(15 days)
The IQ™ Hydrophilic Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature.
The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coating are steerable, spring-tipped guide wires. The IQ™ Hydrophilic is available in a nominal diameter of 0.014 inches, Moderate Support, and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The distal three centimeters of all models are radiopaque spring coils and available in either a straight shapeable or a pre-formed J-Tip. The IQ™ Hydrophilic corewire consists of a PTFE coated SS corewire segment joined via a nickel-chromium alloy coupler to a tapered Nitinol corewire segment. The distal segment of this corewire is coated with an adhesive pre-coat that is jacketed with a Tungsten loaded polyurethane sleeve. This polymer sleeve is coated with ICE® Hydrophilic coating. A SS centering sleeve attaches a SS ribbon to the distal end of the corewire. The distal most portion of the corewire, the centering sleeve and the SS ribbon reside within the hollow center of the 3-cm spring-coil. The 185-centimeter version of the IQ™ Hydrophilic is designed with a proximal extension section that allows connection to the AddWire™ Extension Wire.
The document K032183 describes a Special 510(k) for a device modification to the BSC IQ Hydrophilic Guide Wire. This is a medical device, not an AI/ML algorithm, so many of the requested categories (like training set, test set, experts, MRMC studies) are not applicable. Nonetheless, I will provide the information relevant to the device's acceptance criteria and the study that proves it meets those criteria based on the provided text.
Acceptance Criteria and Device Performance for BSC IQ Hydrophilic Guide Wire (K032183)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Test | Reported Device Performance |
|---|---|---|
| Functional Performance | Torque Response | Met minimum requirements |
| Tip Prolapse | Met minimum requirements | |
| Tip Shapeability | Met minimum requirements | |
| Marking (Brachial and Femoral) | Met minimum requirements (marker location verified) | |
| Material/Coating Integrity | Coating Adherence/Presence | Met minimum requirements |
| Tensile Strength | Met minimum requirements | |
| Combined Load (not specified if a materials test) | Met minimum requirements | |
| Polymer Peel | Met minimum requirements | |
| Safety & Compatibility | Visual Inspection (for defects) | Met minimum requirements |
| Device Compatibility (with other PTCA/PTA devices) | Met minimum requirements | |
| Biocompatibility | Met minimum requirements | |
| Shelf-Life | Product Shelf-Life | Met minimum requirements |
| Substantial Equivalence | Comparison to predicate devices (PT2™ Guide Wire, Luge™ Guide Wire) | Considered substantially equivalent based on intended use, design, and in vitro testing. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify the exact number of guide wires or samples used for each test. It broadly states "Testing and evaluation of the IQ™ Hydrophilic Guide Wires included..."
- Data Provenance: The tests are "Non-Clinical Test Summary," implying laboratory/bench testing. The provenance of external data (e.g., country of origin, retrospective/prospective) is not applicable as this is not a study involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical device approval based on engineering and performance criteria tested in a laboratory setting, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for human-interpreted data, not for direct device performance measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's functional integrity as tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by engineering specifications, material science standards, and predefined pass/fail criteria for each functional and material test (e.g., a specific tensile load must be withstood, coatings must adhere to a certain peel strength). The document states "Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements."
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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AUG - 1 2003
Special 510(k): Device Modification
BSC IQ Hydrophilic Guide Wire
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific Corporation (BSC)One Scimed PlaceMaple Grove, MN 55311 | ||
|---|---|---|---|
| Contact Name andInformation | Anne V. RossiSpecialist, Regulatory AffairsPhone: 763-494-2827Fax: 763-494-2222e-mail: Anne.Rossi@bsci.com | ||
| Date Prepared | July 16, 2003 | ||
| ProprietaryName(s) | IQ™ Hydrophilic Guide Wire | ||
| Common Name | Catheter Guide Wire | ||
| Product Code | 74DQX | ||
| Classification ofDevice | Class II, 21 CFR Part 870.1330 | ||
| Predicate Devices | PT2™ Guide Wire | K030617 | May 21, 2003 |
| Luge™ Guide Wire | K973945 | January 12, 1998 | |
| DeviceDescription | The IQ™ Hydrophilic Guide Wires with ICE® hydrophilic coatingare steerable, spring-tipped guide wires. The IQ™ Hydrophilicis available in a nominal diameter of 0.014 inches, ModerateSupport, and nominal lengths of 185 and 300 centimeters withBrachial and Femoral marks at 90cm and 100cm respectively.The distal three centimeters of all models are radiopaque springcoils and available in either a straight shapeable or a pre-formed J-Tip.The IQ™ Hydrophilic corewire consists of a PTFE coated SScorewire segment joined via a nickel-chromium alloy coupler toa tapered Nitinol corewire segment. The distal segment of thiscorewire is coated with an adhesive pre-coat that is jacketedwith a Tungsten loaded polyurethane sleeve. This polymersleeve is coated with ICE® Hydrophilic coating. A SS centeringsleeve attaches a SS ribbon to the distal end of the corewire.The distal most portion of the corewire, the centering sleeve andthe SS ribbon reside within the hollow center of the 3-cm spring-coil.The 185-centimeter version of the IQ™ Hydrophilic is designedwith a proximal extension section that allows connection to theAddWire™ Extension Wire. |
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The IQ™ Hydrophilic Guide Wires are intended to facilitate the Intended Use of placement and exchange of balloon dilatation catheters or other Device therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Hydrophilic Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
Technological The IQ™ Hydrophilic Guide Wires utilize similar materials and Characteristics methods of construction as the currently marketed PT2™ Guide Wire family of quide wires. The differences in construction are the addition of a spring-coil to the distal most tip and a SS ring at the ribbon/corewire joint.
Non-Clinical Test Testing and evaluation of the IQ™ Hydrophilic Guide Wires Summary included torque response, tip prolapse, tip shapeability, marker location, coating adherence/presence, tensile, combined load, visual inspection, polymer peel, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Hydrophilic Guide Wires met all of the minimum requirements and are adequate for their intended use. The IQ™ Hydrophilic Guide Wires are considered to be substantially equivalent to guide wires currently marketed by Boston Scientific based on a comparison of intended use, design and the results of in vitro testing and evaluation.
KC32183
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "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 a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 1 2003
Boston Scientific Corporation c/o Anne V. Rossi Specialist, Regulatory Affairs One Scimed Place Maple Grove, MN 55311
Re: K032183
IQ™ Hydrophilic Guide Wire Regulation Number: 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: July 16, 2003 Received: July 21, 2003
Dear Ms. Rossi:
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. Anne V. Rossi
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 (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. 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k) Number(if known) | K032183 |
|---|---|
| Device Name | IQ™ Hydrophilic Guide Wire |
| Indications ForUse | The IQ™ Hydrophilic Guide Wires are intended to facilitate theplacement of balloon dilatation catheters or other therapeuticdevices during PTCA, PTA, or other intravascular interventionalprocedures. The IQ™ Hydrophilic Guide Wires are not intendedfor use in the cerebral vasculature. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR §801.109)
Over-The-Counter Use OR
N'DeCartha
iovascular Devices
510(k) Number K032183
§ 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.