(28 days)
Not Found
No
The summary describes a physical medical device (introducer) and its mechanical and material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
This device is an introducer, designed to facilitate the insertion of other devices (like pacing or defibrillator leads, and catheters) into the coronary venous system, rather than directly treating a medical condition itself.
No
Explanation: The device is described as an introducer used as a conduit for other devices and to deliver contrast medium. While delivering contrast medium could be part of a diagnostic procedure, the introducer itself does not perform analysis or generate diagnostic information; it merely facilitates the delivery of the diagnostic medium or other diagnostic tools. Its primary function is access and guidance, not diagnosis.
No
The device description clearly details a physical medical device (introducer) with a shaft, metal braid, coating, hemostasis valve, side-port, and various curve configurations. The performance studies focus on physical and functional testing of this hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body.
- Device Function: The description clearly states that this device is an introducer used to guide leads and catheters into the coronary venous system and inner heart. It has direct contact with the inner heart.
- Intended Use: The intended use is for the introduction of pacing or defibrillator leads and catheters, and to deliver contrast medium into specific branches of the coronary venous system. This is an interventional procedure performed within the body.
The device is a medical device used for a therapeutic and diagnostic procedure performed in vivo (within the living body), not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
For the introduction of various types of pacing or defibrillator leads and catheters.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application (
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Merit Medical Systems, Inc. Alina Stubbs Regulatory Affairs Specialist II 65 Great Valley Parkway Malvern, Pennsylvania 19355
Re: K152116
Trade/Device Name: 5.5 F Worley Advanced LVI Lateral Vein Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 29, 2015 Received: July 30, 2015
Dear Alina Stubbs:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (21 CFR 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Merit Medical Systems, Inc. 5.5 F Worley Advanced LVI Lateral Vein Introducer Special 510(k)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152116
Device Name
5.5 F Worley Advanced LVI Lateral Vein Introducer
Indications for Use (Describe)
For the introduction of various types of pacing or defibrillator leads and catheters.
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 FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimated on any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
- Over-The-Counter Use
_ Over-The-Counter Use (21 CFR 801 Subpart C)
3
510(k) Summary
| General
Provisions | Correspondent Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date of Preparation:
Registration Number: | Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19355
(610) 651-5046
(801) 545-4285
Alina Stubbs
July 29, 2015
2529252 | |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject
Device | Trade Name:
Common/Usual Name:
Classification Name: | 5.5 F Worley Advanced LVI Lateral Vein
Introducer
Sheath Introducer
Introducer, Catheter (21 CFR §870.1340) | |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Coronary Sinus Guide and Lateral Vein
Introducer Kits
Introducer, Catheter (21 CFR §870.1340)
K120158
Merit Medical Systems, Inc.
65 Great Valley Parkway
Malvern, PA 19355
(formerly operating as
Thomas Medical Products, Inc.) | |
| Classification | Class II
21 CFR §870.1340
FDA Product Code: DYB
Review Panel: Cardiovascular | | |
| Intended Use | For the introduction of various types of pacing or defibrillator leads
and catheters. | | |
4
The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to quide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application ( The proximal end of the 5.5 F Worley Advanced LVI Lateral Vein Introducers are equipped with a hemostasis valve that reduces the risk of blood loss and air embolism and a side-port with 3-way stopcock to allow fluid infusion and contrast injection.
There are various versions of the introducer curves that are used according to the anatomy of the present coronary vasculature. The distal soft tip has a radius on the outer diameter and the distal tip further contains a polymeric x-ray marker for enhanced visibility under fluoroscopy.
The materials of construction are primarily polymers.
5
| Summary of the technological characteristics of the modified device | |
|---|---|
| compared to the predicate devices: |
| | Technical
Characteristics | Predicate Device
K120158 | Subject Device |
|----------------------------|-----------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| Comparison to
Predicate | Hemostasis valve
provided | Yes | Yes |
| | Compatible with
.038" guide wire | Yes | Yes |
| | Lengths: | 62 cm | 66cm |
| | French sizes: | 7 F I.D. | 5.5 F I.D. |
| | Curves: | 0 to 180 degree,
single or compound
curves | 0 to 180 degree,
single or compound
curves |
| | Sheath introducer
break-away
hemostasis valve | Yes | Yes |
| | Wire braid
reinforcement
completely
encapsulated | Yes | Yes |
| | Radiopaque tip | Yes | Yes |
| | Side port for infusion
and contrast
injection | Yes | Yes |
| | UV & heat
stabilizers | Yes | Yes |
| | Stiffness
segmentations | 3 | 2 |
| | Device Materials | The materials of
construction are
primarily polymers. | The materials of
construction are
primarily polymers. |
6
The 5.5 F Worley Advanced LVI Lateral Vein Introducer has been thoroughly tested through verification of product specifications and user requirements. The following quality assurance measures were applied during the development of the 5.5 F Worley Advanced LVI Lateral Vein Introducer:
- Risk Analysis ●
- Requirements/Specification Reviews ●
- Design Reviews
- Performance Testing (Verification) including but not limited to: ●
- o Dimensional Tests
- Sheath introducer Curve dimensions ■
- Sheath introducer outer diameter (O.D.) ■
- . Sheath introducer inner diameter (I.D.)
- 트 Sheath introducer free length, overall length
- I o Functional Tests
- Sheath introducer soft tip joint integrity ■
- Sheath introducer valve housing separation
- Sheath introducer tube/valve housing pull force
- . Sheath introducer radiopaque tube segment joint pull force
- 트 Sheath introducer tube joint pull force
- Simulated Use Test o
- Sheath introducer tube slitting with slitter l
- I Sheath introducer radiopaque tip bend
- Visual Tests o
- Kit pouch integrity 트
- 트 Kit package integrity
- . Sheath Introducer visual appearance
- 트 Guiding catheter visual appearance
- l TVI visual appearance
- Slitter (Cutter) visual appearance
- o Dimensional Tests
- . Sterilization Validation
- Biocompatibility Testing .
- o Cytotoxicity
Safety & Performance Tests
7
| International
Standards | No performance standards have been established under section 514
of the Food, Drug and Cosmetic Act for this device. Performance
testing of the 5.5 F Worley Advanced LVI Lateral Vein Introducer
was conducted based on the risk analysis and based on the
requirements of the following international standards:
ISO 11070: 1998(E), Sterile, single-use intravascular catheter
introducers ISO 11135-1: 2007, Sterilization of health care products -
Ethylene oxide - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical
devices AAMI TIR28:2009, Product adoption and process equivalence for
ethylene oxide sterilization ISO 10993-1: 2009, Biological Evaluation of Medical Devices
Part-1: Evaluation and Testing within a risk management
process, ISO 10993-7: 2008, Biological Evaluation of Medical Devices
Part-7 Ethylene Oxide Sterilization Residuals ISO 10993-17: 2002, Biological evaluation of medical devices -
Part 17: Methods for the establishment of allowable limits for
leachable substances ASTM D4169-09, Standard Practice for Performance Testing of
Shipping Containers and Systems ISO 11607-1: 2009, Packaging for terminally sterilized medical
devices - Part 1: Requirements for materials, sterile barrier
systems and packaging systems ISO 14971:2012, Medical devices - Application of risk
management to medical devices |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance
testing, the subject 5.5 F Worley Advanced LVI Lateral Vein
Introducer meets the requirements that are considered essential for
its intended use and is substantially equivalent to the predicate
device, the Coronary Sinus Guide and Lateral Vein Introducer Kits -
K120158, manufactured by Merit Medical Systems, Inc |