(90 days)
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No
The device description and performance studies focus on the mechanical and material properties of a catheter and valve, with no mention of AI or ML technologies.
No.
A CVC Midline catheter is used to deliver fluids and withdraw blood specimens, which are functions related to patient care but do not directly treat a disease or medical condition.
No
Explanation: The device is a catheter designed for administering fluids and withdrawing blood samples. While blood specimen withdrawal is a step in diagnostics, the device itself "establishes peripheral venous access" and does not perform any diagnostic analysis or provide diagnostic information. Its function is to facilitate access for other diagnostic procedures or treatments.
No
The device description clearly details a physical catheter made of silicone rubber tubing with a plastic adapter and a silicone rubber valve. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for establishing peripheral venous access for administering fluids and withdrawing blood specimens from the patient. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic sampling purposes, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter designed to be inserted into a vein. It facilitates the flow of substances into and out of the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze or test biological samples in vitro. It doesn't contain reagents, test strips, or any components typically associated with IVD devices.
In summary, the BMW CVC Midline catheter is a medical device used for accessing the peripheral venous system for therapeutic and diagnostic purposes in vivo, not for performing diagnostic tests in vitro.
N/A
Intended Use / Indications for Use
BMW's CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children, and infants who require peripheral intravenous therapy.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
BMW Medical has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong PIC catheter on an open-ended midline catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter. BMW Medical, Inc.'s midline catheters are single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in diameter to accommodate specific patient populations. A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting. The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the female luer of the proximal hub during aspiration of blood samples.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adults, children, and infants
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data indicate that the valve included in the hub of the BMW CVC Midline catheter is at least as effective in minimizing air embolism and bleedback as are the predicate devices, even when a guide wire or stylet stiffener is passed through the valve. In addition, no hemolysis of blood is observed when aspirating blood through BMW's valve, and aspiration pressures are low. Published biocompatibility flow chart requirements indicate that BMW's hub material meets biocompatibility requirements. Test data collected on the stiffness, elongation at break, radiopacity, flow rate, and tensile and burst strength of the catheter, valve function, and leak test data demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
C. R. Bard, Inc., Groshong Peripherally Inserted Central Venous Catheter and HDC Corp.'s V-Cath® Midline Catheter.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
BMW Medical, Inc.'s Clampless Valved Catheter-Midline (CVC-ML) Premarket Notification
510 K SUMMARY Prepared: August 8, 1996
1. Submitted by:
NOV 1 4 1996
Phil Triolo, Ph. D. V. P. Research and Development BMW Medical, Inc. 3598 West, 1820 South Salt Lake City, UT 84104-4959
Tel: (801) 954-8444, (800) 418-2828 Fax: (801) 954-8484.
2. Contact Person:
Phil Triolo, Ph. D. V. P. Research and Development
3. Device Identification:
| Trade Name: | CVC-Midline Catheter |
|---|---|
| Common Name: | Peripheral Catheter (midline catheter) |
| Classification Name: | Intravascular Catheter |
4. Predicate Device(s):
C. R. Bard, Inc., Groshong Peripherally Inserted Central Venous Catheter and HDC Corp.'s V-Cath® Midline Catheter.
5. Device Description:
BMW Medical has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong PIC catheter on an open-ended midline catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter.
BMW Medical, Inc.'s midline catheters are single lumen catheters. They are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO2) prior to extrusion to impart radiopacity. The catheters vary in diameter to accommodate specific patient populations.
1
BMW Medical, Inc.'s Clampless Valved Catheter-Midline (CVC-ML) Premarket Notification
A 2-piece plastic adapter is attached to the proximal end of each single lumen catheter. The catheter is mechanically locked onto the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows attachment of the catheter to a male luer fitting.
The adapter houses a slitted disc of silicone rubber which serves as a three-way valve. The valve remains closed when the catheter is not in use. The valve opens inward toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens outward toward the female luer of the proximal hub during aspiration of blood samples.
6. Intended Use:
BMW's CVC Midline catheter is designed to establish peripheral venous access for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.
This product is effective for venous access in adults, children, and infants who require peripheral intravenous therapy.
7. Summary of Technological Characteristics of Device in relation to Predicate Device(s):
BMW Medical, Inc. has developed a midline catheter that provides the benefits of the valve incorporated at the distal tip of Groshong catheters on an open-ended midline catheter similar to the V-Cath® Midline marketed by HDC Corp. The BMW valve is external to the central venous system and is protected inside the catheter adapter. This configuration provides the advantages of a normally closed three-way valve while avoiding the influences of continuous direct blood contact that can potentially interfere with the function of valves positioned in the vasculature.
BMW's CVC midlines are trimmed from the distal end, whereas the Groshong catheters are trimmed from the proximal end, necessitating final attachment of the Groshong catheter to the hub by the user.
Because the BMW valve is located in the CVC Midline hub, use of a stylet stiffener or guide wire during catheter placement requires that the stiffener or guide wire pass through the valve. Studies have shown that repeated insertion and removal of the guide wires or stylet through the valve does not compromise its function.
The BMW CVC Midline incorporates fixed suture wings (predicate devices have removable suture wings) and integral extension tubing, Because the extension tubing is attached to the BMW CVC Midlines, the priming volume of the BMW catheter is greater than that of the predicate devices.
2
BMW Medical, Inc.'s Clampless Valved Catheter-Midline (CVC-ML) Premarket Notification
BMW's midline catheter adapter (hub) is fabricated from a medical grade plastic that is not identical to that of the predicate devices. This medical grade material has been used on legally marketed devices for purposes identical to those intended for BMW's CVC Midline catheters.
8. Assessment of Performance Data used to justify Substantial Equivalence Claim
The primary advantages afforded by valved catheters are that they reduce the potential for air embolism and bleedback. Performance data indicate that the valve included in the hub of the BMW CVC Midline catheter is at least as effective in minimizing these potentials as are the predicate devices, even when a guide wire or stylet stiffener is passed through the valve. In addition, no hemolysis of blood is observed when aspirating blood through BMW's valve, and aspiration pressures are low.
Published biocompatibility flow chart requirements indicate that BMW's hub material meets biocompatibility requirements, and is therefore acceptable for use in this catheter application.
Further, test data collected on the stiffness, elongation at break, radiopacity, flow rate, and tensile and burst strength of the catheter, valve function, and leak test data demonstrate that the BMW CVC Midline is substantially equivalent to the predicate HDC V-Cath ® Midline and Bard Groshong PIC catheters.
Based on the above and physical comparisons, the BMW CVC Midline catheter is substantially equivalent to a device combining the performance characteristics of the valved Bard Groshong PIC catheter with the physical performance of HDC's V-Cath® Midline catheter.
9. Conclusion
BMW's CVC Midline catheters are substantially equivalent to a device combining the performance characteristics of the valved Bard Groshong PIC catheter with the physical performance of HDC's V-Cath® Midline catheter.