(182 days)
The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ. The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.
The FindrWIRZ System consists of the following components: A 0.035" x 90 cm FindrWIRZ A 0.025" x 260 cm FindrWIRZ Guide wire introducer Torque device Each FindrWIRZ is configured with a tapered core wire and a distal coil, the 0.035 FindrWIRZ has a proximal PTFE jacket and both wires have a hydrophilic coating. The distal tip of each wire has an encapsulated magnet of opposite polarization which is used for proximity sensing and connection of the two guide wires to facilitate manipulation and positioning of each other. The FindrWIRZ System is sterilized with 100% ethylene oxide.
The FindrWIRZ Guide Wire System is a medical device intended for use in the cardiovascular system for the introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. The provided document is a 510(k) summary, which outlines the device's safety and effectiveness compared to predicate devices. It does not contain detailed information about specific acceptance criteria or an explicit study that proves the device meets those criteria. Instead, it describes general functional testing and biocompatibility testing to support the claim of substantial equivalence.
Here's a breakdown of the information available and what is not explicitly stated in the provided text, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Performance | Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the FindrWIRZ Guide Wire System is safe and effective for its intended use. (Specific functional criteria like tip flexibility, torque response, pushability, or trackability are not detailed in this summary.) |
| Biocompatibility | The materials used in the FindrWIRZ Guide Wire System are commonly used materials in other medical devices. Results of testing demonstrate the FindrWIRZ Guide Wire System is biocompatible. (Specific tests performed, e.g., cytotoxicity, sensitization, irritation, are not detailed.) |
| Sterilization | The FindrWIRZ System is sterilized with 100% ethylene oxide. (Confirmation of sterility and shelf-life stability is implied but not explicitly detailed as performance criteria.) |
| Intended Use | The device is deemed safe and effective for its intended use: introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures in the cardiovascular system, and for manipulation/repositioning of another FindrWIRZ. |
| Substantial Equivalence | Based on intended use, product testing, and information provided, the device is shown to be safe and effective for its intended use and substantially equivalent to the predicate devices (OnTrac, Cronus Wire, Radius Snare Device). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Functional testing" and "Results of testing" for biocompatibility but does not specify sample sizes for any test sets. It also does not provide any information regarding data provenance (e.g., country of origin, retrospective or prospective) as the testing appears to be primarily bench testing and material testing, not human clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable and not provided in the document. The testing described is for the performance and biocompatibility of a physical medical device, not for an algorithm requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided in the document, as it relates to expert review of data, which is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done as this type of study is typically conducted for diagnostic algorithms or imaging interpretation, not for the functional assessment of a guide wire system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
A standalone (algorithm only) performance study was not done as the FindrWIRZ Guide Wire System is a physical medical device and not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The concept of "ground truth" as typically used for AI or diagnostic studies is not applicable here. The "ground truth" for the device's performance would be established through engineering specifications, material standards, and clinical requirements for guide wires, validated through bench testing, material testing, and potentially pre-clinical (animal) studies (though these are not detailed in the summary).
8. The Sample Size for the Training Set:
This information is not applicable and not provided as this device is not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided as the device is not an AI algorithm requiring a training set.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing. It lacks detailed quantitative data on specific acceptance criteria and study methodologies, which is common for this type of regulatory submission for a physical medical device. The concepts of "ground truth," "expert adjudication," "sample size for test sets," and "AI performance studies" do not directly apply to the information presented for the FindrWIRZ Guide Wire System.
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SECTION 4 - 510(K) SUMMARY
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) number: _KOB6364
Date Prepared: February 06, 2008 AUG 1 2 2008
Applicant Information: SentreHEART 2468 Embarcadero Way Palo Alto, CA 94303
Contact Person:
Linda Guthrie, Manager Regulatory Affairs Phone Number: (650) 354-1200 x105 Fax Number: (650) 354-1204
Device Information:
| Trade Name: | FindrWIRZ Guide Wire System |
|---|---|
| Classification: | Class II per 21CFR 870.1330 |
| Classification Name: | Wire, Guide, Catheter |
| Product Code: | DQX |
Physical Description:
The FindrWIRZ System consists of the following components: A 0.035" x 90 cm FindrWIRZ A 0.025" x 260 cm FindrWIRZ Guide wire introducer Torque device
Each FindrWIRZ is configured with a tapered core wire and a distal coil, the 0.035 FindrWIRZ has a proximal PTFE jacket and both wires have a hydrophilic coating. The distal tip of each wire has an encapsulated magnet of opposite polarization which is used for proximity sensing and connection of the two guide wires to facilitate manipulation and positioning of each other. The FindrWIRZ System is sterilized with 100% ethylene oxide.
Intended Use:
The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ.
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SECTION 4 - 510(K) SUMMARY
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The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature. FindrWIRZ are not intended for use in crossing chronic total occlusions.
Contraindications: The FindrWIRZ system is contraindicated for use with rotational atherectorny devices, ferromagnetic interventional devices and Inferior Vena Cava (IVC) filters. The Findr WIRZ system is also contraindicated for use in MRI procedures.
Predicate Devices:
OnTrac, Lake Region (K914138) Cronus Wire, Stereotaxis (K042854) Radius Snare Device, Radius Medical Technologies (K071457)
Safety and Performance:
Performance
Functional testing was conducted to support the claim of substantial equivalence and to demonstrate the FindrWIRZ Guide Wire System is safe and effective for its intended use.
Biocompatibility
The materials used in the FindrWIRZ Guide Wire System are commonly used materials in other medical devices. Results of testing demonstrate the FindrWIRZ Guide Wire System is biocompatible.
Summary:
Based on the intended use, product testing, and information provided in this notification, the subject device has been shown to be safe and effective for its intended use and substantially equivalent to the predicate devices.
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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 depiction of a human figure with three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the organization's name and national scope.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 2006
Sentreheart Inc. c/o Ms. Linda Guthrie 2460 Embarcadero Way Palo Alto, CA 94303
Re: K080364 Trade/Device Name: FindrWirz Guidewire System Regulation Number: 21 CFR 870.1330 Regulatory Class: II Product Code: DQX Dated: July 16, 2008 Received: July 18, 2008
Dear Ms. Guthrie:
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 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
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Page 2 - Ms. Linda Guthrie
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours,
Donna R. Vachner
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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SECTION 3 - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): __K080364
Device Name: FindrWIRZ Guide Wire System
Indications for Use: The FindrWIRZ System is intended for use in the cardiovascular system for introduction and positioning of over-the-wire catheters and therapeutic devices during interventional procedures. A FindrWIRZ may also be used to manipulate and or reposition another FindrWIRZ.
The FindrWIRZ System is not intended for use in the coronary or cerebral vasculature.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NO WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. James
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko80364 SentreHEART CONFIDENTIAL
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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.