(56 days)
The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It 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.
The PV 1900 is a member of the Synchro® Guidewire family of products having a 0.016" 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 peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Boston Scientific (K903606)) 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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. 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 portion 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.
This is a 510(k) premarket notification for a medical device (a guidewire), not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation are not applicable.
However, I can extract the information relevant to the device's performance given the context of this document.
Summary of Device Performance Information Provided:
Since this is a filing for a traditional medical device (guidewire) and not an AI/ML diagnostic or prognostic system, the requested information (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance) for AI/ML devices is not directly applicable in the sense of predictive or classification performance metrics.
Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate guidewires by meeting various physical and mechanical performance characteristics. The "study" refers to the engineering and biological testing performed on the device.
Here's an attempt to map the requested AI/ML-centric questions to the provided information for this traditional medical device:
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Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present acceptance criteria in a quantifiable table with corresponding performance values for each criterion as one would for an AI/ML device (e.g., sensitivity >X%, specificity >Y%). Instead, it states that "Performance testing of materials comprising the PV 1900 Synchro® 0.016" Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." and "Subject product testing has yielded acceptable safety & performance outcomes."
The performance aspects tested and the general outcome are listed.
Acceptance Criteria (Implicit) Reported Device Performance Compliance with ISO 10993-1 for Biocompatibility (for external communicating, blood contact, short duration <24 hours device) Biocompatibility verified; materials test results confirmed biocompatibility. Compliance with ISO 11070:1998 for Performance Testing (dimensional, fatigue, tip flexibility, tip shaping, tensile strength, guidewire compatibility, performance under simulated conditions) Acceptable safety & performance outcomes. Torsional Strength (Specific test) Acceptable results. Torqueability (Specific test) Acceptable results. EO Sterilization (Specific test) Acceptable results. Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to cited predicates Demonstrated through testing and comparison, leading to FDA's determination of substantial equivalence (K050964). No new questions raised regarding safety or efficacy compared to the predicate PVS 1300 Synchro® 0.014" Guidewire, and similarity in basal design, dimensions, generic materials & construction, and hydrophilic coating to competitive predicates. -
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of a "test set" like in an AI/ML study. Performance testing involved various physical and mechanical tests on the guidewire. The number of guidewires or samples used for each specific test (e.g., fatigue, tensile strength) is not detailed.
- Data Provenance: Not applicable in the context of human data. The tests were laboratory and engineering tests on the materials and finished guidewire device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as "ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant here. Performance was assessed through objective physical and mechanical tests following established standards. While engineers and quality control personnel would have interpreted test results, their role is not "ground truth establishment" in this context.
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Adjudication method for the test set:
- Not applicable. Performance was assessed against pre-defined engineering and biocompatibility standards, not through expert adjudication of an output.
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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 a physical medical device (guidewire), not an AI system intended to assist human readers (e.g., radiologists).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used:
- "Ground truth" here is the adherence to established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers, and other specific engineering tests for torsional strength, torqueability, sterilization). The product's physical and biological properties were measured against these objective standards.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm.
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K050964
1 of 2
JUN 1 3 2005
Summary of Safety and Effectiveness
| Amended May 23, 2005 | ||||
|---|---|---|---|---|
| GeneralProvisions | Submitter of 510(k)Premarket Notification: | Boston Scientific - Precision Vascular2405 West Orton CircleWest Valley City, UT 84119Phone: 801.974.1700Fax: 801.974.1740 | ||
| Contact Person: | Rick GaykowskiVP, Regulatory/Clinical AffairsQuality Systems & Operations | |||
| Device Trade Name:Device Generic Name: | PV 1900 Synchro® 0.016" GuidewireGuide Wire | |||
| The predicate devices are listed in the table below. | ||||
| Device | Manufacturer | 510(k) Number/Date | Pro Code | |
| PredicateDevices | Synchro™ .014"Synchro™ .010"TransendAgility-160.016" Guidewire* | Precision VascularPrecision VascularTarget TherapeuticsCordisTerumoThis information is assumed based upon our best knowledge. | K032146, 12 Aug 2003K032146, 12 Aug 2003K971254, 01 Jul 1997*K010511, 01 Mar 2001*K913074, 05 Nov 1991* | DQXDQXDQXDQXDQX |
| 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 PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended forperipheral and neurovascular use. It can be used to selectively introduce and positioncatheters and other interventional devices within the peripheral and neurovasculature.This device should be used only by physicians trained in percutaneous, intravasculartechniques and procedures. | |||
| DeviceDescription | The PV 1900 is a member of the Synchro® Guidewire family of products having a0.016" 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 forperipheral and neuro diagnostic and interventional procedures. The guidewire can betorqued to facilitate navigation through the vasculature. A torque device, (BostonScientific (K903606)) is supplied with the wire to facilitate deployment & positioning. Aguidewire introducer (B. Braun (K760389)) is also supplied and may be used to aidintroduction of the guidewire into the catheter hub and/or hemostasis valve and to |
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| gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. 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 portion 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. | |
|---|---|
| TechnologicalCharacteristics | Technological similarities between the PV 1900 Synchro® 0.016" Guidewire and the PVS 1300 Synchro™ predicate remain identical. This is also true for competitive predicate device features 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" Guidewire. |
| Biocompatibility of the PV 1900 Synchro® 0.016" 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 andPerformanceTests | Performance testing of materials comprising the PV 1900 Synchro® 0.016" 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, guide wire compatibility testing and performance under simulated conditions. Subject product testing has yielded acceptable safety & performance outcomes. |
| In addition, torsional strength, torqueability, and EO sterilization 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 PV 1900 Synchro® 0.016" Guidewires' substantial equivalence to the cited predicate devices. | |
| Summary ofSubstantialEquivalence | Based on the indications for use, technological characteristics, and safety and performance testing, the subject PV 1900 Synchro® 0.016" Guidewire 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 guidewires/cited predicates. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 3 2005
Boston Scientific - Precision Vascular c/o Mr. Rick Gaykowski V.P. Regulatory/Clinical Affairs Quality Systems & Operations 2405 West Orton Circle West Valley City, UT 84119
Re: K050964
PV 1900 Synchro® 0.016" Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: May 23, 2005 Received: May 25, 2005
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.
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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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours,
Donna R. Wchner
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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Indications for Use
510(k) Number (if known): K050964
Device Name (Generic): PV 1900 Synchro® 0.016" Guidewire
The PV 1900 Synchro® 0.016" Guidewire series of Indications For Use: products are intended for general intravascular use, including the neuro and peripheral vasculature. It 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.
× Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Vacher
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K6509664
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§ 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.