The RetroFlex Dilator Kit offers a variety of sizes and is packaged as either a 4-piece set or a 7-piece set. The dilators are made of polyethylene (LDPE and HDPE) with 20% barium sulfate and 1% titanium dioxide to aid in visualization under fluoroscopy. The RetroFlex Dilator Kit is heat-treated and a one-piece mold with a formed tip. The distal tip is tapered with an inner lumen for tracking a .035" guidewire. The hub on the proximal end is bonded with an adhesive, and the dilators are hydrophilic coated to allow smooth arterial dilation. The device is sold and packaged sterile as a 4-piece or 7-piece kit.

AI/ML Overview

The provided K093554 submission describes the RetroFlex™ Dilator Kit, a vessel dilator for percutaneous catheterization. The submission focuses on non-clinical performance testing rather than studies involving human readers or AI algorithms. As such, many of the requested categories related to AI performance, reader studies, and specific statistical performance metrics cannot be directly addressed from this document.

However, I can extract the acceptance criteria and the types of studies performed as detailed in the submission for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test Name	Description of Acceptance / Test Objective	Reported Device Performance / Outcome
Visual Examination	To ensure the device is free from visible defects and meets aesthetic requirements.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Dimensional Verification	To confirm that the device dimensions (e.g., diameter, length of dilators) conform to design specifications.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Tensile Strength (Hub/Shaft)	To evaluate the integrity of the bond between the hub and the shaft, ensuring it can withstand forces during use.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Guidewire Compatibility Test	To verify that the dilator can smoothly track a 0.035" guidewire, allowing for proper introduction.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Hydrophilic Coating (Friction) Test	To assess the lubricity of the hydrophilic coating to ensure smooth arterial dilation and reduce friction during insertion.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Packaging Integrity	To ensure the sterile barrier is maintained throughout the shelf life and during transit.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Product Shelf Life	To determine the stability and integrity of the device over its intended shelf life, ensuring performance and sterility.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Sterilization Validation	To confirm that the chosen sterilization method effectively renders the device sterile and maintains material compatibility.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Biocompatibility (MEM, AO, Blood, Mouse Systemic, Rabbit Intracutaneous, Guinea Pig Maximization, Complement Activation)	To ensure the device materials are safe for contact with human tissue and blood, and do not elicit adverse biological responses.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Microbiology (Endotoxin-Mediated Pyrogenicity)	To detect and quantify endotoxins, ensuring the device is non-pyrogenic.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Chemical (Material Verification)	To confirm the materials used in the device meet specifications (LDPE, HDPE, Barium Sulfate, Titanium Dioxide).	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Chemical (USP Physico-Chemical Test for Plastic Closures)	To assess the chemical properties of plastic components relevant to closures.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)
Chemical (Non-Volatile Residues Test)	To quantify non-volatile residues that might leach from the device materials.	Demonstrated safety and effectiveness; met required standards. (Implicitly passed, as concluded in Section 7.5)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify exact sample sizes for each non-clinical test. The testing appears to be conducted on manufactured device units, following established in-vitro and laboratory testing standards (ISO 10555-1:1997, Sec 4.5). The data provenance is not explicitly stated in terms of country of origin, but it is generated from laboratory testing of the device itself. Given the nature of these tests (e.g., tensile strength, dimensional verification, biocompatibility), they are inherently prospective for the device design being evaluated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable. The device is a physical medical device, not an AI or diagnostic imaging system that requires expert interpretation for ground truth establishment. The ground truth for performance (e.g., tensile strength, sterility) is established by predefined engineering and biological standards and test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Adjudication methods are typically used in clinical studies or AI evaluations where multiple readers/interpreters assess data. The tests performed for this device are objective measurements against specifications.

5. 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 MRMC study was conducted or is applicable to this device submission. This submission does not involve AI or human image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No standalone algorithm performance study was conducted. This device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is based on pre-defined engineering specifications, international standards (e.g., ISO 10555-1:1997), and established biological safety testing protocols. For example, tensile strength ground truth is a specific force value the material must withstand, and biocompatibility ground truth is the absence of cytotoxicity or irritation according to validated assays.

8. The sample size for the training set

This section is not applicable. There is no AI component or training set involved in the validation of this physical device.

9. How the ground truth for the training set was established

This section is not applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for such a purpose.

Summary

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K093554

510(k) Summary

APR 1 3 2010

Applicant:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92614USAPhone: 949.250-3837Fax: 949.756-4408
Date:	November 3, 2009
Contact Persons:	Jason K. LyonPrinciple Project Manager, Regulatory AffairsDean KnightSr. Director of Regulatory Affairs
Proprietary Device Name:	RetroFlex™ Dilator Kit
Common Device Name:	Vessel dilator for percutaneous catheterization(21 CFR 870.1310, Product Code DRE)
Classification:	Class II
Predicate Devices:	Estech - Estech Percutaneous Dilator Insertion Kitcleared under K070749Maxxim Medical, Inc - Vessel Dilatorcleared under K963388Spectranetics Corporation - Visisheath™ Dilator Sheathcleared under K092378
Manufacturer:	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92614USA

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7.2

7.1 Substantially Equivalent To:

The RetroFlex Dilator Kit is substantially equivalent to the predicate devices in intended use, design, specifications, packaging, and sterilization. For each predicate device there are slight variations, yet do not fundamentally change the scientific technology of the devices, which is to dilate vessels for introducing intravascular devices. A summary of equivalency is in Section 11.4 below.

Description of the Device Subject to Premarket Notification:

The RetroFlex Dilator Kit is heat-treated and a one-piece mold with a formed tip. The distal tip is tapered with an inner lumen for tracking a .035" guidewire. The hub on the proximal end is bonded with an adhesive, and the dilators are hydrophilic coated to allow smooth arterial dilation. The device is sold and packaged sterile as a 4-piece or 7-piece kit (Table 7.2.1).

Table 7.2.1 - RetroFlex Dilator Kits
Dilator Kit Set	Dilator Sizes
4-piece dilators	16F, 18F, 20F, and 22F
7-piece dilators	16F, 18F, 20F, 22F, 23F,25F, and 28F

oFlox Dilator Kits

7.3 Indications For Use:

The RetroFlex Dilator Kit is intended for use in dilation of the peripheral vasculature.

7.4 Device Safety and Performance Data:

The RetroFlex Dilator Kit was verified and tested according to performance testing standards ISO 10555-1:1997, Sec 4.5, Sterile Single Use Intravascular Catheters. The following tests have been conducted to demonstrate safety and effectiveness with respect to intended use, design, materials, and performance.

Visual Examination t
Dimensional Verification .
Tensile Strength (Hub/Shaft) .
Guidewire Compatibility Test .
Hydrophilic Coating (Friction) Test .
Packaging Integrity .
Product Shelf Life .
Sterilization Validation .
Biocompatibility .
- Medium Eluate Method (MEM) o
- Agar Overlay Method (AO) o
- Blood Compatibility Test Method o
- Mouse Systemic Injection O
- Rabbit Intracutaneous Irritation ಂ
- Guinea Pig Maximization Test O
- Complement Activation Test O

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. Microbiology
- Endotoxin-Mediated Pyrogenicity o
Chemical .
- Material Verification o

USP Physico-Chemical Test for Plastic Closures o
Non-Volatile Residues Test o

7.5 Conclusion:

Based upon the non-clinical testing noted above and in this 510(k) application, the RetroFlex Dilator Kit meets the required standards and has demonstrated that it is as safe and performs as well as the predicate devices listed in this application.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

APR 1 3 2010

Edwards LifeSciences, LLC c/o Jason Lyon One Edwards Way Irvine, CA 92614

Re: K093554

Trade/Device Name: RetroFlex Dilator Kit Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, vessel, for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: March 19, 2010 Received: March 22, 2010

Dear Mr. Lyon:

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.

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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Duma R. Kirchner

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6. Statement of Indications for Use

Indications for Use

510(k) Number (if known): k (0 9 355

Device Name: RetroFlex™ Dilator Kit:

The RetroFlex™ Dilator Kit is intended for use in dilation of the peripheral vasculature.

Prescription Use × (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)

una R. Vi. Muna

(Division Sian-C Division of Cardiovascular Devices

510(k) Number_Ko 9

Page 1 of

Confidential

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).