(29 days)
The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
The provided text describes a 510(k) submission for guidewires, which are physical medical devices, not software or AI-powered devices. Therefore, the questions related to AI/algorithm performance metrics, expert reviews, ground truth, and training sets are not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate guidewires through material properties and performance testing.
Here's the relevant information that can be extracted from the provided text, structured to best fit your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Verified in accordance with ISO 10993-1 (Biological Evaluation of Medical Devices - Part 1). Materials test results confirmed biocompatibility as an external communicating, blood contact, short duration (<24 hours) device. |
| Dimensional Inspection | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Fatigue Assessment | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Tip Flexibility | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Tip Shaping | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Tensile Strength | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Guidewire Compatibility Testing | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Performance Under Simulated Conditions | Yielded acceptable safety & performance outcomes (as part of overall performance testing). Specific criteria not detailed in this summary. |
| Torsional Strength | Yielded acceptable results. Specific criteria not detailed in this summary. |
| Torqueability | Yielded acceptable results. Specific criteria not detailed in this summary. |
| Corrosion Resistance | Yielded acceptable results. Specific criteria not detailed in this summary. |
Study Proving Device Meets Acceptance Criteria:
The study conducted was a series of "Safety and Performance Tests" on the materials comprising the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires. These tests were performed in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers.
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual performance test (e.g., how many guidewires were tested for tensile strength or fatigue). It generally states "Subject product testing has yielded acceptable safety & performance outcomes."
The data provenance is from laboratory testing of the manufactured guidewires by Precision Vascular. It is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but the manufacturer is based in West Valley City, UT, USA, suggesting the testing was likely conducted in the USA or by a contracted lab.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable. The "ground truth" for a physical medical device like a guidewire is its adherence to predefined engineering specifications and performance standards through physical testing, not expert interpretation of data.
4. Adjudication Method for the Test Set
This question is not applicable, as there was no expert review or "ground truth" establishment in the context of interpretation that would require an adjudication method. The results are from objective physical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
This question is not applicable. This is a physical medical device, not an AI or imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by engineering and material specifications and internationally recognized standards (e.g., ISO 10993-1, ISO 11070:1998). The performance tests directly assess whether the device meets these objective, quantifiable standards.
8. The Sample Size for the Training Set
This question is not applicable. There is no algorithm or AI model being "trained" for this device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable.
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AUG 1 2 2003
510K SUMMARY
K 032146
Summary of Safety and Effectiveness
| Prepared July 11, 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/Clinical Affairs& Quality Systems | |||
| Device Trade Name: | PVS 1300 Synchro® 0.014" & PVS 1600 Synchro®0.010" Guidewires | |||
| Device Generic Name: | Guide Wire | |||
| The predicate devices are listed in the table below. | ||||
| Device | Manufacturer | 510(k) Number,Concurrence Date | ProductCode | |
| PredicateDevices | Synchro™ .014" | Precision Vascular | K002907, 08 Mar 2001 | DQX |
| Synchro™ .010" | Precision Vascular | K023700, 04 Dec 2002 | DQX | |
| Transend-14 | Target Therapeutics | K964611, 28 Jan 1997 | DQX | |
| Agility-14 | Cordis | K001033, 14 Apr 2000 | DQX | |
| MTI Silverspeed | Micro Therapeutics | K001454, 07 Jun 2000 | DQX | |
| Transend-10 | Target Therapeutics | K964611, 02 May 1996* | DQX | |
| Agility-10 | Cordis | K991646, 20 Jul 2000 | DQX | |
| Mirage .008" | Micro Therapeutics | K002212, 03 Aug 2000 | DQX | |
| * This information is assumed based on our best, current knowledge. | ||||
| Classification | Class II, 21 CFR 870.1330, Wire, Guide, Catheter 74DQX | |||
| PerformanceStandards | Performance standards have not been established by FDA under section 514 of theFederal Food, Drug and Cosmetic Act. | |||
| Intended Use | The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series ofproducts are intended for general intravascular use, which includes peripheral andneurovascular use. The device can be used to selectively introduce and positioncatheters and other interventional devices within the peripheral & neurovasculature.The device should be used only by physicians trained in percutaneous, intravasculartechniques and procedures. |
Description products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access
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to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.
Technological Characteristics
Technological similarities between the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires and the cited Synchro™ predicates remain identical. This is also true for competitive predicate device including the basal design and dimensions, generic materials & construction, and hydrophilic coating. There are no new questions raised regarding safety or efficacy of the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro®0.010" guidewires.
Biocompatibility of the PVS 1300 Synchro® 0.014" Guidewire materials have been verified in accordance with ISO 10993-1, Biological Evaluation of Medical Devices -Part 1. Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.
Safety and Performance Tests
Performance testing of materials comprising the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers. Verification testing for the subject device included dimensional inspection, fatigue assessment, tip flexibility, tip shaping, tensile strength, guide wire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes.
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 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires' 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 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires meet the minimum requirements that are considered adequate for their intended use and are substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available guidewires/cited predicates.
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Class III Certification
This section is not applicable to the subject PVS 1300 Synchro™ 0.014" & PVS 1600 Synchro® 0.010" devices, nor the cited predicates, since these products have been classified under Class II.
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Public Health Service
Image /page/3/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem consists of three stylized, overlapping wave-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
AUG 1 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Precision Vascular, Inc. c/o Mr. Rick Gaykowski Vice President, Regulatory/Clinical Affairs and Quality Systems 2405 West Orton Circle West Valley City, UT 84119
Re: K032146
Trade Name: PVS 1300 Synchro®0.014" & PVS 1600 Synchro® 0.010" Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 11, 2003 Received: July 14, 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, 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
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Page 2 – Mr. Rick Gaykowski
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. 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,
Bran D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: PVS 1300 Synchro®0.014" & PVS 1600 Synchro®0.010" Guidewire
Indications for Use:
The PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" Guidewire series of products are intended for general intravascular use, including the neuro and peripheral vasculature. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
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| NECESSARY |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
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| (Division Sign-Off) | |||
| Division of Cardiovascular Devices | |||
| 510(k) Number | K032146 | ||
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.