(25 days)
No
The device description and performance studies focus on mechanical properties and functionality related to catheter placement and support, with no mention of AI or ML.
No.
The device facilitates the placement of other catheters and provides support, but it does not directly treat a disease or condition.
No
The device, Glidesheath, is used to facilitate the placement of a catheter into a vein or artery and to provide support. It is an access and support device, not one that gathers information about a patient's medical condition. Fluoroscopy is mentioned but it's for visualizing the device, not for diagnostic purposes.
No
The device description clearly outlines physical components like sheaths, dilators, guide wires, syringes, and scalpels, and the performance studies focus on physical properties and mechanical testing. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Glidesheath and its accessories are used to facilitate the placement of catheters directly into a vein or artery within the patient's body. This is an invasive procedure performed in vivo (within a living organism).
- No Sample Analysis: There is no mention of analyzing any biological samples taken from the patient. The device's purpose is to aid in accessing the vascular system for other procedures (like inserting a catheter).
The device is a medical device used for vascular access, not for diagnostic testing of biological samples.
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 (comma separated list FDA assigned to the subject device)
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 mini guide wire is available in a stainless steel or a nickel-titanium alloy polyurethane coated configuration. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The A kit also contains a Surflo IV catheter, 2.5ml syringe, and scalpel for use in priming the system and gaining initial access to the vessel. Once access is obtained, the Mini Guide Wire is inserted through the cannula which was 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 Ditator 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (Glidesheath).
- 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.
Therefore the performance of the modified Glidesheath is substantially equivalent to the performance of the predicate device the Glidesheath which was cleared under K033681.
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.
K863138, K891087, K771205, K954234
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).
0
Kob2858
OCT 2 0 2006
SECTION II. 510(K) SUMMARY
A. Device Name
| 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 predicate device, Glidesheath K033681.
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 mini guide wire is available in a stainless steel or a nickel-titanium alloy polyurethane coated configuration. The Inserter does not contact blood and is used strictly for guiding the Guide Wire into a cannula or Introducer.
The A kit also contains a Surflo IV catheter, 2.5ml syringe, and scalpel for use in priming the system and gaining initial access to the vessel. Once access is obtained, the Mini Guide Wire is inserted through the cannula which was 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 Ditator 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
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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.
D. Principle Of Operation / Technology
The Glidesheath and its accessories are operated manually or by a manual process.
E. Design / Materials
Differences in materials between the modified device and the predicate device the Glidesheath cleared under K033681 raise no new issues of safety and effectiveness.
F. Specifications
| Part | Modified Glidesheath | Glidesheath cleared under
K033681 |
|-------------------------------------|----------------------------------------------------------------------------|--------------------------------------|
| Introducer Sheath
Size
Length | 4, 5 & 6 French
10-25 cm | 5 & 6 French
10-25 cm |
| Dilator
Length | 15.5 – 30.5 cm | 15.5 – 30.5 cm |
| Guide Wire OD | 0.021" – 0.038" | 0.021" – 0.038" |
| Guide Wire
Configurations | Stainless Steel or
Nickel-Titanium alloy
coated with
Polyurethane | Stainless Steel |
| Accessory Devices | Obturator
Surflo IV catheter
Scalpel
2.5 ml Syringe | Obturator |
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G. Performance
The Glidesheath is comprised of an introducer sheath and a dilator. Only the introducer sheath was modified. The dilator was not modified. The nitinol mini guidewire is the same guidewire as the one cleared under K863138. The Surflow IV catheter (cleared under K891087), Syringe (cleared under K771205), and the RADIFOCUS Obturator (cleared under K954234) have not been modified. The scalpel is a class I exempted devices.
The following verification tests were performed to demonstrate the substantial equivalence of the modified device (Glidesheath) to the unmodified device (Glidesheath).
- 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.
Therefore the performance of the modified Glidesheath is substantially equivalent to the performance of the predicate device the Glidesheath which was cleared under K033681.
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.
3
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 10-6
H. Substantial Equivalence
The modified Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Glidesheath, cleared under K033681. Differences between the two devices do not raise any significant issues of safety or effectiveness.
I. Submitter Information
| Prepared By: | Mr. Mark Unterreiner
Sr. Regulatory Affairs Specialist |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared For: | Terumo Medical Corporation
950 Elkton Blvd.
Elkton, MD 21921
Phone: (410) 392-7213
Fax: (410) 398-6079
Email: mark.unterreiner@terumomedical.com |
| Date Prepared: | September 22, 2006 |
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 2006
Terumo Medical Corporation c/o Mr. Mark Unterreiner Sr. Regulatory Affairs Specialist 950 Elkton Boulevard Elkton, MD 21921
Re:
K062858 Glidesheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II (two) Product Code: DYB Dated: September 22, 2006 Received: September 25, 2006
Dear Mr. Unterreiner:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Mark Unterreiner
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 that I Dr Has Intal that the and regulations administered by other Federal agencies. You must or any I subtat Uthe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Erth 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. 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 promated predicate device results in a classification 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. bohner
Image /page/5/Picture/5 description: The image shows a stylized signature. The signature appears to be a combination of cursive letters, possibly an 'S' and an 'M' or 'N', connected in a fluid, looping manner. The overall impression is that of a quick, stylized autograph.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
1062858 510(k) Number (if known):_
Glidesheath Device Name:
Indications For Use:
The Glidesheath is used to facilitate placing a catheter through the skin into a The Oldesheath to accure is an accessory device which is used for vem of artery. The sheath into the vein or artery. The RADIFOCUS Obturator is placement of the onealin intolicy is used by placing it into the sheath to create an also an accessory actrise who whe support to the indwelling sheath while it occlusion and farther promise in or artery after removal of a catheter.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please Do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duna R. Vochner
(Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
10/ki Number_4062 858
00004