(49 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PVS "Pivot™" Steerable Delivery System® Microcatheter:
Acceptance Criteria and Device Performance
The submission does not explicitly list quantitative "acceptance criteria" in the format of a requirement and a corresponding measured value for the individual performance tests. Instead, it states that the tests "yielded acceptable results" or were "verified in accordance with" standards. The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices and meeting established industry standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to ISO 10993-1 for Biocompatibility | "Biocompatibility of the PVS 'Pivot™' Steerable Delivery System® Microcatheter has been verified in accordance with ISO 10993-1... Test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) devices." |
| Adherence to ISO 10555-1 for Sterile, Single-Use Intravascular Catheters | "Performance testing of the PVS 'Pivot™' Steerable Delivery System® Microcatheter was conducted in accordance with ISO 10555-1... 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." |
| Acceptable Torsional Strength | "In addition, torsional strength... tests also yielded acceptable results." |
| Acceptable Torqueability | "...torqueability... tests also yielded acceptable results." |
| Acceptable Corrosion Resistance | "...corrosion resistance tests also yielded acceptable results." |
| Substantial Equivalence to Predicate Devices | "Based on the indications for use, technological characteristics, and safety and performance testing, the subject PVS 'Pivot™' Steerable Delivery System® Microcatheter... is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not specify the exact sample sizes (number of devices) used for each individual performance test (e.g., dimensional inspection, burst strength, tensile strength). The data provenance is not mentioned, as these are in vitro engineering tests rather than clinical data from patients. The tests are prospective in the sense that they were conducted specifically for this submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This is not applicable as the studies described are in vitro performance and biocompatibility tests on the device itself, not clinical studies involving "ground truth" derived from expert consensus on patient cases. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there were no patient cases or expert readings requiring adjudication. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was performed. This document describes a medical device (a microcatheter), not an AI algorithm. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for the device's performance is derived from established engineering test methods and their defined pass/fail criteria according to ISO standards and internal specifications, rather than clinical outcomes or expert consensus on patient data. -
The sample size for the training set:
Not applicable, as this is a physical medical device and does not involve AI or machine learning algorithms that require a "training set." -
How the ground truth for the training set was established:
Not applicable, for the same reason as point 7.
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K03776
JAN 1 6 2004
Summary of Safety and Effectiveness
| Prepared 26 November 2003 | |||||
|---|---|---|---|---|---|
| Submitter of 510(k)Premarket Notification: | Precision Vascular2405 West Orton CircleWest Valley City, UT 84119Phone: 801.974.1700Fax: 801.974.1740 | ||||
| GeneralProvisions | Contact Person: | Rick GaykowskiVice President, Regulatory/ClinicalAffairs & 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. | |||||
| PredicateDevices | Device | Manufacturer | 510(k) Number,Concurrence Date | ProductCode | |
| 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 | ||||
| PerformanceStandards | Performance standards have not been established by FDA under section 514 of theFederal Food, Drug and Cosmetic Act. | ||||
| Intended Use | The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be usedto access tortuous vasculature for sub-selective controlled infusion or delivery ofdiagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, andneurovasculature, and for guide wire exchange/support during diagnostic orinterventional procedures. | ||||
| DeviceDescription | The PVS "Pivot™" Steerable Delivery System® Microcatheter is a 1.9F/2.4F (nominaldistal/proximal) tubular device, ~150 cm in length, with a lumen to be used for deliveryof contrast, drugs, or embolics. The lumen is constructed from a polymeric materialand has an inside diameter of 0.0165". The device is coated on the outer diameter witha lubricious coating over the distal segment of the device. Two radiopaque markersare positioned at the distal tip of the device to aid visualization under fluoroscopy. Theproximal end of the device has a standard luer adapter for attachment of accessoriesand 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 abilityto be steered like a guide wire as needed. |
· ·
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| TechnologicalCharacteristics | 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 thetechnological characteristics may differ slightly, it has been demonstrated that thereare 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 hasbeen verified in accordance with ISO 10993-1, Biocompatibility of Medical Devices –Part 1. Test results confirmed biocompatibility of the subject device when tested as anexternal communicating, blood contact, short duration (<24 hours) devices. | |
| Safety andPerformanceTests | Performance testing of the PVS "Pivot™" Steerable Delivery System® Microcatheterwas conducted in accordance with ISO 10555-1, Sterile, Single-Use IntravascularCatheters - Part 1. Verification testing for the subject device included dimensionalinspection, hub integrity, flow rate measurements, burst strength, tensile strength,guidewire compatibility testing and performance under simulated conditions. Subjectproduct testing is believed to have yielded acceptable results. |
| In addition, torsional strength, torqueability, and corrosion resistance tests also yieldedacceptable results. The results of these tests, in conjunction with the substantialequivalence claims as outlined in the premarket notification, effectively demonstratethe PVS "Pivot™" Steerable Delivery System® Microcatheter is substantialequivalence to the cited predicate devices. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject PVS "Pivot™" Steerable Delivery System®Microcatheter meets the minimum requirements that are considered adequate for itsintended use and is substantially equivalent in design, materials, sterilization,principles of operation and indications for use to current commercially availablecatheters/cited predicates. |
... . . . ..
:"
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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 6 2004
Precision Vascular c/o Mr. Rick Gaykowski Vice President, Regulatory/Clinical Affairs & Quality Systems 2405 West Orton Circle West Valley City, UT 84119
Re: K033726
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
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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
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9
510(k) Number (if known): _ << 033726
Device Name: PVS "Pivot™" Steerable Delivery System® Microcatheter
Indications for Use:
The PVS "Pivot™" Steerable Delivery System® Microcatheter is intended to be used to access thereoutin agants into the distributed infusion or delivery of diagnostic, embolic, and therapedition and distal, peripheral, coronary, and neurovasculature, and for guidewire exchange/support during diagnostic or interventional procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| --------------------------------------- | --- |
OR
Over-the-Counter Use
(Division Sign-off)
Division of Cardiovascular Devices
| 510(K) Number | K033726 (SM. K) |
|---|---|
| --------------- | ----------------- |
§ 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).