(90 days)
The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.
The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.
The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.
This document describes the Steerable Introducer 8.5F, a medical device for introducing cardiovascular catheters. The information provided focuses on the device's design, intended use, and the performance data submitted to the FDA for 510(k) clearance.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly defined with numerical targets in the provided text. Instead, the document states that the device was tested to "meet the device intended use and to ensure conformance to the product specifications" and "meets all its physical and performance specifications." The performance data section lists the types of tests conducted and generally states that the device "passed" or "meets" these specifications.
Therefore, the table can be constructed as follows:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to product specifications | Meets all physical and performance specifications |
| Shaft deflection | Tested and met specifications |
| Simulated Use | Tested and met specifications |
| Torsional stiffness | Tested and met specifications |
| Radiopacity visualization | Tested and met specifications (distal tip and dilator are radiopaque) |
| Hemostasis | Tested and met specifications |
| Leak testing | Tested and met specifications |
| Guidewire compatibility | Tested and met specifications |
| Transseptal needle compatibility | Tested and met specifications |
| Distribution tests | Tested and met specifications |
| Usability studies | Tested and met specifications |
| Shelf life (functional and mechanical integrity) | Passed 13-month accelerated age study; not compromised post-aging |
| Biocompatibility (ISO 10993-1 for limited exposure) | Satisfies ISO 10993-1 requirements |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests listed (e.g., shaft deflection, simulated use, leak testing). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature). The studies appear to be bench testing and laboratory studies conducted as part of the device development and regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies described are primarily performance and safety tests for a physical medical device, not diagnostic or AI-driven systems requiring ground truth established by medical experts in the traditional sense.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human assessment where disagreements in interpretation need to be resolved. The studies described are engineering and biological performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic aids (like AI algorithms) by comparing human readers' performance with and without the aid. The Steerable Introducer 8.5F is a physical medical device, not a diagnostic AI system.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study in the context of an "algorithm only without human-in-the-loop performance" was not done. This device is a physical tool, not an algorithm. The performance data relates to the physical and mechanical properties of the device itself.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI studies (e.g., pathology, expert consensus) is not directly applicable here. The "ground truth" for this device's performance studies would be the objective measurements and engineering standards (e.g., a shaft deflecting to a certain angle, a guidewire fitting, no leaks under specific pressure) that define whether the device meets its specifications and intended function. These are inherent physical properties or design requirements.
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" as this is not an AI/machine learning device. The device's design is based on engineering principles and similarities to predicate devices, not data-driven machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 1, 2019
Freudenberg Medical LLC Mary Prunty Regulatory Affairs Manager 2301 Centennial Boulevard Jeffersonville, Indiana 47130
Re: K191190
Trade/Device Name: Steerable Introducer 8.5F Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2019 Received: May 3, 2019
Dear Mary Prunty:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachel Neubrander Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191190
Device Name
Indications for Use (Describe)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
GENERAL INFORMATION
| Primary Submission Contact | Mary PruntyRegulatory Affairs Managerc/o Freudenberg Medical LLC2301 Centennial BoulevardJeffersonville, IN 47130Phone: +353 (0) 71 9638833Fax: +353 (0) 71 9671345Email: mprunty@vistamed.net |
|---|---|
| Secondary Submission Contact | Larry BenderDirector of QualityFreudenberg Medical LLC2301 Centennial Boulevard,Jeffersonville, Indiana 47130Tel: 812-280-2354Fax: 812-280-2355 |
Date of Summary
01 May 2019
Email: Larry.Bender@freudenbergmedical.com
DEVICE INFORMATION
| Device Information | |
|---|---|
| Trade Name | Steerable Introducer |
| Common Name | 8.5F Steerable Introducer S/M/L |
| Classification Name | Catheter Introducer |
| Classification Regulation | 870.1340 |
| Class | II |
| Panel | Cardiovascular |
| Product Code | DYB |
| Predicate Device(s) | Agilis NxT™ Steerable IntroducerLarge Curl (K081645) |
| Agilis NxT™ Steerable IntroducerSmall/Medium Curl (K061363) |
510(K) TYPE AND REASON FOR SUBMISSION
This is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the 8.5F Steerable Introducer, with small, medium and large curl.
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DEVICE DESCRIPTION
The steerable introducer consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed Tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing (see illustration below). The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration.
The steerable introducer usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.
Image /page/4/Figure/5 description: The image shows a medical device with several labeled parts. The parts include the dilator hub (1), dilator (2), hemostatic valve (3), 3-way stopcock (4), steering control (5), device handle (6), introducer sheath (7), steerable section (8), and radiopaque marker (9). The device appears to be a type of catheter or endoscope used for medical procedures.
Image /page/4/Figure/6 description: This image shows a medical instrument with labels indicating its various dimensions. The top part of the image shows the instrument's handle, lumen length, usable length, inner diameter, and outer diameter. The bottom part of the image shows the dilator ID, dilator OD, and dilator usable length.
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INTENDED USE
The 8.5F Steerable Introducer is intended to provide a conduit allowing introduction, removal, and exchange of compatible therapeutic and/or diagnostic tools into the cardiovascular system while maintaining hemostasis. The device facilitates access to the left and right sides of the heart, including left atrium and left ventricle access through the interatrial septum. It features a deflectable distal tip that enables guidance of compatible tools.
INDICATIONS FOR USE
The Steerable Introducer is indicated when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
TECHNOLOGICAL CHARACTERISTICS
The 8.5F Steerable Introducer (Small / Medium / Large Curl) are comparable to the predicate devices previously cleared under K061363 (Small / Medium Curl) & K081645 (Large Curl), with the following similarities:
- Indications for Use
- Fundamental scientific technology
- Basic sheath design (dimensions, tip shape)
- User interface with handle (rotating actuator for deflection)
- Materials ●
- . Sterilization process
The 8.5F Steerable Introducer distal tip is radiopaque for visualization under fluoroscopy to facilitate introduction into the cardiovascular system and features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device. A steering control knob is provided on the handle, along with a hemostasis valve and flush port with 3-way stop-cock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The included dilator is radiopaque for visualization under fluoroscopy. It is sized for a close fit to the introducer sheath and accommodates insertion over the included 0.032in guidewire and standard 98cm transseptal needle. A proximal dilator hub includes a female luer tapered fitting for flushing.
PERFORMANCE DATA
The 8.5F Steerable Introducer has been tested to meet the device intended use and to ensure conformance to the product specifications. The 8.5F Steerable Introducer has been tested and meets all its physical and performance specifications on the bench including, but not limited to:
- Shaft deflection
- Simulated Use
- Torsional stiffness ●
- Radiopacity visualization
- Hemostasis ●
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- Leak testing
- Guidewire compatibility ●
- Transseptal needle compatibility
- Distribution tests ●
- Usability studies
SHELF LIFE TESTING
Shelf life verification testing was completed with a 13 month accelerated age study to ensure that device specifications were met. All testing passed. Testing demonstrated the functional and mechanical characteristics of the device were not compromised post aging.
BIOCOMPATIBILITY
In addition, the 8.5F Steerable Introducer was tested for biocompatibility as per ISO 10993-1 for limited exposure (<24 hours) to circulating blood. The device is to be sterilized by ethylene oxide to a sterility assurance level (SAL) of 10th These performance requirements are similar to those described by the predicate device. The testing demonstrated the device satisfies ISO 10993-1 requirements, indicating the device is as safe and effective as the predicate device.
SUBSTANTIAL EQUIVALENCE
The 8.5F Steerable Introducer is substantially equivalent to the Agilis NxTTM Steerable Introducer Large Curl (K081645 Model G408324) and Agilis NxTTM Steerable Introducer Small/Medium Curl (K061363). The 8.5F Steerable Introducer has the same intended use for introducing compatible therapeutic / diagnostic tools into the chambers of the heart. Test data demonstrate the technological difference between the Steerable Introducer and its predicate do not raise any safety and efficacy issues.
CONCLUSION
Based on the test data and the same intended use, the 8.5F Steerable Introducer is found to be substantially equivalent to its predicate.
§ 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).