The Confida™ Adaptive Sheath is intended to provide a conduit through the iliofemoral vessels for the insertion of diagnostic or interventional devices used during cardiovascular procedures, including transcatheter aortic valve replacement (TAVR).

Device Description

The Confida™ Adaptive Sheath is a single-use, disposable, hydrophilically coated sheath designed to provide a flexible and hemostatic conduit for the insertion of diagnostic and interventional devices, including devices used in transcatheter aortic valve replacement (TAVR). The Confida™ Adaptive Sheath is a prescription use device, intended to be used by professionals in healthcare/hospital facilities. There is only one model of the Confida™ Adaptive Sheath, corresponding to model number CAS131830.

The Confida™ Adaptive Sheath is comprised of two components:
● Dilator component: The Dilator component includes a flexible, tapered distal tip that facilitates atraumatic tracking through the vasculature. The Dilator component contains an internal lumen able to accommodate up to a 0.035in (0.89mm) guidewire.
● Introducer Sheath component: A hydrophilic coating is applied to the sheath body to reduce the forces required for insertion into and withdrawal from the vasculature. The seal housing contains a hemostatic valve assembly designed to minimize blood loss during device use. The Introducer Sheath component contains a sideport extension with a three-way valve, providing a means for fluid to be flushed through the Introducer Sheath component during clinical use. The sheath body temporarily expands in diameter to allow the introduction and removal of devices up to 18 Fr in outer diameter, including devices used in TAVR procedures.

There are no specific accessories required for use with the Confida™ Adaptive Sheath. The Confida™ Adaptive Sheath is designed for use with guidewires up to 0.035in (.89mm) in diameter, and has been developed for use with various devices used in diagnostic and interventional procedures, including TAVR procedures.

The Confida™ Adaptive Sheath is classified as a surgically invasive device for short-term use (<24 hours) contacting circulatory blood, per ISO 10993-1:2009. The Confida™ Adaptive Sheath is sterilized by Ethylene Oxide (EtO) to a minimum sterility assurance level (SAL) of 10-6.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Confida™ Adaptive Sheath," and thus does not contain information about an AI/ML-based device or a comparative effectiveness study with human readers. The document details the device's technical specifications, indications for use, comparison to predicate devices, and non-clinical testing performed to establish substantial equivalence.

Therefore, many of the requested criteria, such as those related to AI/ML performance, ground truth, expert adjudication, multi-reader multi-case studies, and training/test set sample sizes for AI, are not applicable to this document.

However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria as they relate to the non-clinical performance of a medical device seeking 510(k) clearance.

Here's a breakdown of what can be extracted and what cannot:

Acceptance Criteria and Reported Device Performance (Inferred from Non-Clinical Testing):

The document states: "The results of the non-clinical testing performed for the Confida™ Adaptive Sheath show that all acceptance criteria were met."

While the specific numerical acceptance criteria values are not provided, the types of tests performed indicate the performance characteristics that were evaluated and for which criteria would have been established. The "reported device performance" is simply that it met all established acceptance criteria for each of these tests.

Acceptance Criteria Category (Inferred)	Reported Device Performance (Implied)
System Pressure Capability: Leak and Hemostasis	Met criteria for minimizing blood loss and maintaining integrity.
Dimensional Measurement	Met specified design dimensions.
Tensile Strength	Withstood specified tensile forces without failure.
Coating Integrity	Maintained coating as specified for reduced insertion forces.
Particulate	Did not shed particulates beyond acceptable limits.
Kink Resistance	Maintained lumen patency under specified bending forces.
Device and Delivery System Interaction Forces	Ensured smooth and proper interaction with other devices.
Simulated Use: System Recovery and Device Functionality	Performed as intended during simulated clinical use scenarios.
Usability Testing for Design Validation	Met usability requirements for healthcare professionals.
In Vivo Design Validation Testing (Animal Model)	Demonstrated acceptable performance and safety in a biological system.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Pyrogen, Hemolysis, PTT, Complement Activation, Thromboresistance, Chemical Characterization)	Met ISO 10993-1:2009 standards for biological safety.
Sterilization Validation	Achieved specified Sterility Assurance Level (SAL).
Packaging and Shelf Life (Product and Package)	Maintained integrity and sterility over specified shelf life.

Study Details (Based on Non-Clinical Testing):

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "non-clinical evaluations" which would involve a defined number of units or replicates for each test (e.g., number of sheaths tested for tensile strength, number of samples for biocompatibility). These numbers are not provided in this summary.
- Data Provenance: The data originates from internal testing conducted by Medtronic, Inc. The document does not specify a country of origin for the data beyond "USA" for Medtronic's address. The studies are prospective in nature, as they involve performing new tests on the device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device's non-clinical testing. "Ground truth" in this context refers to established engineering specifications, material standards (e.g., ISO 10993), and predetermined performance limits, rather than expert interpretation of medical images or conditions. The "experts" would be the engineers, scientists, and technicians conducting the tests and evaluating the results against the pre-defined criteria.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for consensus-building in interpreting complex subjective data (e.g., medical images). For non-clinical device testing, results are typically objective measurements against predefined specifications. Any discrepancies would be resolved through standard quality control and technical review processes, not a formal adjudication panel.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not relevant to a medical device like a catheter introducer sheath and its 510(k) clearance process. An MRMC study is specific to diagnostic aids, particularly those involving AI/ML for image interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical instrument, not an algorithm. Standalone performance refers to AI/ML algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance evaluation is based on:
  - Engineering specifications and design requirements: These define the intended dimensional, mechanical, and functional properties of the device.
  - International standards (e.g., ISO 10993-1:2009 for biocompatibility): These provide established methodologies and acceptance criteria for specific tests.
  - Bench testing methodologies: Standardized or validated internal methods for evaluating physical and chemical properties.
  - Predicate device performance: The performance of previously cleared devices often serves as a benchmark for substantial equivalence.
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. There is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 7, 2015

Medtronic, Inc. c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K152054

Trade/Device Name: Confida Adaptive Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: July 23, 2015 Received: July 23, 2015

Dear Mark Job:

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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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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,

Bram D. Zuckerman -S

Bram Zuckerman, MD Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name Confida™ Adaptive Sheath

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

As required by the Safe Medical Devices Act of 1990, coded under Section 513, part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Date Prepared:	April 13, 2015
Applicant/Submitter:	Medtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432USAPhone: (763) 526-7890Fax: (763) 526-7888
Contact Person:	Matthew LobeckRegulatory Affairs SpecialistMedtronic Heart ValvesPhone: (763) 514-9515Fax: (763) 514-9521Email: matthew.lobeck@medtronic.com
Device Trade Name:	Confida™ Adaptive Sheath
Model Number:	CAS131830
Device CommonName:	Confida Sheath
Classification Name:	Catheter Introducer
Classification:	Class II, 21 CFR 870.1340
Product Code:	DYB
Predicate Devices:	Primary Predicate Device: Medtronic Sentrant Introducer Sheath with Hydrophilic Coating (K123990, cleared April 26, 2013) Secondary Predicate Device: Edwards eSheath Introducer Set (K141696, cleared September 18, 2014)
Device Description:	The Confida™ Adaptive Sheath is a single-use, disposable, hydrophilicallycoated sheath designed to provide a flexible and hemostatic conduit for theinsertion of diagnostic and interventional devices, including devices used intranscatheter aortic valve replacement (TAVR). The Confida™ AdaptiveSheath is a prescription use device, intended to be used by professionals inhealthcare/hospital facilities. There is only one model of the Confida™Adaptive Sheath, corresponding to model number CAS131830.

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The Confida™ Adaptive Sheath is comprised of two components:

● Dilator component: The Dilator component includes a flexible, tapered distal tip that facilitates atraumatic tracking through the vasculature. The Dilator component contains an internal lumen able to accommodate up to a 0.035in (0.89mm) guidewire. Introducer Sheath component: A hydrophilic coating is applied ● to the sheath body to reduce the forces required for insertion into and withdrawal from the vasculature. The seal housing contains a hemostatic valve assembly designed to minimize blood loss during device use. The Introducer Sheath component contains a sideport extension with a three-way valve, providing a means for fluid to be flushed through the Introducer Sheath component during clinical use. The sheath body temporarily expands in diameter to allow the introduction and removal of devices up to 18 Fr in outer diameter, including devices used in TAVR procedures. There are no specific accessories required for use with the Confida™ Adaptive Sheath. The Confida™ Adaptive Sheath is designed for use with guidewires up to 0.035in (.89mm) in diameter, and has been developed for use with various devices used in diagnostic and interventional procedures, including TAVR procedures. The Confida™ Adaptive Sheath is classified as a surgically invasive device for short-term use (<24 hours) contacting circulatory blood, per ISO 10993-1:2009. The Confida™ Adaptive Sheath is sterilized by Ethylene Oxide (EtO) to a minimum sterility assurance level (SAL) of 10-6. The Confida™ Adaptive Sheath is intended to provide a conduit for the Statement of insertion of diagnostic and interventional devices into the vasculature and Intended Use: minimize blood loss associated with such insertions. Statement of The Confida™ Adaptive Sheath is intended to provide a conduit through Indications for Use: the iliofemoral vessels for the insertion of diagnostic or interventional devices used during cardiovascular procedures, including transcatheter aortic valve replacement (TAVR). The Indications for Use of the Confida™ Adaptive Sheath are within the Comparison of scope of the Indications for Use of both predicate devices. While Indications for Use to Predicate Devices: differences exist between the Indications for Use of the subject and predicate devices, these differences do not raise any new issues of safety and effectiveness of the subject device: nor do these differences result in a subject device intended use that differs significantly from the intended use of the predicate devices. The Confida™ Adaptive Sheath is contraindicated for unheparinized Contraindications: patients and patients presenting with an intolerance to anticoagulation therapy.

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Comparison of The Confida™ Adaptive Sheath has the following similarities to the Technological predicate devices: Characteristics to Predicate Device(s): Intended Use (all predicates) ● ● Indications for Use (all predicates) Target population (all predicates) ● Fundamental scientific technology (all predicates) ● ● Operating principle (all predicates) ● Expandability (secondary predicate) . Guidewire compatibility (all predicates) Hemostasis technology (all predicates) ● ● Packaging Materials (primary predicate) Sterility Assurance Level (all predicates) ● ● Method of sterilization (secondary predicate) The following technological characteristics of the Confida™ Adaptive Sheath differ from the predicate devices: Device working length ● . Device materials In order to demonstrate substantial equivalence of the subject device Summary of Non-Clinical Data: (ConfidaTM Adaptive Sheath) to the predicate devices, the following nonclinical evaluations were performed: ● System Pressure Capability: Leak and Hemostasis Testing ● Dimensional Measurement Testing Tensile Strength Testing ● ● Coating Integrity . Particulate Testing . Kink Resistance Testing Device and Delivery System Interaction Forces Testing ● ● Simulated Use: System Recovery and Device Functionality Testing ● Usability Testing for Design Validation In Vivo Design Validation Testing in an Animal Model ● Biocompatibility testing was also performed on the Confida™ Adaptive Sheath per the requirements of ISO 10993-1: 2009, as listed below: Cytotoxicity Study using the ISO MEM Elution Method ● ISO Sensitization (Maximization Method) ● ISO Intracutaneous Reactivity ● ● ISO Systemic Toxicity . Material Mediated Pyrogen Study ASTM Hemolysis Study . ASTM Partial Thromboplastin Time (PTT) Coagulation Testing ● C3a and SC5b-9 Complement Activation Testing ● ● Thromboresistance

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. Chemical Characterization Testing In addition, sterilization validation, packaging, and shelf life testing (product and package) was performed on the Confida™ Adaptive Sheath. The results of the non-clinical testing performed for the Confida™ Adaptive Sheath show that all acceptance criteria were met. The non-clinical evaluations verify the Confida™ Adaptive Sheath is substantially equivalent to the predicate devices and is adequate for its intended use. Based on the information above, the Confida™ Adaptive Sheath is Conclusion: substantially equivalent in intended use, performance, and fundamental scientific technology to the predicate devices, the Medtronic Sentrant Introducer Sheath with Hydrophilic Coating (K123990) and the Edwards eSheath Introducer Set (K141696).

Regulation Number and Section

§ 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).