(71 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a steerable introducer, with no mention of AI or ML capabilities.
No
The device is an introducer for various cardiovascular catheters, facilitating their placement in the heart, rather than providing therapy itself.
No
The device is an introducer for various cardiovascular catheters, designed for physical access and positioning within the heart, not for disease detection or diagnosis.
No
The device description clearly outlines physical components like a dilator, stylet, tear-away introducer sheath, hemostasis valve, sideport, and reinforced Pebax sheath with a radiopaque marker. The performance studies also detail mechanical testing of these physical components.
Based on the provided information, the Percu-Pro™ Steerable Introducer is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction of various cardiovascular catheters into the heart." This is a procedure performed in vivo (within a living organism), not in vitro (outside of a living organism, typically on biological samples).
- Device Description: The description details a device designed for physical insertion and manipulation within the body (steerable introducer, sheath, dilator, stylet). It's a tool for accessing and navigating within the cardiovascular system.
- Lack of IVD Characteristics: IVD devices are typically used to examine biological samples (blood, urine, tissue, etc.) to diagnose diseases or conditions. The Percu-Pro™ Steerable Introducer does not perform any analysis or testing of biological samples.
The device is clearly intended for use in a medical procedure performed directly on a patient, making it a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Percu-Pro™ Steerable Introducer is intended to be used for the introduction of various cardiovascular catheters into the heart, including the left side of the heart through the inter-atrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB, DRA
Device Description
The Cardiosolutions Percu-Pro™ Steerable Introducer is provided as a 9Fr and 14Fr Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer sheath. The 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 65 cm 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 diameter; 9Fr has 65 cm working lengths.
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 9Fr 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 suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Percu-Pro™ Steerable Introducer K120086
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 1 9 2013
510(k) Summary
Special 510(k)
As required by section 807.92(c) _________
| Company
| Name | Cardiosolutions Inc. |
|---|---|
| As required by section 807.92(c) | |
| Address | 375 West St. |
| West Bridgewater MA 02379 | |
| Phone: 781-344-0801 | |
| Fax: 781-344-0803 | |
| Contact Person | Michele Lucey |
| Date Prepared | April 24, 2013 |
| Trade Name | Percu-Pro™ Steerable Introducer |
| Common Name | Steerable Introducer |
| Classification | |
| Name | Steerable Guide Catheter |
| Catheter Introducer | |
| Product Code | DYB, DRA |
| Regulation # | 870.1340, 870.1280 |
| Class | 2 |
| Panel | Cardiovascular |
| Predicate | |
| Devices | Percu-Pro™ Steerable Introducer K120086 |
| Device | |
| Description | The Cardiosolutions Percu-Pro™ Steerabl e Introducer is provided as a 9Fr |
| and 14Fr | |
| Introducer. The set also consists of a dilator (14Fr only), stylet, and tear-away introducer | |
| sheath. The steerable introducer is designed to pro vide flexible catheter positioning i n | |
| the cardiac anatomy. The steer able introducer provides both proximal tip and distal tip | |
| steering and is fitted with a hem ostasis valve to minim ize blood loss duri ng catheter | |
| introduction and/or exchange. A sideport with stopcock is provided for air or bloo d | |
| aspiration, fluid infusion, blood sampling, and pressure monitoring. The i ntroducer | |
| sheath is rei nforced Pebax and the distal tip has a radiopaque marker to im prove | |
| fluoroscopic visualization. The device is pro vided in 65 cm working len gths. The | |
| device is provided sterile and is intended for single use only. | |
| The purpose of this submission is to add an ad ditional device diameter; 9Fr has | |
| 65 cm working lengths. | |
| Intended Use | The Percu-Pro™ Steerable Introducer is intended to be used for the introdu ction 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 9Fr Percu-Pro™ Steerable Introducer are identical to the 14Fr | |
| Percu-Pro™ Steerable Introducer predicate device. No additional biocompatibility is | |
| required. | |
| Design verification testing performed on the 9Fr device consisted of mechanical testing | |
| conducted in accordance with the ISO 10555 St erile, single-use intravascular catheters | |
| Part 1: General requirem ents (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 | |
| A summary of the testing performed is included in the 510(k) submission. All test | |
| results demonstrate that the properties and performance of the device are suitable for its | |
| intended use. | |
| Substantial | |
| Equivalence | The 9Fr Percu-Pro™ Steerable Introducer is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials, technology, and function. There ar e | |
| no differences between devices which would raise new issues of safety or effectiveness. |
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2013
Cardiosolutions, Inc. c/o Michele Lucey Vice President Regulatory and Quality Compliance 375 West Street West Bridgewater, MA 02379
Re: K131332
Trade Name: Percu-ProTM Stecrable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRA Dated: June 21, 2013 Received: June 26, 2013
Dear Ms. Lucey:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unlinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and 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
3
Page 2 - Ms. Michele Lucey
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 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.A. Hillman
for
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use Statement
510(k) Number: K131332
Device Name: Percu-Pro™ Steerable Introducer
Indications for Use:
The Percu-Pro™ Steerable Introducer is intended to be used for the 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.Z. Zillman
Cardiosolutions Inc.