(551 days)
The DSPM-70 Blood Pressure Measurement System is suitable for measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used for management of intraoperative and post-surgical critically ill patients. The information measured is suitable for use in derivation of blood pressure parameters such as heart rate, systolic pressure, diastolic pressure, and mean pressure, Not to be used where there is the potential for accidental entry of the catheter into the heart or other site in the body where patient safety may be compromised. The transmitter portion of the product is intended to be secured to the skin with tape with the distal tip of the pressure sensing catheter placed in the vasculature at a physician specified site. The system is intended to be limited to use in a single patient for less than 7 days. The external equipment may be reused. While the DSPM-70 is indicated for 7 days use, research has shown that in some patient populations, risk of infection increases when indwelling catheters remain in use for longer than 72 hours. Duration of use should be determined by institutional guidelines and consideration of various sources of risk to the patient. The DSPM-70 has no feature that provides the ability to draw blood from the patient. [ 4 French models: ] Intended for use on critically ill intra-operative and postsurgical patients at sites suitable for insertion of a 4 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.061 inches such as the Terumo Medical model SR-OX1451CA 14 Ga x 2 inch Surflo I.V. Catheter. Introducer sheath should remain in place after insertion. Not intended for neonatal use. [2 French models:] Intended for use on critically ill intra-opcrative and postsurgical patients at sites suitable for insertion of a 2 French intravascular catheter under intensive nursing and physician care. Use an introducer sheath with an inside diameter of 0.034 inches such as the Terumo Medical model SR-OX1832CA 18 Ga x 1 1/4 inch Surflo I.V. Catheter. Introducer sheath should remain in place after inscrtion. Neonatal applications are limited to femoral artery use only.
The DSI Blood Pressure Measurement System (DSPM-70) consists of the following components: 1. Pressure Transmitter with Catheter 2. External Data Receiver 3. Analog Adapter 4. Ambient Pressure Reference 5. External Power Supply 6. Signal Detector 7. Replacement Gcl. The pressure transmitter is a small anatomically disc-shaped device that houses the power source (battery), circuitry, RF coil and pressure sensing diaphragm. The transmitter device is intended to be placed during surgery on the chest and secured with tape. It is a short duration non-permanent product. A small diameter catheter is integrated with the transmitter and functions as the pressure conduit between the blood stream and the device. This catheter is filled with a fluid and the distal tip is sealed with a biocompatible gel. The gel transmits the pressure of the blood to the internal catheter fluid which, in turn, transmits the pressure to the device. The External Data receiver contains a specific RF antennae which receives the signals from the transmitter. The data from the device is received and recorded for physician use. The external receiver does not process the data or make any data calculations. The external unit is powered by the Power Supply. The Analog Adapter is an interface between the single channel transmitter and external analog recording instruments. The Analog Adapter along with the Ambient Pressure Reference discussed below, provide a calibrated analog signal allowing easy connection to most computerized data acquisition systems or strip chart recorders. The Ambient Pressure Reference component of the system provides continuous measurement of ambient barometric pressure. Continuous patient blood pressure is the difference between the pressure measured by the device and the ambient barometric pressure in the room. The power supply is a 110 VAC adapter that plugs into a standard outlet and connects to the receiver. The power supply is rated at 110 VAC and 60 Hz. It has been designed to meet UL and CSA requirements. The signal detector is a device that can be used by the physician as a tool to determine if the device is operating or in standby mode. The transmitter operates at a specific frequency range that is detected by the signal detector. If the signal is detected, the signal detector emits an audible tone.
The provided document is a 510(k) Summary for the DSI Blood Pressure Measurement System (DSPM-70). It focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria.
Therefore, the requested information cannot be fully extracted from the provided text. Specifically, there is no mention of:
- Acceptance Criteria and Reported Device Performance: No specific performance metrics or acceptance criteria are listed.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication): The document does not describe any specific studies with test sets, ground truth establishment, or expert involvement.
- MRMC Comparative Effectiveness Study: There is no mention of such a study.
- Standalone Performance Study: No details about an algorithm-only (standalone) performance study are provided.
- Ground Truth Type: As no study is described, the type of ground truth used is not mentioned.
- Training Set Sample Size and Ground Truth Establishment: These details are relevant for AI/ML devices, but this document describes a physical medical device and its components, not an AI model.
What can be extracted from the document related to substantial equivalence, which is a form of demonstrating acceptability:
The document aims to establish substantial equivalence of the DSPM-70 to an existing legally marketed device, the Mikro-Tip Catheter Pressure Transducer by Millar Instruments, Inc.
Summary of Substantial Equivalence (as substitute for acceptance criteria and proof of meeting them):
| Feature/Criterion | Predicate Device (Millar Mikro-Tip Catheter Pressure Transducer) | DSPM-70 (DSI Blood Pressure Measurement System) | Determination from Document |
|---|---|---|---|
| Clinical Indications for Use | Same (Implicitly, as DSPM-70 is for measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used) | Measurement of real-time blood pressure data wherever indwelling blood pressure catheters and transducers are currently used for management of intraoperative and post-surgical critically ill patients. | Substantially Equivalent |
| Basic Overall Function | Measures intra-vascular pressure. Data monitored and recorded on an external unit. | Monitors intra-vascular pressure. Data monitored and recorded on an external unit. | Substantially Equivalent |
| Methods of Manufacturing | Substantially Equivalent | ||
| Materials Used | Biocompatible materials | All materials used are biocompatible and have been used in numerous previously cleared products. | Substantially Equivalent |
This table represents the "acceptance criteria" and "reported device performance" in the context of a 510(k) submission focused on substantial equivalence. The "study" proving it meets these (equivalence) criteria is the comparison presented in the 510(k) document itself, where the submitter asserts that the clinical indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.
Regarding other points:
- Sample size and data provenance: Not applicable as no performance study data is presented. The document is a regulatory submission, not a study report.
- Number of experts and qualifications: Not applicable. The determination of substantial equivalence is made by the FDA based on the comparison provided in the 510(k), not on expert consensus for a test set.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone performance: Not applicable.
- Type of ground truth: Not applicable.
- Training set sample size and how ground truth was established: Not applicable, as this is a physical device submission, not an AI/ML device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).