(122 days)
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature,
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman venous Guidewires for Left Ventricular Lead Delivery. These two Boston Scientific Guidewires are hydrophilic coated steerable guidewires available in a 182.2 cm length. The distal tip is shapeable. For product specifications, including wire diameter, length, tip style and radiopaque tip length, please refer to the product label.
The provided text describes a 510(k) premarket notification for the ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires. This is a medical device submission, and the studies described are typically focused on demonstrating substantial equivalence to a predicate device rather than complex clinical performance trials with acceptance criteria for sensitivity, specificity, etc., as would be seen for AI/ML-based diagnostic devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (guidewires), acceptance criteria are typically specified as meeting performance benchmarks comparative to predicate devices. The text states:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from Study) |
|---|---|
| Tip flexibility (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Device delivery support (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Lead compatibility (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| Guidewire usage (Substantial Equivalence to predicate) | Bench testing performed; results provide reasonable assurance of conformance to requirements and substantial equivalence. |
| No new safety or performance issues identified | No new safety or performance issues were identified during device testing. |
| Overall Substantial Equivalence to predicate devices | The device is considered substantially equivalent to the Boston Scientific ChoICE PTCA guidewire family (K964551) based on Indications for Use, technological characteristics, safety, and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
The study described is bench testing. Therefore, the concept of "test set" and "data provenance" in the context of clinical data (e.g., country of origin, retrospective/prospective) is not directly applicable.
- Sample Size: The document does not specify the exact number of guidewires or samples tested for each bench test (tip flexibility, delivery support, lead compatibility, guidewire usage). It only states that "Bench testing was performed."
- Data Provenance: The data is generated from laboratory bench testing of the devices themselves, not from patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable to this type of device and study. Ground truth in this context is established through engineering and performance specifications and comparison to predicate devices, not by expert medical consensus.
4. Adjudication Method for the Test Set
This section is not applicable as there are no human readers or expert consensus involved in establishing the "ground truth" for the bench tests. Performance is measured against engineering specifications and predicate device characteristics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the goal is to evaluate if AI assistance improves their diagnostic accuracy. The guidewire is a physical medical device, not a diagnostic AI tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This concept is relevant for AI/ML algorithms. The device described is a physical guidewire; it does not involve algorithms for its primary function.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering Specifications: Conformance to pre-defined physical and mechanical properties.
- Predicate Device Characteristics: Direct comparison of the new guidewires' performance and characteristics to those of the legally marketed predicate devices (Boston Scientific ChoICE PTCA guidewire family and Guidant HI-TORQUE Whisper View Guidewire). The primary goal is to show "substantial equivalence."
8. Sample Size for the Training Set
This section is not applicable. There is no "training set" in the context of a physical medical device like a guidewire. Training sets are used for machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as #8.
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ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires
510(k) Summar per 21 CFR §807.92
-2 2009 JUL
| Submitter'sName andAddress | Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact Nameand Information | Stacey A. StrandRegulatory Affairs Specialist IITel: 763.255.0688Fax: 763.494.2222E-mail: strands@bsci.com | ||
| Date Prepared | February 26, 2009 | ||
| ProprietaryName(s) | ACUITY Strait-Trak™ and ACUITY™ Mailman™venous Guidewires | ||
| Common Name | Guide Wire | ||
| Product Code | DQX | ||
| Classification ofDevice | Catheter GuidewireClass II, 21 CFR Part 870.1330 | ||
| PredicateDevices | Boston ScientificCholCEExtra Support andMailman PTCAGuidewires | K964551 | May 21, 1997 |
| GuidantHI-TORQUEWhisper ViewGuidewire | K061453 | June 22, 2006 | |
| DeviceDescription | Boston Scientific ACUITY Strait-Trak and ACUITY Mailmanvenous Guidewires for Left Ventricular Lead Delivery.These two Boston Scientific Guidewires are hydrophiliccoated steerable guidewires available in a 182.2 cm length.The distal tip is shapeable. For product specifications,including wire diameter, length, tip style and radiopaque tiplength, please refer to the product label. |
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Traditional 510(k) Notification ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires 2082
Indication for Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Use venous quidewires are intended to facilitate the placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature. Comparison of The ACUITY Strait-Trak and ACUITY Mailman venous Technological quidewires incorporate a substantially equivalent design, Characteristics packaging, fundamental technology, manufacturing, and sterilization as those featured in the predicate Boston Scientific ChoICE PTCA quidewire family. Support of Bench testing was performed to support a determination of Substantial substantial equivalence (i.e. tip flexibility, device delivery Equivalence support, lead compatibility, and guidewire usage) to the predicate BSC CholCE quidewires. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were identified during device testing. The Indication for Use for the ACUITY Strait-Trak and ACUITY Mailman venous quidewires is substantially equivalent to the Guidant HI-TORQUE Whisper View Guidewire Indications for Use statement. Conclusion Based on the Indications for Use. technological characteristics, safety and performance testing, the ACUITY Strait-Trak and ACUITY Mailman venous quidewires have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the Boston Scientific ChoICE PTCA guidewire family (K964551; cleared May 21, 1997).
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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 depiction of an eagle or bird-like figure with three wing-like extensions. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 2 2009
Boston Scientific Corporation c/o Ms. Stacey A. Strand Regulatory Affairs Specialist II One Scimed Place Maple Grove, MN 55311
Re: K090554
ACUITY Mailman and ACUITY Strait-Trak Venous Guidewires Regulation Number: 21 CFR 870. 1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: June 2, 2009 Received: June 3, 2009
Dear Ms. Strand:
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 - Ms. Stacey A. Strand
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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 (240) 276-3150 or at its Internet address
1
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
M. A. Willever
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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Traditional 510(k) Notification ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires
Indications for Use
510(k) Number (if known):
Device Name: ACUITY Strait-Trak™ and ACUITY™ Mailman™ venous Guidewires
Indications for Use:
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman Venous Guidewires are intended to facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature,
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
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)
M. A. Willeboerner
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number Ko90554
Page 1 of 1
§ 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.