(395 days)
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 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.
Here's a breakdown of the acceptance criteria and study information for the Leaderflex Mini and Leaderflex Nano devices, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Leaderflex K141026) rather than defining explicit "acceptance criteria" as pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, the acceptance criteria are implicitly met by demonstrating that the new devices (Leaderflex Mini and Nano) are as safe and effective as the predicate device, despite minor design changes. This is primarily shown through adherence to recognized standards and bench testing.
The "reported device performance" is described through the comparison of technological characteristics and compliance with various international standards for medical devices.
| Feature | Acceptance Criteria (Implied by Substantial Equivalence Goal) | Reported Device Performance (Leaderflex Mini & Nano) |
|---|---|---|
| Indications for Use | Must be substantially equivalent or a subset of the predicate device's indications, without raising new safety/effectiveness questions. | Indicated for: • Peripheral venous catheterization (midline) in any patient population with consideration given to the adequacy of vascular anatomy and appropriateness of procedure • Arterial catheterization (This is a subset of the predicate, removing central venous catheterization). |
| User Group | Same as predicate. | Clinicians qualified to place intravascular catheters such as nurses or doctors. |
| Use Environment | Same as predicate. | Clinical setting appropriate for aseptic technique. |
| Anatomical Placement | Same as predicate. | Peripheral veins in any patient population with consideration given to the adequacy of vascular anatomy. |
| Single Use | Same as predicate. | Yes. |
| Material Biocompatibility | Must meet established biocompatibility standards. | Complies with ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process". |
| Sterilization | Must meet established sterilization standards. | Supplied Sterile, EtO Sterilization (ISO 11135:2014, ISO 10993-7:2008), AAMI TIR 28, AAMI ST 72. |
| Shelf-life | Same as predicate. | 5 years. |
| Functional Performance (Catheter) | Must meet general requirements for intravascular catheters, demonstrating that dimensional differences do not affect clinical safety or effectiveness. | Compliance with ISO 10555-1:2013 "Intravascular catheters-Sterile and single-use catheters-Part 1: General requirements". Performance testing was done per this standard to demonstrate that minor dimensional differences in the catheter, guidewire, and introducer needles do not affect safety or effectiveness. |
| Flow Rate | Must be appropriate for the intended use and consistent with smaller gauge sizes. | Range: 3 to 17 ml/min (Predicate: 4.4 to 17 ml/min). The difference is attributed to smaller gauge and is considered acceptable. |
| Luer Taper | Must comply with standards for conical fittings. | Complies with ISO 594-1 & 2 "Conical Fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1 and Part 2". |
| Risk Management | Must follow accepted risk management principles. | Complies with ISO 14971:2019 "Medical Devices – Application of risk management to medical devices". |
| Packaging | Must comply with standards for packaging of sterile medical devices. | Complies with ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier System of Medical Devices" and ISO 11607-1:2019 "Packaging for terminally sterilized medical device-Part 1: Requirements for materials, sterile barrier systems and packaging systems". |
2. Sample Size Used for the Test Set and the Data Provenance
This submission is for a medical device (intravascular catheter) which primarily relies on non-clinical (bench) testing and comparison to a predicate device for demonstrating substantial equivalence. It does not involve a "test set" in the context of an AI/algorithm-driven device with a dataset of patient cases.
- Sample Size for Test Set: Not applicable in the context of a dataset of patient cases. Performance testing was conducted on samples of the physical devices.
- Data Provenance: The data provenance for non-clinical testing refers to the standards (e.g., ISO, AAMI, ASTM) that govern the methodologies. The document does not specify a country of origin for the test data, as it's typically bench testing performed by the manufacturer or accredited labs. The testing is prospective in the sense that the tests were performed on the new device designs to demonstrate compliance, but not in the clinical trial sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is a physical medical device, not an AI/software device requiring expert-labeled ground truth for a test set of images or clinical outcomes.
4. Adjudication Method for the Test Set
Not applicable. There's no "ground truth" to adjudicate in the typical sense of a diagnostic software. Device compliance is determined by meeting the specified requirements of the various ISO and ASTM standards.
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
Not applicable. This device is an intravascular catheter; it is not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by the requirements of recognized international and national standards (e.g., ISO 10555-1 for intravascular catheters, ISO 10993-1 for biocompatibility). Device performance is measured against these established engineering and biological criteria through bench testing.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device. There is no training set as would be used for machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
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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
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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 (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
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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) | |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------- |
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 (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 TherapeuticIntravascular 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.
| ProductCode | Model | CatheterUsableLength (cm) | Gauge | DiameterOD, ID(mm) | Flow Rate(ml/min) | GuidewireLength(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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| ProductCode | Model | CatheterUsableLength (cm) | Gauge | DiameterOD, ID(mm) | Flow Rate(ml/min) | GuidewireLength(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:
| ComparativeCharacteristics | Proposed Device:Leaderflex Mini and LeaderflexNano | Predicate Device:Leaderflex | Comments: |
|---|---|---|---|
| 510(k) Number | K212370 | K141026 | |
| Indication for Use | Leaderflex Mini and LeaderflexNano are indicated for:• Peripheral venouscatheterization (midline) inany patient population withconsideration given to theadequacy of vascularanatomy andappropriateness ofprocedure, or• Arterial catheterization | Leaderflex catheters are indicatedfor:• Arterial catheterization inadults• Central venouscatheterization (jugular,subclavian) in children• Peripheral venouscatheterization (Midline) inany patient population withconsideration given toadequacy of vascularanatomy andappropriateness ofprocedure. | See Comment#1 below |
| Prescriptionrequired? | Yes, Rx Only | Yes, Rx Only | Same |
| User Group | Clinicians qualified to placeintravascular catheters such asnurses or doctors | Clinicians qualified to placeintravascular catheters such asnurses or doctors | Same |
| Use Environment | Clinical setting appropriate foraseptic technique | Clinical setting appropriate foraseptic technique | Same |
| ComparativeCharacteristics | Proposed Device:Leaderflex Mini and LeaderflexNano | Predicate Device:Leaderflex | Comments: |
| Anatomicalplacementlocations | Peripheral veins in any patientpopulation with consideration givento the adequacy of vascularanatomy(Peripheral veins are available innumerous anatomical locations suchas scalp, hand, arm, foot, or leg) | Peripheral veins in any patientpopulation with consideration givento the adequacy of vascularanatomy(Peripheral veins are available innumerous anatomical locations suchas scalp, hand, arm, foot, or leg) | Same |
| Single Use | Yes | Yes | Same |
| Principle DeviceComponents(Sterile,Disposable, SingleUse) | Catheter Hub, Clamp, Fixation Wing,Tube | Catheter Hub, Clamp, Fixation Wing,Tube | Same |
| Other devices forinterfacing/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 PCHP3REU-8H9D273 | Polycarbonat PCHP3REU-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 ofMaterials | 24G- Leaderflex Mini26G- Leaderflex Nano | 22G- Leaderflex | SeeComment #3below |
| Technical Features/Design | 2cm, 3cm, 4cm | 4cm, 6cm, 8cm, 20cm | SeeComment #3below |
| Catheter GaugeSizes | 23cm and 25cm | 23cm, 26cm and 50 cm | SeeComment #3below |
| Catheter UsableLength | 24G Leaderflex Mini: 21G x 2.0cm26G Leaderflex Nano: 24G x 2.5cm | 22G Leaderflex: 21G x 4.2 cm | SeeComment #3below |
| Guidewire LengthDimension | 3 to 17 ml/min | 4.4 to 17 ml/min | See |
| Introducer NeedleDimension | |||
| Flow Rate (ml/min) | |||
| ComparativeCharacteristics | Proposed Device:Leaderflex Mini and LeaderflexNano | Predicate Device:Leaderflex | Comments: |
| Comment #4below | |||
| Markings | Yes:Leaderflex catheters and guidewires | No | SeeComment #5below |
| Shelf-life | 5 years | 5 years | Same |
| PerformanceStandardsCompliance | ISO 10555-1 | ISO 10555-1ISO 10555-3 | DifferentComment #6 |
| PackagingDescription | Peel Pouch | Peel Pouch | Same |
| Discussion ofdifferences intechnologicalcharacteristics: | Comment #1:The indications for use statements are nearly identical for the subject and predicatedevices except that the proposed device is a subset of the predicate device andremoves the central venous catheterization indication. The indications remainidentical for peripheral venous catheterization and for arterial catheterization. Thisdifference does not affect safety or effectiveness of the subject device.Comment #2:The subject devices include an optional guidewire insertion aid which assists clinicianswith seeing the wire when threading the catheter on the wire. The predicate/kit doesnot have this optional accessory. This difference does not affect the safety oreffectiveness of the subject device.Comment #3:The Leaderflex Mini and Nano catheters, guidewire and introducer needles have minordimensional differences compared to the predicate device. The subject device isavailable in 24g/26g size with lengths of 2, 3, 4 cm. The predicate is available in a 22 gsize with lengths of 4, 6, 8 & 20cm length. The smaller length and gauge is to make thesubject device more suitable for smaller veins compared to the predicate device.Performance testing was done per ISO 10555-1:2013 to demonstrate that the minordimensional differences in the catheter, guidewire and introducer needles do not affectthe clinical safety or effectiveness of the device.The Leaderflex Mini and Nano device and associated needle and guidewire meet theadequate performance tests specification as the predicate device in terms of beingtested to internationally recognized standards and critical functional requirementstested to internal bench test procedures. These dimensional difference do not affect thesafety 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 slightlyfaster.Comment #5: | ||
| ComparativeCharacteristics | Proposed Device:Leaderflex Mini and LeaderflexNano | 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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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 (<30 days). The devices comply with the following recognized standard:
- . ISO 10993-1:2018 "Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process (Complies with)
Sterility and Shelf-life:
- . ISO 11135:2014 Sterilization of healthcare products-Ethylene Oxide-Requirements (Complies with)
- AAMI TIR 28 (Complies with)
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- AAMI ST 72 (Complies with)
- ASTM F1980-16 "Standard Guide for Accelerated Aging of Sterile Barrier System . of Medical Devices" (Complies with)
- . ISO 11607-1:2019 "Packaging for terminally sterilized medical device-Part 1: Requirements for materials, sterile barrier systems and packaging systems" (Complies with)
- ISO 10993-7:2008 "Biological evaluation of medical devices=Part 7: Ethylene . Oxide sterilization residuals
5.12. Clinical Testing:
Not applicable
5.13. Conclusion:
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Leaderflex Nano and the Leaderflex Mini are substantially equivalent to the Leaderflex device with respect to indications for use, target population, treatment method, and technological characteristics.
§ 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).