(122 days)
Not Found
No
The document describes a physical guidewire and its intended use for lead placement, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a guidewire intended to facilitate the placement of leads, which is an accessory to a therapeutic device rather than a therapeutic device itself.
No
Explanation: The device is a guidewire intended to facilitate the placement of leads, which is a procedural aid, not a diagnostic tool. It does not identify or characterize a disease or condition.
No
The device description clearly states it is a physical guidewire, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the placement of Boston Scientific or Guidant Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature." This describes a device used in vivo (within the body) for a medical procedure, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a guidewire, which is a tool used during interventional procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a medical device used for a therapeutic or interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Boston Scientific ACUITY Strait-Trak and ACUITY Mailman venous quidewires are intended to facilitate the placement of Left Ventricular (LV) leads within the Coronary Sinus (CS) vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary Sinus (CS) vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to support a determination of Substantial equivalence (i.e. tip flexibility, device delivery 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
176
40554
tof2-
ACUITY Strait-Trak™ and ACUITY™ Mailman™ Venous Guidewires
510(k) Summar per 21 CFR §807.92
-2 2009 JUL
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|
| Contact Name
and Information | Stacey A. Strand
Regulatory Affairs Specialist II
Tel: 763.255.0688
Fax: 763.494.2222
E-mail: strands@bsci.com | | |
| Date Prepared | February 26, 2009 | | |
| Proprietary
Name(s) | ACUITY Strait-Trak™ and ACUITY™ Mailman™
venous Guidewires | | |
| Common Name | Guide Wire | | |
| Product Code | DQX | | |
| Classification of
Device | Catheter Guidewire
Class II, 21 CFR Part 870.1330 | | |
| Predicate
Devices | Boston Scientific
CholCE
Extra Support and
Mailman PTCA
Guidewires | K964551 | May 21, 1997 |
| | Guidant
HI-TORQUE
Whisper View
Guidewire | K061453 | June 22, 2006 |
| Device
Description | 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. | | |
1
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).
2
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.
3
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
4
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
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