(238 days)
Not Found
No
The summary describes a combination product for pressure monitoring and central venous access, focusing on hardware components and performance metrics related to pressure measurement and catheter function. There is no mention of AI, ML, or any computational analysis of the pressure data that would suggest the use of such technologies.
No.
The device is used for continuous measurement of blood pressure and for short-term peripheral access to the central venous system, which are diagnostic and access functions, not therapeutic.
No
Explanation: The device is described as a "pressure monitoring system" intended for "continuous measurement of blood pressures or other physiological pressures" and a "catheter" for "short term peripheral access to the central venous system." While it measures physiological parameters, its primary stated purpose isn't to diagnose a condition but rather to monitor and provide access.
No
The device description explicitly lists hardware components such as a blood pressure monitoring line, disposable pressure transducer, and catheter. The performance studies also focus on hardware-related testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "continuous measurement of blood pressures or other physiological pressures" and "short term peripheral access to the central venous system." This describes a device used in vivo (within the body) for monitoring and access, not for testing samples in vitro (outside the body).
- Device Description: The components listed (pressure monitoring line, transducer, catheter) are all consistent with a device used for physiological monitoring and vascular access within a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
Product codes (comma separated list FDA assigned to the subject device)
DRS, LJS
Device Description
The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:
- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap
The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.
The product is sold sterile, single use, and non-pyrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
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)
Non Clinical Data Summary:
Sensor Testing:
Standard: ANSI/AAMI BP-22, 1994
Acceptance Criteria:
Operating Pressure Range: -50 mmHg to +300 mmHg
Sensitivity: 5µV/V/mmHg, +/- 2% (typically 500 hours
Storage Temperature: -25 C to +65 C
Defibrillation Withstand: 5 discharges/5 minutes of 360 joules @ 50 Ω load)
Natural Frequency: > 20 Hz in saline
Phase Shift: 20 Hz
Phase Shift:
§ 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
Attachment 1
DEC 2 2 2010
న్. 510(k) Summary
(10118 Trade Name: ReavillMED Pressure Monitoring System Common Name: Blood Pressure Monitoring/Transducer Peripheral Inserted Central Catheter Intravascular Catheter Classification Name: Extravascular blood pressure transducer 21 CFR 870.2850. This device is categorized as DRS and is regulated as Class II. . Percutaneous, implanted, long-term intravascular catheter 21 CFR 880.5970. This device is categorized as LJS and is regulated as Class II. Intravascular catheter 21 CFR 880.5200. This device is categorized as LJS and is regulated as Class II. ー ReavillMED LLC Submitter Information: 888 E. Belvidere Rd., Suite 212 Grayslake, IL 60030 USA Tel: 847-856-0355 Fax: 847-856-0355 Michele Vovolka Summary Prepared By: President, Vantage Consulting International, Ltd. Date Prepared: December 1, 2010 Predicate Devices: Utah Pressure Monitoring Device (K842352) Utah Disposable Pressure Transducer (K841788) Bard POLY PER-Q-CATH PICC CATHETERS: POLY RADPICC (K031129) UMBILI-CATH-P (K940871)
Device Description:
The ReavillMED pressure monitoring device is a combination product consisting of the following components within a single device:
- . Blood pressure monitoring line and end cap
- . Disposable pressure transducer
- Single lumen polyurethane reverse taper catheter .
- . Catheter hub with suture wing tabs and slip tip cap
The single lumen catheter is packaged within a pressure monitoring line to maintain a sterile environment. A transducer is attached to the distal end of the monitoring line.
The product is sold sterile, single use, and non-pyrogenic.
Indications for Use:
The ReavillMED product is combination product containing a pressure monitoring system and a peripherally inserted central catheter. The pressure monitoring system is intended for continuous measurement of blood pressures or other physiological pressures. The catheter is intended for short term peripheral access to the central venous system.
1
Attachment 1
Technological Characteristics:
The technological characteristics of the ReavillMED device are compatible to those of the following predicate devices.
Utah Medical Disposable Pressure Transducer (K841788):
| • Intended use | • Unbalance | • Phase shift |
|---|---|---|
| • Sensor materials | • Overpressure protection | • Output impedance |
| • Wire connector material | • Operating temperature | • Input impedance |
| • Housing assembly materials | • Excitation voltage & frequency | • Sterility |
| • Operating pressure range | • Operating life | • Leakage current |
| • Sensitivity | • Storage temperature | • Natural frequency |
| • Zero drift with time | • Defibrillation withstand | |
| Utah Medical Pressure Monitoring Line (K842352): | ||
| • Intended use | • Dimensions | • Sterility |
| • Tubing connectors material | • Hardness | • Performance |
| • Pressure tubing material | ||
| Poly RADPICC (K031129): | ||
| • Intended Use | • Sterility | • Dimensional diameter and length |
| • ISO 10553 Parts 1 and 3 | ||
| UMBILI-CATH-P (K940871): | ||
| • Intended Use | • Sterility | • Contact duration |
- · Material
- · Sterility
- · ISO 10553 Parts 1 and 3
Non Clinical Data Summary:
The following testing was performed on the ReavillMED Blood Pressure Monitoring Device
| Testing Performed | Standard | Acceptance Criteria | Results |
|---|---|---|---|
| Sensor Testing | ANSI/AAMI BP-22, 1994 | Operating Pressure Range: -50 | |
| mmHg to +300 mmHg | |||
| Sensitivity: 5µV/V/mmHg, +/- 2% | |||
| (typically 500 hours | |||
| Storage Temperature: -25 C to +65 C | |||
| Defibrillation Withstand: 5 | |||
| discharges/5 minutes of 360 joules @ | |||
| 50 Ω load) | |||
| Natural Frequency: > 20 Hz in saline | |||
| Phase Shift: |