(127 days)
Not Found
No
The summary describes a mechanical device (balloon catheter and inflation unit) and its intended use for angioplasty. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes
The device is indicated for percutaneous, transluminal angioplasty of stenotic lesions in arteries, which is a therapeutic medical procedure.
No
The device is described as a "Peripheral Balloon Catheter System" indicated for "percutaneous, transluminal angioplasty of stenotic lesions." This is a therapeutic procedure to open blocked arteries, not a diagnostic one.
No
The device description explicitly lists hardware components such as a catheter, inflation unit, connecting cable, battery pack, and gas cylinder.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous, transluminal angioplasty of stenotic lesions in arteries. This is a therapeutic procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The device components are a catheter, inflation unit, cable, battery, and a cylinder of nitrous oxide. These are all tools used for a medical procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used to treat a condition within the body.
N/A
Intended Use / Indications for Use
The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries.
The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.
Product codes
DQY, LIT
Device Description
The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
superficial femoral and popliteal arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional testing was conducted on the CVSi Peripheral Balloon Catheter System to ensure that the product will function according to its Instructions for Use. All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
CVSi™ Peripheral Balloon Catheter System 510(k) Premarket Notification
FEB 1 9 2003
510(k) Summary CryoVascular Systems, Incorporated CVSi™ Peripheral Balloon Catheter System
This 510(k) summary for the CVSi™ Peripheral Balloon Catheter System is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
GENERAL INFORMATION
| Manufacturer: | CryoVascular Systems, Inc.
160 Knowles Drive
Los Gatos, California 95032
(408) 376-3675 (phone)
(408) 376-3677 (fax)
Est. Reg. No. (to be applied for) |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | R. Michael Crompton
Vice President, Regulatory / Clinical Affairs
and Quality Assurance |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | CVSi™ Peripheral Balloon Catheter System |
| Generic/Common Name: | Balloon Dilatation Catheter (21 CFR § 870.1250) |
PREDICATE DEVICES
CVSi Peripheral Balloon Catheter System; CryoVascular Systems, Inc. (K022061) (1)
OPTA LP PTA Catheter; Cordis/A Johnson & Johnson Company (K971448) (2)
INTENDED USE
The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries.
Injector and Syringe, Angiographic (21 CFR § 870.1650)
DEVICE DESCRIPTION
The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ Catheter Inflation Unit, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cylinder.
1
SUBSTANTIAL EQUIVALENCE
The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices identified previously. The CVSi Peripheral Balloon Catheter System is substantially equivalent to the predicate devices with regard to intended use, function, materials, and sterilization method.
Testing performed on the CVSi Peripheral Balloon Catheter System demonstrates the device is substantially equivalent to the predicate devices and does not raise new questions regarding safety and effectiveness with respect to balloon dilatation catheters.
FUNCTIONAL PERFORMANCE TESTING
Functional testing was conducted on the CVSi Peripheral Balloon Catheter System to ensure that the product will function according to its Instructions for Use. All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended.
BIOCOMPATIBILITY EVALUATION
Biocompatibility testing was conducted on the CVSi Peripheral Balloon Catheter System materials to ensure acceptability when used as directed. The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing for an External Communicating Device in contact with Circulating Blood for a contact duration of A-Limited (