(99 days)
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
Leaderflex is a radiopaque biostable polyurethane catheter suitable for a variety of venous and arterial applications. Leaderflex is inserted via Seldinger technique.
The provided text is a 510(k) Premarket Notification submission for the Leaderflex catheter. The document does not describe an acceptance criteria table, a study proving device performance against such criteria, or any of the detailed study parameters requested in the prompt (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already legally marketed, rather than presenting new clinical study data to prove performance against specific acceptance criteria.
The key points from the provided text are:
- Device: Leaderflex intravascular catheter
- Intended Use: Arterial catheterization in adults, central venous catheterization in children, peripheral venous catheterization (Midline) in any patient population.
- Predicate Devices: Vygon Leaderflex (K052564), Bard Powerglide Midline Catheter (K121073), Bard Poly Per-Q-Cath Midline (K001901).
- Demonstration of Equivalence: The submission states, "Leaderflex is identical to the legally marketed Vygon predicate device. The subject device shares the midline indication with both the Bard Powerglide and Poly Per-Q-Cath Midline catheters. A risk analysis has been completed to show that the safety and effectiveness of the device has not been altered with the addition of the midline indication." This is the core of their argument for substantial equivalence.
Therefore, I cannot populate the requested table or provide information on the study parameters because the document does not contain this type of performance data or study design. The FDA's 510(k) clearance in this case is based on the claim of substantial equivalence to existing devices, not on new clinical performance data meeting specific criteria.
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JUL 3 0 2014
Leaderflex Premarket Notification 510(k) Submission
21 April 2014
PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR §807.92)
510k number: K141026 Applicant: Vygon Corporation 2750 Morris Road, Suite A200 Lansdale, PA 19446 Contact Name: Jillian Mikovich Regulatory Affairs Manager Phone: 800-473-5414 Fax: 215-672-6740 Leaderflex Trade Name: Common Name: Intravascular Catheter 21 CFR 880.5200 Regulation Number: Product Code: FOZ Catheter, Intravascular, Therapeutic, Short-term Less than 30 days Classification Name: Regulatory Class: Class II Vygon Leaderflex, K052564 Predicate Devices: Bard Powerglide Midline Catheter, K121073 Bard Poly Per-Q-Cath Midline, K001901 April 21, 2014 Date Prepared: Device Description: Leaderflex is a radiopaque biostable polyurethane catheter suitable for a variety of venous and arterial applications. Leaderflex is inserted via Seldinger technique. Intended Use: 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 Technology Characteristics: Leaderflex is identical to the legally marketed Vygon predicate device. The subject device shares the midline indication with both the Bard Powerglide and Poly Per-Q-Cath Midline catherters. Non-Clinical Summary: The subject device is completely identical to the Vygon predicate and shares a common indication with both Bard predicates. A risk analysis
has been completed to show that the safety and effectiveness of the device has not been altered with the addition of the midline indication.
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Given the above, the subject device, using Vygon Leader-Flex, Bard Powerglide Midline and Bard Poly Per-Q-Cath Midline as the predicate devices, meets regulatory requirements for Demonstration of substantial equivalence (see Premarket Notification Review Program 6/30/86 (K86-3) FDA blue book memorandum, "Guidance on the CDRH Premarket Notification Review Program").
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2014
Vygon Corporation Jillian Mikovich Regulatory Affairs Manager 2750 Morris Road, Suite A200 Lansdale, PA 19446
Re: K141026
Trade/Device Name: Leaderflex Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular catheter Regulatory Class: II Product Code: FOZ Dated: July 17, 2014 Received: July 18, 2014
Dear Ms. Mikovich:
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. 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.
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Page 2 - Ms. Mikovich
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
MarySTBber-S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510{k) Number (if known) K141026
Device Name Leaderflex
Indications for Use (Describe) 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
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FDAIUSE ONLY ్రాల్యే శిశు శాశాల, ప్ర
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Digitally signed by Richard C. Chapman -S Date: 2014.07.29 12:37:10 -04'00'
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§ 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).