(395 days)
No
The document describes a physical medical device (catheter and accessories) and its intended use and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a catheter used for peripheral venous or arterial access, which is a diagnostic or access tool rather than a therapeutic treatment itself.
No
The device is a catheter used for peripheral venous or arterial catheterization, which are interventional procedures, not diagnostic ones.
No
The device description clearly states it is a radiopaque biostable polyurethane catheter and includes physical accessories like an introducer needle and guidewire, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "Peripheral venous catheterization (midline)" and "Arterial catheterization." These are procedures for accessing blood vessels within the body, not for examining specimens taken from the body.
- Device Description: The description details a catheter designed for insertion into veins and arteries. It mentions accessories like needles and guidewires, all related to the physical insertion and placement of the catheter within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is used in the body for therapeutic or diagnostic access, not for analyzing samples outside the body.
N/A
Intended Use / Indications 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
Product codes
FOZ
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.
The Leaderflex Mini and Leaderflex Nano are single use and provided sterile, via ethylene oxide sterilization according to ISO 11135.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral veins in any patient population with consideration given to the adequacy of vascular anatomy (Peripheral veins are available in numerous anatomical locations such as scalp, hand, arm, foot, or leg)
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Clinicians qualified to place intravascular catheters such as nurses or doctors
Clinical setting appropriate for aseptic technique
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The catheters described in this summary were either tested or comply with the following FDA recognized standards:
Performance Testing-Bench
- ISO 10555-1:2013 "Intravascular catheters-Sterile and single-use catheters-Part 1: General requirements"
- ISO 14971:2019 "Medical Devices – Application of risk management to medical devices" ISO 594-1 & 2 "Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1 and Part 2" (Complies with)
Biocompatibility:
The Leaderflex Mini and Leaderflex Nano are classified as: Externally Communicating, Circulating Blood, Prolonged Contact (
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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 (865) 824-6355 Email: jayw@maegroups.com
- 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 |
| 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
4
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
Code | Model | Catheter
Usable
Length (cm) | Gauge | Diameter
OD, ID
(mm) | Flow Rate
(ml/min) | Guidewire
Length
(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
Code | Model | Catheter
Usable
Length (cm) | Gauge | Diameter
OD, ID
(mm) | Flow Rate
(ml/min) | Guidewire
Length
(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
Characteristics | Proposed Device:
Leaderflex Mini and Leaderflex
Nano | Predicate Device:
Leaderflex | Comments: |
|---------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K212370 | K141026 | |
| 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 | Leaderflex catheters are indicated
for:
• Arterial catheterization in
adults
• Central venous
catheterization (jugular,
subclavian) in children
• Peripheral venous
catheterization (Midline) in
any patient population with
consideration given to
adequacy of vascular
anatomy and
appropriateness of
procedure. | See Comment
#1 below |
| Prescription
required? | Yes, Rx Only | Yes, Rx Only | Same |
| User Group | Clinicians qualified to place
intravascular catheters such as
nurses or doctors | Clinicians qualified to place
intravascular catheters such as
nurses or doctors | Same |
| Use Environment | Clinical setting appropriate for
aseptic technique | Clinical setting appropriate for
aseptic technique | Same |
| Comparative
Characteristics | Proposed Device:
Leaderflex Mini and Leaderflex
Nano | Predicate Device:
Leaderflex | Comments: |
| Anatomical
placement
locations | Peripheral veins in any patient
population with consideration given
to the adequacy of vascular
anatomy
(Peripheral veins are available in
numerous anatomical locations such
as scalp, hand, arm, foot, or leg) | Peripheral veins in any patient
population with consideration given
to the adequacy of vascular
anatomy
(Peripheral veins are available in
numerous anatomical locations such
as scalp, hand, arm, foot, or leg) | Same |
| Single Use | Yes | Yes | Same |
| Principle Device
Components
(Sterile,
Disposable, Single
Use) | Catheter Hub, Clamp, Fixation Wing,
Tube | Catheter Hub, Clamp, Fixation Wing,
Tube | Same |
| Other devices for
interfacing/
Accessories | Guidewire, Introducer Needle,
Guidewire Insertion Aid | Guidewire, Introducer Needle | See Comment
#2 below |
| Sterilization | Supplied Sterile, EtO Sterilization
(ISO 11135) | Supplied Sterile, EtO Sterilization
(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
HP3REU-8H9D273 | Polycarbonat PC
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
Materials | 24G- Leaderflex Mini
26G- Leaderflex Nano | 22G- Leaderflex | See
Comment #3
below |
| Technical Features/Design | 2cm, 3cm, 4cm | 4cm, 6cm, 8cm, 20cm | See
Comment #3
below |
| Catheter Gauge
Sizes | 23cm and 25cm | 23cm, 26cm and 50 cm | See
Comment #3
below |
| Catheter Usable
Length | 24G Leaderflex Mini: 21G x 2.0cm
26G Leaderflex Nano: 24G x 2.5cm | 22G Leaderflex: 21G x 4.2 cm | See
Comment #3
below |
| Guidewire Length
Dimension | 3 to 17 ml/min | 4.4 to 17 ml/min | See |
| Introducer Needle
Dimension | | | |
| Flow Rate (ml/min) | | | |
| Comparative
Characteristics | Proposed Device:
Leaderflex Mini and Leaderflex
Nano | Predicate Device:
Leaderflex | Comments: |
| | | | Comment #4
below |
| Markings | Yes:
Leaderflex catheters and guidewires | No | See
Comment #5
below |
| Shelf-life | 5 years | 5 years | Same |
| Performance
Standards
Compliance | ISO 10555-1 | ISO 10555-1
ISO 10555-3 | Different
Comment #6 |
| Packaging
Description | Peel Pouch | Peel Pouch | Same |
| Discussion of
differences in
technological
characteristics: | Comment #1:
The indications for use statements are nearly identical for the subject and predicate
devices except that the proposed device is a subset of the predicate device and
removes the central venous catheterization indication. The indications remain
identical for peripheral venous catheterization and for arterial catheterization. This
difference does not affect safety or effectiveness of the subject device.
Comment #2:
The subject devices include an optional guidewire insertion aid which assists clinicians
with seeing the wire when threading the catheter on the wire. The predicate/kit does
not have this optional accessory. This difference does not affect the safety or
effectiveness of the subject device.
Comment #3:
The Leaderflex Mini and Nano catheters, guidewire and introducer needles have minor
dimensional differences compared to the predicate device. The subject device is
available in 24g/26g size with lengths of 2, 3, 4 cm. The predicate is available in a 22 g
size with lengths of 4, 6, 8 & 20cm length. The smaller length and gauge is to make the
subject device more suitable for smaller veins compared to the predicate device.
Performance testing was done per ISO 10555-1:2013 to demonstrate that the minor
dimensional differences in the catheter, guidewire and introducer needles do not affect
the clinical safety or effectiveness of the device.
The Leaderflex Mini and Nano device and associated needle and guidewire meet the
adequate performance tests specification as the predicate device in terms of being
tested to internationally recognized standards and critical functional requirements
tested to internal bench test procedures. These dimensional difference do not affect the
safety or effectiveness.
Comment #4:
The flow rate of the subject device is 3-17 mL/minute whereas, the predicate is 4.4-
17mL/min The predicate device has a slightly larger gauge thus the flow rate is slightly
faster.
Comment #5: | | |
| Comparative
Characteristics | Proposed Device:
Leaderflex Mini and Leaderflex
Nano | Predicate Device:
Leaderflex | Comments: |
| | The subject device has the addition of black locational markings on the catheter as well as on the guidewire which the predicate device does not. The purpose of the location markings is to provide the user a better indication of how much of the subject device has been placed into the body. The black ink has been used on other cleared devices and does not affect safety or effectiveness of the proposed device. The predicate device is being reviewed now to add the same black locational markings under the Quality Management System change control process.
Comment #6:
Both subject device and the predicate device conform to ISO 10555-1, testing to ISO 10555-3 is not applicable as the subject device does not have a central venous indication. | | |
| | Although there are slight differences in the design features of the subject device and the predicate device, these differences were found to be minor and do not affect the safety or effectiveness, as discussed in the Comments above for each difference identified. The principle of operation remains the same for both devices. The Leaderflex Mini and Nano device is considered substantially equivalent to the predicate device in indication for use and technological characteristics (design and materials) based on the above evaluation. | | |
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7
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5.11. Summary of Non-Clinical Testing
The catheters described in this summary were either tested or comply with the following FDA recognized standards:
Performance Testing-Bench
- . ISO 10555-1:2013 "Intravascular catheters-Sterile and single-use catheters-Part 1: General requirements"
- . ISO 14971:2019 "Medical Devices – Application of risk management to medical devices" ISO 594-1 & 2 "Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1 and Part 2" (Complies with)
Biocompatibility:
The Leaderflex Mini and Leaderflex Nano are classified as: Externally Communicating, Circulating Blood, Prolonged Contact (