(257 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological interactions of a chitosan-based granular material for hemostasis, with no mention of AI or ML technologies.
Yes
The device is indicated for use as a temporary topical dressing for external bleeding control, which is a therapeutic purpose.
No
The device description indicates it is a hemostatic agent used to stop bleeding by forming a physical barrier, not to diagnose a condition. Its function is therapeutic rather than diagnostic.
No
The device is a physical, granular haemostatic agent and does not involve any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary topical dressing for external bleeding control associated with minor wounds." This describes a device applied directly to the body to treat a physical condition (bleeding).
- Device Description: The description details a "chitosan-based haemostatic agent presented in a granular form" that is "applied directly to the source of bleeding in a topical wound." It works by creating a "physical barrier or seal to stop the flow of blood." This is a mechanical action on the body.
- IVD Definition: In vitro diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro) to analyze these samples.
The Bondiloxs Topical Haemostatic Granules are applied to the body (in vivo) to directly interact with and stop bleeding. This is a therapeutic or procedural device, not a diagnostic one that analyzes samples.
N/A
Intended Use / Indications for Use
Bondiloxs Topical Hemostatic 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.
Product codes
QSY, FRO
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
External bleeding associated with wounds
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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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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
1
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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.
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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 Ltd
Electra House, Crewe Business Park
Crewe, Cheshire
CW1 6GL
United Kingdom |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact:- | Dr Andrew Whitton
Head of Regulatory Affairs
Telephone: + 44 (0)1270 500019
Facsimile:- + 44 (0)1270 500045
Email: 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.
5
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 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 until | ||
| hemostasis is achieved. It | ||
| 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, | ||
| it quickly forms a strong seal | ||
| that completely covers the | ||
| wound. | 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 until | ||
| hemostasis is achieved. It | ||
| 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, | ||
| it quickly forms a strong seal | ||
| that completely covers the | ||
| wound. | ||
| Material/chemical | ||
| Composition | A chitosan-based hemostatic | |
| granulate. | A chitosan-based hemostatic | |
| granulate. | ||
| Indications for Use | ||
| (Prescription/Rx | ||
| only) | 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. | Indicated for use as a | |
| temporary topical dressing for | ||
| bleeding control associated | ||
| with minor wounds, including | ||
| control of minor external | ||
| bleeding and exudate from | ||
| sutures and/or surgical | ||
| procedures. | ||
| Indicated for temporary | ||
| external treatment for |
6
| | Bondiloxs Topical
Hemostatic Granules | CELOX Pro |
|--------------------------------------------------------------------------|---------------------------------------------------|---------------------------------------------------|
| | | controlling moderate to severe
bleeding. |
| 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 | 10-6 | 10-6 |
| Biocompatibility
testing completed
in accordance with
ISO 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.
7
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.