(34 days)
K120086, 131332
K120086, 131332
No
The description focuses on mechanical and physical properties of a steerable introducer, with no mention of AI or ML.
No.
The device is used for the introduction of cardiovascular catheters, not for directly treating a condition or disease.
No
The device is an introducer used to deliver other cardiovascular catheters. Its purpose is to facilitate the placement of diagnostic or therapeutic catheters, not to perform a diagnostic function itself. While it aids in procedures that might be diagnostic, the device itself is a delivery tool.
No
The device description clearly outlines physical components like a sheath, dilator, stylet, hemostasis valve, and sideport, indicating it is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of various cardiovascular catheters into the heart". This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The device is a "Steerable Introducer" used to guide catheters. This is a surgical/interventional tool, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
The device is an invasive medical device used for facilitating cardiovascular procedures.
N/A
Intended Use / 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.
Product codes
DYB, DRA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, inter-atrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification testing performed on the modified device consisted of mechanical testing conducted in accordance with the ISO 10555 Sterile, single-use intravascular catheters Part 1: General requirements (as amended, 1999, 2004) and in consideration of FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long Term Intravascular Catheters. The following tests were completed:
Visual Surface Inspection
Dimensional Verification
Corrosion Resistance
Tensile Break Force
Tip Separation Force
Freedom from Leakage Under Pressure
Air Leakage During Aspiration
Luer Hub Compliance
Flexural Fatigue Tolerance
In Vitro Simulated Use Studies
Functional Performance Testing
Radiopacity
Shelf Life
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Percu-Pro™ Steerable Introducer K120086, 131332
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
.
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
1
510(k) Summary
Special 510(k)
As required by section 807.92(c)
| Company
| Name | Cardiosolutions Inc. | |||
|---|---|---|---|---|
| Address | 375 West St. | |||
| West Bridgewater MA 02379 | ||||
| Phone: 781-344-0801 | ||||
| Fax: 781-344-0803 | ||||
| Contact Person | Christine Santagate | |||
| Date Prepared | December 17, 2013 | |||
| Trade Name | Dexterity™ Steerable Introducer | |||
| Common Name | Steerable Introducer | |||
| Classification | ||||
| Name | Catheter Introducer | |||
| Product Code | DYB, DRA | |||
| Regulation # | 21 CFR 870.1340 | |||
| Class | 2 | |||
| Panel | Cardiovascular | |||
| Predicate | ||||
| Devices | Percu-Pro™ Steerable Introducer K120086, 131332 | |||
| Device | ||||
| Description | 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 | Included Accessories | |||
| 14FR 65 and 85 | ||||
| CM | Dilator | Stylet | Tear-away | |
| introducer sheath | ||||
| 14Fr 105 CM | Dilator | NA | Tear-away | |
| introducer sheath | ||||
| 9Fr 65CM | 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. | ||||
| Intended 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. | ||||
| Safety and | ||||
| Performance | ||||
| Testing | No performance standards have been established under Section 514 of the Food, Drug | |||
| and Cosmetic Act for these devices. | ||||
| The materials used in the 14 Fr 105 CM Dexterity™ Steerable Introducer are identical to | ||||
| the Dexterity™ Steerable Introducer predicate device. No additional biocompatibility is | ||||
| required. | ||||
| Design verification testing performed on the modified device consisted of mechanical | ||||
| testing conducted in accordance with the ISO 10555 Sterile, single-use intravascular | ||||
| catheters Part 1: General requirements (as amended, 1999, 2004) and in consideration of | ||||
| FDA Guidance on Premarket Notification 510(k) Submission for Short Term and Long | ||||
| Term 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
2
ﺮ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ
ﺗ
.
Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
3
. .
| o | Shelf Life | |
|---|---|---|
| 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. | ||
| Substantial | ||
| Equivalence | The 14Fr 105 CM Dexterity™ Steerable Introducer is substantially equivalent to the | |
| predicate devices in terms of intended use, design, materials, technology, and function. | ||
| There are no differences between devices which would raise new issues of safety or | ||
| effectiveness. |
Premarket Notification for the Cardiosolutions Dexterity™ Steerable Introducer
.
.
4
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
5
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
6
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