(77 days)
K95 1 129
Not Found
No
The description focuses on the physical and electrical properties of a pressure transducer and does not mention any AI/ML components or functionalities.
No
The device is described as a pressure transducer that converts hemodynamic pressure waveforms into electrical signals for display on monitoring equipment. It is a diagnostic tool, not a therapeutic one as it does not directly treat or alleviate a medical condition.
Yes
The device is used to convert hemodynamic pressure waveforms into electrical signals that can be displayed using separate monitoring equipment, which is a diagnostic function.
No
The device description clearly details a physical, reusable pressure transducer with a piezoresistive bridge circuit and diaphragms, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert hemodynamic pressure waveforms into electrical signals for display on monitoring equipment. This is a physiological measurement taken directly from the body (in vivo), not a test performed on a sample of biological material outside the body (in vitro).
- Device Description: The description explicitly states it's a "non-fluid pathway device" and that "fluid contact is limited to the dome portion of the system." IVD devices typically involve contact with biological fluids or tissues for analysis.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or diagnostic tests performed on samples.
Therefore, the MX960 reusable pressure transducer is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
74 DRS
Device Description
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.
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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity - µV/V/mmHg: 5.0 Nominal
Unbalance - mmHg: 0 ± 50
Zero Drift - mmHg:
§ 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
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.
1
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 | 200 |
| Calibration Requirement - mmHg | 100 ± 3 | 100 ± 3 | Not Specified |
| Accuracy - mmHg | meets or exceeds AAMI | meets or exceeds AAMI |