(108 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a peel-away sheath/dilator introducer, with no mention of AI or ML.
No
The device is described as an introducer for diagnostic or therapeutic devices, not a therapeutic device itself.
No
Explanation: The device is an introducer sheath and dilator, explicitly stated to be used for the percutaneous introduction of diagnostic or therapeutic devices, not as a diagnostic device itself.
No
The device description clearly outlines physical components made of polyethylene, including a sheath, dilator, and hubs, and describes bench testing related to physical properties like tensile strength and insertion force. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of diagnostic or therapeutic devices into the vasculature." This describes a device used in vivo (within the body) to facilitate the insertion of other devices.
- Device Description: The description details a physical introducer sheath and dilator designed for insertion into blood vessels. It focuses on the mechanical aspects of the device and its function in facilitating access to the vasculature.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis on biological specimens.
The device is clearly intended for direct use within the patient's body to aid in medical procedures, which is characteristic of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Product codes
DYB
Device Description
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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)
Bench testing performed on the GlideThru™ Peel-Away Sheath/Dilator Introducer demonstrates substantially equivalent functionality to the predicate device. The following performance testing has been completed for the subject device:
- Tensile testing
- Biocompatibility
- Sheath surface free from extraneous matter
- Radiodetectability
- Luer testing
- Simulated Use testing
- Penetration/Insertion force
The results of the comparison testing have demonstrated that the GlideThru is comparable to the predicate device in the following aspects: radiopacity, tensile strength, and penetration/insertion force.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
510(k) SUMMARY
JAN 4 2013
SUMMARY OF SUBSTANTIAL EQUIVALENCE FOR ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER
1. Submitter Information
| Name: | Arrow International, Inc. (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Julie Lawson |
| Regulatory Affairs Specialist | |
| Telephone Number: | (610) 378-0131 Extension 603256 |
| Fax Number: | (610) 478-3179 |
| Email: | julie.lawson@teleflex.com |
Date Prepared: January 3, 2012
2. Device Name
| Device Trade Name: | Arrow ® GlideThru™ Peel-Away Sheath/Dilator Introducer |
|---|---|
| Common Name: | Peel-Away Sheath/Dilator Introducer |
| Classification Name: | Class II, DYB, Introducer, Catheter, 21CFR 870.1340 |
3. Predicate Device
Xentech Medical, Inc. Tearaway Introducer Sheath (K000313)
4. Device Description
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is a single use introducer designed to facilitate insertion of a device into the vasculature. The Peel-Away Sheath/Dilator Introducer Assembly is a unit comprised of a peel-away sheath introducer and a dilator. The Peel-Away sheath has a non-tapered body with a tapered tip to provide a smooth transition from the dilator. The Peel-Away sheath is a radiopaque polyethylene extruded sheath body with a molded polyethylene hub. The hub is designed with wings and a thin-wall peel groove on both sides that facilitate splitting the hub and sheath after a catheter is placed through the sheath. The sheath hub is also designed to allow the dilator to lock into the sheath during the insertion procedure. The polyethylene dilator has a tapered tip and an ergonomic hub that locks into the sheath hub during the insertion procedure. The dilator hub also features a Luer lock connection on the proximal end. The Peel-Away sheath/dilator introducer is available in 3 Fr. - 7 Fr. configurations with usable lengths of 7 and 10 cm.
1
5. Intended Use
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
6. Technological Characteristics
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath (K000313) in terms of intended use, general design, and functional performance.
7. Nonclinical Testing
Bench testing performed on the GlideThru™ Peel-Away Sheath/Dilator Introducer demonstrates substantially equivalent functionality to the predicate device. The following performance testing has been completed for the subject device:
- Tensile testing o
- Biocompatibility o
- O Sheath surface free from extraneous matter
- Radiodetectability O
- Luer testing o
- Simulated Use testing O
- Penetration/Insertion force o
8. Conclusions
The subject device is similar in design and intended use to the predicate device. The results of the performance testing have demonstrated substantially equivalent functionality to the predicate device. The results of the comparison testing have demonstrated that the GlideThru is comparable to the predicate device in the following aspects: radiopacity, tensile strength, and penetration/insertion force. Any differences between the subject and predicate sheath introducers do not raise new issues of safety or effectiveness. The Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer is substantially equivalent to the Xentek Medical, Inc. Tearaway Introducer Sheath.
2
DEPARTMENT-OF-HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JAN 4 2013
Arrow® International, Inc. c/o Julie Lawson Regulatory Affairs Specialist Arrow® International, Inc 2400 Bernville Road Reading, PA 19605
Re: K122854
Trade/Device Name: Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer Arrow® Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology
Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II Product Code: DYB Dated: December 19, 2012 Received: December 20, 2012
Dear Ms. Lawson:
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
3
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 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 D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Kl22859
Device Name: Arrow GlideThru™ Peel-Away Sheath/Dilator Introducer
Indications for Use: -
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for the percutaneous introduction of diagnostic or therapeutic devices into the vasculature.
Indications for Use (JACC product):
The Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter™ with Chlorag ard® Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable JACC 100 may not exceed 300 psi. The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.
Chlorag ard Technology treatment on the external surface of the catheter body as well as the entire fluid pathway of the catheter has been shown to be effective in reducing microbial colonization on catheter surfaces. Antimicrobial effectiveness was evaluated using in vivo and in vivo test methods and no correlation between these testing methods and clinical outcome has currently been ascertained. It is not intended to be used for the treatment of existing infections.
Prescription Use x (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| (Division Sign-Off) Division of Cardiovascular Devices | |||
| 510(k) Number | K122854 |