(87 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or specific algorithms. The device description focuses on mechanical components and functional testing.
Yes.
The device is indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries, which is a therapeutic intervention.
No
The device is indicated for percutaneous, transluminal angioplasty of stenotic lesions, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly lists hardware components including a catheter, inflator, connecting cable, battery pack, recharging unit, battery receptacle, and a disposable 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 superficial femoral and popliteal arteries." This is a therapeutic procedure performed in vivo (within the body) to treat blockages in blood vessels.
- Device Description: The device is a "Peripheral Balloon Catheter System" used for angioplasty. This is a medical device used for a physical intervention, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (inflating a balloon to open a vessel).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the 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, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr 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 Cateter System to perform as intended.
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 (
§ 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
SEP 2 0 2002
CVSi™ Peripheral Balloon Catheter System 510(k) Premarket Notification
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) |
| Injector and Syringe, Angiographic (21 CFR § 870.1650) |
PREDICATE DEVICES
- FOCUS PV Balloon Dilatation Catheter by CardioVascular Dynamics (K944016) (1)
- OPTA LP PTA Catheter Cordis/A Johnson & Johnson Company (K971448) (2)
- ACS 20/20 Indeflator by Guidant/Advanced Cardiovascular Systems, Inc. (K896849) (3)
- Breeze Digital Balloon Inflation Device by NAMIC USA (K953676) (4)
INTENDED USE
The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries.
DEVICE DESCRIPTION
The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr 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 (