(49 days)
Boston Scientific ACUITY WHISPER VIEW™ Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature.
The ACUITY Whisper View guide wire family comprises three individual guide wires with different support profiles: Extra Support (ES), Distal Support (DS), and Extra Distal Support (EDS). The guide wires have a nominal diameter of 0.014 inches (0.36 mm) and a length of 190 centimeters, and are available with a straight distal tip that is shapeable or a preformed coronary sinus (CS) J-shaped tip. The guide wire is coated with a hydrophilic coating for increased lubricity.
The ACUITY Whisper View guide wires are available in the following models, rail supports, and tip shapes:
Model 4640, Extra Support (ES), Straight
Model 4641, Extra Support (ES), CS-J
Model 4642, Distal Support (DS), Straight
Model 4643, Distal Support (DS), CS-J
Model 4647, Extra Distal Support (EDS), Straight
Model 4648, Extra Distal Support (EDS), CS-J
Here's an analysis of the provided text regarding the ACUITY Whisper View™ Guide Wires, focusing on acceptance criteria and supporting studies:
This document is a 510(k) Summary and the FDA's acceptance letter for the Boston Scientific ACUITY Whisper View™ Guide Wires. It outlines a comparison to predicate devices, and the testing conducted is primarily for demonstrating substantial equivalence rather than establishing formal acceptance criteria for a novel device. As such, the "acceptance criteria" here are implicitly related to meeting the performance characteristics of the predicate device.
Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative "acceptance criteria" in a table format with specific thresholds. Instead, it describes the new device's performance in relation to its predicate device. The underlying acceptance criterion for a 510(k) submission is that the new device performs at least as well as, or equivalently to, the legally marketed predicate device for its intended use.
Here's an interpretation of the performance criteria and how the device met them, based on the text:
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (Summary) |
|---|---|
| Intended Use: Facilitate LV lead placement. | The ACUITY Whisper View guide wire has the same intended use as the predicate (Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature). |
| Technological Characteristics: | Inherently substantially equivalent to the predicate. |
| - Stainless steel core wire | Uses a stainless steel core wire. |
| - Same lengths, support, and shape options | Offers the same lengths, guide wire support, and shape options (Extra Support (ES), Distal Support (DS), Extra Distal Support (EDS); Straight or CS-J tip). |
| - Radiopaque distal end for fluoroscopy | Distal end is radiopaque and can be seen under fluoroscopy for device placement. |
| - Highly lubricious for smooth delivery | Described as "highly lubricious for smooth delivery of therapeutic devices." |
| - Biocompatibility | "Biocompatibility ... testing were also completed," implying satisfactory results. |
| - Packaging/Shelf Life | "packaging/shelf life ... testing were also completed," implying satisfactory results. |
| - Sterility | "sterility testing were also completed," implying satisfactory results. |
| Mechanical Performance: (e.g., tensile strength, | "Design verification testing, including mechanical bench testing... were conducted to verify that the performance of the ACUITY Whisper View guide wires are substantially equivalent to the predicate devices." "Test results confirm that Boston Scientific ACUITY Whisper View guide wires meet all of the minimum requirements and are adequate for their intended use." (This indicates performance was equivalent or better). |
| torque, flexibility, etc. - implied tests ) | |
| Animal Testing Performance: (to simulate in-vivo | "design validation animal testing... were conducted to verify that the performance of the ACUITY Whisper View guide wires are substantially equivalent to the predicate devices." |
| use) |
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes for the mechanical bench testing or animal testing. It only states that these tests were "conducted."
- The data provenance is not mentioned (e.g., country of origin). The testing was "non-clinical," implying laboratory and animal studies, not human patient data.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- This is not applicable as the studies described are non-clinical (bench and animal testing). The "ground truth" for these types of tests would be established by engineering specifications, predicate device performance, and observed animal physiological responses, rather than expert interpretation of images or patient outcomes.
-
Adjudication Method for the Test Set:
- Not applicable for non-clinical bench and animal testing.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical Test Summary: Clinical evaluation was not required." This indicates that human reader performance or AI-assisted performance in a clinical setting was not assessed.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system.
-
The Type of Ground Truth Used:
- For the mechanical bench testing, the ground truth would be based on engineering specifications, material properties, and the performance characteristics of the predicate device.
- For the animal testing, the ground truth would be based on physiological observations, device navigability, and any tissue reactions within the animal model, compared to expected performance and predicate device behavior.
-
Sample Size for the Training Set:
- This is not applicable as the device is a physical medical device. There is no AI algorithm being trained.
-
How the Ground Truth for the Training Set was Established:
- Not applicable as there is no training set for an AI algorithm.
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APR - 8 2011
|< 110479
| 510(K) SUMMARY | 4100 Hamline Avenue NorthSt. Paul, MN 55112-5798 | |
|---|---|---|
| 651.582.4000 Tel651.582.5134 Fax | ||
| Date Prepared: | February 16, 2011 | www.bostonscientific.com |
| Submitted By: | Boston Scientific Corporation | |
| Cardiac Rhythm Management | ||
| 4100 Hamline Avenue North | ||
| St. Paul, Minnesota 55112-5498 | ||
| Contact Person: | Kirstin Johnston | |
| Regulatory Affairs Specialist | ||
| Telephone: (800) 227-3422 or direct, (651) 582-5871 | ||
| FAX: (612) 582-5134 | ||
| Email: kirstin.johnston@bsci.com | ||
| Trade Name: | ACUITY Whisper View™ GUIDE WIRES | |
| Common Name: | Guide Wire | |
| Classification: | Class II, 21 CFR 870.1330 | |
| Product Code: | DQX | |
| Predicate Devices: | Guidant HI-TORQUE Whisper View™ Guide Wire (K061453,cleared 06/22/2006) | |
| Boston Scientific ACUITY™ Mailman™ (Model 7081) andACUITY Strait-Trak™ (Model 7082) Venous Guide wires (K090554,cleared 07/2/2009) | ||
| Device Description: | The ACUITY Whisper View guide wire family comprises threeindividual guide wires with different support profiles: Extra Support(ES), Distal Support (DS), and Extra Distal Support (EDS). The guidewires have a nominal diameter of 0.014 inches (0.36 mm) and alength of 190 centimeters, and are available with a straight distal tipthat is shapeable or a preformed coronary sinus (CS) J-shaped tip.The guide wire is coated with a hydrophilic coating for increasedlubricity. | |
| The ACUITY Whisper View guide wires are available in thefollowing models, rail supports, and tip shapes:Model 4640, Extra Support (ES), StraightModel 4641, Extra Support (ES), CS-J | ||
- Model 4642, Distal Support (DS), Straight .
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- Model 4643, Distal Support (DS), CS-J .
Intended Use of the
Substantial
Equivalence:
-
Model 4647, Extra Distal Support (EDS), Straight .
Boston Scientific ACUITY Whisper View™ Guide Wires with -
Model 4648, Extra Distal Support (EDS), CS-J �
Device: Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature. Similarities: Both the ACUITY Whisper View and the predicate HI-Technological TORQUE Whisper View guide wires use a stainless steel core wire in Characteristics: the same lengths, guide wire support and shape options. The distal end of each device is radiopaque and can be seen under fluoroscopy for device placement. Both devices are highly lubricious for smooth delivery of therapeutic devices. The ACUITY Whisper View guide wire has the same intended use, same operating principle, similar design, uses similar materials, and has a similar performance. Differences: The ACUITY Whisper View guide wires differ from the predicate HI-TORQUE Whisper View in the following aspects: design and material changes to the distal tip coil, radiopaque polymer jacket material, and hydrophilic coating. The ACUITY Whisper View guide wire uses the same radiopaque polymer jacket material and hydrophilic coating as used on Boston Scientific's ACUITYTM Mailman™ and ACUITY Strait-Trak™ guide wires (K061453). Non-Clinical Test Design verification testing, including mechanical bench testing, and Summary: design validation animal testing, were conducted to verify that the performance of the ACUITY Whisper View guide wires are substantially equivalent to the predicate devices. Biocompatibility, packaging/shelf life, and sterility testing were also completed. Test results confirm that Boston Scientific ACUITY Whisper View guide wires meet all of the minimum requirements and are adequate for their intended use. Clinical Test Clinical evaluation was not required. Summary: Statement of
The Boston Scientific ACUITY Whisper View guide wires are substantially equivalent to the predicate Guidant HI-TORQUE Whisper View guide wires based on a comparision of intended use, design, and the results of the testing and evaluation.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the wings and body of the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kirstin Johnston Regulatory Affairs Specialist Boston Scientific Corp. 4100 Hamline Ave, North St. Paul. MN 55112
APR - 8 2011
Re: K110479
Trade/Device Name: ACUITY Whisper View Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II (two) Product Code: DQX Dated: March 23, 2011 Received: March 24, 2011
Dear Ms. Johnston:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 -- Ms. Kirstin Johnston
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); medical device reporting (reporting of medical device-rclated adverse events) (21 CFR 803), 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHOffices/ucm115809.hym for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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 STATEMENT
| 510(k) Number (if known): | K110479 |
|---|---|
| Device Name: | ACUITY WHISPER VIEW™ GUIDE WIRE |
| Indications For Use: | Boston Scientific ACUITY WHISPER VIEW™ Guide Wires with Hydrophilic Coating are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the coronary venous vasculature. |
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
| AND/OROver-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)
(Division Sign-Off)
Esr Division of Cardiovascular Devices
510(k) Number________________________________________________________________________________________________________________________________________________________________
§ 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.