(29 days)
Not Found
No
The description focuses on the physical components and performance characteristics of a standard introducer sheath, with no mention of AI or ML capabilities.
No
The device is an introducer sheath designed to provide a conduit for the introduction of other diagnostic or interventional devices, not to directly treat a medical condition.
No
The device is an introducer sheath intended to provide a conduit for the introduction of other devices, including diagnostic devices, but it is not itself a diagnostic device.
No
The device description explicitly lists physical, disposable components (introducer sheath, dilator) and describes physical performance testing (dimensions, kink resistance, bond tensile strength, etc.), indicating it is a hardware device.
No, 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 FlexSeal™ Introducer Sheath is a medical device used in vivo (within the body) to facilitate the introduction of other devices into the peripheral vasculature. It acts as a conduit and helps minimize blood loss during procedures.
- Lack of Diagnostic Testing: The description clearly states its purpose is to provide access for diagnostic or interventional devices, not to perform a diagnostic test itself on a sample. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, based on the intended use and device description, the FlexSeal™ Introducer Sheath is a medical device used for procedural access, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The FlexSeal™ Introducer Sheath with Hydrophilic Coating contains the following disposable components:
- o One sterile introducer sheath with an active spring loaded hemostatic valve
- o One sterile radiopaque dilator
The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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)
The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested to meet the device intended use and to ensure conformance to the product specifications.
The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested and meets all its physical and performance specifications on the bench including:
- Visual surface inspection
- Dimensions ●
- Radioapacity visualization o
- Guidewire compatibility ●
- Hemostasis valve leakage ●
- Kink resistance ●
- Bond tensile strength ●
- Hydrophilic coating integrity ●
- Luer compliance ●
- Cracking pressure ●
- USP particulate test
- Packaging tests ●
- Distribution tests ●
- Usability studies
In addition, the FlexSeal™ Introducer Sheath with Hydrophilic Coating was tested for biocompatibility per ISO 10993-1 for short duration contact with circulating blood (
§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2016
Libra Medical Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K161659
Trade/Device Name: FlexSeal Introducer Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 14, 2016 Received: June 16, 2016
Dear Mark 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. 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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Brian D. Pullin -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K161659
Device Name
FlexSealTM Introducer Sheath with Hydrophilic Coating.
Indications for Use (Describe)
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY 1
ADMINISTRATIVE INFORMATION 1.1
Date of Summary Preparation: July 15, 2016
1.2 NAME/ADDRESS OF SPONSOR
Belinda Jackson Freudenberg Medical MIS, Inc 2301 Centennial Boulevard Jeffersonville, Indiana 47130 Tel: 805-576-5308 Fax: 812-280-2325 Email: Belinda.Jackson@freudenbergmedical.com
1.3 CONTACT INFORMATION
| Primary Submission Contact | Sew-Wah Tay, PhD
Regulatory Consultant,
Libra Medical Inc. |
|------------------------------|------------------------------------------------------------------|
| Secondary Submission Contact | Ming-Cheng Chew
Regulatory Consultant, |
1.4 DEVICE INFORMATION
| Trade Name | FlexSeal™ Introducer Sheath with Hydrophilic
Coating |
|---------------------------|---------------------------------------------------------|
| Common Name | Introducer Sheath |
| Classification Name | Catheter Introducer |
| Classification Regulation | 870.1340 |
| Class | II |
| Panel | Cardiovascular |
| Product Code | DYB |
Libra Medical Inc.
1.5 510(K) TYPE AND REASON FOR SUBMISSION
This 510(k) is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the FlexSeal™ Introducer Sheath with Hydrophilic Coating.
1.6 PREDICATE DEVICE
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is substantially equivalent to the DrySeal devices (K121234).
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1.7 DEVICE DESCRIPTION
The FlexSeal™ Introducer Sheath with Hydrophilic Coating contains the following disposable components:
- o One sterile introducer sheath with an active spring loaded hemostatic valve
- o One sterile radiopaque dilator
The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.
1.8 INDICATIONS FOR USE
The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions.
1.9 TECHNOLOGICAL CHARACTERISTICS
The sheath shaft's is radiopaque and its external surface has a hydrophilic coating to facilitate introduction into the cardiovascular system. The introducer sheath is radiopaque and has a tapered leading tip and a marker band within the tip for visualization.
The distal end of the sheath features a platinum/iridium radiopaque marker for visualization under fluoroscopy. Proximal to the shaft is a housing that contains an extension tube with a 3way stopcock. The hub is an active valve which can be manually open for device introduction to provide hemostasis and minimize blood loss. The dilator is radiopaque with a tapered distal tip. It's lumen is compatible with a 0.035" guidewire.
The technological characteristics of the device is similar to the predicate device. Both device are introducer sheaths with radiopaque shaft with hydrophilic coating and a hemostatic valve designed specifically to minimize blood loss. The design of the hemostatic valves are different but this difference does not affect the safety or efficacy of the device.
1.10 PERFORMANCE DATA
The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested to meet the device intended use and to ensure conformance to the product specifications.
The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested and meets all its physical and performance specifications on the bench including:
- Visual surface inspection
- Dimensions ●
- Radioapacity visualization o
- Guidewire compatibility ●
- Hemostasis valve leakage ●
5
- Kink resistance ●
- Bond tensile strength ●
- Hydrophilic coating integrity ●
- Luer compliance ●
- Cracking pressure ●
- USP particulate test
- Packaging tests ●
- Distribution tests ●
- Usability studies
In addition, the FlexSeal™ Introducer Sheath with Hydrophilic Coating was tested for biocompatibility per ISO 10993-1 for short duration contact with circulating blood (