(95 days)
No
The description focuses on the physical characteristics, materials, and intended use of a vascular access cannula and introducer kit. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes.
The device is a cannula intended for use in extracorporeal support such as cardiopulmonary bypass, which is a therapeutic intervention.
No
The device is a cannula used for extracorporeal support, such as cardiopulmonary bypass. Its function is to cannulate blood vessels, perfuse vessels or organs, or connect with extracorporeal equipment, which are therapeutic and supportive functions, not diagnostic ones.
No
The device description clearly details a physical cannula made of polyurethane with a coating, introducer kit, and various physical characteristics (size, tip, insertion marks). There is no mention of software as the primary or sole component of the device.
Based on the provided text, the NovaPort® One Vascular Access cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass." This describes a device used on a patient for a medical procedure, not a device used to test samples from a patient to diagnose a condition.
- Device Description: The description details a physical device (cannula, introducer) designed for insertion into blood vessels. It discusses materials, coating, insertion methods, and connection to extracorporeal equipment. This aligns with a surgical or interventional device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information. The device's function is to facilitate blood flow for extracorporeal support.
Therefore, the NovaPort® One Vascular Access cannula is a medical device used for a therapeutic or supportive procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to limited to
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
0
TRADITIONAL 510(K)
510(k) Summary
For the Novalung® GmbH NovaPort® One Vascular Access DEC - 6 2011
SUBMITTER/510(k) HOLDER: I.
Novalung® GmbH Zukunftspark 1 D-74076 Heilbronn, Germany Telephone: +49 7131 2706 - 0 Telefax: +49 7131 2706 - 299 FDA Establishment Registration Number: 3004569487
II. CONTACT PERSON
Leann Christman, MEd Telephone: (734) 995-9089 ext. 232 Fax: (734) 995-0840 Email: Ichristman@MC3Corp.com
III. DEVICE NAME
Proprietary Trade Name: NovaPort® One Vascular Access Common/Usual Name: Percutaneous Cannula and Introducer Set
DEVICE CLASS: IV.
Class II
CLASSIFICATION NAME: V.
Cardiopulmonary bypass vascular catheter, cannula, or tubing Classification regulation: Sec. 870.4210
PRODUCT CODES: VI.
DWF
VII. PREDICATE DEVICES
K052524, Bio-Medicus Multi-Stage Venous Femoral Percutaneous Kit K024069. One Piece Pediatric Arterial Cannula 7000 Models
PRODUCT DESCRIPTION VIII.
The NovaPort® One Vascular Access cannula with Novalung coating are a wire reinforced, thin walled femoral cannula made of polyurethane. A cone without wire reinforcement allows clamping and serves as transition to a connector. The beveled tip is not a separate piece and is part of the whole cannula body. The NovaPort® one cannulas are inserted percutaneously into
1
vessels. Insertion depth marks aid in positioning the cannula. They have a beveled tip that is made as part of the PVC body.
The Cannula is intended to be used to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal equipment. The cannula introducer is intended to facilitate proper insertion and placement of the appropriate sized cannula within the vessel for cardiopulmonary bypass.
All surfaces of the NovaPort® One which come into contact with blood are protected with the Novalung Coating. This coating is a bioactive, stable, biocompatible and non-thrombogenic surface. This coating consists of high molecular weight heparin from pig mucosa bound covalently and ionically to immobilized polypeptides.
NovaPort® one cannula is available in insertion lengths of 90 mm and with outer diameters of 13 F, 17 F, 19 F and 21 F. All are supplied sterile with Novalung coated, non-pyrogenic, and are single use.
IX. INDICATIONS OF USE
ﮯ ﻣﻌﻤ ﮨ
The NovaPort® One Vascular Access cannula with its associated Introducer Kit is a Novalung coated percutaneous cannula intended to be used to cannulate blood vessels in patients requiring extracorporeal support such as cardiopulmonary bypass. The application of NovaPort® One cannula is limited to limited to