(34 days)
The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.
The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of the following components based on the model#:
Size and Working Length: 14FR 65 and 85 CM, Included Accessories: Dilator, Stylet, Tear-away introducer sheath
Size and Working Length: 14Fr 105 CM, Included Accessories: Dilator, NA, Tear-away introducer sheath
Size and Working Length: 9Fr 65CM, Included Accessories: NA, Curved Stylet, NA
The Dexterity steerable introducer is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer provides both proximal tip and distal tip steering and is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with stopcock is provided for air or blood aspiration, fluid infusion, blood sampling, and pressure monitoring. The introducer sheath is reinforced Pebax and the distal tip has a radiopaque marker to improve fluoroscopic visualization. The device is provided in various diameters and working lengths. The device is provided sterile and is intended for single use only.
The purpose of this submission is to add an additional device working length, 105 CM, to the 14Fr Introducer product offering. In addition the intended use statement is modified to include the term percutaneous for clarification only. This change is not a change to the intended use of the device.
This document describes the Cardiosolutions Dexterity™ Steerable Introducer, a medical device designed for the introduction of cardiovascular catheters into the heart. The information provided outlines the acceptance criteria and the summary of testing performed to demonstrate substantial equivalence to predicate devices, rather than a standalone clinical study on human subjects with ground truth established by experts.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists performance tests conducted, implying these are the acceptance criteria, and states that "All test results demonstrate that the properties and performance of the device are substantially equivalent to the predicate device and suitable for its intended use." Specific quantitative performance values are not provided in this summary.
| Acceptance Criterion (Test Name) | Reported Device Performance |
|---|---|
| Visual Surface Inspection | Met (implied by "All test results demonstrate...") |
| Dimensional Verification | Met (implied by "All test results demonstrate...") |
| Corrosion Resistance | Met (implied by "All test results demonstrate...") |
| Tensile Break Force | Met (implied by "All test results demonstrate...") |
| Tip Separation Force | Met (implied by "All test results demonstrate...") |
| Freedom from Leakage Under Pressure | Met (implied by "All test results demonstrate...") |
| Air Leakage During Aspiration | Met (implied by "All test results demonstrate...") |
| Luer Hub Compliance | Met (implied by "All test results demonstrate...") |
| Flexural Fatigue Tolerance | Met (implied by "All test results demonstrate...") |
| In Vitro Simulated Use Studies | Met (implied by "All test results demonstrate...") |
| Functional Performance Testing | Met (implied by "All test results demonstrate...") |
| Radiopacity | Met (implied by "All test results demonstrate...") |
| Shelf Life | Met (implied by "All test results demonstrate...") |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes design verification testing on the modified device, specifically a 14Fr 105 CM Dexterity™ Steerable Introducer. It does not specify the sample size for each test. The testing is described as occurring in a laboratory setting (in vitro simulated use), and therefore the data provenance is laboratory testing, not human subject data from a specific country or retrospective/prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is a steerable introducer catheter, and the evaluation is based on engineering and performance specifications, not on expert interpretation of diagnostic images or clinical outcomes. The "ground truth" for these tests would be the established engineering specifications and standards (e.g., ISO 10555).
4. Adjudication Method for the Test Set:
Not applicable. The tests are objective engineering and performance tests, not subjective assessments requiring adjudication by multiple experts.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to existing predicate devices through engineering and performance testing, not on assessing the improvement of human readers with or without AI assistance. The device itself is an introducer, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical instrument (catheter introducer), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the design verification tests, the ground truth is based on engineering specifications, international standards (ISO 10555), and FDA guidance documents for intravascular catheters.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The device is evaluated based on its physical and mechanical properties.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of device.
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ﻬﺎ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
007-1
K140015
FEB - 5 2014
SECTION 7.0
·
SPECIAL 510(K) SUMMARY
:
Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
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510(k) Summary
Special 510(k)
As required by section 807.92(c)
| CompanyName | Cardiosolutions Inc. | |||
|---|---|---|---|---|
| Address | 375 West St.West Bridgewater MA 02379Phone: 781-344-0801Fax: 781-344-0803 | |||
| Contact Person | Christine Santagate | |||
| Date Prepared | December 17, 2013 | |||
| Trade Name | Dexterity™ Steerable Introducer | |||
| Common Name | Steerable Introducer | |||
| ClassificationName | Catheter Introducer | |||
| Product Code | DYB, DRA | |||
| Regulation # | 21 CFR 870.1340 | |||
| Class | 2 | |||
| Panel | Cardiovascular | |||
| PredicateDevices | Percu-Pro™ Steerable Introducer K120086, 131332 | |||
| DeviceDescription | The Cardiosolutions Dexterity™ Steerable Introducer is provided as a 9Fr and 14FrIntroducer. The set also consists of the following components based on the model#: | |||
| Size and WorkingLength | Included Accessories | |||
| 14FR 65 and 85CM | Dilator | Stylet | Tear-awayintroducer sheath | |
| 14Fr 105 CM | Dilator | NA | Tear-awayintroducer sheath | |
| 9Fr 65CM | NA | Curved Stylet | NA | |
| The Dexterity steerable introducer is designed to provide flexible catheter positioning inthe cardiac anatomy. The steerable introducer provides both proximal tip and distal tipsteering and is fitted with a hemostasis valve to minimize blood loss during catheterintroduction and/or exchange. A sideport with stopcock is provided for air or bloodaspiration, fluid infusion, blood sampling, and pressure monitoring. The introducersheath is reinforced Pebax and the distal tip has a radiopaque marker to improvefluoroscopic visualization. The device is provided in various diameters and workinglengths. The device is provided sterile and is intended for single use only. | ||||
| The purpose of this submission is to add an additional device working length, 105 CM,to the 14Fr Introducer product offering. In addition the intended use statement ismodified to include the term percutaneous for clarification only. This change is not achange to the intended use of the device. | ||||
| Intended Use | The Dexterity™ Steerable Introducer is intended to be used for the percutaneousintroduction of various cardiovascular catheters into the heart, including the left side ofthe heart through the inter-atrial septum. | |||
| Safety andPerformanceTesting | No performance standards have been established under Section 514 of the Food, Drugand Cosmetic Act for these devices. | |||
| The materials used in the 14 Fr 105 CM Dexterity™ Steerable Introducer are identical tothe Dexterity™ Steerable Introducer predicate device. No additional biocompatibility isrequired. | ||||
| Design verification testing performed on the modified device consisted of mechanicaltesting conducted in accordance with the ISO 10555 Sterile, single-use intravascularcatheters Part 1: General requirements (as amended, 1999, 2004) and in consideration ofFDA Guidance on Premarket Notification 510(k) Submission for Short Term and LongTerm Intravascular Catheters. The following tests were completed: | ||||
| o | Visual Surface Inspection | |||
| o | Dimensional Verification | |||
| o | Corrosion Resistance | |||
| o | Tensile Break Force | |||
| o | Tip Separation Force | |||
| o | Freedom from Leakage Under Pressure | |||
| o | Air Leakage During Aspiration | |||
| o | Luer Hub Compliance | |||
| o | Flexural Fatigue Tolerance | |||
| o | In Vitro Simulated Use Studies | |||
| o | Functional Performance Testing | |||
| o | Radiopacity |
Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
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ﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
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Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
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| o | Shelf Life | |
|---|---|---|
| All test results demonstrate that the properties and performance of the device aresubstantially equivalent to the predicate device and suitable for its intended use. | ||
| SubstantialEquivalence | The 14Fr 105 CM Dexterity™ Steerable Introducer is substantially equivalent to thepredicate devices in terms of intended use, design, materials, technology, and function.There are no differences between devices which would raise new issues of safety oreffectiveness. |
Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
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Image /page/4/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2014
Cardiosolutions Inc. Christine Santagate Manager of Regulatory Consulting Services 375 West St. West Bridgewater, MA 02379
Re: K140015
Trade/Device Name: Cardiosolutions Dexterity Steerable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: January 7, 2014 Received: January 8, 2014
Dear Ms. Santagate,
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 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
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Page 2 - Christine Santagate
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,
M. Ar. Heele
for 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
K140015 510(k) Number:
Device Name: Dexterity™ Steerable Introducer
Indications for Use:
The Dexterity™ Steerable Introducer is intended to be used for the percutaneous introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.
Prescription Use X (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)
M. L. Hillman
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).