(80 days)
BMW's multi-lumen central venous catheters have the same intended use as Bard Access Systems' Groshong long-term central venous catheters, and Bard's Hickman preamendment long-term central venous catheters.
BMW's Clampless Valved Catheter-Tunneled is designed for patients who require long-term access to the central venous system for administration of fluids including, but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, 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 intravenous therapy.
BMW Medical has developed a catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong catheter on an open-ended catheter. The BMW valve is external to the central venous system and is protected inside the rigid catheter adapter.
BMW Medical, Inc.'s multi-lumen catheters are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO,) prior to extrusion to impart radiopacity. The catheters vary in diameter and number of lumens to accommodate specific applications.
A silicone rubber joint permanently attaches the multi-lumen catheter tubing to the 2 or 3 legs required to access each lumen of a dual or a triple lumen catheter. A 2-piece rigid plastic adapter is attached to the proximal end of each single lumen leg. Each leg is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows for 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 toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens toward the female luer of the proximal hub during aspiration of blood samples.
The provided text is a 510(k) summary for a medical device (BMW Medical, Inc.'s Multi-Lumen Clampless Valved Catheter-Tunneled) and does not contain the information requested in your bullet points regarding acceptance criteria and a study proving a device meets them in the context of an AI/ML device.
The document describes a physical medical device (a catheter) and its comparison to predicate devices, focusing on physical properties, materials, and basic functional performance like flow rate and leak tests. It's a premarket notification for a traditional medical device, not an AI/ML diagnostic or assistive tool.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance (for AI/ML performance): The text discusses "performance data" for the catheter's valve (reducing air embolism, bleedback, no hemolysis, low aspiration pressures) and physical properties (stiffness, elongation, radiopacity, flow rate, tensile/burst strength). However, these are for a physical device, not an AI algorithm.
- Sample sized used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone performance was done: Not applicable (for AI).
- The type of ground truth used: For the physical device, it's about physical measurements and functional characteristics against established standards or predicate devices, not "ground truth" as understood in AI/ML.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document describes the regulatory submission for a physical medical device (a catheter) and therefore does not contain the information you requested about acceptance criteria and studies related to an AI/ML device's performance.
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BMW Medical, Inc.'s Multi-Lumen Clampless Valved Catheter-Tunneled (CVC-Tunneled) Premarket Notification
510 K SUMMARY
Prepared: Sept. 11, 1996
K963806
Dec. 12, 1996
1. Submitted by:
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: Clampless Valved Catheter-Tunneled (CVC-T Multi-lumen Central Venous Catheter Common Name: Classification Name: Intravascular Catheter, Long-term
4. Predicate Device(s):
Bard Access Systems, Inc., (Bard) Groshong Multi-Lumen Central Venous Catheters and Hickman Multi-Lumen Central Venous Catheters.
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BMW Medical, Inc.'s Multi-Lumen Clampless Valved Catheter-Tunneled (CVC-Tunneled) Premarket Notification
5. Device Description:
BMW Medical has developed a catheter that provides the benefits of the valve incorporated at the distal tip of the Groshong catheter on an open-ended catheter. The BMW valve is external to the central venous system and is protected inside the rigid catheter adapter.
BMW Medical, Inc.'s multi-lumen catheters are composed of extruded silicone rubber tubing which is homogeneously mixed with barium sulfate (BaSO),) prior to extrusion to impart radiopacity. The catheters vary in diameter and number of lumens to accommodate specific applications.
A silicone rubber joint permanently attaches the multi-lumen catheter tubing to the 2 or 3 legs required to access each lumen of a dual or a triple lumen catheter. A 2-piece rigid plastic adapter is attached to the proximal end of each single lumen leg. Each leg is mechanically locked onto the barbed end of the adapter with a silicone rubber sleeve. The other end of the adapter terminates in a female luer which allows for 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 toward the distal tip of the catheter when fluids are infused into the patient via the catheter, and it opens toward the female luer of the proximal hub during aspiration of blood samples.
6. Intended Use:
BMW's multi-lumen central venous catheters have the same intended use as Bard Access Systems' Groshong long-term central venous catheters, and Bard's Hickman preamendment long-term central venous catheters.
BMW's Clampless Valved Catheter-Tunneled is designed for patients who require long-term access to the central venous system for administration of fluids including, but not limited to, hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, 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 intravenous therapy.
7. Summary of Technological Characteristics of Device in relation to Predicate Device(s):
BMW Medical, Inc. has developed a multi-lumen tunneled central venous catheter that provides the benefits of the valve incorporated at the distal tip of Bard's multilumen Groshong catheters on an open-ended catheter similar to Bard's Hickman multi-lumen central venous catheters. 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.
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BMW Medical, Inc.'s Multi-Lumen Clampless Valved Catheter-Tunneled (CVC-Tunneled) Premarket Notification
BMW's Multi-lumen tunneled CVCs are trimmed from their distal ends whereas the Groshong legs may be trimmed from the proximal ends, necessitating final attachment of the Groshong catheters to their hubs by the user.
BMW's 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 Multi-lumen CVCs.
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 Multi-lumen CVC-Tunneled is at least as effective in minimizing these potentials as are the predicate devices. 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 Multi-lumen CVC-Tunneled is substantially equivalent to the predicate Hickman and Groshong multi-lumen central venous catheters manufactured by C. R. Bard.
Based on the above and physical comparisons, BMW's Multi-lumen Clampless Valved Catheter-Tunneled products were found to exhibit physical features and performance and safety characteristics which fall within the range of values typically found for Bard's open-ended Hickman catheters and valved Groshong catheters.
9. Conclusion
The BMW Clampless Valved Catheter-Tunneled products are substantially equivalent to Bard's valved Groshong and open-ended Hickman catheters.
§ 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.”