(49 days)
Not Found
No
The description focuses on the mechanical and material properties of a steerable microcatheter and does not mention any computational or algorithmic functions, particularly those related to AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is a delivery system for therapeutic agents, not a therapeutic agent itself. It is a tool for clinical intervention with a diagnostic or therapeutic purpose, but it does not directly perform the therapy.
No
The device is described as a delivery system for various agents and for guide wire exchange/support during diagnostic or interventional procedures, but it does not perform diagnostic functions itself. It facilitates the delivery of diagnostic agents, but is not a diagnostic device.
No
The device description clearly details a physical microcatheter with a lumen, polymeric material, lubricious coating, radiopaque markers, and a luer adapter. Performance studies also focus on physical properties and mechanical testing.
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 within the body to access vasculature and deliver agents or support procedures. This is an in vivo application.
- Device Description: The description details a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body for interventional procedures.
N/A
Intended Use / Indications for Use
The PVS "Pivot™" Steerable Delivery System® 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
Device Description
The PVS "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal distal/proximal) tubular device, ~150 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)
Performance testing of the PVS "Pivot™" Steerable Delivery System® Microcatheter was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1. Verification testing for the subject device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guidewire compatibility testing and performance under simulated conditions. Subject product testing is believed to have yielded acceptable results. In addition, torsional strength, torqueability, and corrosion resistance tests also yielded acceptable results. The results of these tests, in conjunction with the substantial equivalence claims as outlined in the premarket notification, effectively demonstrate the PVS "Pivot™" Steerable Delivery System® Microcatheter is substantial equivalence to the cited predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K03776
JAN 1 6 2004
Summary of Safety and Effectiveness
| Prepared 26 November 2003 | |||||
|---|---|---|---|---|---|
| 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 | |||||
| General | |||||
| Provisions | Contact Person: | Rick Gaykowski | |||
| Vice President, Regulatory/Clinical | |||||
| Affairs & Quality Systems | |||||
| Device Trade Name: | PVS "Pivot™" Steerable Delivery System® | ||||
| Microcatheter | |||||
| Device Generic Name: | Infusion Catheter | ||||
| The predicate devices are listed in the table below. | |||||
| Predicate | |||||
| Devices | Device | Manufacturer | 510(k) Number, | ||
| Concurrence Date | Product | ||||
| Code | |||||
| SDS 0.018" | PVS, Inc. | K020733, 21 March 2002 | KRA | ||
| SDS 0.010" | PVS, Inc. | K032494, 05 Sep 2003 | 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 "Pivot™" Steerable Delivery System® 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 "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominal | ||||
| distal/proximal) tubular device, ~150 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 "Pivot™" Steerable Delivery System®
Microcatheter 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 "Pivot™"
Steerable Delivery System® Microcatheter. |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Biocompatibility of the PVS "Pivot™" Steerable Delivery System® Microcatheter 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 ( PVS "Pivot™" Steerable Delivery System® Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: Class II Product Code: KRA Dated: November 26, 2003 Received: November 28, 2003
Dear Mr. Gaykowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Rick Gaykowski
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Ilise D. Haryfor
Bram D. Zuckerman, M Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
9
510(k) Number (if known): _