(316 days)
Not Found
No
The device description focuses on mechanical components and fluid dynamics, with no mention of AI/ML terms or functionalities.
No.
The device maintains catheter patency and aids in monitoring line functions, but it does not directly treat a disease or condition. Its primary function is to facilitate fluid flow within a monitoring system.
No
The device is described as an accessory to a catheter-transducer system that permits continuous flow to maintain catheter patency, and its functions are related to managing fluid flow and pressure within such systems (e.g., fast flush, pressure spike for system verification, over-pressure protection), not to diagnose a medical condition.
No
The device description clearly outlines physical components (seven small components ultrasonically welded together) and mechanical functions (continuous flow, fast flush feature, pressure spike, pressure relief capability). This indicates a hardware-based 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 maintain catheter patency by providing a continuous flow of fluid. This is a mechanical function related to the delivery of fluid and maintaining an open pathway, not for performing tests on biological samples to diagnose or monitor a medical condition.
- Device Description: The description focuses on the physical components, flow rates, pressure capabilities, and mechanical features (fast flush, pressure spike, pressure relief). There is no mention of analyzing biological samples or generating diagnostic information.
- Lack of IVD Characteristics: The description does not include any elements typically associated with IVDs, such as:
- Reagents
- Assays
- Measurement of analytes in biological samples (blood, urine, tissue, etc.)
- Diagnostic interpretation of results
The device is an accessory to a catheter-transducer system, which is used for pressure monitoring, but the flush device itself is a fluid management component, not a diagnostic one.
N/A
Intended Use / Indications for Use
A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.
Product codes
74DRS
Device Description
The flush device is comprised of seven small components which, when ultrasonically welded together, constitute the finished product. The device is supplied in two configurations; adult and neonate. The adult configuration differs from the neonate configuration by flow rate and color. The adult flow specification is a nominal 3 milliliters per hour (ml/hr) with a static head pressure of 250 millimeters of mercury (mmHg). The neonate flow specification is a nominal 30 ml/hr at 250 mmHg static head pressure.
The device has a fast flush feature which can be momentarily actuated by squeezing the tabs on either side of the device. The fast flush feature is used to aid in filling and debubbling the pressure monitoring lines.
The device has the capability of creating a momentary pressure spike to verify the frequency response of the pressure monitoring system. The pressure spike is created by pulling up and releasing (snapping) the pull tab on top of the device.
The device incorporates a pressure relief capability to provide over-pressure protection to the transducer. At pressures greater than 600 mmHg (11.6 psi), the silastic control component stretches and allows fluid to by-pass the flow restrictor thereby providing over-pressure protection.
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
Adult, Neonate
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Merit Medical. The logo consists of a black square with three white diagonal lines inside, followed by the word "MERIT" in black and the word "MEDICAL" in white with black outlines. The logo is simple and modern, and it is likely used to represent the company's brand.
Merit Medical Systems, Summary of Safety and Effectiveness, Flush Device, Page 1
APR 1 5 1997
510(k) SUMMARY OF SAFETY and EFFECTIVENESS
| Date of Summary: | May 31, 1996 | MERIT MEDICAL | |
|---|---|---|---|
| Submitter's name: | Merit Medical Systems, Inc. | ||
| 1600 West Merit Parkway | |||
| South Jordan, UT 84095-2415 | |||
| (801) 253-1600 | SYSTEMS, INC. | ||
| Contact Person: | Dennis (Dan) Reigle | 1600 WEST | |
| Name of device: | Continuous Flush Device | MERIT PARKWAY | |
| Class: | Class II | SOUTH JORDAN, | |
| Classification name: | The flush device is an accessory to an extravascular | ||
| blood pressure transducer (product code 74DRS). | UTAH 84095 | ||
| Predicate device: | Predicate devices are flush device manufactured by: | ||
| Spectramed, Inc. | |||
| Critical Care Division | |||
| 1900 Williams Blvd | |||
| Oxnard, CA 93030 | |||
| (800) 235-5945 | Baxter Healthcare Corporation | ||
| Edwards Critical Care Division | |||
| 17221 Red Hill Avenue | |||
| Irvine, CA 92714 | |||
| (800) 424-3278 | 801-253-1600 | ||
| FAX 801-253-1651 |
INDICATIONS FOR USE
A continuous flush device is an accessory to a catheter-transducer system that permits a continuous flow to maintain catheter patency.
DEVICE DESCRIPTION
The flush device is comprised of seven small components which, when ultrasonically welded together, constitute the finished product. The device is supplied in two configurations; adult and neonate. The adult configuration differs from the neonate configuration by flow rate and color. The adult flow specification is a nominal 3 milliliters per hour (ml/hr) with a static head pressure of 250 millimeters of mercury (mmHg). The neonate flow specification is a nominal 30 ml/hr at 250 mmHg static head pressure.
1
The device has a fast flush feature which can be momentarily actuated by squeezing the tabs on either side of the device. The fast flush feature is used to aid in filling and debubbling the pressure monitoring lines.
The device has the capability of creating a momentary pressure spike to verify the frequency response of the pressure monitoring system. The pressure spike is created by pulling up and releasing (snapping) the pull tab on top of the device.
The device incorporates a pressure relief capability to provide over-pressure protection to the transducer. At pressures greater than 600 mmHg (11.6 psi), the silastic control component stretches and allows fluid to by-pass the flow restrictor thereby providing over-pressure protection.
| Feature | Merit Flush Device | Spectramed Flush Device | Baxter Flush Device |
|---|---|---|---|
| Intended Use | For use in physiological | ||
| pressure measurements | |||
| which require | |||
| continuous flow to | |||
| maintain catheter | |||
| patency. | For use in physiological | ||
| pressure measurements | |||
| which require | |||
| continuous flow to | |||
| maintain catheter | |||
| patency. | For use in physiological | ||
| pressure measurements | |||
| which require | |||
| continuous flow to | |||
| maintain catheter | |||
| patency. | |||
| Adult flow | |||
| rate | $3\pm1$ ml/hr @ 250 | ||
| mmHg pressure | $3\pm1$ cc/hr @ 300 | ||
| mmHg | $3\pm1$ ml/hr (blue Snap- | ||
| Tab™) | |||
| Neonate flow | |||
| rate | $30\pm10$ ml/hr @ 250 | ||
| mmHg pressure | 30 cc/hr | $30\pm10$ ml/hr (yellow | |
| Snap-Tab™) | |||
| Fast flush | |||
| mode | Yes | Yes | Yes |
| Bypass | |||
| pressure | >600 mmHg (11.6 psi) | Yes - unknown bypass | |
| pressure | Yes - >500 mmHg | ||
| (9.7 psi) | |||
| Sterilization | Ethylene Oxide Gas | Ethylene Oxide Gas | Ethylene Oxide Gas |
| Single Use | Yes | Yes | Yes |
| Pyrogen Free | Yes | Yes | Yes |
| Packaging | Tyvek™ pouch | Tyvek™ pouch | Tyvek™ pouch |
| Step | |||
| response | |||
| capability | Yes - via pull tab | Yes - by bouncing lever | Yes - via the Snap-Tab™ |
| Adult Colors | Adult devices supplied | ||
| with squeeze tabs in | |||
| white, red, blue or | |||
| green. | Different models for | ||
| adults, neonate | |||
| applications | Blue color | ||
| Neonate | |||
| Colors | Neonate devices | ||
| supplied with squeeze | |||
| tabs in yellow color. | Different models for | ||
| adults, neonate | |||
| applications | Yellow color | ||
| 510k | This submission | K873168 | K792141 |