(57 days)
Not Found
No
The device description and performance testing focus on the physical characteristics and mechanical performance of the introducer kit components. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No.
The device is an introducer, designed to assist in the introduction of other devices (diagnostic or therapeutic) into a vessel, but it does not perform a therapeutic function itself.
No
The device is an introducer kit designed to aid in the insertion of other diagnostic or therapeutic devices into a vessel, not to perform diagnostics itself. Its intended use is to assist, not to diagnose.
No
The device description clearly outlines physical components such as a guidewire, needle, syringe, and percutaneous introducer, all of which are hardware. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the introduction of diagnostic or therapeutic devices into a vessel." This describes a device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details components like guidewires, needles, syringes, and introducers, all of which are used for accessing and introducing devices into blood vessels. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnostic purposes. IVDs typically involve analyzing biological samples in vitro (outside the body).
Therefore, this device is a medical device used for in vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:
- Percutaneous Introducer only, or
- Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire
A description of each individual component is provided below:
Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.
18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.
Syringe
The 10ml syringe design allows for insertion into the needle.
Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Percutaneous Introducer and Kit was subjected to a full battery of performance testing including pre-determined acceptance criteria: As expected, the device met all acceptance criteria. The results of the performance testing (i.e., dimensional, tensile, radiopacity, corrosion resistance, leakage, etc.) demonstrate that these devices are substantially equivalent to the currently marketed predicate devices, adequately meets their intended use, and are acceptable for commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Image /page/0/Picture/2 description: The image shows the logo for Teleflex Medical. The logo is in black and features a stylized "T" followed by the word "Teleflex" in a bold, sans-serif font. Below "Teleflex" is the word "MEDICAL" in a smaller, sans-serif font.
FEB 2 1 2013
510(K) SUMMARY
SUBMITTER: 1.
Manufacturer:
Teleflex Medical 50 Plantation Drive Jaffrey, NH 03452 Telephone #(603) 532-7706 Establishment Registration Number: 1221019
Owner/Operator:
Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 Owner/Operator #9062981
Official Contact:
Dawn I. Moore Telephone: Date Prepared:
Regulatory Affairs Manager 734-368-2214 December 20, 2012
2. DEVICE:
Percutaneous Introducer and Kit Tradename: Classification Name: Introducer, Catheter Class Il Classification: Introducer Kit Common Name: Cardiovascular Classification Panel: DYB Product Code: Regulation Number: 870.1340
PREDICATE DEVICES: 3.
- Teleflex Percutaneous Introducer cleared under 510(k) Premarket Notification . #K060219
- Greatbatch Medical PTFE Peelable Introducer Kit cleared under 510(k) . Premarket Notification #K102540.
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DEVICE DESCRIPTION: 4.
Teleflex Medical OEM's Percutaneous Introducer and Kit is used to assist in the introduction of diagnostic or therapeutic devices into a vessel. These devices will be marketed in two configurations:
- Percutaneous Introducer only, or
- Percutaneous Introducer. Needle, Kit including Introducer Syringe and Guidewire
A description of each individual component is provided below:
Guidewire
The guidewire is designed to allow ease of movement through the vessels of the bodv.
18 Ga Needle
The 18 Ga Needle design allows the syringe to be attached to it and for the guidewire to be inserted through it.
Syringe
The 10ml syringe design allows for insertion into the needle.
Percutaneous Introducer
The Percutaneous Introducer uses a secure locking luer collar hub design and also incorporates an ergonomic handle design. This protects against separation of the dilator and sheath assembly during insertion. The introducer is designed to allow the dilator to be advanced over the guidewire into the vessel thus facilitating the introduction of the sheath into the vessel. This device design is such that after advancement into the vessel the dilator can be removed to allow access through the sheath of the customer's chosen device. For easy removal, the split sheath can be removed by breaking the hub and removing the two halves of the sheath while still within the vessel. The sheath hub is designed to snap cleanly. The sheath peels easily and evenly, thus reducing complications during the procedure.
INDICATIONS FOR USE: ડ.
This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS: 6.
Comparisons of the proposed and predicate devices show that the technological characteristics such as intended use, materials, kit components, performance characteristics and packaging are identical or substantially equivalent to the currently marketed predicate devices.
NONCLINICAL PERFORMANCE DATA: 7.
The Percutaneous Introducer and Kit was subjected to a full battery of performance testing including pre-determined acceptance criteria: As expected, the device met all acceptance criteria. The results of the performance testing (i.e., dimensional, tensile, radiopacity, corrosion resistance, leakage, etc.) demonstrate that these devices are substantially equivalent to the currently marketed predicate devices, adequately meets their intended use, and are acceptable for commercial distribution.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
February 21, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
Public Health Service
Teleflex Medical Dawn Moore, Regulatory Affairs Manager 50 Plantation Drive Jaffrey, NH 03452
Re: K123974
Trade/Device Name: Percutaneous Introducer Kit Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer. Catheter Regulatory Class: Class II Product Code: DYB Dated: December 20, 2012 Received: December 26, 2012
Dear Ms. Moore:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,
Matthew G. Hillebrenner
for
Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K123974
Device Name: Percutaneous Introducer and Kit
Indications for Use:
This product is to assist in the introduction of diagnostic or therapeutic devices into a vessel.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Matthew @ @ @ lebrenner
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