(95 days)
The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or interventional procedures.
The Parodi Guidewire Assembly is a disposable medical device designed for single use only. It is a multi-component system which can be manipulated to vary the stiffness characteristics as required during a procedure. The device is available in 2 main configurations: 2-piece system: Comprising a 0.014" guidewire and Outer 0.035" member. 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" member and an Intermediate stiffener. A 3-piece system is depicted in figure 1 below. The Intermediate Stiffener is not present in a 2-piece system. A hydrophilic coating is applied to the distal portion of the wire of the 0.014" guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal portions of these devices. The wire is packaged in a polyethylene hoop contained within a sealed pouch. A torque device is included within the pouch to assist with torquing the device if required.
The Parodi Guidewire is a medical device used to guide catheters during diagnostic or interventional procedures. The device's performance was evaluated through in vitro bench testing to ensure it met acceptance criteria and performed comparably to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Properties | Tip flexibility | (Not specified) | Met acceptance criteria |
| Lateral stiffness | (Not specified) | Met acceptance criteria | |
| Device compatibility | (Not specified) | Met acceptance criteria | |
| Biocompatibility | Biological Safety | Adherence to ISO 10993-1 | Established through biocompatibility testing |
2. Sample Size for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the in vitro bench tests. The tests were performed "in vitro," indicating they were laboratory-based and not on human subjects. The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Brivant Ltd. based in Galway, Ireland, suggesting the testing was likely conducted in a similar region or organized by the company. The study was a non-clinical, in-vitro study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study involved in-vitro bench testing of physical characteristics and biocompatibility, not clinical evaluation requiring expert interpretation of results to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for in-vitro bench testing. The evaluation would have involved objective measurements and comparisons against predefined criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This was an in-vitro bench testing study of a physical device, not an AI or imaging-related study that would involve human readers or MRMC analysis.
6. Standalone Performance Study
Yes, a standalone performance evaluation was conducted for the device. The "in vitro bench testing performance evaluations demonstrated that the Parodi Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate." This indicates the device's performance was assessed independently against established criteria.
7. Type of Ground Truth Used
For the in-vitro bench tests, the "ground truth" was based on predefined technical specifications and objective measurements of the device's physical properties (e.g., tip flexibility, lateral stiffness, device compatibility) and adherence to recognized standards for biocompatibility (ISO 10993-1).
8. Sample Size for the Training Set
This information is not applicable. The Parodi Guidewire is a physical medical device, not a machine learning or AI model, thus it does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons mentioned in point 8.
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K093515 page 1 of 2
Traditional 510(k) Notification Parodi Guidewire
FEB 1 6 2010
510(k) Summary
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バ
as required by 21 CFR 807.92(c)
| Device Name | Parodi Guidewire | ||
|---|---|---|---|
| Submittersname/contactdetails | Brivant Ltd, | ||
| Parkmore West Business Park, | |||
| Galway, | |||
| Ireland | |||
| Contact Details: | |||
| Tomas Furey | |||
| Operations Manager, | |||
| Tel: +353 91 385037 | |||
| Fax: +353 91 766598 | |||
| SummaryPreparation Date | 04th November 2009 | ||
| Device Name &Classification | Trade Name:Parodi Guidewire | ||
| Common Name:Guidewire | |||
| Classification Name:Catheter, Guidewire | |||
| Device Classification:Class II, 21 CFR §870.1330 | |||
| Intended Use | The Parodi Guidewire is designed to direct a catheter to the desired anatomical | ||
| location during diagnostic or interventional procedures. | |||
| Device Description | The Parodi Guidewire Assembly is a disposable medical device designed for | ||
| single use only. It is a multi-component system which can be manipulated to vary | |||
| the stiffness characteristics as required during a procedure. | |||
| The device is available in 2 main configurations: | |||
| 2-piece system: Comprising a 0.014" guidewire and Outer 0.035"member. | |||
| 3-piece system: Comprising a 0.014" guidewire, Outer 0.035" memberand an Intermediate stiffener. A 3-piece system is depicted in figure 1below. The Intermediate Stiffener is not present in a 2-piece system.A hydrophilic coating is applied to the distal portion of the wire of the 0.014"guidewire and the 0.035" outer assembly. PTFE coating is applied to the proximal | |||
| portions of these devices. | |||
| The wire is packaged in a polyethylene hoop contained within a sealed pouch. Atorque device is included within the pouch to assist with torquing the device if | |||
| required. | |||
| Predicate Devices | Manufacturer | 510k | Date |
| Brivant Ltd, Brivant Guidewire | K060551 | 07 Jun 2006 | |
| Terumo Radiofocus Glidewire for coronary usewith platinum coil | K953533 | 18 Oct 1995 | |
| Boston Scientific Amplatz Superstiff Guidewire | K944959 | 04 Nov 1994 | |
| Principle ofOperation | The Parodi Guidewire is operated manually by a manual process | ||
| Comparison ofTechnological | Although differing in construction to the predicate wires, the Parodi wire is | ||
| designed to have similar performance characteristics to the predicate devices |
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Traditional 510(k) Notification Parodi Guidewire
| Characteristics | depending on the level of stiffness (configuration) selected by the user.In vitro bench testing was performed to support a determination of substantialequivalence (i.e. tip flexibility, lateral stiffness, tip flexibility and devicecompatibility) between the Parodi Guidewires (in its various configurations) andthe predicate devices.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 and materials between the Parodi wire and the predicate devicesraise no new issues of safety and effectiveness such that the Parodi Guidewire isconsidered substantially equivalent to the predicate devices. |
|---|---|
| PerformanceTesting (non-clinical) | In vitro bench testing performance evaluations demonstrated that the ParodiGuidewire met the acceptance criteria defined in the product specification andperformed comparably to the predicate.Biological Safety of the device has been established through biocompatibilitytesting carried out in compliance with ISO 10993-1 |
| Conclusions | Based on safety and performance testing, technological characteristics and theindications for use for the device, the Parodi Guidewire has been demonstratedto be appropriate for its intended use and is considered to be substantiallyequivalent to the predicate devices. |
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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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract image of an eagle or other bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
FEB 1 6 2010
Brivant, Limited c/o Mr. Tomas Furey Operations Manager Parkmore West Business Park Galway, Ireland
Re: K093515
Trade/Device Name: Parodi Guidewire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II (two) Product Code: DQX Dated: January 18, 2010 Received: January 22, 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.
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Page 2 - Mr. Tomas Furey
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing on models.
Forth in the reads 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 100-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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 notfication" (21CFR Pract, 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 tolli the (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Dma R. Vicher
Image /page/3/Picture/8 description: The image contains a handwritten symbol that appears to be a stylized signature or initial. It consists of a curved line at the top, resembling a wave or a simplified letter, connected to a more angular line below. The overall impression is that of a quick, fluid stroke, possibly representing the letter 'B' or a similar character.
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):__K093515
Device Name: Parodi Guidewire
Indications For Use:
The Parodi Guidewire is designed to direct a catheter to the desired anatomical location during diagnostic or 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Luner
(Division Sign-Off) (Division Sign Sign Similar Devices
510(k) Number K093515
Page 1 of
§ 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.