(69 days)
Not Found
No
The device description focuses on mechanical seals and manual operation, with no mention of AI/ML terms or functionalities.
No
The device is a control valve designed to maintain hemostasis and prevent fluid loss during interventional procedures, not to treat a disease or condition.
No
The device is a control valve used with diagnostic/interventional devices, not a diagnostic device itself.
No
The device description clearly describes a physical valve with mechanical components (clamp seal, BBC seal, cap) and mentions pressure injections, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain hemostasis (control bleeding) during the introduction and withdrawal of diagnostic/interventional devices within the vasculature. This is a function performed in vivo (within the living body) during a medical procedure.
- Device Description: The description details a mechanical valve designed to create a seal around devices entering the body. This is a physical barrier function, not a diagnostic test performed on a sample in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The COPILOT™ Bleedback Control Valve's function is purely procedural and related to controlling bleeding during an interventional procedure.
N/A
Intended Use / Indications for Use
The COPILOT™ Bleedback Control Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic/interventional devices.
The COPILOT™ Bleedback Control Valve is indicated for maintaining a seal around diagnostic/interventional devices with an outside diameter
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Attachment B - 510(k) Summary
| Submitter | Guidant Corporation, Vascular Intervention
Advanced Cardiovascular Systems, Inc.
26531 Ynez Road, Temecula CA 92591
Contact: Stacey Simon
Phone: (909) 914-4527, Fax: (909) 914-6690 |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date | May 26, 1999 |
| Device name | Device Trade Name: COPILOT™ Bleedback Control Valve
Device Common Name: Hemostatic Valve
Device Classification Name: Adaptor, Stopcock, Manifold, Fitting,
Cardiopulmonary Bypass
Device Classification: Class II |
| Summary of
substantial
equivalence | The design, materials, method of operation, and intended use features
of the Guidant COPILOT™ Bleedback Control Valve are substantially
equivalent with regard to these features in the predicate device, the
ACS .096" Rotating Hemostatic Valve (K854261). |
| Device
description | The COPILOT™ Bleedback Control Valve has a 0.096" (2.44 mm)
inside diameter. This device has two seals that operate independently:
the clamp seal and the bleedback control (BBC) seal. The clamp seal
can be opened or closed by rotating the cap. Closing of the clamp seal
allows for pressure injections up to 400 psi and also secures the
diagnostic/interventional device in position within the vasculature.
The BBC seal is a diaphragm seal that forms around diagnostic/
interventional devices as they move into and out of the vasculature.
This seal provides minimal fluid loss without restricting device
movement. The BBC seal is open when the cap is pressed down, and
closed when the cap is released. An open BBC seal allows air and fluid
to be purged and allows the advancement/ withdrawal of diagnostic/
interventional devices. |
| Intended use | The COPILOT™ Bleedback Control Valve is intended to maintain
hemostasis during the introduction/withdrawal and use of
diagnostic/interventional devices. |
| Indications
statement | The COPILOT™ Bleedback Control Valve is indicated for maintaining
a seal around diagnostic/interventional devices with an outside
diameter