(30 days)
The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. 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 and includes a proximal hub with a female luer tapered fitting for flushing.
This document is a 510(k) premarket notification for a medical device (Steerable Introducer 12F), seeking a determination of substantial equivalence to a predicate device. It details the device's technical characteristics, intended use, and performance data from various tests. However, it does not describe an AI/ML-based device or its acceptance criteria and study in the context of AI/ML performance.
The information provided in the document refers to a physical medical device (a steerable catheter introducer) and its non-AI related performance testing (e.g., dimensional, material, mechanical, biocompatibility, sterilization).
Therefore, I cannot extract the information required by your prompt, as it specifically asks for details related to an AI/ML device's acceptance criteria and the study proving it meets those criteria.
The provided text does not contain any information about:
- AI/ML Acceptance Criteria or Device Performance: There is no mention of metrics like sensitivity, specificity, AUC, or any other performance indicators typically used for AI/ML models.
- Test Set Sample Size or Data Provenance: This document is about a physical medical device, not a software algorithm tested on data.
- Experts for Ground Truth/Adjudication: This concept is not applicable here.
- MRMC Comparative Effectiveness Study: Not relevant for a physical device.
- Standalone AI Algorithm Performance: There is no AI algorithm.
- Type of Ground Truth: Not applicable.
- Training Set Sample Size or Ground Truth Establishment: Not applicable.
The document focuses on:
- Device Description: Physical attributes and components.
- Intended Use & Indications for Use: What the device is meant to do (introduce catheters into the heart).
- Technological Characteristics: How it operates (bi-directional steering, radiopacity).
- Performance Data: Bench testing (e.g., deflection, kink resistance, hemostasis), biocompatibility testing (ISO 10993-1), and sterilization methods, all aimed at demonstrating the device's safety and effectiveness as a physical product.
- Substantial Equivalence Claim: Comparing the new device's features and performance to a legally marketed predicate device (FlexCath Advance K123591) to show it's "as safe and effective."
In conclusion, based on the provided text, I cannot answer your request as it pertains to AI/ML device performance and testing. The document describes a traditional physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Freudenberg Medical LLC % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K192422
Trade/Device Name: Steerable Introducer 12F Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: August 31, 2019 Received: September 4, 2019
Dear Prithul Bom:
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
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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 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 (QS) 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 medical devices and radiation-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,
Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: 06/30/2020 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K192422 |
|---|---|
| Device Name | Steerable Introducer |
Indications for Use (Describe)
The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into
the chambers of the heart. The sheath deflection facilitates catheter positioning.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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002_Attachment A – Updated Section 5
Traditional 510(k) – Steerable Introducer 12F
510(K) SUMMARY 5
ADMINISTRATIVE INFORMATION 5.1
- Date of Summary Preparation: 12 Aug 2019
CONTACT INFORMATION 5.2
| Primary Submission Contact | Mary Prunty |
|---|---|
| Director Global Regulatory Affairs | |
| c/o Freudenberg Medical, LLC | |
| 2301 Centennial Boulevard | |
| Jeffersonville, IN 47130 | |
| Phone: +353 (0) 71 9638833 | |
| Fax: +353 (0) 71 9671345 | |
| Email: mprunty@vistamed.net |
| Secondary Submission Contact | Larry Bender |
|---|---|
| Director of Quality | |
| Freudenberg Medical, LLC | |
| 2301 Centennial Boulevard | |
| Jeffersonville, IN 47130 | |
| Tel: 812-280-2354 | |
| Fax: 812-280-2355 | |
| Email:Larry.Bender@freudenbergmedical.com |
DEVICE INFORMATION 5.3
| Device Information | |
|---|---|
| Trade Name | Steerable Introducer 12F |
| Common Name | Steerable Introducer 12F |
| Classification Name | Steerable Catheter |
| Classification Regulation | 870.1280 |
| Class | II |
| Panel | Cardiovascular |
| Product Code | DRA |
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Traditional 510(k) - Steerable Introducer 12F
510(K) TYPE AND REASON FOR SUBMISSION 5.4
This 510(k) is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the Steerable Introducer.
5.5 PREDICATE DEVICE
The Steerable Introducer is substantially equivalent to the FlexCath Advance (K123591, Model 4FC12).
5.6 DEVICE DESCRIPTION
The Steerable Introducer consists of a single use, bi-directional steerable sheath connected to a handle with steering controls, a hemostasis valve with side port and 3-way stopcock, a tapered dilator and compatible guidewire. 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 and includes a proximal hub with a female luer tapered fitting for flushing.
Image /page/4/Figure/10 description: This image shows a medical device with several labeled parts. The device includes a dilator hub (1), a dilator (2), and a hemostatic valve (3). It also features a 3-way stopcock (4), a steering control (5), a device handle (6), an introducer sheath (7), a steerable section (8), and a radiopaque marker (9).
The Steerable Introducer usable length, lumen length, outer diameter, and inner diameter/tool compatibility specifications are indicated on the product label. The distal end of the steerable sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.
Note: Only the steerable sheath and dilator are included in the scope of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the device. References to the "device" in this submission, includes both the sheath and dilator.
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002_Attachment A - Updated Section 5
Traditional 510(k) - Steerable Introducer 12F
Image /page/5/Figure/3 description: This image shows a diagram of a medical instrument with labels indicating different measurements. The top part of the diagram shows the "Inner diameter", "Outer diameter", "Usable length", and "Lumen length". The bottom part of the diagram shows "Dilator ID", "Dilator OD", and "Dilator usable length".
5.7 INTENDED USE
The 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.
5.8 INDICATIONS FOR USE
The Steerable Introducer is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The sheath deflection facilitates catheter positioning.
TECHNOLOGICAL CHARACTERISTICS રું. વ
The Steerable Introducer distal tip is radiopaque for visualization under fluoroscopy to facilitate introduction into the cardiovascular system and features 180° bidirectional 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 other guidewires up to 0.035in in diameter. A proximal dilator hub includes a female luer tapered fitting for flushing.
The Steerable Introducer has some minor differences, when compared to the predicate device - FlexCath Advance. However, these differences do not alter the fundamental scientific technology or raise new questions of device performance.
- Sheath OD: The Sheath OD difference is negligible. This difference does not ●
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Traditional 510(k) - Steerable Introducer 12F
Third Party Reviewer Questions
impact on the device safety or compatibility with insertion through a 16F standard introducer.
- . Deflection: The Steerable Introducer 12F has dual pullwires for bi-directional steering, as opposed to the single pullwire unidirectional deflection operation utilized by the predicate device. This feature provides additional flexibility and control to the user and matches deflection performance of the reference device (Agilis NxT) without compromising safety.
- Guidewire: The compatible guidewire is included with the Steerable Introducer ● 12F as a convenience and it matches the guidewire provided with the reference device
- Dilator OD: The Dilator OD difference is negligible, with no impact on sheath ● compatibility.
- Dilator Useable Length: The difference in Dilator Useable Length does not ● present an added safety risk. It was selected to minimize the dilator extension beyond the sheath when assembled yet provide a suitable smooth transition for insertion.
- Dilator Total Length: The difference in Dilator Total Length is based on the ● difference in Dilator Useable Length, as detailed above.
- Dilator Shape: A curved dilator is provided as a further aid in tracking over a wire through the septum and provides added functionality but no increased safety risk.
- Shelf Life: Based on current test data, the Steerable Introducer 12F device will ● initially be labeled with a 12-month shelf life. Upon successful completion of the testing extended aging as described in the protocol, the shelf life of the device will be updated accordingly.
5.10 PERFORMANCE DATA
The Steerable Introducer has been tested to meet the device intended use and to ensure conformance to the product specifications. The Steerable Introducer has been tested and meets all its physical and performance specifications on the bench including:
- Visual surface inspection ●
- Dimensional
- Shaft deflection
- . Simulated Use
- . Torsional stiffness
- Kink resistance .
- . Radiopacity visualization
- Hemostasis
- Leak testing
- Guidewire compatibility ●
- Bond tensile strength .
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Traditional 510(k) – Steerable Introducer 12F
- Particulate tests
- . Packaging tests
- . Distribution tests
- . Usability studies
In addition, the Steerable Introducer was tested for biocompatibility as per ISO 10993-1 for limited exposure (<24 hours) to circulating blood, and meets all specifications including:
- · Cytotoxicity
- . MEM Elution Test
- Skin Sensitization ●
- . ISO Guinea Pig Maximization Sensitization Test
- Irritation (in-vivo) ●
- . Intracutaneous Toxicity
- Acute Systemic & Material Mediate Pyrogen ●
- Systemic Injection ■
- Material Mediated Pyrogen
- Genotoxicity ●
- Ames Test ■
- Chromosome Aberration Assay
- Ames Test ■
- Hemocompatibility ●
- Haemolysis, ASTM Method. Indirect Contact - Human blood
- Haemolysis, ASTM Method. Direct Contact - Human blood
- Partial Thromboplastin Time. Direct Contact Human ■ plasma
- I Complement Activation. Direct Contact - Human Blood Serum
- In-vivo Sheep Thrombogenicity. Direct Implantation
The device is to be sterilized by ethylene oxide to a sterility assurance level (SAL) of 10-6.
These performance requirements are similar to those described by the predicate device. The testing showed that the device meets specifications before and after aging, indicating that the device is as safe and effective as the predicate device.
5.11 SUBSTANTIAL EQUIVALENCE
The Steerable Introducer is substantially equivalent to the FlexCath Advance (K123591, Model 4FC12). It has the same intended use for introducing compatible therapeutic / diagnostic tools into the chambers of the heart. The test data showed that the technological difference between the Steerable Introducer and its predicate do not raise safety and efficacy issues.
5.12 CONCLUSION
Based on the test data and the same intended use, the Steerable Introducer is found to be substantially equivalent to its predicate device.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).