(15 days)
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 neurovasculature for selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.
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.
The provided text describes a medical device, the PVS 1500 SDS (an infusion catheter), and its testing to demonstrate substantial equivalence to predicate devices, rather than a study evaluating an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance for PVS 1500 SDS
The study primarily focused on demonstrating the PVS 1500 SDS's substantial equivalence to existing predicate devices by meeting established performance standards for infusion catheters.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices - Part 1 | Confirmed biocompatibility as an external communicating, blood contact, short duration (<24 hours) device. |
| Safety and Performance | ISO 10555-1, Sterile, Single-Use Intravascular Catheters - Part 1 | Yielded acceptable results. |
| - Dimensional inspection | Acceptable results. | |
| - Hub integrity | Acceptable results. | |
| - Flow rate measurements | Acceptable results. | |
| - Burst strength | Acceptable results. | |
| - Tensile strength | Acceptable results. | |
| - Guide wire compatibility testing | Acceptable results. | |
| - Performance under simulated conditions | Acceptable results. | |
| - Torsional strength | Acceptable results. | |
| - Torqueability | Acceptable results. | |
| - Corrosion resistance | Acceptable results. |
Information Not Applicable or Not Provided in the Text (Primarily relevant for AI/ML studies):
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document doesn't specify sample sizes for each performance test, nor does it mention data provenance in the context of an AI/ML test set. The tests described are laboratory-based engineering and material performance tests.
- 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): Not applicable. "Ground truth" in this context refers to the physical and chemical properties of the device, established through standardized testing procedures, not expert interpretation of data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance was measured against established engineering standards.
- 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: Not applicable. This is not an AI/ML device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from standardized engineering and biocompatibility testing against recognized industry standards (ISO 10993-1, ISO 10555-1).
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
Summary of Study Approach:
The study for the PVS 1500 SDS was a series of benchtop and laboratory-based engineering and biocompatibility tests. The objective was to demonstrate that the device's physical, mechanical, and biological properties met established standards for infusion catheters and were substantially equivalent to legally marketed predicate devices. The "acceptance criteria" were the thresholds and specifications defined by relevant ISO standards (ISO 10993-1 and ISO 10555-1) for medical devices of this type. The device "met the acceptance criteria" by yielding "acceptable results" in all conducted tests.
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MAR 2 1 2002
Summary of Safety and Effectiveness
Prepared January 25, 2002
| 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, Quality Assurance,Regulatory and Clinical Affairs | ||||
| Device Trade Name:Device Generic Name: | Not Yet DeterminedInfusion Catheter | ||||
| PredicateDevices | 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 | ||||
| PerformanceStandards | Performance standards have not been established by FDA under section 514 of theFederal Food, Drug and Cosmetic Act. | ||||
| Intended Use | The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusionof diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, andneurovasculature, and for guide wire exchange/support during diagnosticOrinterventional procedures. | ||||
| DeviceDescription | The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be usedfor delivery of contrast, drugs, or embolics. The lumen is constructed from a polymentmaterial and has an inside diameter of 0.021". The device is coated on the outerdiameter with a lubricious coating over the distal segment of the device. Tworadiopaque markers are positioned 31 mm apart at the distal tip of the device to aidvisualization under fluoroscopy. The proximal end of the device has a standard lueradapter for attachment of accessories and can be used to flush the 1500 SDS. Thesubject 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 asneeded. | ||||
Precision Vascular Systems, Inc. PVS 1500 SDS Device
Premarket Notification
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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 (<24 hours) device.
Safety and Performance Tests
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.
Summary of Substantial Equivalence
Based on the indications for use, technological characteristics, and safety and performance testing, the subject PVS 1500 SDS 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.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three heads, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 1 2002
Mr. Ned Devine Program Manager Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548
K020733 Re:
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
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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
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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.
§ 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).