(77 days)
The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.
The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system. The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.
The Medex, Inc. MX960 Reusable Pressure Transducer underwent performance testing against the ANSI/AAMI BP22-1994 standard for blood pressure transducers.
Here's a breakdown of the acceptance criteria and the study details:
1. Acceptance Criteria and Reported Device Performance
| PARAMETER | AAMI SPECIFICATION (Acceptance Criteria) | MX960 Performance (Reported Device Performance) |
|---|---|---|
| Sensitivity - µV/V/mmHg | Disclosure | 5.0 Nominal |
| Unbalance - mmHg | 0 ± 75 | 0 ± 50 |
| Zero Drift - mmHg | Disclosure | ≤ 2 in 4 hrs after 5 min |
| Input Impedance - OHMS | < 3000 | 630 Nominal |
| Output Impedance - OHMS | > 200 | 300 ± 10% |
| Calibration Requirement - mmHg | Not Specified | 100 ± 3 |
| Accuracy - mmHg | < ± 1% or < ±3% | meets or exceeds AAMI |
| Compensated Temperature Range - °C | 15 to 40 | 15 to 40 |
| Storage Temperature Range - °C | -25 to 70 | -25 to 70 |
| Temperature Coefficient of Sensitivity - %/°C | Disclosure | 0 ± 0.1 |
| Temperature Coefficient of Offset - mmHg/°C | Disclosure | 0 ± 0.3 |
| Operating Pressure - mmHg | -30 to 300 | 30 to 300 |
| Overpressure - mmHg | -400 to 4000 | -400 to 4000 |
| Volumetric Displacement - µL/100mmHg | Not Specified | Not Specified |
| Symmetry - | 1 ± 5% | 1 ± 5% |
| Defibrillator Withstand - per AAMI | 5 in 5 min at 360J | 5 in 5 min at 360J |
| Leakage Current of 115 VAC at 60 Hz - µA | < 10 | < 5 |
| Light Sensitivity - per AAMI | Disclosure | < 1mmHg shift |
| Mechanical Shock Withstand - per AAMI | Disclosure | 3 falls from 1m |
| Phase Shift - per AAMI | < 5° | < 5° |
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample size used for the test set in terms of the number of individual devices or the duration/number of tests performed for each parameter. It indicates that the MX960 was "aggressively tested."
- The data provenance is not specified (e.g., country of origin, retrospective or prospective). It is an in-house performance test against a recognized standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a physical transducer, not an AI or diagnostic imaging device that requires expert interpretation for ground truth. The "ground truth" for its performance is established by standardized measurements against the ANSI/AAMI BP22-1994 specifications using calibrated testing equipment. Therefore, no human experts are directly involved in establishing "ground truth" in the way they would be for image analysis or disease diagnosis.
4. Adjudication method for the test set:
- Not applicable, as this is a performance test against objective engineering specifications, not a diagnostic task requiring adjudication.
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:
- Not applicable. This is a performance test for a reusable pressure transducer, not a device involving AI or human interpretation in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a standalone performance test of a physical medical device. The "algorithm" here is the transducer's internal mechanism, and its performance is measured directly.
7. The type of ground truth used:
- The ground truth is based on the ANSI/AAMI BP22-1994 standard specifications for blood pressure transducers. This standard defines the acceptable ranges and limits for various operational and performance parameters.
8. The sample size for the training set:
- Not applicable. This is a physical device performance test, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable for the reasons mentioned above.
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510(k) Summary
Image /page/0/Picture/3 description: The image shows the logo for "medexinc.". The logo is black and white. The logo has a symbol on the left side that looks like a stylized flower or star. The text "medexinc." is in a bold, sans-serif font.
This summary regarding 510(k) safety and effectiveness and being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
§ 807.92 (a)(1) Submitter's (and Contact) Names, Address, Telephone No., Summary Date
- · John Toomey Senior Project Engineer Medex, Inc. 6250 Shier-Rings Road Dublin, Ohio 43017 (614) 791 5415
- · 04.09.96
& 807.92 (a)(2) Device Name (Including Trade Name), Common Name, Classification Name
- · MX960
- · Reusable Pressure Transducer
- · Transducer, Blood Pressure, Extravascular (CV, 74 DRS)
$ 807.92 (a)(3) Legally Marketed Predicate Device to Which Equivalence is Claimed
- · Medex, Inc.'s MX860 NOVATRANS IT reusable pressure transducer ( K95 1 129).
$ 807.92 (a)(4) Description of the Premarket Notification Device
- · The MX960 reusable pressure transducer is a non-fluid pathway device. A pressure waveform is conveyed through a disposable dome which is coupled to the reusable pressure transducer during pressure monitoring. Both the transducer and dome have mutually exclusive diaphragms. Accordingly, fluid contact is limited to the dome portion of the system.
- · The materials which comprise the MX960 have been aggressively tested per the ANSVAAMI/ISO 10993 "Biological Evaluation of Medical Devices" and the "Tripartite Biocompatibility Guidance for Medical Devices". All materials have successfully met these standards.
§ 807.92 (a)(5) Intended Use
- · The MX960 reusable pressure transducer is used to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment.
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Image /page/1/Picture/0 description: The image shows the logo for Medex Inc. The logo consists of a symbol on the left, followed by the text "medexinc." The symbol on the left appears to be four stylized figures arranged in a diamond shape. The text "medexinc" is in a bold, sans-serif font, and there is a registered trademark symbol after the "c".
S 807.92 (a)(6) Technical Characteristics Summary
| Property | Predicate MX860 | (MX860) |
|---|---|---|
| Intended Use | The MX860 reusable pressure transducer's intended use is to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment. | The MX860 reusable pressure transducer's intended use is to convert hemodynamic pressure waveforms via a piezoresistive bridge circuit into electrical signals which can then be displayed using separate monitoring equipment. |
| Pressure Sensor Component | Piezoresistive Wheatstone bridge network | Piezoresistive Wheatstone bridge network |
| Isolated Fluid Path | Yes | Yes |
| Performance Specific AAMI | Meets or exceeds ANSI/AAMI BP22-1994 | Meets or exceeds ANSI/AAMI BP22-1994 |
| Transducer Housing | Polycarbonate | Polycarbonate |
| Housing Diamter | 0.657" | 0.657" |
§ 807.92 (b)(1), (b)(3) Performance Testing Assessment
- · The MX960 was aggressively tested against the American National Standard for Blood Pressure Transducers, ANSI/AAMI BP22-1994. In all cases, the MX960 meets or exceeds AAMI specifications. The following table list the AAMI requirements, and the respective performance of the MX860 and the MX960.
| PARAMETER | PREDICATE MX860 | MX960 | AAMI SPECIFICATION |
|---|---|---|---|
| Sensitivity - µV/V/mmHg | 5.0 Nominal | 5.0 Nominal | Disclosure |
| Unbalance - mmHg | 0 ± 50 | 0 ± 50 | 0 ± 75 |
| Zero Drift - mmHg | ≤ 2 in 4 hrs after 5 min | ≤ 2 in 4 hrs after 5 min | Disclosure |
| Input Impedance - OHMS | 630 Nominal | 630 Nominal | < 3000 |
| Output Impedance - OHMS | 300 ± 10% | 300 ± 10% | > 200 |
| Calibration Requirement - mmHg | 100 ± 3 | 100 ± 3 | Not Specified |
| Accuracy - mmHg | meets or exceeds AAMI | meets or exceeds AAMI | < ± 1% or < ±3% |
| Compensated Temperature Range - °C | 10 to 45 | 15 to 40 | 15 to 40 |
| Storage Temperature Range - °C | 25 to 70 | -25 to 70 | -25 to 70 |
| Temperature Coefficient of Sensitivity - %/°C | 0 ± 0.1 | 0 ± 0.1 | Disclosure |
| Temperature Coefficient of Offset - mmHg/°C | 0 ± 0.3 | 0 ± 0.3 | Disclosure |
| Operating Pressure - mmHg | 30 to 300 | 30 to 300 | -30 to 300 |
| Overpressure - mmHg | -700 to 4000 | -400 to 4000 | -400 to 4000 |
| Volumetric Displacement - µL/100mmHg | Not Specified | Not Specified | Not Specified |
| Symmetry - | 1 ± 5% | 1 ± 5% | 1 ± 5% |
| Defibrillator Withstand - per AAMI | 5 in 5 min at 360J | 5 in 5 min at 360J | 5 in 5 min at 360J |
| Leakage Current of 115 VAC at 60 Hz - µA | < 3 | < 5 | <10 |
| Light Sensitivity - per AAMI | < 1mmHg shift | < 1mmHg shift | Disclosure |
| Mechanical Shock Withstand - per AAMI | 3 falls from 1m | 3 falls from 1m | Disclosure |
| Phase Shift - per AAMI | < 5° | < 5° | < 5° |
§ 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).