(80 days)
Bard Access Systems, Inc., (Bard) Groshong Multi-Lumen Central Venous Catheters and Hickman Multi-Lumen Central Venous Catheters.
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No
The device description and performance studies focus on the physical characteristics and mechanical function of a central venous catheter and its valve, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a central venous catheter used for administering fluids and withdrawing blood samples, which are supportive functions for medical treatment rather than direct therapeutic actions to treat a disease.
No
The device is a central venous catheter used for administering fluids and withdrawing blood. It is a therapeutic and access device, not a diagnostic one.
No
The device description clearly details physical components made of silicone rubber and plastic, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Function: The BMW multi-lumen central venous catheter is designed to be inserted into the central venous system of a patient. Its purpose is to administer fluids and withdraw blood from the patient's body.
- Intended Use: The intended use clearly describes the administration of substances into the patient and the withdrawal of blood from the patient. This is an in-vivo (within the living body) application, not an in-vitro (outside the living body) diagnostic test.
While the device is used for blood specimen withdrawal, the device itself is not performing a diagnostic test on the blood. It is simply facilitating the collection of the sample. The diagnostic testing would be performed separately on the collected blood specimen using other IVD devices.
N/A
Intended Use / Indications for 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.
Product codes
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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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
central venous system
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 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.
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.
Bard Access Systems, Inc., (Bard) Groshong Multi-Lumen Central Venous Catheters and Hickman Multi-Lumen Central Venous Catheters.
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.
Not Found
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).
Not Found
§ 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 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.
1
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.
2
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.