(17 days)
No
The device description and performance studies focus on mechanical properties and functionality for catheter placement, with no mention of AI or ML.
No.
The device (Glidesheath) is used to facilitate the placement of a catheter, but it does not directly treat or diagnose a disease or condition. It is an access device, not a therapeutic one.
No
The device is explicitly described as being used to facilitate the placement of a catheter, which is an interventional or therapeutic function, not a diagnostic one. While it is visible under fluoroscopy (an imaging modality), its purpose is not to gather diagnostic information about a patient's condition.
No
The device description clearly outlines physical components (introducer sheath, dilator, mini guide wire, obturator) made of materials like bismuth, and describes their physical interaction with the body (insertion into veins/arteries). 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:
- Intended Use: The intended use is to facilitate the placement of a catheter into a vein or artery. This is a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device components (sheath, dilator, guide wire, obturator) are all designed for physical insertion into the body to aid in a medical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze a sample (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties and functionality of the device for insertion and support, not on the accuracy or reliability of any diagnostic measurements.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly operates in vivo (within the body) to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
Product codes
74 DYB
Device Description
The Glidesheath is comprised of an introducer sheath and a dilator.
The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The Inserter docs not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The Obturator also provides support to the indwelling Sheath after the catheter is removed.
The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vein or artery
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
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (RADIFOCUS® Introducer II).
- Leakage/clogging.
- Tensile strength of connections.
- Separation force of dilator and sheath.
- Internal sliding resistance.
- External sliding resistance.
- Penetration force.
None of the data raises any new issues of safety and effectiveness. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Key Metrics
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
SECTION II. SUMMARY AND CERTIFICATION
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION PERTAINING TO SUBSTANTIAL EQUIVALENCE
Device Name A.
| Proprietary Name | Glidesheath |
|---|---|
| Classification Name | Introducer, Catheter |
| Common Name | Introducer Sheath |
B. Intended Use
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
Note: This is the same intended use as the RADIFOCUS® Introduccr II Kit , K954234.
C. Device Description
The Glidesheath is comprised of an introducer sheath and a dilator.
The Glidesheath is used to facilitate placement of a catheter through the skin into a vein or artery. A Mini Guide Wire (with Inserter) may be included with the Glidesheath. The Inserter docs not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The Mini Guide Wire is inserted through a cannula placed in the patient's blood vessel. The Glidesheath is then inserted over the Mini Guide Wire and into the blood vessel. The Mini Guide Wire is then withdrawn from the vessel. The Dilator maintains the integrity of the Sheath and dilates the blood vessel while the Glidesheath is being placed into the vessel. The Dilator can be removed and an appropriate catheter can then be inserted. The RADIFOCUS Obturator is an accessory device which creates an occlusion when inserted into the Sheath. The
1
Obturator also provides support to the indwelling Sheath after the catheter is removed.
The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
Principle Of Operation / Technology D.
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
The Glidesheath and its accessories are operated manually or by a manual process.
Design / Materials E.
Differences in materials between the Glidesheath and the RADIFOCUS® Introducer II Kit, K954234 raise no new issues of safety and effectiveness.
| Part | Glidesheath | RADIFOCUS® Introducer II,
K954234 |
|-------------------------------------|--------------------------|--------------------------------------|
| Introducer Sheath
Size
Length | 5 & 6 French
10-25 cm | 4 – 11 French
5 - 110 cm |
| Dilator
Length | 15.5 - 30.5 cm | 6 - 110 cm |
| Guide Wire OD | 0.021" – 0.038" | 0.021" – 0.038" |
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G. Performance
ﻧﮯ ﭘﺮ ﺳﻤ
The Glidesheath is comprised of an introducer sheath and a dilator. Only the introducer sheath was modified. The dilator was not modified.
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (RADIFOCUS® Introducer II).
- Leakage/clogging .
- Tensile strength of connections .
- Separation force of dilator and sheath .
- Internal sliding resistance .
- External sliding resistance .
- Penetration force .
None of the data raises any new issues of safety and effectivencss. Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness.
Therefore the performance of the Glidesheath is substantially equivalent to the performance of the RADIFOCUS® Introducer II, cleared under K954234.
H. Additional Safety Information
Manufacturing controls include visual, functional, dimensional and sterility tests.
Blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
The introducer sheath is classified as Externally Communicating Devices, Circulating Blood, Prolonged Contact (24 hrs to 30 days). Results of the testing demonstrate that the blood contacting materials are biocompatible.
Sterilization conditions have been validated in accordance with ANSI / AAMI / ISO 11135-1994, Medical Devices -- Validation and routine control of ethylene oxide sterilization and EN 550. The device is sterilized to a SAL of 106.
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I. Substantial Equivalence
The Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the RADIFOCUS® Introducer II, cleared under K954234. Differences between the two devices do not raise any significant issues of safety or effectiveness.
Submitter Information J.
| Prepared By: | Mr. Mark Unterreiner
Regulatory Affairs Specialist |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation
125 Blue Ball Road
Elkton, MD 21921
Phone: (410) 392-7213
Fax: (410) 398-6079
Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | November 21, 2003 |
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 1 2003
Mr. Mark Unterreiner Regulatory Affairs Specialist Terumo Medical Corporation 125 Blue Ball Road Elkton, MD 21921
K033681 Re: Trade Name: Glidesheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer. Regulatory Class: II Product Code: 74 DYB Dated: November 21, 2003 Received: November 23, 2003
Dear Mr. Unterreiner:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 3 iQ(x) premaince is substantially equivalent (for the indications
referenced above and have determined the device as againers in interstate referenced above and have detellimbed the devices marketed in interstate for use stated in the enclosure) to tegally markets the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment the of the Federal Food. Drug. commerce prior to May 28, 1976, the enactiven and of the Federal Food, Drug, devices that have been reclassined in accondice was are archarded application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approvate of the general controls provisions of the Act. The Act. The You may, therefore, market the device, subject to the general sommal registration, listing of
general controls provisions of the Act include requirements for amount misbrandi general controls provisions of the Act mender requirements on the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FDA may be subject to such additional controlis. Existing major regalato of the Marketion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 . In a be found in the Code of I cacral regarations, your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subscribed with other requirements of the Act
that FDA has made a determination that your device coderal econoise. You must that FDA has made a delerimilations administered by other Federal agencies. You must a or any Federal statutes and regulations and united to registration and listing (21
comply with all the Act's requirements, including, but not limited to: registration and lis comply with all the Act s requirements, meridants, out how man and one of the many of the many
5
Page 2 - Mr. Mark Unterreiner
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QD) regalantis (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premarked notification: "The PDF intrailigstification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific acrison. I for in vitro diagnostic devices), please contact the Office of additionally 21 Of I Creat 586. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639. Iffice of Compliance at (301) 594-4639. Also, please note the your de roo, prease ochabranding by reference to premarket notification" (21 CFR Part 807.97). Tegulation on thinked, "Thisorians on your responsibilities under the Act may be obtained from the Other general mionmation on Jose, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Jessa D. Harrison
Bram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Note: This is the same intended use as the predicate device, K954234
| 510(k) Number (if known): | K033681 |
|---|---|
| Device Name: | Glidesheath |
Indications For Use:
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery. The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery. The RADIFOCUS Obturator is also an accessory device which is used by placing it into the sheath to create an occlusion and further provide support to the wall of the indwelling sheath while it remains in place within the vein or artery after removal of a catheter.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Qlar 12/11/03
vision Sign-off Division of Cardio 510(K) Numbe
(Optional Format 1-2-96)