K Number
K093554
Device Name
RETROFLEX DILATOR KIT
Date Cleared
2010-04-13

(147 days)

Product Code
Regulation Number
870.1310
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RetroFlex™ Dilator Kit is intended for use in dilation of the peripheral vasculature.
Device Description
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.
More Information

Not Found

No
The device description and performance studies focus on the physical properties and mechanical performance of a dilator kit, with no mention of software, algorithms, or data processing that would indicate AI/ML.

No
A dilator is used to open, increase the diameter, or facilitate access to a body cavity or vessel, which is not considered a therapeutic function; instead, it is an instrument used in a procedural context.

No

The device is a dilator kit used to open peripheral vasculature, which is a therapeutic rather than diagnostic function. Its purpose is to facilitate access or expansion, not to detect or identify a medical condition.

No

The device description clearly outlines physical components made of polyethylene, barium sulfate, and titanium dioxide, and describes manufacturing processes like heat-treating and molding. It also details physical performance testing. This indicates a hardware-based medical device, not a software-only one.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is "dilation of the peripheral vasculature." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
  • Device Description: The device is a physical dilator designed to be inserted into blood vessels. It's made of materials suitable for this purpose and has features for tracking a guidewire and facilitating insertion.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a therapeutic/interventional device used to physically modify the patient's anatomy.

N/A

Intended Use / Indications for Use

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

Product codes

DRE

Device Description

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 (Table 7.2.1).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral vasculature

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

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
  • . Microbiology
    • Endotoxin-Mediated Pyrogenicity o
  • Chemical .
    • Material Verification o
  • USP Physico-Chemical Test for Plastic Closures o
  • Non-Volatile Residues Test o

Key Metrics

Not Found

Predicate Device(s)

K070749, K963388, K092378

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

K093554

510(k) Summary

APR 1 3 2010

| Applicant: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
USA
Phone: 949.250-3837
Fax: 949.756-4408 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | November 3, 2009 |
| Contact Persons: | Jason K. Lyon
Principle Project Manager, Regulatory Affairs

Dean Knight
Sr. 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 Kit
cleared under K070749

Maxxim Medical, Inc - Vessel Dilator
cleared under K963388

Spectranetics Corporation - Visisheath™ Dilator Sheath
cleared under K092378 |
| Manufacturer: | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA 92614
USA |

1

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 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 (Table 7.2.1).

Table 7.2.1 - RetroFlex Dilator Kits
Dilator Kit SetDilator Sizes
4-piece dilators16F, 18F, 20F, and 22F
7-piece dilators16F, 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

2

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

4

  • 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.

3

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

4

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

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