(257 days)
Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.
The product is a chitosan-based haemostatic agent presented in a granular form in a sealed pouch. It is applied directly to the source of bleeding in a topical wound and pressure applied for up to 3 minutes until hemostasis is achieved. Bondiloxs Topical Hemostatic Granules achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, Bondiloxs Topical Hemostatic Granules quickly forms a strong seal that completely covers the wound.
The provided document is a 510(k) summary for the Bondiloxs Topical Hemostatic Granules. It details the device's comparison to a predicate device and includes information about performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical thresholds. Instead, it describes performance characteristics and states that the device's performance was "adequate to support a determination of substantial equivalence to the predicate." The acceptance criterion effectively is that the Bondiloxs Topical Hemostatic Granules performs equivalently to the predicate device, CELOX Pro, in relevant tests.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Hemostasis (Gel plug formation) | Equivalent to predicate device (CELOX Pro) | Bondiloxs Topical Hemostatic Granules and Celox Pro work equivalently well in stopping bleeding. |
| Adhesion strength of plug | Equivalent to predicate device (CELOX Pro) | Not explicitly stated beyond general equivalence for hemostasis. Implied to be equivalent as part of overall haemostatic function. |
| Bleeding control in moderate bleeding situations (porcine model) | Equivalent to predicate device (CELOX Pro) | The results demonstrate that the Bondiloxs Topical Hemostatic Granules and Celox Pro work equivalently well in stopping bleeding in this wound model. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. | Demonstrated to be in compliance with the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices), including cytotoxicity, irritation/sensitization, and systemic toxicity testing. Performance was "adequate". |
| Sterilization validation | Compliance with ISO 11137-1 | Performed in compliance with ISO 11137-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the animal (porcine) bleeding model tests. It refers to "representative wound models."
- Data Provenance: The studies appear to be prospective in nature, as they involve actively testing the device and predicate in bench and animal models. The country of origin for the data is not explicitly stated, but the manufacturer is Medtrade Products Ltd based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of a topical hemostatic granule device where performance is assessed through objective measurements (e.g., stopping bleeding, plug formation, adhesion strength, biocompatibility assays) rather than expert interpretation of images or clinical outcomes requiring consensus. The ground truth would be established by the experimental setup and objective measurements.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies involving human interpretation where disagreements need to be resolved. Performance was assessed through objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a topical hemostatic medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation would have been conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm or AI-based device. The device itself is a standalone product.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Objective Measurements: Such as the observation of hemostasis (stopping of bleeding), gel plug formation, and adhesion strength in bench and animal models.
- Standardized Biological and Sterilization Testing: Compliance with ISO 10993 and ISO 11137 standards for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) and sterilization validation.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance was evaluated against a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
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April 21, 2023
Medtrade Products Ltd. Andrew Whitton Head of Regulatory Affairs Electra House Crewe Business Park Crewe, CHESHIRE CW1 6GL United Kingdom
Re: K161274 Trade/Device Name: Bondiloxs Topical Hemostatic Granules Regulatory Class: Unclassified Product Code: QSY
Dear Andrew Whitton:
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 January 18, 2017. 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
Medtrade Products Ltd. Andrew Whitton Head of Regulatory Affairs Electra House Crewe Business Park Crewe, CW1 6GL GB
Re: K161274
Trade/Device Name: Bondiloxs Topical Hemostatic Granules Regulatory Class: Unclassified Product Code: FRO Dated: December 19, 2016 Received: December 23, 2016
Dear Andrew Whitton:
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 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.
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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 yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K161274
Device Name
Bondiloxs Topical Hemostatic Granules
Indications for Use (Describe)
Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.
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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Section 5 – 510(k) Summary
This Traditional 510(k) notification is to provide the basis for determining substantial equivalence of the Medtrade Products Bondiloxs Topical Hemostatic Granules to the predicate device presented below.
| Submitted by:- | Medtrade Product LtdElectra House, Crewe Business ParkCrewe, CheshireCW1 6GLUnited Kingdom |
|---|---|
| Contact:- | Dr Andrew WhittonHead of Regulatory AffairsTelephone: + 44 (0)1270 500019Facsimile:- + 44 (0)1270 500045Email: andrew.whitton@medtrade.co.uk |
| Date prepared:- | 9th January 2016 |
| Device Name: | Bondiloxs Topical Hemostatic Granules |
| Common Name:- | Hemostatic granules |
| Trade/Proprietary Names:- Not yet defined | |
| Product Code:- | FRO |
| Classification Name:- | Dressing, Wound, Drug |
| Classification:- | Unclassified |
Legally marketed device(s) for substantial equivalence comparison:-
CELOX Pro, manufactured by Medtrade Products Ltd, and cleared under 510(k) number K093593.
Device Description :-
The product is a chitosan-based haemostatic agent presented in a granular form in a sealed pouch. It is applied directly to the source of bleeding in a topical wound and pressure applied for up to 3 minutes until hemostasis is achieved.
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Bondiloxs Topical Hemostatic Granules achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, Bondiloxs Topical Hemostatic Granules quickly forms a strong seal that completely covers the wound.
Indications for use:
Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.
Comparison to the predicate device:
The technological characteristics of both the Bondiloxs Topical Hemostatic Granules and the predicate, Celox Pro, are described in the following table:
| Bondiloxs Topical | CELOX Pro | |
|---|---|---|
| Hemostatic Granules | ||
| Design | The product is a chitosan-based haemostatic agentpresented in a granular form ina sealed pouch. It is applieddirectly to the source ofbleeding in a topical woundand pressure applied untilhemostasis is achieved. Itachieves its principle intendedaction (hemostasis) bycreating a physical barrier orseal to stop the flow of blood.When poured on a wound andupon contact with blood orexudate, in combination withmanual pressure to the wound,it quickly forms a strong sealthat completely covers thewound. | The product is a chitosan-based haemostatic agentpresented in a granular form ina sealed pouch. It is applieddirectly to the source ofbleeding in a topical woundand pressure applied untilhemostasis is achieved. Itachieves its principle intendedaction (hemostasis) bycreating a physical barrier orseal to stop the flow of blood.When poured on a wound andupon contact with blood orexudate, in combination withmanual pressure to the wound,it quickly forms a strong sealthat completely covers thewound. |
| Material/chemicalComposition | A chitosan-based hemostaticgranulate. | A chitosan-based hemostaticgranulate. |
| Indications for Use(Prescription/Rxonly) | Indicated for use as atemporary topical dressing forexternal bleeding controlassociated with minor wounds,including control of minorexternal bleeding and exudatefrom sutures and/or surgicalprocedures and for temporaryexternal treatment forcontrolling moderate bleeding. | Indicated for use as atemporary topical dressing forbleeding control associatedwith minor wounds, includingcontrol of minor externalbleeding and exudate fromsutures and/or surgicalprocedures.Indicated for temporaryexternal treatment for |
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| Bondiloxs TopicalHemostatic Granules | CELOX Pro | |
|---|---|---|
| controlling moderate to severebleeding. | ||
| For single use | Yes | Yes |
| Forprescriptionuse(Rx only) | Yes | Yes |
| Method ofsterilisation | Gamma Irradiation inaccordance with ISO 11137 | Gamma Irradiation inaccordance with ISO 11137 |
| Sterility assurancelevel | 10-6 | 10-6 |
| Biocompatibilitytesting completedin accordance withISO 10993 | Yes | Yes |
The indications for use of the Bondiloxs Topical Hemostatic Granules are essentially identical to those of the predicate device, Celox Pro, but with the removal of the use on severe bleeding.
Both the Bondiloxs Topical Hemostatic Granules and the predicate, Celox Pro, are composed of the same raw materials but just in slightly different ratios.
Performance Data:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing of the Bondiloxs Topical Hemostatic Granules and its packaging was conducted on all of the main performance characteristics. The performance of the Bondiloxs Topical Hemostatic Granules was also analysed in bench testing against the predicate device, Celox Pro, with reqard to both the ability to form a gel plug and the adhesion strength of the plug to the site of bleeding.
Performance testing in porcine bleeding models was performed for both the Bondiloxs Topical Hemostatic Granules and Celox Pro. Representative wound models were used to test the performance in moderate bleeding situations of both the Bondiloxs Topical Hemostatic Granules and Celox Pro. The results demonstrate that the Bondiloxs Topical Hemostatic Granules and Celox Pro work equivalently well in stopping bleeding in this wound model.
The biocompatibility of the Bondiloxs Topical Hemostatic Granules has been demonstrated to be in compliance with the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices). Specific analysis included cytotoxicity testing in line with ISO 10993-5, irritation and sensitization testing in line with ISO 10993-10 and systemic toxicity testing in line with ISO 10993-11.
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Sterilization validation has been performed 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.
The results of the biocompatibility and performance testing conducted on the Bondiloxs Topical Hemostatic Granules were adequate to support a determination of substantial equivalence to the predicate.
Summary Statement of Substantial Equivalence:-
The indications for use and performance testing for the Bondiloxs Topical Hemostatic Granules demonstrates that it is substantially equivalent to the predicate device; CELOX Pro (510(k) # K093593) manufactured by Medtrade Products Ltd.
N/A