(70 days)
BMW's CVC-PICC is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.
BMW Medical, Inc.'s peripherally inserted central venous catheters are configured as long-term single lumen catheters. They 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 length and 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 proximal hub during aspiration of blood samples.
The provided text is a 510(k) Premarket Notification for a medical device and describes its equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a novel device would. Therefore, much of the requested information regarding sample size, expert ground truth, adjudication, MRMC studies, and training sets is not applicable to this type of submission.
However, I can extract the information provided regarding performance and equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Reduce potential for air embolism | "Performance data indicate that the BMW CVC-PIC catheter is at least as effective in minimizing these potentials as are the predicate devices..." |
| Reduce bleedback | "Performance data indicate that the BMW CVC-PIC catheter is at least as effective in minimizing these potentials as are the predicate devices..." |
| Valve function maintained after guide wire/stylet passage | "...even when a guide wire or stylet stiffener is passed through the valve located in the CVC-PICC hub. Studies have shown that repeated insertion and removal of the guide wires or stylet through the valve does not compromise its function." |
| No hemolysis of blood during aspiration | "No hemolysis of blood is observed when aspirating blood through BMW's valve..." |
| Low aspiration pressures | "...aspiration pressures are low." |
| Biocompatibility of hub material | "Published biocompatibility flow chart requirements indicate that the BMW's hub material meets biocompatibility requirements, and is therefore acceptable for use in this catheter application." |
| Catheter stiffness comparable to predicate | "Further, test data collected on the stiffness... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Elongation at break comparable to predicate | "Further, test data collected on the... elongation at break... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Radiopacity comparable to predicate | "Further, test data collected on the... radiopacity... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Flow rate comparable to predicate | "Further, test data collected on the... flow rate... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Tensile strength comparable to predicate | "Further, test data collected on the... tensile... strength... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Burst strength comparable to predicate | "Further, test data collected on the... burst strength... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Valve function comparable to predicate | "Further, test data collected on the... valve function... demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
| Leak test results comparable to predicate | "Further, test data collected on the... leak test data demonstrate that the BMW CVC-PICC is substantially equivalent to the predicate devices." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any tests, nor does it detail the provenance of the data (country, retrospective/prospective). The tests mentioned appear to be laboratory or bench tests ("performance data," "test data collected on") rather than clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a 510(k) submission based on engineering and performance testing for substantial equivalence, not a study requiring expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance appears to be based on established engineering standards and comparative performance against the predicate devices in various physical and functional tests. For biocompatibility, "published biocompatibility flow chart requirements" served as the standard.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
Not applicable.
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OCT 1 1996
BMW Medical Inc.'s Clampless Valved Catheter-PICC Premarket Notification
510 K SUMMARY Prepared: August 8, 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-PICC (CVC-PICC) Common Name: Peripherally Inserted Central Catheter (PICC) Classification Name: Long-Term Intravascular Catheter
4. Predicate Device(s):
Groshong Long-term PICC and HDC V-Cath® PICC.
5. Device Description:
BMW Medical has developed a peripherally inserted central venous catheter that provides the benefits of the valve incorporated at the distal top of the Groshong catheter on an open-ended PIC catheter. The BMW valve is external to the central venous system and is protected inside the catheter adapter.
BMW Medical, Inc.'s peripherally inserted central venous catheters are configured as long-term single lumen catheters. They 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 length and diameter to accommodate specific patient populations.
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BMW Medical Inc.'s Clampless Valved Catheter-PICC 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 proximal hub during aspiration of blood samples.
6. Intended Use:
BMW's CVC-PICC is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, 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 peripherally inserted central venous catheter that provides the benefits of the valve incorporated at the distal tip of Groshong catheter on an open-ended PIC catheter similar to the V-Cath® 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 the central venous system and continuous direct blood contact that can potentially interfere with the function of valves continually exposed to blood flow. Additionally, BMW's CVC-PICC's are trimmed from the distal end, whereas the Groshong PICC's 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-PICC 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-PICC incorporates fixed suture wings (predicate devices have removable suture wings) and integral extension tubing, Because the extension
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BMW Medical Inc.'s Clampless Valved Catheter-PICC Premarket Notification
tubing is attached to the BMW CVC-PICC's, the priming volume of the BMW catheter is greater than that of the predicate devices.
BMW's catheter adapter (hub) is fabricated from a medical grade plastic that is not identical to that of the predicate devices. This material has been used for purposes identical to those intended for BMW's CVC-PICC in other products.
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 BMW CVC-PIC 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 located in the CVC-PICC hub. 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 the 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-PICC is substantially equivalent to the predicate devices.
Based on the above and physical comparisons, the BMW CVC-PICC is substantially equivalent to the predicate devices, the Bard Groshong PICC, and HDC's V-Cath® PICC.
9. Conclusion
BMW's CVC-PIC catheters are substantially equivalent to Bard's Groshong PICC's and HDC Corp.'s V-Caths®.
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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.”