(210 days)
Not Found
No
The device description and performance studies focus on the physical properties and function of a vascular sheath and valve, with no mention of AI or ML algorithms for data analysis, image processing, or decision support.
No.
The device is an introducer sheath and dilator, used to provide a conduit for other endovascular devices. It does not treat a disease or condition itself.
No
The device is described as an introducer sheath intended to provide a conduit for other endovascular devices. Its function is to facilitate the insertion of medical devices, not to diagnose conditions. While it allows for identification under fluoroscopy, this is for positioning during a procedure, not for diagnostic purposes.
No
The device description clearly outlines physical components like a sheath, valve, dilator, and syringe, and the performance studies focus on physical properties and sterilization, indicating it is a hardware 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 provide a conduit for inserting endovascular devices into the vasculature and minimize blood loss. This is a procedural device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical device (sheath, valve, dilator, syringe) used for accessing and working within blood vessels.
- 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) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is clearly used in vivo to facilitate a medical procedure.
N/A
Intended Use / Indications for Use
The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The GORE® DrySeal Sheath consists of a hydrophilic coated introducer sheath with GORE® DrySeal Valve attached, a dilator, and a syringe.
The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.
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)
Substantial Equivalence: Documentation provided includes a detailed comparison which demonstrates that the proposed GORE® DrySeal Sheath hydrophilic coated introducer sheath is substantially equivalent to the predicate GORE® DrySeal Sheath cleared under K093791. A hydrophilic coating has been added to the GORE® DrySeal Sheath. No other changes were made to the introducer sheath, DrySeal Valve or dilator from that cleared under K093791.
Additionally, the following tests/evaluations were performed to confirm equivalence to the predicate device:
- Biocompatibility .
- Sterilization Validations .
- Packaging Integrity .
- Product Shelf-Life .
- Design Verification .
Key Results: The results demonstrate that the lubricity of the GORE® DrySeal Sheath with hydrophilic coating performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate device. Any differences in the technological characteristics do not raise any new issues of safety and efficacy. In terms of intended use, design, material composition and technological characteristics, the GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the 510(k) predicate device. The proposed device meets the performance criteria of design verification as specified by test protocols. The GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the predicate device.
Biocompatibility testing results (Pass/Fail):
- Cytotoxicity (MEM Assay (qualitative)): Pass
- Sensitization (Murine Local Lymph Node Assay): Pass
- Intracutaneous Reactivity (Intracutaneous Irritation Test): Pass
- Acute System Toxicity (Acute Systemic Study in Mice): Pass
- Hemocompatibility (Complement Activation, Hemolysis Assay, In vivo Thrombogensis, Prothrombin Time Assay): Pass
- Pyrogenicity (Rabbit Pyrogen Test): Pass
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
510(k) Premarket Notification GORE® DrySeal Sheath Conclusion (Statement of Equivalence)
510(K) SUMMARY
NOV 2 0 2012
Device Name:
Proprietary Name:
Common Name:
Classification Name:
Device Classification:
Product Code:
Date Summary Prepared:
Contact Person:
GORE® DrySeal Sheath with hydrophilic coating
GORE® DrySeal Sheath with hydrophilic coating
Introducer Sheath
Catheter, Introducer (per 870.1340)
Class II
DYB
April 17, 2012 October 5, 2012, revised
Alicia L. Hemphill, M.S., RAC
Regulatory Affairs Medical Products Division W. L. Gore & Associates, Inc. 3450 West Kiltie Lane Flagstaff, AZ 86002-0500
Telephone: (928) 864-4328 Facsimile: (928) 864-4304 E-mail: ahemphil@wlgore.com
1
Device Description
The GORE® DrySeal Sheath consists of a hydrophilic coated introducer sheath with GORE® DrySeal Valve attached, a dilator, and a syringe.
The introducer sheath is a polyethylene tube with a tapered leading tip and marker band incorporated within the sheath material to allow identification under fluoroscopy. The sheath has an insert molded hub on the trailing end, which is attached to the GORE® DrySeal Valve.
The GORE® DrySeal Valve is comprised of an outer silicone tube and an inner film tube. The region between the silicone tube and film tube is pressurized by injecting 2.5mL of saline into the space, using the provided syringe, during procedural preparation of the device.
The dilator has a tapered leading end and provides dilatation of the access vessel. A mark on the trailing end of the dilator ensures correct positioning of the dilator within the sheath.
Device Modification
A hydrophilic coating has been added to the GORE® DrySeal Sheath. No other changes were made to the proposed device from that cleared under K093791.
Predicate Devices
GORE® DrySeal Sheath with hydrophilic coating:
GORE® DrySeal Sheath (K093791)
Indications
The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
2
Biocompatibility
Results for all biocompatibility testing demonstrate that the materials used meet the requirements of ANSI/AAMI/ISO 10993.
| Test | Test Description | Result
(Pass/Fail) |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------|
| Cytotoxity
ISO 10993-5 | MEM Assay (qualitative) | Pass |
| 1Sensitization
ISO 10993-10 | Murine Local Lymph Node
Assay | Pass |
| Intracutaneous
Reactivity
ISO 10993-10 | Intracutaneous Irritation Test | Pass |
| Acute System Toxicity
ISO 10993-11
ISO 10993-12 | Acute Systemic Study in Mice | Pass |
| Hemocompatibility
ISO 10993-4
ISO 10993-12 | Complement Activation
Hemolysis Assay
In vivo Thrombogensis
Prothrombin Time Assay | Pass |
| Pyrogenicity
ISO 10993-11
ISO 10993-12 | Rabbit Pyrogen Test | Pass |
1 Additional Sensitization Testing Submitted September 18, 2012
Substantial Equivalence
GORE® DrySeal Sheath, W. L. Gore & Associates, K093791.
Documentation provided includes a detailed comparison which demonstrates that the proposed GORE® DrySeal Sheath hydrophilic coated introducer sheath is substantially equivalent to the predicate GORE® DrySeal Sheath cleared under K093791. A hydrophilic coating has been added to the GORE® DrySeal Sheath. No other changes were made to the introducer sheath, DrySeal Valve or dilator from that cleared under K093791.
Additionally, the following tests/evaluations were performed to confirm equivalence to the predicate device:
- Biocompatibility .
- Sterilization Validations .
- Packaging Integrity .
- Product Shelf-Life .
3
510(k) Premarket Notification GORE® DrySeal Sheath Conclusion (Statement of Equivalence)
- Design Verification .
Any differences in the technological characteristics do not raise any new issues of safety and efficacy.
The results demonstrate that the lubricity of the GORE® DrySeal Sheath with hydrophilic coating performs as designed, is suitable for its intended use, and that it is substantially equivalent to the predicate device.
Conclusion
Any differences in the technological characteristics do not raise any new issues of safety and efficacy. In terms of intended use, design, material composition and technological characteristics, the GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the 510(k) predicate device.
4
Testing in Support of Substantial Equivalence Determination
| Performance Testing | Applicable Test Standard |
|---|---|
| Lubricity | Comparative Analysis |
| Particulation | Comparative Analysis |
| Biocompatibility | ANSI/AAMI/ISO 10993-1 |
| Sterilization Validation | ANSI/AAMI/ISO 11135-1 |
| AAMI TIR 28 | |
| Product Expiration Dating | Gore Internal Procedures |
Conclusion
The proposed device meets the performance criteria of design verification as specified by test protocols. The GORE® DrySeal Sheath with hydrophilic coating is substantially equivalent to the predicate device.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of an abstract human figure with three flowing lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 2 0 2012
W.L. GORE & Associates, Inc. c/o Alicia L. Hemphill Regulatory Affairs Associate 3450 West Kiltie Lane Flagstaff, AZ 86001
Re: K121234
Trade/Device Name: GORE® DrySeal Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: November 13, 2012 Received: November 15, 2012
Dear Ms. Hemphill:
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
6
Page 2 - Ms. Alicia Hemphill
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
Digitally signed by Matthew G.
Hillebrenner
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People,
0.9.2342.19200300.100.1.1=1300213272,
cn=Matthew G. Hillebrenner
Date: 2012.11.20 10:48:56 -05'00'
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
510(k) Premarket Notification GORE® DrySeal Sheath Indication For Use
INDICATION FOR USE
510(k) Number (if known):
K121234 TBD
Device Name:
GORE® DrySeal Sheath with hydrophilic coating
Intended Use / Indication For Use:
The GORE® DrySeal Sheath with hydrophilic coating is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions.
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.S. Klleber
on of Cardiovascular Devices
510(k) Number K121234
Page 3 of 43