(21 days)
The IQ™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ™ Guide Wires are not intended for use in the cerebral vasculature. The devices are provided non-pyrogenic, sterile, and intended for one procedure only.
The IQTM Guide Wires are silicone-coated, steerable, spring-coil guide wires available in a nominal diameter of 0.014 inches (0,36 mm) and nominal lengths of 185 and 300 centimeters with Brachial and Femoral marks at 90cm and 100cm respectively. The tip will have Floppy flexibility, while the rail will offer Moderate Support (MS). The distal two centimeters of all models are radiopaque and available in either a straight shapeable or a pre-formed J-Tip. The IQTM Guide Wires will be available with and without a lesion length marker system. The 185-centimeter version is designed with a proximal extension section that allows connection to the AddWireTM Extension Wire.
This document pertains to the 510(k) premarket notification for the IQ™ Guide Wire. The information provided describes the device, its intended use, technological characteristics, and a summary of non-clinical testing. However, it does not include the specific details needed to answer the questions about acceptance criteria and a study proving those criteria are met for a device that uses AI/algorithm. This is a traditional medical device, a guide wire, and its performance is evaluated through standard physical and mechanical tests, not AI model performance metrics.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, how training ground truth was established) are not applicable to this type of device and the information provided in the 510(k) summary.
Here's an attempt to answer the questions based on the available information, noting the aspects that are not applicable for this device:
1. A table of acceptance criteria and the reported device performance
The document provides a general statement about the tests conducted and their outcome rather than specific, quantified acceptance criteria and performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Torque response satisfactory | Met minimum requirements |
| Tip prolapse satisfactory | Met minimum requirements |
| Tip shapeability satisfactory | Met minimum requirements |
| Radiopacity satisfactory | Met minimum requirements |
| Marker location accurate | Met minimum requirements |
| Lubricity satisfactory | Met minimum requirements |
| Coating adherence/presence satisfactory | Met minimum requirements |
| Tensile and shear strength satisfactory | Met minimum requirements |
| Combined load handling satisfactory | Met minimum requirements |
| Visual inspection satisfactory | Met minimum requirements |
| Device compatibility satisfactory | Met minimum requirements |
| Biocompatibility satisfactory | Met minimum requirements |
| Product shelf-life adequate | Met minimum requirements |
Study Proving Acceptance Criteria Met:
The document states: "Testing and evaluation of the IQ™ Guide Wires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ™ Guide Wires met all of the minimum requirements and are adequate for their intended use." This indicates non-clinical in vitro testing was performed.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. Standard practice for physical and mechanical tests of this nature would involve testing a statistically representative sample from multiple manufacturing lots, but the specific numbers are not disclosed in this summary.
- Data Provenance: Not applicable in the context of typical AI data provenance. The tests are in vitro physical and mechanical evaluations, likely performed in the manufacturer's R&D or testing facilities (Boston Scientific Corporation, Maple Grove, MN, USA).
- Retrospective or Prospective: Not applicable for in vitro physical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI models (e.g., expert interpretation of medical images) is not relevant for in vitro physical and mechanical testing of a guide wire. The "ground truth" for these tests would be the established engineering standards and specifications for device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of data, which is not relevant for in vitro physical testing. The test results would be quantitative measurements against predefined specifications.
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 a physical medical device (guide wire), not an AI-assisted diagnostic or prognostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This involves a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI context. For the in vitro testing, the "ground truth" would be established engineering specifications, industry standards (e.g., ISO, ASTM), and internal Boston Scientific quality requirements.
8. The sample size for the training set
Not applicable. This device does not involve an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not involve an AI algorithm or a training set.
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FEB 1 2 2004
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific Corporation (BSC)Two 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 | January 21, 2004 |
| ProprietaryName(s) | IQTM Guide Wire |
| Common Name | Catheter Guide Wire |
| Product Code | 74DQX |
| Classification ofDevice | Class II, 21 CFR Part 870.1330 |
| Predicate Device | |
| IQTM Hydrophilic Guide Wire K032183 August 01, 2003 | |
| DeviceDescription | The IQTM Guide Wires are silicone-coated, steerable,spring-coil guide wires available in a nominal diameter of0.014 inches (0,36 mm) and nominal lengths of 185 and300 centimeters with Brachial and Femoral marks at90cm and 100cm respectively. The tip will have Floppyflexibility, while the rail will offer Moderate Support (MS).The distal two centimeters of all models are radiopaqueand available in either a straight shapeable or a pre-formed J-Tip. The IQTM Guide Wires will be available withand without a lesion length marker system. The 185-centimeter version is designed with a proximal extensionsection that allows connection to the AddWireTM ExtensionWire. |
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| Intended Use of Device | The IQ ™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or PTA or other intravascular interventional procedures. The IQ ™ 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 Characteristics | The IQ ™ Guide Wires utilize similar materials and methods of construction as the IQ ™ Hydrophilic Guide Wires (K032183, August 01, 2003). The main differences in construction are the full-length outer spring coil with an inner coil instead of a spring tip and polymer sleeve, and silicone coating instead of hydrophilic coating. The IQ ™ Marker version also has marker coils, which the IQ ™ Hydrophilic does not. |
| Non-Clinical Test Summary | Testing and evaluation of the IQ ™ Guide Wires included torque response, tip prolapse, tip shapeability, radiopacity, marker location, lubricity, coating adherence/presence, tensile and shear, combined load, visual inspection, device compatibility, biocompatibility, and product shelf-life. Test results verified that the IQ ™ Guide Wires met all of the minimum requirements and are adequate for their intended use. The IQ ™ Guide Wires are considered 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. |
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2004
Boston Scientific Corporation Ms. Anne V. Rossi Regulatory Affairs Specialist Two Scimed Place Maple Grove, MN 55311
K040140 Re:
Trade/Device Name: IQ™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 21, 2004 Received: January 22, 2004
Dear Ms. Rossi:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) prematically equivalent (for the indications
referenced above and have determined the device is subsets marketed in interstate referenced above and have decemined the devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance while approval application (PMA).
and Cosmetic Act (Λct) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The Act. The You may, therefore, market the device, sayee to ure gents for annual registration, listing of
general controls provisions of the Act include required withing and general controls provisions of the Fee merade requires against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is classified (see above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regents may be subject to such additional controller Linesting of Parts 800 to 898. In addition, FDA may be found in the Code of Featurening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA stissuance of a raded and and other requirements of the Act that ITA has made a decemmation that Jour Star Federal agencies. You must of ally redelar statutes and regariants aincluding, but not limited to: registration and listing (21 comply with an the Ace srequirements) and manufacturing practice requirements as set
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Page 2 - Ms. Anne V. Rossi
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) rms let notification. The FDA finding of substantial equivalence of your device to a legally premainted 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) 594-4648. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Dana R. Lechner
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
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: IQ™ Guide Wire___________________________________________________________________________________________________________________________________________________
Indications For Use:
The IQ™ Guide Wires are intended to facilitate the placement of balloon dilatation The IQ -- Gulde Villes are intended to facilitate the , PTA, or other intravascular interventional procedures.
The IQ™ Guide Wires are not intended for use in the cerebral vasculature.
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Doug R. Lochner
(Division Sign-Off) Division of Cardiovascular Device
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number_604 614 b
§ 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.