(23 days)
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.
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.
The provided document is a 510(k) summary for a medical device (PVS 1700 Steerable Delivery System®-10 Microcatheter), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.
Therefore, many of the requested details about specific acceptance criteria from a clinical study, sample size, expert ground truth establishment, and MRMC studies are not applicable or available in this type of regulatory submission. The device is primarily evaluated through bench testing and comparison to existing, cleared devices.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it provide detailed performance numbers in a table. Instead, it generally states that tests "yielded acceptable results" or "confirmed biocompatibility."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 standards for an external communicating, blood contact, short duration (<24 hours) device. | "Test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) devices." |
| Dimensional Inspection: Conform to specified dimensions. | "Verification testing for the subject device included dimensional inspection… Subject product testing is believed to have yielded acceptable results." (No specific dimensions or ranges reported, but implied conformance to design specifications). |
| Hub Integrity: Maintain structural integrity of the hub. | "Verification testing for the subject device included… hub integrity… Subject product testing is believed to have yielded acceptable results." (No specific integrity metrics reported). |
| Flow Rate Measurements: Achieve specified flow rates. | "Verification testing for the subject device included… flow rate measurements… Subject product testing is believed to have yielded acceptable results." (No specific flow rates reported). |
| Burst Strength: Withstand internal pressure without bursting. | "Verification testing for the subject device included… burst strength… Subject product testing is believed to have yielded acceptable results." (No specific burst pressure reported). |
| Tensile Strength: Withstand pulling forces without breaking. | "Verification testing for the subject device included… tensile strength… Subject product testing is believed to have yielded acceptable results." (No specific tensile strength reported). |
| Guidewire Compatibility: Function correctly with guidewires. | "Verification testing for the subject device included… guidewire compatibility testing and performance under simulated conditions. Subject product testing is believed to have yielded acceptable results." (No specific compatibility metrics reported). |
| Torsional Strength: Withstand twisting forces. | "In addition, torsional strength… tests also yielded acceptable results." (No specific torsional strength reported). |
| Torqueability: Ability to transmit torque for steering. | "In addition, …torqueability… tests also yielded acceptable results." (No specific torqueability metrics reported. The device is described as having "the ability to be steered like a guide wire as needed," which implies this aspect was evaluated and found acceptable). |
| Corrosion Resistance: Resist degradation from corrosion. | "In addition… corrosion resistance tests also yielded acceptable results." (No specific corrosion resistance metrics reported). |
| Substantial Equivalence: Similar in design, materials, sterilization, principles of operation, and indications for use to predicate devices, raising no new questions of safety and efficacy. | "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." "Based on the indications for use, technological characteristics, and safety and performance testing, the subject PVS 1700 Steerable Delivery System®-10 meets the minimum requirements that are considered adequate for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available catheters/cited predicates." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of patient data for clinical studies, as the evaluation primarily involved bench testing (performance testing) and biocompatibility testing. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).
For bench tests, typically multiple units of the device are tested, but the exact sample sizes for each specific test (e.g., how many catheters were burst tested) are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The ground truth for this device's evaluation (bench testing) is based on engineering specifications, material science standards (ISO), and direct physical measurements/observations, not on expert consensus from clinical cases.
4. Adjudication Method for the Test Set
Not applicable, as this device was evaluated via bench testing rather than through a clinical study requiring human interpretation or adjudication of patient cases.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is not relevant for the regulatory pathway (510(k) for a microcatheter) and the type of evidence presented (bench testing for substantial equivalence).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical microcatheter, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth used for proving the device meets acceptance criteria is primarily:
- Engineering specifications and design requirements: For dimensional inspection, flow rate, tensile strength, burst strength, torqueability, torsional strength, and guidewire compatibility.
- International Standards (ISO 10993-1 and ISO 10555-1): For biocompatibility and performance testing of intravascular catheters.
- Comparison to predicate devices: To establish substantial equivalence in terms of technological characteristics and indications for use.
8. The Sample Size for the Training Set
Not applicable. This isn't an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Summary of Safety and Effectiveness
| Prepared 11 August 2003 | |||||
|---|---|---|---|---|---|
| GeneralProvisions | Submitter of 510(k)Premarket Notification: | Precision Vascular2405 West Orton CircleWest Valley City, UT 84119Phone: 801.974.1700Fax: 801.974.1740 | |||
| Contact Person: | Rick GaykowskiVice President, Regulatory/ClinicalAffairs & Quality Systems | ||||
| Device Trade Name:Device Generic Name: | PVS 1700 Steerable Delivery System®-10Infusion Catheter | ||||
| The predicate devices are listed in the table below. | |||||
| Device | Manufacturer | 510(k) Number,Concurrence Date | ProductCode | ||
| PredicateDevices | 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 | ||||
| PerformanceStandards | Performance standards have not been established by FDA under section 514 of theFederal Food, Drug and Cosmetic Act. | ||||
| Intended Use | The PVS 1700 Steerable Delivery System®-10 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 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominaldistal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery ofcontrast, drugs, or embolics. The lumen is constructed from a polymeric material andhas an inside diameter of 0.0165". The device is coated on the outer diameter with alubricious coating over the distal segment of the device. Two radiopaque markers arepositioned 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 1700 Steerable Delivery System®-10and predicate devices include the basal tubular design and dimensions, polymericmaterials 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 1700 SteerableDelivery System®-10. |
|---|---|
| Safety andPerformanceTests | Biocompatibility of the PVS 1700 Steerable Delivery System®-10 has been verified inaccordance with ISO 10993-1, Biocompatibility of Medical Devices - Part 1. Testresults confirmed biocompatibility of the subject device when tested as an externalcommunicating, blood contact, short duration (<24 hours) devices.Performance testing of the PVS 1700 Steerable Delivery System®-10 was conductedin accordance with ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1.Verification testing for the subject device included dimensional inspection, hubintegrity, flow rate measurements, burst strength, tensile strength, guidewirecompatibility testing and performance under simulated conditions. Subject producttesting 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 1700 Steerable Delivery System®-10 substantial equivalence to the citedpredicate devices. |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety andperformance testing, the subject PVS 1700 Steerable Delivery System®-10 meetsthe minimum requirements that are considered adequate for its intended use and issubstantially equivalent in design, materials, sterilization, principles of operation andindications for use to current commercially available catheters/cited predicates. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2003
Precision Vascular Systems, Inc. c/o Mr. Rick Gaykowski 2405 West Orton Circle West Valley City, UT 84119
Re: K032494 PVS 1700 Steerable Delivery System®-10 Microcatheter Regulation Number: 870.1210/1330 Regulation Name: Continous Flush Catheter/Catheter Guide Wire Regulatory Class: Class II Product Code: KRA Dated: August 11, 2003 Received: August 13, 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. Iisting 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.
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Page 2 - Mr. Rick Gaykowski
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 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) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Page 1 of 1
KO32494 510(k) Number (if known): _
Device Name: PVS 1700 Steerable Delivery System®-10 Microcatheter
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.
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 __
N. Leartus
§ 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).