The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Description

The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products having a 0.010" outside diameter, being a sterile, single use/disposable product, with a 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 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 product is 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 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (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.

AI/ML Overview

The provided document describes the PVS 1600 Synchro® 0.010" Neuro Guidewire and its demonstration of substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics as would typically be presented for a new or significantly modified device under a comprehensive clinical trial.

However, based on the information provided, I can extract the relevant details regarding the safety and performance tests conducted to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria with corresponding performance statistics in a tabular format as one would expect from a controlled study with predefined thresholds. Instead, it states that "Subject product testing has yielded acceptable safety & performance outcomes" and that tests "also yielded acceptable results." The criteria are implied to be met if the PVS 1600 Synchro® 0.010" Neuro Guidewire is comparable to its predicate devices and conforms to relevant standards.

Therefore, the table below provides the performance tests conducted and the general outcome stated in the document. The "Acceptance Criteria" are inferred from the context of demonstrating substantial equivalence to predicate devices and adherence to relevant standards (ISO 10993-1, ISO 11070:1998).

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility in accordance with ISO 10993-1	Materials test results confirmed biocompatibility of the subject device when tested as an external communicating, blood contact, short duration (<24 hours) device.
Conformance to ISO 11070:1998 for Intravascular Catheter Introducers (Verfification Testing)
- Dimensional Inspection	Subject product testing yielded acceptable safety & performance outcomes.
- Fatigue Assessment	Subject product testing yielded acceptable safety & performance outcomes.
- Tip Flexibility	Subject product testing yielded acceptable safety & performance outcomes.
- Tip Shaping	Subject product testing yielded acceptable safety & performance outcomes.
- Tensile Strength	Subject product testing yielded acceptable safety & performance outcomes.
- Guidewire Compatibility Testing	Subject product testing yielded acceptable safety & performance outcomes.
- Performance under Simulated Conditions	Subject product testing yielded acceptable safety & performance outcomes.
Torsional Strength (Comparable to Predicates)	Yielded acceptable results.
Torqueability (Comparable to Predicates)	Yielded acceptable results.
Corrosion Resistance (Comparable to Predicates)	Yielded acceptable results.
Technological similarities to predicate devices	Technological similarities between the PVS 1600 Synchro® 0.010" Neuro Guidewire and the PVS 1300 Synchro™ predicate remain identical. Comparative truth for competitive predicate device features including basal design and dimensions, generic materials & construction, and hydrophilic coating. Where characteristics differ, no new questions raised regarding safety or efficacy.

2. Sample Size and Data Provenance for the Test Set:

Sample Size: The document does not specify numerical sample sizes for the performance tests conducted. It refers to "Performance testing of materials" and "Subject product testing."
Data Provenance: The document does not provide details about the country of origin of the data or whether the tests were retrospective or prospective. These appear to be laboratory-based engineering performance tests rather than clinical studies on patient data.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. The document describes engineering and materials performance tests, not clinical studies involving expert interpretation or ground truth establishment based on human review.

4. Adjudication Method (Test Set):

Not applicable, as no adjudication by experts for ground truth is mentioned. The tests appear to be objective measurements against engineering standards and comparison to predicate devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for substantial equivalence based on technological characteristics and performance testing, not a clinical trial evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The device is a physical medical instrument (guidewire), not an AI algorithm or software device that would perform a standalone analysis. The performance studies focus on the physical and material properties of the guidewire.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is implied to be:

Compliance with established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers).
Comparative performance against existing legally marketed predicate devices, demonstrating similar safety and efficacy profiles.
Objective measurements of physical and mechanical properties.

8. Sample Size for the Training Set:

Not applicable. The guidewire is a physical device, not an AI, machine learning, or software device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

Summary

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DEC 0 4 2002

K023700
page 1 of 2

Summary of Safety and Effectiveness

	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/Clinical Affairs& Quality Systems
	Device Trade Name:Device Generic Name:		PVS 1600 Synchro® 0.010" NGWGuide Wire
	The predicate devices are listed in the table below.
PredicateDevices	Device	Manufacturer		510(k) Number,Concurrence Date	ProductCode
	Synchro™ .014"	Precision Vascular		K002907, 08 March 2001	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 1600 Synchro® 0.010" Neuro Guidewire series of products is intended forneurovascular use. It can be used to selectively introduce and position catheters andother interventional devices within the neurovasculature. This device should be usedonly by physicians trained in percutaneous, intravascular techniques and procedures.
DeviceDescription	The PVS 1600 is a member of the Synchro® Neuro Guidewire family of productshaving a 0.010" outside diameter, being a sterile, single use/disposable product, with ashapeable tip which is used to gain intravascular access to and facilitate the positioningand exchange of interventional devices in small diameter, tortuous vasculature forneuro diagnostic and interventional procedures. The guidewire can be torqued tofacilitate navigation through the vasculature. A torque device, (Merit Medical Systems(K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewireintroducer (B. Braun (K760389)) is also supplied and may be used to aid introduction ofthe guidewire into the catheter hub and/or hemostasis valve and to gently shape theguidewire's distal flexible tip, if desired, according to standard practice. Neither theguidewire introducer or the torque device are intended to enter the body. The product

Prepared November 1, 2002

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is 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 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (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 similarities between the PVS 1600 Synchro® 0.010" Neuro Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also comparatively true for competitive predicate device features including the basal design and dimensions, generic materials & construction, and hydrophilic coating. In instances where the technological characteristics may differ, it has been demonstrated that there are no new questions raised regarding safety or efficacy of the PVS 1600 Synchro® 0.010" Neuro Guidewire.

Biocompatibility of the PVS 1600 Synchro® 0.010" Neuro 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

Technological

Characteristics

Performance testing of materials comprising the PVS 1600 Synchro® 0.010" Neuro Guidewire 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, quide 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 1600 Synchro® 0.010" Neuro Guidewires' substantial equivalence to the cited predicate devices.

Based on the indications for use, technological characteristics, and safety and Summary of performance testing, the subject PVS 1600 Synchro® 0.010" Neuro Guidewire meets Substantial the minimum requirements that are considered adequate for its intended use and is Equivalence substantially equivalent in design, materials, sterilization, principles of operation and indications for use to current commercially available quidewires/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 consists of a stylized graphic of three human profiles facing right, arranged in a stacked formation. The profiles are depicted in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 4 2002

Mr. Rick Gaykowski Corporate Vice President, Regulatory/Clinical Affairs and Quality Systems Precision Vascular Systems, Inc. 2405 West Orton Circle West Valley City, Utah 84119

Re: K023700

Trade/Device Name: PVS 1600 Synchro® 0.010" Neuro Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: November 1, 2002 Received: November 4, 2002

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 incan 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. 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) 594-4659. 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). 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,

L. Mark N. Mullinson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): J

Device Name: PVS 1600 Synchro®0.010" Neuro Guidewire

Indications for Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use		OR		Over-the-Counter Use
(Per 21 CFR 801.109)

Mah n Milliken

(Division Sign-Off)

Division of General, Restorative

and Neurological Devices

510(k) Number	K023700
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Regulation Number and Section

§ 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.