Leaderflex Mini and Leaderflex Nano

K212370 · Vygon USA · FOZ · Aug 29, 2022 · General Hospital

Device Facts

• Record ID: K212370
• Device Name: Leaderflex Mini and Leaderflex Nano
• Applicant: Vygon USA
• Product Code: FOZ · General Hospital
• Decision Date: Aug 29, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Leaderflex mini and Leaderflex nano are indicated for: •Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or • Arterial catheterization

Device Story

Radiopaque biostable polyurethane catheters; inserted via Seldinger technique; used for peripheral venous (midline) or arterial catheterization. Operated by clinicians (nurses/doctors) in in-patient/out-patient settings. Device includes introducer needle, guidewire, and guidewire insertion aid. Provides vascular access; enables fluid/medication delivery. Benefits patient by facilitating access in smaller veins via 24G/26G configurations and shorter lengths (2-4cm). Features black locational markings for depth monitoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing per ISO 10555-1, ISO 594-1/2, and biocompatibility evaluation per ISO 10993-1.

Technological Characteristics

Materials: TECOFLEX EG60D B40 (catheter), PELLETHANE 90A 25B (wing), VITAMIDE 6 BK10 (extension line), Polycarbonate (hub), Stainless Steel (clamp/guidewire). Energy: None (passive). Form: 24G/26G catheters, 2-4cm length. Sterilization: Ethylene Oxide (ISO 11135). Standards: ISO 10555-1, ISO 10993-1, ISO 11607-1, ASTM F1980-16.

Indications for Use

Indicated for peripheral venous catheterization (midline) in any patient population or arterial catheterization.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

• Leaderflex (K141026)

Submission Summary (Full Text)

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August 29, 2022

Vygon USA Jay Wigley Regulatory Affairs Manager 2750 Morris Rd Suite A200 Lansdale, Pennsylvania 19446

Re: K212370

Trade/Device Name: Leaderflex Mini and Leaderflex Nano Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: May 26, 2022 Received: May 31, 2022

Dear Jay Wigley :

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K212370

Device Name Leaderflex Mini and Leaderflex Nano

Indications for Use (Describe)

Leaderflex mini and Leaderflex nano are indicated for:

•Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure, or

· Arterial catheterization

| Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> <input type="checkbox"/> </div> |
|-------------------------------------------------|----------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# K212370 510(k) Summary

- 5.1.Applicant: Vygon USA 2750 Morris Road Suite A200 Lansdale, PA US 19446
- 5.2.Sponsor Contact Person:

Jay Wigley Contractor, acting as Regulatory Manager Vygon USA 2750 Morris Road Suite A200 Lansdale, PA US 19446 [phone] Email: [e-mail]

- 5.3.Regulatory Correspondent/ 510(k) Submission Contact: Same as above
- 5.4.Date Prepared: August 26, 2022

### 5.5.Device Information:

| Trade Name | Leaderflex Mini and Leaderflex Nano |
|----------------|--------------------------------------------------------------------|
| | |
| Product Code | FOZ |
| Common Name | Short-Term Less Than 30 Days Therapeutic<br>Intravascular Catheter |
| Classification | Class II |
| Regulation | 21 CFR 880.5200 – Intravascular catheter |

- 5.6.Predicate Device:
Leaderflex (K141026)

- 5.7.Submission Purpose:
The purpose of this 510(k) submission is to implement design changes to the predicate Leaderflex (K141026) to create a product line extension: Leaderflex Mini and Leaderflex Nano

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with additional working diameters and lengths to encompass different configurations of Leaderflex models along with associated accessories- guidewire and needle. These modifications to the Leaderflex do not change the indications for use of the device, nor do they change the fundamental scientific technology of the device.

### 5.8.Device Description:

Leaderflex Mini and Leaderflex Nano are a radiopaque biostable polyurethane catheters suitable for peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure. Leaderflex Mini and Leaderflex Nano catheters are inserted via Seldinger technique, same as the predicate device. The Leaderflex mini and Leaderflex nano catheters are intended to be used by clinicians such as nurses at in- and out-patient locations. The primary requirement for environment of use is to ensure the environment is appropriate for supporting aseptic technique. These catheters are typically inserted into a peripheral vein on the forearm or leg, with the catheter tip located below the axilla of the arm or below the groin of the leg; however, the catheter is not limited to these anatomical placement locations. This is the same environment of use and anatomical location as the predicate device.

The subject Leaderflex Mini and Leaderflex Nano devices are accompanied by compatible accessories necessary to perform the Seldinger technique; these include: an introducer needle, guidewire, and guidewire insertion aid. The predicate Leaderflex device (K141026) is currently available in 22G configurations with usable lengths of 4cm, 6cm, 8cm and 20cm. The subject device will extend the device configurations to include 24G (Leaderflex Mini) and 26G catheters (Leaderflex Nano) with usable lengths of 2cm, 3cm, and 4cm and will add introducer needle and guidewires.

The subject device also introduces a new guidewire insertion aid for all gauge sizes. The overall device description of the subject and predicate Leaderflex models is the same.

| Product<br>Code | Model | Catheter<br>Usable<br>Length (cm) | Gauge | Diameter<br>OD, ID<br>(mm) | Flow Rate<br>(ml/min) | Guidewire<br>Length<br>(cm) |
|-----------------|-------|-----------------------------------|-------|----------------------------|-----------------------|-----------------------------|
| VYLFM1002 | Mini | 2 | 24G | 0.73, 0.53 | 17ml/min | 23 |
| VYLFM1003 | Mini | 3 | 24G | 0.73, 0.53 | 16ml/min | 23 |
| VYLFM1004 | Mini | 4 | 24G | 0.73, 0.53 | 15ml/min | 23 |
| VYLFN1002 | Nano | 2 | 26G | 0.51, 0.33 | 5ml/min | 25 |
| VYLFN1003 | Nano | 3 | 26G | 0.51, 0.33 | 4ml/min | 25 |

The proposed device models are detailed below:

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| Product<br>Code | Model | Catheter<br>Usable<br>Length (cm) | Gauge | Diameter<br>OD, ID<br>(mm) | Flow Rate<br>(ml/min) | Guidewire<br>Length<br>(cm) |
|-----------------|-------|-----------------------------------|-------|----------------------------|-----------------------|-----------------------------|
| VYLFN1004 | Nano | 4 | 26G | 0.51, 0.33 | 3ml/min | 25 |

The Leaderflex Mini and Leaderflex Nano are single use and provided sterile, via ethylene oxide sterilization according to ISO 11135.

### 5.9.Indication for Use:

Leaderflex mini and Leaderflex nano are indicated for:

- Peripheral venous catheterization (midline) in any patient population with consideration . given to the adequacy of vascular anatomy and appropriateness of procedure, or
- . Arterial catheterization

#### 5.10. Comparison of Technological Characteristics:

The table below includes a comparison of technological characteristics between the new devices and those of the predicate device:

| Comparative<br>Characteristics | Proposed Device:<br>Leaderflex Mini and Leaderflex<br>Nano | Predicate Device:<br>Leaderflex | Comments: |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K212370 | K141026 | |
| Indication for Use | Leaderflex Mini and Leaderflex<br>Nano are indicated for:<br>• Peripheral venous<br>catheterization (midline) in<br>any patient population with<br>consideration given to the<br>adequacy of vascular<br>anatomy and<br>appropriateness of<br>procedure, or<br>• Arterial catheterization | Leaderflex catheters are indicated<br>for:<br>• Arterial catheterization in<br>adults<br>• Central venous<br>catheterization (jugular,<br>subclavian) in children<br>• Peripheral venous<br>catheterization (Midline) in<br>any patient population with<br>consideration given to<br>adequacy of vascular<br>anatomy and<br>appropriateness of<br>procedure. | See Comment<br>#1 below |
| Prescription<br>required? | Yes, Rx Only | Yes, Rx Only | Same |
| User Group | Clinicians qualified to place<br>intravascular catheters such as<br>nurses or doctors | Clinicians qualified to place<br>intravascular catheters such as<br>nurses or doctors | Same |
| Use Environment | Clinical setting appropriate for<br>aseptic technique | Clinical setting appropriate for<br>aseptic technique | Same |
| Comparative<br>Characteristics | Proposed Device:<br>Leaderflex Mini and Leaderflex<br>Nano | Predicate Device:<br>Leaderflex | Comments: |
| Anatomical<br>placement<br>locations | Peripheral veins in any patient<br>population with consideration given<br>to the adequacy of vascular<br>anatomy<br>(Peripheral veins are available in<br>numerous anatomical locations such<br>as scalp, hand, arm, foot, or leg) | Peripheral veins in any patient<br>population with consideration given<br>to the adequacy of vascular<br>anatomy<br>(Peripheral veins are available in<br>numerous anatomical locations such<br>as scalp, hand, arm, foot, or leg) | Same |
| Single Use | Yes | Yes | Same |
| Principle Device<br>Components<br>(Sterile,<br>Disposable, Single<br>Use) | Catheter Hub, Clamp, Fixation Wing,<br>Tube | Catheter Hub, Clamp, Fixation Wing,<br>Tube | Same |
| Other devices for<br>interfacing/<br>Accessories | Guidewire, Introducer Needle,<br>Guidewire Insertion Aid | Guidewire, Introducer Needle | See Comment<br>#2 below |
| Sterilization | Supplied Sterile, EtO Sterilization<br>(ISO 11135) | Supplied Sterile, EtO Sterilization<br>(ISO 11135) | Same |
| Product Codes | FOZ | FOZ | Same |
| Materials | TECOFLEX EG60D B40 | TECOFLEX EG60D B40 | Same |
| Catheter tube | PELLETHANE 90A 25B | PELLETHANE 90A 25B | Same |
| Wing | PELLETH.80 AE BLAU | PELLETH.80 AE BLAU | Same |
| Extension line | VITAMIDE 6 BK10 NATURAL | VITAMIDE 6 BK10 NATURAL | Same |
| Luer hub | Polycarbonat PC<br>HP3REU-8H9D273 | Polycarbonat PC<br>HP3REU-8H9D273 | Same |
| Clamp | Stainless Steel | Stainless Steel | Same |
| Guidewire | ABS, stainless steel | ABS, stainless steel | Same |
| Introducer Needle | Meets ISO 10993-1 requirements | Meets ISO 10993-1 requirements | Same |
| Biocompatibility of<br>Materials | 24G- Leaderflex Mini<br>26G- Leaderflex Nano | 22G- Leaderflex | See<br>Comment #3<br>below |
| Technical Features/Design | 2cm, 3cm, 4cm | 4cm, 6cm, 8cm, 20cm | See<br>Comment #3<br>below |
| Catheter Gauge<br>Sizes | 23cm and 25cm | 23cm, 26cm and 50 cm | See<br>Comment #3<br>below |
| Catheter Usable<br>Length | 24G Leaderflex Mini: 21G x 2.0cm<br>26G Leaderflex Nano: 24G x 2.5cm | 22G Leaderflex: 21G x 4.2 cm | See<br>Comment #3<br>below |
| Guidewire Length<br>Dimension | 3 to 17 ml/min | 4.4 to 17 ml/min | See |
| Introducer Needle<br>Dimension |…