(79 days)
Not Found
No
The summary describes a mechanical introducer sheath and dilator with a hydrophilic coating and hemostatic valve. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical and mechanical properties.
No.
This device is an introducer sheath intended to provide a conduit for other diagnostic or interventional devices, not to treat a medical condition itself.
No
The device is an introducer sheath, which provides a conduit for the introduction of other devices, including diagnostic devices, but it is not itself a diagnostic device.
No
The device description clearly outlines physical, disposable components (introducer sheath, dilator) and describes bench testing of physical and performance specifications, 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 clearly states that the device 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." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details a physical introducer sheath and dilator designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the FlexSeal Introducer Sheath with Hydrophilic Coating is an invasive medical device used in interventional procedures, not an IVD.
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
DYB
Device Description
The FlexSeal Introducer set contains the following disposable components:
- One sterile introducer sheath with an active spring loaded hemostatic valve
- One sterile radiopaque dilator
The FlexSeal Introducer set consists of an introducer sheath with hydrophilic coating and a dilator. The device size is 21Fr with a 56 cm shaft. An active hemostatic valve is integrated into the sheath. A Ring Lock at the proximal end of the device assists with the control of the hemostatic valve.
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
The FlexSeal has been tested to meet the device intended use and to ensure conformance to the product specifications.
The FlexSeal has been tested and meets all its physical and performance specifications on the bench including:
- Visual surface inspection
- Dimensions
- Guidewire compatibility
- Leakage
- Kink resistance
- Bond tensile strength
- Hydrophilic coating integrity
- Luer compliance
- Cracking pressure
- USP particulate test
- Packaging tests
- Distribution tests
- Simulated Use
- Shelf Life Testing
The following tests were leveraged from the predicate device:
- Radiopacity
- Dilator hub dimensions
- Corrosion
In addition, the FlexSeal 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 30, 2019
Freudenberg Medical MIS, Inc % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K190628
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: May 21, 2019 Received: May 22, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Kenneth Cavanaugh Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190628
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) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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3
1 510(K) SUMMARY
ADMINISTRATIVE INFORMATION 1.1
May 29th, 2019 Date of Summary Preparation:
1.2 CONTACT INFORMATION
| Primary Submission Contact | Ming Cheng Chew
Regulatory Consultant,
Libra Medical Inc.
Tel: 763-232-3701
Email: mcchew@libramed.com |
|------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Secondary Submission Contact | Sew-Wah Tay, PhD
Regulatory Consultant,
Libra Medical Inc.
Tel: 612-801-6782 |
Sponsor Larry Bender Freudenberg Medical MIS, Inc 2301 Centennial Boulevard Jeffersonville, Indiana 47130 Tel: 812-280-2354 Email: Larry.Bender@freudenbergmedical.com
Email: swtay@libramed.com
1.3 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 |
| Previous Submissions | None |
1.4 510(K) TYPE AND REASON FOR SUBMISSION
This 510(k) is a special 510(k) and is submitted to obtain marketing clearance for a line extension of the FlexSeal device family.
4
1.5 PREDICATE DEVICE
The FlexSeal Introducer Sheath with Hyrdophilic Coating is substantially equivalent to the FlexSeal Introducer Sheath with Hydrophilic Coating devices (K161659).
1.6 DEVICE DESCRIPTION
The FlexSeal Introducer set contains the following disposable components:
- One sterile introducer sheath with an active spring loaded hemostatic valve ●
- One sterile radiopaque dilator
The FlexSeal Introducer set consists of an introducer sheath with hydrophilic coating and a dilator. The device size is 21Fr with a 56 cm shaft. An active hemostatic valve is integrated into the sheath. A Ring Lock at the proximal end of the device assists with the control of the hemostatic valve.
1.7 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.
1.8 TECHNOLOGICAL CHARACTERISTICS
The sheath shaft's external surface has a hydrophilic coating to facilitate introduction into the cardiovascular system. The introducer sheath has a tapered leading tip and a marker band within the tip for visualization. Proximal to the shaft is a housing that contains an extension tube with a 3-way stopcock. The hub is an active valve which can be manually open for device introduction to provide hemostasis and minimize blood loss. These features are the same as the predicate.
The dilator has a tapered distal tip. Its lumen is compatible with a 0.035" guidewire. This is the same as the predicate.
The Ring Lock at the proximal end of the hub allows the user to keep the valve in partially open positions without the need to manually hold the valve open. This feature is not present on the predicate, but does not change the function of the device. The Ring Lock is an extra feature to assist the physician when using the device, but if it is not engaged, the device still functions the same as the predicate device.
1.9 PERFORMANCE DATA
The FlexSeal has been tested to meet the device intended use and to ensure conformance to the product specifications.
The FlexSeal has been tested and meets all its physical and performance specifications on the bench including:
- Visual surface inspection .
- Dimensions .
5
- Guidewire compatibility ●
- . Leakage
- Kink resistance ●
- Bond tensile strength ●
- Hydrophilic coating integrity ●
- Luer compliance ●
- Cracking pressure ●
- USP particulate test ●
- Packaging tests
- Distribution tests
- Simulated Use
- Shelf Life Testing
The following tests were leveraged from the predicate device:
- Radiopacity ●
- Dilator hub dimensions ●
- Corrosion ●
In addition, the FlexSeal was tested for biocompatibility per ISO 10993-1 for short duration contact with circulating blood (