(23 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a steerable microcatheter, with no mention of AI or ML capabilities.
No.
The device is a delivery system for therapeutic agents, but it does not inherently provide therapy itself.
No
The device is a microcatheter intended for the delivery of agents (diagnostic, embolic, and therapeutic) and for guidewire support, not for diagnosing conditions itself.
No
The device description clearly outlines a physical, tubular device made of polymeric material with a lumen, radiopaque markers, and a lubricious coating. It is a hardware device intended for physical insertion into vasculature.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for accessing vasculature and delivering agents within the body. This is an interventional device, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen for delivery, radiopaque markers for visualization under fluoroscopy, and steerability. These are characteristics of an in-vivo device.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or performing tests on samples outside the body.
Therefore, the PVS 1700 Steerable Delivery System®-10 Microcatheter is an interventional medical device, not an IVD.
N/A
Intended Use / Indications for Use
The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of dlagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guldewire exchangelsupport during diagnostic or interventional procedures.
Product codes
KRA
Device Description
The PVS 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
distal, peripheral, coronary, and neurovasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility of the PVS 1700 Steerable Delivery System®-10 has been verified in accordance with ISO 10993-1, Biocompatibility of Medical Devices - Part 1. Test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
Summary of Safety and Effectiveness
| Prepared 11 August 2003 | |||||
|---|---|---|---|---|---|
| General | |||||
| Provisions | Submitter of 510(k) | ||||
| Premarket Notification: | Precision Vascular | ||||
| 2405 West Orton Circle | |||||
| West Valley City, UT 84119 | |||||
| Phone: 801.974.1700 | |||||
| Fax: 801.974.1740 | |||||
| Contact Person: | Rick Gaykowski | ||||
| Vice President, Regulatory/Clinical | |||||
| Affairs & Quality Systems | |||||
| Device Trade Name: | |||||
| Device Generic Name: | PVS 1700 Steerable Delivery System®-10 | ||||
| Infusion Catheter | |||||
| The predicate devices are listed in the table below. | |||||
| Device | Manufacturer | 510(k) Number, | |||
| Concurrence Date | Product | ||||
| Code | |||||
| Predicate | |||||
| Devices | SDS 0.018" | PVS, Inc. | K020733, 21 March 2002 | KRA | |
| Excelsior SL-10 | BSC/Target | K013789, 06 Dec 2001 | DQY | ||
| Rebar-14 | Micro Therapeutics | K993672, 04 Jan 2000 | KRA | ||
| Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter, KRA | ||||
| Performance | |||||
| Standards | Performance standards have not been established by FDA under section 514 of the | ||||
| Federal Food, Drug and Cosmetic Act. | |||||
| Intended Use | The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used | ||||
| to access tortuous vasculature for sub-selective controlled infusion or delivery of | |||||
| diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and | |||||
| neurovasculature, and for guide wire exchange/support during diagnostic or | |||||
| interventional procedures. | |||||
| Device | |||||
| Description | The PVS 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal | ||||
| distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of | |||||
| contrast, drugs, or embolics. The lumen is constructed from a polymeric material and | |||||
| has an inside diameter of 0.0165". The device is coated on the outer diameter with a | |||||
| lubricious coating over the distal segment of the device. Two radiopaque markers are | |||||
| positioned at the distal tip of the device to aid visualization under fluoroscopy. The | |||||
| proximal end of the device has a standard luer adapter for attachment of accessories | |||||
| and can be used to flush the lumen. The subject device has the ability to access distal, | |||||
| tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability | |||||
| to be steered like a guide wire as needed. |
.
.. . . .
1
| Technological
Characteristics | Technological similarities between the PVS 1700 Steerable Delivery System®-10
and predicate devices include the basal tubular design and dimensions, polymeric
materials and construction, and hydrophilic coating. In instances where the
technological characteristics may differ slightly, it has been demonstrated that there
are no new questions raised regarding safety and efficacy of the PVS 1700 Steerable
Delivery System®-10. |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance
Tests | Biocompatibility of the PVS 1700 Steerable Delivery System®-10 has been verified in
accordance with ISO 10993-1, Biocompatibility of Medical Devices - Part 1. Test
results confirmed biocompatibility of the subject device when tested as an external
communicating, blood contact, short duration (