133] | |
| | • FDA Guidance, Information to Support a Claim of Electromagnetic
Compatibility (EMC) of Electrically-Powered Medical Devices, July
11, 2016 | |
| | Packaging and Transportation: | |
| | • EN ISO 2233:2001, Packaging - Complete, filled transport packages
and unit loads - Conditioning for testing | |
| | • ASTM D4169 - 16 (2016), Standard Practice for Performance
Testing of Shipping Containers and Systems [FDA Recognition
Number: 14-499] | |
| | • EN ISO 11607-1:2020 (Equivalent to ISO 11607-1:2019), Packaging for
terminally sterilized medical devices - Part 1: Requirements for
materials, sterile barrier systems and packaging systems [FDA
Recognition Number: 14-530] | |
4
5
6
-
· 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 Pyrogen Test
- FDA Guidance. Submission and Review of Sterility Information in . Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, January 21, 2016
7
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).
8
| Summary of
Substantial
| Equivalence | 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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