(15 days)
Not Found
No
The document describes a physical medical device (catheter) and its mechanical properties and performance, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is intended to deliver therapeutic agents, but it is not itself a therapeutic agent or device. It is a delivery system.
No
Explanation: The device is intended for accessing vasculature and delivering agents, as well as for guide wire exchange/support during procedures. While it can deliver diagnostic agents, its primary function is not to diagnose conditions itself.
No
The device description clearly details a physical, tubular device made of polymer material with a lumen, radiopaque markers, and a luer adapter. It also describes performance testing related to physical properties like burst strength, tensile strength, and torqueability, which are characteristic of hardware devices, not software.
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 for the delivery of agents and guide wire support. This is an in vivo application.
- Device Description: The description details a tubular device with a lumen for delivering substances and features for navigation within the body (radiopaque markers, lubricious coating, steerability). This aligns with an in vivo device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
Therefore, the PVS 1500 SDS is an interventional medical device used for procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic Or interventional procedures.
The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and THE TVS TOOD CDO To Incondotive, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.
Product codes (comma separated list FDA assigned to the subject device)
DQO, KRA
Device Description
The PVS 1500 SDS is a 2.4 F 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 polyment material and has an inside diameter of 0.021". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 31 mm apart 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 1500 SDS. 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 1500 SDS was conducted in accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1. Verification testing for the sublect device included dimensional inspection, hub integrity, flow rate measurements, burst strength, tensile strength, guide wire compatibility testing and performance under simulated conditions. Subject product testing is believed to have vielded 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 1500 SDS' 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
MAR 2 1 2002
Summary of Safety and Effectiveness
Prepared January 25, 2002
| 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, Quality Assurance,
Regulatory and Clinical Affairs | | |
| | Device Trade Name:
Device Generic Name: | | Not Yet Determined
Infusion Catheter | | |
| Predicate
Devices | The predicate devices are listed in the table below. | | | | |
| | | | | 510(k) Number, | Product |
| | Device | | Manufacturer | Concurrence Date | Code |
| | FasTracker-18 | | Target Therapeutics | K960806, 02 May 1996* | DQO |
| | Rebar-18 | | Micro Therapeutics | K001966, 20 Jul 2000 | KRA |
| | This information is assumed based on our best, current knowledge. | | | | |
| Classification | Class II, 21 CFR 870.1210, Continuous Flush Catheter | | | | |
| 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 1500 SDS is intended to be used to access tortuous vasculature for infusion
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 1500 SDS is a 2.4 F 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 polyment
material and has an inside diameter of 0.021". The device is coated on the outer
diameter with a lubricious coating over the distal segment of the device. Two
radiopaque markers are positioned 31 mm apart 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 1500 SDS. 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. | | | | |
| | | | | | |
Precision Vascular Systems, Inc. PVS 1500 SDS Device
Premarket Notification
1
Technological Characteristics
Technological similarities between the PVS 1500 SDS and predicate devices include the basal tubular design and dimensions, polymeric materials and construction, and hydrophilic coating. In instances where the technological characteristics are different, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the PVS 1500 SDS.
Biocompatibility of the PVS 1500 SDS has been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices - Part 1. Test results confirmed bjocompatibility of the subject device when tested as an external communicating, blood contact, short duration ( PVS 1500 SDS Regulation Number: 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II (two) Product Code: KRA Dated: January 25, 2002 Received: March 6, 2002
Dear Mr. Devine:
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, listing 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 listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Ned Devine
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Systems (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) This letter wif anow you to organizations of substantial equivalence of your device to a legally premarket notincation. The PDF minuting of cation 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 and If you desire specific aurroo for you invitro diagnostic devices), please contact the Office of additionally 21 CHT Furt 007.10 10 11:10 PM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Compliance at (301) 591-1800. I fine of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entralion on your responsibilities under the Act may be obtained from the Other general informational 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,
N. Dea. Meller
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K020733
Device Name: PVS 1500 SDS
Indications for Use:
The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and THE TVS TOOD CDO To Incondotive, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use the image is of poor quality and I am unable to extract the text.