CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)

K963097 · Bmw Medical, Inc. · LJS · Oct 18, 1996 · General Hospital

Device Facts

• Record ID: K963097
• Device Name: CLAMPLESS VALVED CATHETER-PICC (CVC-PICC)
• Applicant: Bmw Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Oct 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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.

Device Story

CVC-PICC is a long-term, single-lumen, peripherally inserted central venous catheter. Device consists of extruded silicone rubber tubing mixed with barium sulfate for radiopacity; proximal end features a 2-piece plastic adapter housing a slitted silicone rubber three-way valve. Valve remains closed when inactive; opens inward for infusion and outward for blood aspiration. Unlike predicate devices with distal valves, BMW valve is located externally within the catheter hub, protecting it from continuous central venous blood contact. Catheter is trimmed from the distal end during placement. Device allows passage of stylet stiffeners or guide wires through the valve without compromising function. Used by clinicians for venous access; provides benefits of reduced air embolism and bleedback risk.

Clinical Evidence

Bench testing only. Data includes performance evaluations of valve function, leak testing, flow rates, tensile and burst strength, radiopacity, and material biocompatibility. Studies confirmed that repeated insertion/removal of guide wires or stylets through the hub-based valve does not compromise function. Aspiration testing showed no hemolysis and low aspiration pressures.

Technological Characteristics

Single-lumen catheter composed of silicone rubber with barium sulfate (BaSO4) for radiopacity. Features a 2-piece medical-grade plastic adapter (hub) containing a slitted silicone rubber three-way valve. Includes fixed suture wings and integral extension tubing. Mechanical operation; no energy source or software.

Indications for Use

Indicated for adults, children, and infants requiring peripheral access to the central venous system for fluid administration (hydration, antibiotics, chemotherapy, analgesics, nutrition, blood products) and blood specimen withdrawal.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Predicate Devices

• Groshong Long-term PICC
• HDC V-Cath® PICC

Submission Summary (Full Text)

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OCT 10 1996
K 963097

# 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: [phone]
Fax: [phone]

### 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 (BaSO₄) 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®.