(7 days)
Not Found
No
The device description and intended use focus on physical components and their function in facilitating catheter placement. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device facilitates placing a catheter and supporting the sheath, but it does not treat a disease or condition itself.
No
The device description clearly states its purpose is to "facilitate placing a catheter through the skin into a vein or artery." It does not mention any function for detecting, diagnosing, or monitoring medical conditions. It is an access and support device for other instruments.
No
The device description clearly outlines physical components like a sheath, dilator, guide wire, and obturator, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to facilitate placing a catheter through the skin into a vein or artery. This is a direct intervention on the patient's body for access, not for examining specimens in vitro (outside the body).
- Device Description: The description details the physical components (sheath, dilator, guide wire, obturator) and how they are used to access blood vessels. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using reagents or assays.
The device is a medical device used for vascular access, which is a procedural tool, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial 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 indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial 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 coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. 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 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, including but not limited to the radial artery, after removal of a catheter. The Obturator is sold separately.
The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
Accessories to the Glidesheath are the mini guide wire, Surflo IV catheter, Syringe, and Scalpel, and the RADIFOCUS Obturator. Depending on the product code, these accessories may or may not be contained within the kit. All of the accessories are packaged with the Glidesheath in a pouch prior to sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
vein or artery including but not limited to the radial 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)
A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the Glidesheath is substantially equivalent to the performance of the Glidesheath cleared under K062858 and the Cordis Avanti™ cleared under K962746.
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).
0
Korzuyy
SEP 1 8 2008
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 including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial 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, including but not limited to the radial artery, after removal of a catheter.
C. Device Description
The Glidesheath is comprised of an introducer sheath and a dilator. The Glidesheath is coated with a hydrophilic coating to reduce the frictional resistance of the sheath when inserting or removing the sheath from the patient's blood vessel. The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial artery. 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.
1
The 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, including but not limited to the radial artery, after removal of a catheter. The Obturator is sold separately.
The Sheath, Dilator and Obturator contain bismuth, making these devices visible under fluoroscopy.
Accessories to the Glidesheath are the mini guide wire, Surflo IV catheter, Syringe, and Scalpel, and the RADIFOCUS Obturator. Depending on the product code, these accessories may or may not be contained within the kit. All of the accessories are packaged with the Glidesheath in a pouch prior to sterilization.
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 K062858 and the Cordis Avanti™ cleared under K962746 raise no new issues of safety and effectiveness.
F. Specifications
| Sheath Sizes: | 4, 5 & 6 French |
|---|---|
| Sheath Length: | 10-25 cm |
| Dilator Length: | 15.5 - 30.5 cm |
| Guide Wire OD: | 0.021"-0.038" |
| 10 - 180cm | |
| Surflo IV Catheter: | 16G-22G |
| 1" – 2.5" length |
Hydrophilic Coating: 10-25cm (entire length of Sheath)
2
G. Performance
A risk/hazard analysis was conducted according to EN ISO 14971 Medical Devices -Application of risk management to medical devices. Performance characteristics for this new indication for use were determined. Then it was justified that the performance of the Glidesheath is substantially equivalent to the performance of the Glidesheath cleared under K062858 and the Cordis Avanti™ cleared under K962746.
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 EN ISO 11135-1, Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 10-6.
Substantial Equivalence H.
The Glidesheath is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the predicate device the Glidesheath, cleared under K062858 and the Cordis Avanti™ cleared under K962746. Differences between the devices do not raise any significant issues of safety or effectiveness.
3
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: | August 21, 2008 |
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 8 2008
Terumo Corporation c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Rc: K082644 Glidesheath Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Introducer Regulatory Class: Class II Product Code: DYB Dated: September 10, 2008 Received: September 11, 2008
Dear Mr. Job:
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.
5
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 marketed 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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. Vuhmer
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
| 510(k) Number (if known): | K082644 |
|---|---|
| Device Name: | Glidesheath™ |
Indications For Use:
The Glidesheath is used to facilitate placing a catheter through the skin into a vein or artery including but not limited to the radial artery.
The Mini Guide Wire is an accessory device which is used for placement of the sheath into the vein or artery including but not limited to the radial 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 indwelling sheath while it remains in place within the vein or artery, including but not limited to the radial 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)
uma P. Vachner
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_Ko 8 264 4