(24 days)
The IQ™ 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™ Guide Wires are not intended for use in the cerebral vasculature.
The IQ™ 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 has Floppy flexibility, while the rail offers 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 IQ™ 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 AddWire™ Extension Wire.
This 510(k) summary (K052783) is for a medical device called the "IQ™ Guide Wire," a catheter guide wire used in interventional procedures. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device rather than presenting new clinical study data with acceptance criteria based on performance. As such, the requested information elements related to clinical study design, acceptance criteria, and performance metrics are not applicable in the way they would be for a device requiring de novo clinical validation.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided 510(k) summary, specific numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance are not applicable. This submission relies on "substantial equivalence" to a predicate device, meaning the new device is demonstrated to be as safe and effective as a legally marketed device without requiring new clinical performance metrics to be established against specific criteria.
The general "acceptance criterion" for this type of submission is the demonstration that the device's technological characteristics, materials, and intended use are similar enough to the predicate device such that it raises no new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as a clinical "test set" with associated ground truth for performance evaluation (e.g., sensitivity, specificity) was not conducted or reported in this 510(k) submission. The evaluation was primarily based on non-clinical (bench) testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as a clinical test set requiring expert ground truth establishment for performance metrics was not conducted or reported.
4. Adjudication Method for the Test Set:
Not applicable, as a clinical test set requiring adjudication was not conducted or reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses how AI assistance impacts human reader performance. The IQ™ Guide Wire is a physical medical device, not an AI software system aiding interpretation, and the submission is focused on substantial equivalence based on non-clinical testing.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The IQ™ Guide Wire is a physical medical device, not an algorithm. Its performance is evaluated through bench testing and comparison to a predicate device, not standalone algorithmic output.
7. Type of Ground Truth Used:
For the non-clinical tests mentioned ("Bench, product shelf life, and biocompatibility test results"), the "ground truth" would be established by:
- Bench Testing: Engineering specifications, industry standards, and established physical/mechanical properties of materials.
- Product Shelf Life: Accelerated aging studies and real-time stability studies, with the "truth" being the device meeting its performance specifications over time.
- Biocompatibility Testing: International standards (e.g., ISO 10993) and established toxicological profiles, with the "truth" being the device not eliciting adverse biological responses.
8. Sample Size for the Training Set:
Not applicable, as this device is not an AI/ML algorithm that requires a "training set." The evaluation is based on non-clinical testing of physical device samples.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of device submission.
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Ko52783
000 2 7 2009
510(k) Summary
per 21 CFR §807.92
| Submitter's Name and Address | Boston Scientific Corporation (BSC)Two Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name and Information | Diane BrinzaSpecialist, Regulatory AffairsPhone: 763-694-3061Fax: 763-694-6966e-mail: brinzad@bsci.com |
| Date Prepared | September 30, 2005 |
| Proprietary Name(s) | IQ™ Guide Wire |
| Common Name | Catheter Guide Wire |
| Product Code | DQX |
| Classification of Device | Class II, 21 CFR Part 870.1330 |
| Predicate Device | IQ™ Guide Wire K040140 February 12, 2004 |
| Device Description | The IQ™ 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 has Floppy flexibility, while the rail offers 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 IQ™ 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 AddWire™ Extension Wire. |
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| Intended Use ofDevice | The IQ™ Guide Wires are intended to facilitate theplacement and exchange of balloon dilatation catheters orother therapeutic devices during PTCA or PTA or otherintravascular interventional procedures. The IQ™ GuideWires are not intended for use in the cerebral vasculature.The devices are provided non-pyrogenic, sterile, andintended for one procedure only. |
|---|---|
| TechnologicalCharacteristics | The IQ™ Guide Wires utilize similar materials andmethods of construction as the IQ™ Guide Wires(K040140, February 12, 2004). The IQ™ Marker versionalso has marker coils. |
| Non-Clinical TestSummary | Bench, product shelf life, and biocompatibility test resultsverified that the IQ™ Guide Wires met all of the specifiedrequirements and are suitable for their intended use.The IQ™ Guide Wires are considered substantiallyequivalent to guide wires currently marketed by BostonScientific based on a comparison of intended use, designand the results of in vitro testing and evaluation. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2005
Boston Scientific Corporation c/o Ms. Diane Brinza Specialist, Regulatory Affairs Two Scimed Place Maple Grove. MN 55311
K052783 રિટ: IO™ Guide Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II Product Code: DQX Dated: September 30, 2005 Received: October 3, 2005
Dear Ms. Brinza:
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. Diane Brinza
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised fill I DA s issualled of a backlines with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmation administered by other Federal agencies. You must or any Federal Statutes and regulations daministered wy not limited to: registration and listing (21 comply with an the Act 3 requirements, moraansy.
CFR Part 807); labeling (21 CFR Part 801); good manufacturing became and setting aloctor CFR Part 807), labeling (21 CFR Part 807), government 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections on Eevice as described in your device to Age) I his leter will andw you to begin maneting your as the receivelence of your device to a legally premarket notification: "The PDF miching of eastion 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 If you desire specific darres 10-3 at (240) 276-0120. Also, please note the regulation entitled, contact the Orited of Comphance at (210) =76 art 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other geleral information on your responser Assistance at its toll-free number (800) 638-204 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Bhimmerhofer
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 Statement
| 510(k) Number(if known) | K052783 |
|---|---|
| Device Name | IQ™ Guide Wire |
| Indications ForUse | The IQ™ Guide Wires are intended to facilitate theplacement of balloon dilatation catheters or othertherapeutic devices during PTCA, PTA, or otherintravascular interventional procedures. |
| The IQ™ Guide Wires are not intended for use in thecerebral vasculature. |
Prescription Use
(Per Part 21 CFR §801 Subpart D)
AND/OR
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)
B. M. Minor
(Division Sign-Off) Division of Cardiovascular Devloes 510(k) Number
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.