(36 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a mechanical guidewire, with no mention of AI/ML, image processing, or data-driven algorithms.
No
The device, a guidewire, is intended to facilitate the placement of catheters for diagnostic and interventional procedures, but it does not inherently treat a condition or restore a function.
No
The device is a steerable guidewire intended to facilitate the placement of catheters for diagnostic and interventional procedures. It is a tool for navigating the vasculature, not for diagnosing conditions itself.
No
The device description clearly states it is a physical guidewire made of stainless steel with a polymer and radiopaque tip, and a hydrophilic coating. This is a hardware device, not software.
Based on the provided information, the Sequitor™ Steerable Guidewire is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures." This describes a device used within the body during a medical procedure, not a device used to test samples outside the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details a physical guidewire designed for insertion into blood vessels.
- Anatomical Site: The anatomical site is the "peripheral vasculature," which is within the human body.
- Lack of IVD Characteristics: There is no mention of testing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Sequitor™ Steerable Guidewire is a medical device used for interventional procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.
Product codes
DQX
Device Description
The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic imaging
Anatomical Site
peripheral vasculature, vascular anatomy
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)
In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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510(k) Summary for the BioSphere Medical, Inc. Sequitor™ Steerable Guidewire
SUBMITTER/510(K) HOLDER 1.
JUN - 2 2006
BioSphere Medical, Inc. 1050 Hingham Street Rockland, MA 02370 USA
Contact Person: Irina Kulinets, Senior Director Regulatory Affairs and Quality Assurance Telephone: 781-681-7900
Date Prepared: April 12, 2006
2. DEVICE NAME
Sequitor™ Steerable Guidewire Proprietary Name: Common/Usual Name: Vascular Guidewire Classification Name: Catheter Guidewire
3. PREDICATE DEVICES
- . Radius Medical Cougar Guidewire (K011287 AND K032129)
- Boston Scientific Corporation, Transend Guidewire (K022357) .
4. DEVICE DESCRIPTION
The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.
5. INTENDED USE
The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
BioSphere Medical, Inc. bases its claim of the substantial equivalence of the Sequitor™ Steerable Guidewire with the cited predicate devices based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics. In all cases, the guidewires are used to navigate to target areas of the vascular anatomy and provide support to additional tools, such as microcatheters. Accurate placement is assured through visualization of the radiopaque portions of the guidewire using fluoroscopic imaging. Like predicate devices, the Sequitor™ Steerable Guidewire is available in a range of sizes to permit selection of the most appropriate size for the vasculature and the therapeutic and diagnostic tools. All cited guidewires are intended for singe use and are provided. sterile.
7. PERFORMANCE TESTING
In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IIN = 2 2006
BioSphere Medical, Inc. c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K061171 Sequitor™ Steerable Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: May 24, 2006 Received: May 25, 2006
Dear Ms. Robinson:
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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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. bochner
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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510(k) Number (if known): Ko6117 |
Device Name: BioSphere Sequitor™ Steerable Guidewire
Indications for Use:
The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. buchner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K061171