(349 days)
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
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.
The provided document is a 510(k) summary for the OMNI-STAT Vascular Rapid device, asserting its substantial equivalence to a predicate device (CELOX Vascular). This type of submission focuses on demonstrating equivalence to an already legally marketed device rather than proving de novo safety and effectiveness through, for example, a clinical trial with specific acceptance criteria on performance metrics like sensitivity, specificity, and AUC, as one might see for an AI/ML medical device.
Therefore, the information typically found in acceptance criteria and study results for an AI/ML device (e.g., performance metrics, sample sizes for test/training sets, ground truth establishment with expert consensus, MRMC studies) is not present in this document because it is not relevant to a 510(k) submission for this type of device.
This document describes a physical hemostatic dressing, not an AI/ML device. The "performance data" section refers to bench testing (e.g., tack adhesion, absorbency, tensile strength, packaging integrity) and evaluations of biocompatibility and sterilization, all aimed at demonstrating the new device's similarity and acceptable performance compared to the predicate, especially given a minor modification (addition of a bio-adhesive).
To directly answer your request based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the format of strict numerical thresholds for parameters like sensitivity or specificity because it's not an AI/ML device with such performance metrics. Instead, "acceptance criteria" are implied by the comparative testing against the predicate device and relevant standards.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Bench Testing (Functionality) | - Tack Adhesion: Performed for both subject and predicate devices. OMNI-STAT Vascular Rapid "having a slightly better adhesion profile than CELOX Vascular." All testing on both devices "meet the defined criteria."- Absorbency: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."- Wet Tensile Strength and Elongation: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."- Dimension: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria."- Packaging Integrity & Strength: Performed for both subject and predicate devices. All testing on both devices "meet the defined criteria." |
| Biocompatibility | - ISO 10993-1 Compliance: No new testing was carried out on the subject device. Compliance was established based on "toxicology risk assessment and data from CELOX Vascular and CELOX Rapid Gauze" (predicate and reference devices). The rationale states the device "is deemed in compliance with the requirements of ISO 10993-1." |
| Sterilization | - Validation: Assessed and evaluated in compliance with ISO 11137-1. Sterilization dose audits are carried out using VDmax25 as defined in ISO 11137-1. Achieves Sterility Assurance Level (SAL) of 10^-6, consistent with the predicate. |
| Shelf-life | - Duration: 3 Years based on predicate stability data (Note: Predicate device has 5 Years, but the new device relies on predicate data for 3 years). |
| Hemostasis Efficacy | - Porcine Bleeding Models: No new pre-clinical testing was deemed necessary for substantial equivalence for the modified device. Previous testing in porcine bleeding models was performed for both the predicate devices (CELOX Vascular and CELOX Rapid Gauze), and the results "demonstrate that they both support the claim with regards to the control of bleeding and hemostasis being achieved." The document implies that because the modified device is substantially equivalent in design and materials (with an improved adhesion profile), these existing efficacy data for the predicate are sufficient. |
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" for a diagnostic performance evaluation. For bench testing (e.g., tack adhesion, absorbency), specific sample sizes are not provided in this summary but are usually defined per test protocol (e.g., n=3, 5, or 10 replicates).
- Data Provenance: Not specified regarding "country of origin." The testing was "carried out in line with Medtrade products Ltd Design Control process," implying it was conducted by or for the manufacturer (Medtrade Product Ltd, based in the UK). The data is retrospective in the sense that the testing for this device has been completed, and the results are being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable. The device is a physical hemostatic dressing, and its performance (e.g., adhesion, absorbency) is measured by objective mechanical/material tests, not by expert interpretation of images or signals that would require a "ground truth" established by experts in an AI/ML context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as there is no expert adjudication process for this type of device's performance evaluation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by standardized physical/chemical tests (e.g., ASTM, ISO standards for materials, sterility) and previously conducted pre-clinical studies (e.g., porcine bleeding models) for the predicate device, which established its hemostatic efficacy. It is not based on expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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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
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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.
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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
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
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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 LtdElectra House, Crewe Business ParkCrewe, CheshireCW1 6GLUnited Kingdom |
|---|---|
| Establishment Registration No.: | 9614493 |
| Contact: | Ms Mina PatelRegulatory Affairs ManagerMedtrade Product LtdElectra House, Crewe Business ParkCrewe, CheshireCW1 6GLUnited KingdomTelephone: + 44 (0)1270 500019Facsimile: + 44 (0)1270 500045Email: 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 RapidSubject Device#K190012 | CELOX VascularPredicate Device#K093519 |
|---|---|---|
| Design | OMNI-STAT Vascular Rapid is achitosan-based hemostaticdressing/ pad presented in asealed foil pouch, consisting ofhemostatic granules with a bio-adhesive bonded to one side anon-woven base gauze and witha PU foam film backing theother side of the gauze.OMNI-STAT Vascular Rapidachieves its principle intendedaction (hemostasis) by creatinga physical barrier or plug to stopthe flow of blood. The granulescoated sides is applied directlyto the access site and the pointof compression, while thesheath is still in place. When thesheath is removed, and theproduct comes into contact withblood, with pressure appliedOMNI-STAT Vascular Rapidwith the bio-adhesive quicklyforms a gel like plug absorbingthe water from the blood. | CELOX Vascular is a chitosan-based hemostatic dressing/pad presented in a sealed foilpouch, consisting ofhemostatic granules bonded toone side a non-woven gauzeand with a PU foam filmbacking the other side of thegauze.CELOX Vascular achieves itsprinciple intended action(hemostasis) by creating aphysical barrier or plug to stopthe flow of blood. The granulescoated sides is applied directlyto the access site and thepoint of compression, while thesheath is still in place. Whenthe sheath is removed, and theproduct comes into contactwith blood, with pressureapplied CELOX Vascularquickly forms a gel like plugabsorbing the water from theblood. |
| Material/chemicalComposition | A chitosan-based hemostaticgranules coated dressing/pad,with a bio-adhesive and PUfoam film backing | A chitosan-based hemostaticgranules coated dressing/padand PU foam film backing |
| Indicationsfor Use(Prescription/Rx only) | OMNI-STAT Vascular Rapid isindicated for the localmanagement and control ofsurface bleeding from vascularaccess sites, percutaneouscatheters or tubes utilizingintroducer sheaths up to16French | CELOX Vascular is indicatedfor the local management andcontrol of surface bleedingfrom vascular access sites,percutaneous catheters ortubes utilizing introducersheaths up to 16French |
| Category | OMNI-STAT Vascular RapidSubject Device#K190012 | CELOX VascularPredicate Device#K093519 |
| For single use | Yes | Yes |
| For prescriptionuse(Rx only) | Yes | Yes |
| Method ofsterilisation | Gamma Irradiation inaccordance with ISO 11137 | Gamma Irradiation inaccordance with ISO 11137 |
| Sterilityassurance level | Achieve Sterility Assurance10-6 | Achieve Sterility Assurance10-6 |
| Shelf-life | 3 Years based on predicatestability data | 5 Years |
| Biocompatibilitytestingcompleted inaccordance withISO 10993 | No testing was carried out onsubject device;biocompatibility profile wasestablished based ontoxicology risk assessmentand data from CELOXVascular and CELOX RapidGauze. | Yes |
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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
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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.
N/A