(349 days)
K110386 – CELOX Rapid Z-Fold Gauze
No
The device description and performance studies focus on the physical and chemical properties of a hemostatic dressing, with no mention of AI or ML.
Yes
The device is indicated for the "local management and control of surface bleeding," which describes a therapeutic action.
No
Explanation: The device, OMNI-STAT Vascular Rapid, is a hemostatic dressing/pad designed to control surface bleeding. Its intended action is to create a physical barrier or plug to stop the flow of blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "chitosan-based hemostatic dressing/ pad" and describes its physical components and mechanism of action as a physical barrier. There is no mention of software as part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes". This describes a device used on the body to control bleeding, not a device used to test samples from the body to diagnose a condition.
- Device Description: The description details a "chitosan-based hemostatic dressing/ pad" that works by creating a "physical barrier or plug to stop the flow of blood". This is a mechanical action to control bleeding, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OMNI-STAT Vascular Rapid is intended to control surface bleeding from vascular access sites.
OMNI-STAT Vascular Rapid / CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French.
Product codes (comma separated list FDA assigned to the subject device)
QSY, FRO
Device Description
OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved.
OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vascular access sites
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)
Bench testing was conducted on the subject device and its packaging, evaluating main performance characteristics.
The performance of the OMNI-STAT Vascular Rapid was analyzed against the predicate device, CELOX Vascular, through the following comparison tests:
- Tack Adhesion
- Absorbency
- Wet Tensile Strength and Elongation
- Dimension
- Packaging Integrity & Strength
"All testing completed on both the subject device and predicate devices meet the defined criteria."
Pre-clinical testing was not deemed necessary for substantial equivalence.
Testing in porcine bleeding models was performed for the predicate devices CELOX Vascular and CELOX Rapid Gauze. The results "demonstrate that they both support the claim with regards to the control of bleeding and hemostasis being achieved."
Biocompatibility was assessed through a toxicology risk assessment and data from CELOX Vascular and CELOX Rapid Gauze, in compliance with ISO 10993-1.
Sterilization validation was assessed and evaluated in compliance with ISO 11137-1. Sterilization dose audits were carried out using VDmax25 as defined in standard ISO 11137-1.
The biocompatibility and non-clinical performance evaluations demonstrated adequacy to support substantial equivalence to the original unmodified CELOX Vascular predicate device for the intended indications of use.
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.
K093519 – CELOX Vascular
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.
K110386 – CELOX Rapid Z-Fold Gauze
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
N/A
0
Image /page/0/Picture/0 description: The image shows the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
April 21, 2023
Medtrade Product Ltd Mina Patel Regulatory Affairs Manager Electra House, Electra way, Crewe Business Park Crewe. Cheshire CW1 6GL United Kingdom
Re: K190012 Trade/Device Name: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid Regulatory Class: Unclassified Product Code: QSY
Dear Mina Patel:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 18, 2019. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov.
Sincerely,
Julie A. Morabito -S
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 18, 2019
Medtrade Product Ltd Mina Patel Regulatory Affairs Manager Electra House, Electra way, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Re: K190012
Trade/Device Name: OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid Regulatory Class: Unclassified Product Code: FRO Dated: November 15, 2019 Received: November 18, 2019
Dear Mina Patel:
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.
2
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
Lixin Liu -S
Kimberly Ferlin, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name:
OMNI-STAT Vascular Rapid
CELOX Vascular Rapid
Indications for Use (Describe)
OMNI-STAT Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French
CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, perculaneous catheters or tubes utilizing introducer sheaths up to 16French
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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SECTION 5
510(k) SUMMARY
This Traditional 510(k) Premarket Notification is to provide the basis for determining substantial equivalence of the Medtrade Products Ltd OMNI-STAT® Vascular Rapid to the predicate device presented below. The 510(k) # given is K190012.
| Submitted by: | Medtrade Product Ltd
Electra House, Crewe Business Park
Crewe, Cheshire
CW1 6GL
United Kingdom |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No.: | 9614493 |
| Contact: | Ms Mina Patel
Regulatory Affairs Manager
Medtrade Product Ltd
Electra House, Crewe Business Park
Crewe, Cheshire
CW1 6GL
United Kingdom
Telephone: + 44 (0)1270 500019
Facsimile: + 44 (0)1270 500045
Email: mina.patel@medtrade.co.uk |
| | |
| Date prepared: | 18th Dec 2019 |
| Device Identification: | |
| Device Name: | OMNI-STAT® Vascular Rapid |
| Common Name: | Dressing - Vascular Closure |
| Trade/Proprietary Names: | OMNI-STAT® Vascular Rapid,
CELOX™ Vascular Rapid |
| Model Number: | FG08834311 Size: 2in x 2in / 51mm x 51mm |
| Product Code: | FRO |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified |
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Predicate Device
510(K) number K093519 – CELOX Vascular
Reference Device
510(K) number K110386 – CELOX Rapid Z-Fold Gauze
Device Description:
OMNI-STAT Vascular Rapid is a chitosan-based hemostatic dressing/ pad presented in a sealed foil pouch, consisting of hemostatic granules with a bioadhesive bonded to one side of non-woven gauze and with a PU foam film backing on the other side of the gauze. The dressing is designed to control surface bleeding from vascular access sites. The granules coated side is applied directly to the access site and pressure applied until hemostasis is achieved.
OMNI-STAT Vascular Rapid achieves its principle intended action (hemostasis) by creating a physical barrier or plug to stop the flow of blood. The granules coated sides is applied directly to the access site and the point of compression, while the sheath is still in place. When the sheath is removed, and the product comes into contact with blood, with pressure applied OMNI-STAT Vascular Rapid with the bio-adhesive quickly forms a gel like plug absorbing the water from the blood.
Intended Use
OMNI-STAT Vascular Rapid in intended to control surface bleeding from vascular access sites.
Indications for use:
OMNI-STAT Vascular Rapid / CELOX Vascular Rapid is indicated for the local management and control of surface bleeding from vascular access sites, percutaneous catheters or tubes utilizing introducer sheaths up to 16French.
Comparison of technological characteristics with the predicate device:
The technological characteristics of both the OMNI-STAT Vascular Rapid and the predicate device, CELOX Vascular are described in the following table:
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| Category | OMNI-STAT Vascular Rapid
Subject Device
#K190012 | CELOX Vascular
Predicate Device
#K093519 |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | OMNI-STAT Vascular Rapid is a
chitosan-based hemostatic
dressing/ pad presented in a
sealed foil pouch, consisting of
hemostatic granules with a bio-
adhesive bonded to one side a
non-woven base gauze and with
a PU foam film backing the
other side of the gauze.
OMNI-STAT Vascular Rapid
achieves its principle intended
action (hemostasis) by creating
a physical barrier or plug to stop
the flow of blood. The granules
coated sides is applied directly
to the access site and the point
of compression, while the
sheath is still in place. When the
sheath is removed, and the
product comes into contact with
blood, with pressure applied
OMNI-STAT Vascular Rapid
with the bio-adhesive quickly
forms a gel like plug absorbing
the water from the blood. | CELOX Vascular is a chitosan-
based hemostatic dressing/
pad presented in a sealed foil
pouch, consisting of
hemostatic granules bonded to
one side a non-woven gauze
and with a PU foam film
backing the other side of the
gauze.
CELOX Vascular achieves its
principle intended action
(hemostasis) by creating a
physical barrier or plug to stop
the flow of blood. The granules
coated sides is applied directly
to the access site and the
point of compression, while the
sheath is still in place. When
the sheath is removed, and the
product comes into contact
with blood, with pressure
applied CELOX Vascular
quickly forms a gel like plug
absorbing the water from the
blood. |
| Material/
chemical
Composition | A chitosan-based hemostatic
granules coated dressing/pad,
with a bio-adhesive and PU
foam film backing | A chitosan-based hemostatic
granules coated dressing/pad
and PU foam film backing |
| Indications
for Use
(Prescription
/Rx only) | OMNI-STAT Vascular Rapid is
indicated for the local
management and control of
surface bleeding from vascular
access sites, percutaneous
catheters or tubes utilizing
introducer sheaths up to
16French | CELOX Vascular is indicated
for the local management and
control of surface bleeding
from vascular access sites,
percutaneous catheters or
tubes utilizing introducer
sheaths up to 16French |
| Category | OMNI-STAT Vascular Rapid
Subject Device
#K190012 | CELOX Vascular
Predicate Device
#K093519 |
| For single use | Yes | Yes |
| For prescription
use
(Rx only) | Yes | Yes |
| Method of
sterilisation | Gamma Irradiation in
accordance with ISO 11137 | Gamma Irradiation in
accordance with ISO 11137 |
| Sterility
assurance level | Achieve Sterility Assurance
10-6 | Achieve Sterility Assurance
10-6 |
| Shelf-life | 3 Years based on predicate
stability data | 5 Years |
| Biocompatibility
testing
completed in
accordance with
ISO 10993 | No testing was carried out on
subject device;
biocompatibility profile was
established based on
toxicology risk assessment
and data from CELOX
Vascular and CELOX Rapid
Gauze. | Yes |
7
Both the OMNI-STAT Vascular Rapid and the predicate device CELOX Vascular are composed of the same raw materials besides in addition of a bio-adhesive in OMNI-STAT Vascular Rapid. This leads to OMNI-STAT Vascular Rapid having a slightly better adhesion profile than CELOX Vascular.
Legally marketed device(s) for substantial equivalence comparison:
The OMNI-STAT® Vascular Rapid is a modification to an existing device cleared in K093519 CELOX™ Vascular on 14th Jan 2010 with the addition of granules used in CELOX™ Rapid Gauze cleared in K110386 on 10th May 2011.
The reason for the modification and key benefit of OMNI-STAT Vascular Rapid to CELOX™ Vascular is the enhanced adhesion profile achieved with the addition of a bio-adhesive.
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Performance Data
Non-Clinical Performance Data:
The following performance data was carried out in line with Medtrade products Ltd Design Control process in support of the substantial equivalence for the modified device:
Bench testing of OMNI-STAT Vascular Rapid - the subject device and its packaging was conducted on all of the main performance characteristics. The performance of the OMNI-STAT Vascular Rapid was also analysed in bench testing against the predicate device, CELOX Vascular. The following comparison tests were performed:
- Tack Adhesion 1)
-
- Absorbency
- Wet Tensile Strength and Elongation 3)
- Dimension 4)
- Packaging Integrity & Strength 5)
All testing completed on both the subject device and predicate devices meet the defined criteria.
No additional pre-clinical testing was deemed necessary to support substantial equivalence between the OMNI-STAT Vascular Rapid and the cleared predicate device. Testing in porcine bleeding models was performed for both the predicate devices CELOX Vascular and CELOX Rapid Gauze. The results demonstrate that they both support the claim with regards to the control of bleeding and hemostasis being achieved.
The biocompatibility of the OMNI-STAT Vascular Rapid has been assessed and a rationale compiled stating the device is deemed in compliance with the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices) based on toxicology risk assessment and data from the predicate device CELOX Vascular and the reference device CELOX Rapid Gauze.
Sterilization validation has been assessed and evaluated in compliance with ISO 11137-1 - Sterilization of healthcare products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices.
Sterilisation dose audits are carried out using VDmax25 as defined in standard ISO 11137-1.
The biocompatibility and non-clinical performance evaluations carried out for OMNI-STAT Vascular Rapid has demonstrated that they were adequate to
9
support determination of substantial equivalent to the original unmodified CELOX Vascular predicate device for the intended indications of use.
Summary Statement of Substantial Equivalence:
The OMNI-STAT Vascular Rapid device is similar in composition to predicate device CELOX Vascular cleared under K093519 on Jan 14, 2010 with the addition of CELOX Rapid Granules used in CELOX Rapid Gauze cleared under K110386 on May 10, 2011 both of which are manufactured by Medtrade Products Ltd. The intended use and indications of use of the two devices (subject and predicate) are identical for the subject device OMNI-STAT Vascular Rapid and the predicate device CELOX Vascular and the above data demonstrating that the subject device is substantially equivalent to the predicate device CELOX Vascular.