(29 days)
The Cruiser-18 Guidewires are intended for use in the peripheral vasculature. The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PPCI).
The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness.
Here's an analysis of the provided text regarding the Cruiser-18 Guidewire, focusing on acceptance criteria and supporting studies.
Important Note: The provided document is a 510(k) Summary for a medical device. This type of submission relies heavily on bench testing and comparison to predicate devices to demonstrate substantial equivalence, rather than extensive clinical studies or AI algorithm performance evaluations as might be found for software as a medical device. Therefore, many of the requested points related to AI, clinical trials, and multi-reader studies will not be applicable.
Acceptance Criteria and Study Overview for Cruiser-18 Guidewire
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Performance | - Tensile Strength | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| - Torque Strength | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Outer Diameter measurement | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Torque Response | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| - Tip Flexibility | Met acceptance criteria defined in product specification; performed comparably to predicate device. | |
| Material/Integrity | - Coating Adherence/Coating Integrity | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| Compatibility | - Catheter Compatibility | Met acceptance criteria defined in product specification; performed comparably to predicate device. |
| Biological Safety | - Biocompatibility Testing | Followed ISO 10993-1. |
Study that Proves the Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is described as "In vitro bench tests" carried out to demonstrate equivalence with reference to the FDA's guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995." The results demonstrated that the Cruiser-18 Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "in vitro bench tests" and "performance evaluations" but does not detail the number of units or samples tested for each criterion.
- Data Provenance: The tests are in vitro bench tests, meaning they were conducted in a laboratory setting, not with human subjects. The data does not originate from a specific country in terms of patient data, but rather from laboratory testing performed by Brivant Ltd (located in Ireland). The study is inherently prospective in the sense that the tests were designed and executed to evaluate the new device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable as the device is a physical medical device (guidewire) being evaluated through bench testing against engineering specifications, not an AI algorithm requiring expert consensus for ground truth on medical images or diagnoses. The "ground truth" here is defined by engineering specifications and predicate device performance.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the evaluation involves physical measurements and functional tests against predefined specifications, not subjective expert judgment that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a physical guidewire, not an AI algorithm intended to assist human readers in interpreting medical cases. No MRMC study was conducted or is relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Not applicable. This device is not an algorithm. Its performance is inherent to its physical properties and function as a guidewire, operated manually by a clinician.
7. Type of Ground Truth Used
The ground truth used for these performance evaluations is based on:
- Product Specifications: Predefined engineering and performance criteria for the guidewire.
- Predicate Device Performance: Performance characteristics established from the legally marketed predicate devices (Brivant Guidewire K060551 and Courier Guidewire K073082).
- Regulatory Guidance: Referenced the FDA's "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995."
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Cruiser-18 - 510(k) Application
510(k) Summary as required by 21 CFR 807.92(c)
| Device Name | Cruiser-18 Guidewire | ||||
|---|---|---|---|---|---|
| Submitters name/contact details | Brivant Ltd,Parkmore West Business Park,Galway,IrelandContact Details:Tomas FureyOperations Manager,Tel: +353 91 385037Fax: +353 91 766598 | SEP 3 2010 | |||
| Summary Preparation Date | 19th July 2010 | ||||
| Device Name & Classification | Trade Name: | Cruiser-18 Guidewire | |||
| Common Name: | Guidewire | ||||
| Classification Name: | Catheter, Guidewire | ||||
| Device Classification: | Class II, 21 CFR §870.1330 | ||||
| Product Code: | DQX | ||||
| Intended Use | Intended Use: | The Cruiser-18 Guidewires are intended for use in the peripheral vasculature. | |||
| Contraindications:The Cruiser-18 guide wire is not intended for use in the coronary or cerebral vasculature.Patients judged not acceptable for percutaneous intervention (PPCI) | |||||
| Device Description | The guide wire is a disposable medical device designed for single use only. It consists of a 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 13cm segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness. This reduced section is covered with a spring coil of equivalent diameter to the main core body. The coiled segment consists of a stainless steel coil placed over a radiopaque coil made of a platinum tungsten alloy. This coil provides greater visibility on x-ray equipment. The profile of the reduced section is varied to provide a range of products with mixed stiffness. | ||||
| Predicate Devices | Manufacturer | 510k | Date | ||
| Brivant Ltd, Brivant Guidewire | K060551 | 07 Jun 2006 | |||
| Brivant Ltd, Courier Guidewire | K073082 | 09 Jan 2008 | |||
| Principle of Operation | The Cruiser-18 Guidewire is operated manually by a manual process | ||||
| Comparison of | The Cruiser-18 wire has minor differences in construction to the approved |
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.
| Cruiser-18 - 510(k) Application | |
|---|---|
| TechnologicalCharacteristics | Brivant Guidewire.In vitro bench testing was performed to support a determination of substantialequivalence (i.e. tip flexibility, tip flexibility and device compatibility) betweenthe Cruiser-18 Guidewires (in its various configurations) and the predicatedevices.The results of these tests provide reasonable assurance that the proposed devicehas been designed and tested to assure conformance to the requirements for itsintended use and performs comparably to the predicate devices. The differencesin construction between the Cruiser-18 wire and the predicate device raise nonew issues of safety and effectiveness such that the Cruiser-18 Guidewire isconsidered substantially equivalent to the predicate devices. |
| PerformanceTesting (non-clinical) | In vitro bench tests were carried out to demonstrate equivalence with referenceto the FDAs guidance document "Coronary and Cerebrovascular GuidewireGuidance, Jan 1995".The following bench tests were performed:- Tensile Strength- Torque Strength- Outer Diameter measurement- Torque Response- Catheter Compatibility- Coating Adherence/Coating Integrity- Tip FlexibilityThe results from these performance evaluations demonstrated that the Cruiser-18 Guidewire met the acceptance criteria defined in the product specificationand performed comparably to the predicate device. Biological Safety of thedevice has been established through biocompatibility testing carried out incompliance with ISO 10993-1 |
| Conclusions | Based on safety and performance testing, technological characteristics and theindications for use for the device, the Cruiser-18 Guidewire has beendemonstrated to be appropriate for its intended use and is considered to besubstantially equivalent to the predicate devices. |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Brivant, Ltd. c/o Tomas Furey, Operations Manager Parkmore West Business Park Galway, County Galway Ireland
3 2010 SEP
Re: K102211
Trade/Device Name: Cruiser-18 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: July 20, 2010 Received: August 5, 2010
Dear Mr. Furey:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
R. Vahner
A 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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Cruiser-18 - 510(k) Application
Indications for Use Statement
8 2010 SEP
510(k) Number (if known): K102211
Device Name: Cruiser-18 Guidewire Indications for Use: The Cruiser-18 Guidewires are intended for use in the peripheral vasculature The Cruiser-18 guide wire is not intended for use in the Contraindications: coronary or cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PPCI)
Duma D. helmer
wascular Devices
510(k) Number
§ 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.