(334 days)
Under the supervision of a healthcare professional Bondiloxs Topical Hemostatic Dressing is 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 and for temporary external treatment for controlling moderate to severe bleeding.
Bondiloxs Topical Hemostatic Dressing is a sterile non-woven dressing comprising of chitosan fibres which aids the gelling and absorbency potential of the dressing. Bondiloxs Topical Hemostatic Dressing achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the Bondiloxs Topical Hemostatic Dressing directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding. The dressing promotes localized clotting formation to help stop bleeding. The Bondiloxs Topical Hemostatic Dressing is packed in a foil/foil pouch. The pouch provide an integral barrier that maintains dressing sterility post irradiation vet allows easy opening and aseptic dressing removal by the end user. The Bondiloxs Topical Hemostatic Dressing is available in various sizes ranging up to a maximum of 15cm x 15cm and is available in a flat dressing or z-folded for fast and intuitive application.
The provided document is a 510(k) summary for the Bondiloxs Topical Hemostatic Dressing. It aims to demonstrate substantial equivalence to a predicate device, CELOX Gauze PRO (K113560), rather than outlining acceptance criteria and a study proving the device meets those criteria from scratch. Therefore, much of the requested information regarding specific acceptance criteria, test set details, expert involvement, and ground truth establishment is not explicitly present.
However, I can extract the available information and highlight what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for device performance. Instead, it relies on demonstrating that the Bondiloxs device is "as safe and effective as" and "substantially equivalent to" the predicate device, CELOX Gauze PRO. The performance data is described qualitatively.
| Parameter | Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|---|
| Hemostatic efficacy | To be equivalent to the predicate device in controlling bleeding in various injury types and severities. | Established using in-vivo testing in different injury types, including: Epigastric artery wound model (heparinized and non-heparinized), Liver cruciate model (mild to moderate bleeding), Liver dissection model (moderate bleeding), Epigastric sever model (mild topical bleeding), and Saphenous femoral 2.7mm punch (moderate to major bleeding). These models assessed the device's ability to control different severities of bleeding. The document concludes "The biocompatibility and performance testing including the in-vivo testing for the Bondiloxs Topical Hemostatic Dressing has demonstrated that the device is safe and effective for the indications of use." |
| Absorbency | To meet relevant standards. | Bench testing in accordance with relevant standards. |
| Tensile Strength | To meet relevant standards. | Bench testing in accordance with relevant standards. |
| Gelling Properties | To meet relevant standards. | Bench testing in accordance with relevant standards. |
| Pack Integrity | To be maintained (e.g., dye penetration and burst test). | Bench testing (dye penetration and burst test). |
| Sterility | Sterility Assurance Level (SAL) of 1x10^-6. | Achieved via terminal sterilization by gamma irradiation to a SAL of 1x10^-6, validated in compliance with ISO 11137-1:2006. |
| Biocompatibility | To be demonstrated in accordance with BS EN ISO 10993-1 (cytotoxicity, sensitization, irritation). | Demonstrated through assessment according to BS EN ISO 10993-1, including cytotoxicity, sensitization, and irritation testing. The testing "demonstrated that the device is safe for the indications of use." |
| Shelf Life | To be determined through stability studies. | Determined using stability studies at ambient conditions (real-time aging 25°C/60% RH) and in a controlled environment (40°C/75% RH). (Specific duration not provided in this summary). |
| Manufacturing Quality Controls | Compliance with GMP and ISO 14971 for risk analysis; device meets established specifications prior to release. | Bondiloxs Topical Hemostatic Dressing is manufactured according to product specifications and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971, and manufacturing controls developed and implemented. The device meets all established specifications prior to release. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified quantitatively in the document. The in-vivo studies mention "different injury types" and "various animal models," but no number of animals or trials.
- Data Provenance: The studies are described as "in-vivo studies" and "bench testing." No country of origin for the data is explicitly stated. The nature of the studies implies prospective experimental design (animal models and bench tests).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth for performance in this context is based on direct observation of hemostasis in animal models and objective measurements in bench tests, not on expert adjudication of diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as the evaluation is based on direct measurement of physiological outcomes (hemostasis) and physical properties, not on subjective interpretations requiring adjudication.
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 device is a topical hemostatic dressing, not an AI-assisted diagnostic tool or an imaging device requiring human reader interpretation. No MRMC study was conducted or is relevant for this type of 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 (dressing), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the "hemostatic efficacy" performance would be considered outcomes data from the animal models (i.e., whether bleeding was controlled or stopped). For other properties (absorbency, tensile strength, sterility), the ground truth is established by objective measurements against physical/chemical standards.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2023
Medtrade Product Ltd. Claire Ryan Head of Regulatory and Quality Assurance Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Re: K132333 Trade/Device Name: Bondiloxs Topical Hemostatic Dressing Regulatory Class: Unclassified Product Code: QSY
Dear Claire Ryan:
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 June 25, 2014. 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 for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 25. 2014
Medtrade Product Ltd Mr. Jonathan Ranfield Quality & Regulatory Director Electra House, Crewe Business Park Crewc, Cheshire CWI 6GL United Kingdom
Re: K132333
Trade/Device Name: Bondiloxs Topical Hemostatic Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 19, 2014 Received: March 24, 2014
Dear Mr. Ranfield:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Jonathan Ranfield
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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" (21CFR 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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INDICATIONS FOR USE
K132333 510(k) Number (if known):
Device Name: Bondiloxs Topical Hemostatic Dressing
Indications for Use:
Under the supervision of a healthcare professional Bondiloxs Topical Hemostatic Dressing is 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 and for temporary external treatment for controlling moderate to severe bleeding.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jiyoung Dang -S
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Image /page/4/Picture/1 description: The image shows the logo for Medtrade, a company that produces innovative medical products. The logo features the word "Medtrade" in a simple, sans-serif font, with the words "Innovative Medical Products" written in a smaller font below. A curved line wraps around the word "Medtrade", adding a touch of visual interest to the design.
Section 5 - Traditional 510(k) Notification :- 510(k) Summary
This Traditional 510(k) notification is to provide substantial equivalence for Medtrade Products Bondiloxs Topical Hemostatic Dressing, which is substantially equivalent to currently marketed hemostatic dressings intended for temporary external treatment for controlling minor and moderate to severe bleeding.
1. Submitted by:
Medtrade Product Ltd Electra House, Crewe Business Park Crewe, Cheshire CW1 6GL United Kingdom
Establishment Registration Number: 9614493
Contact Person:-
Mr Jonathan D Ranfield Quality & Regulatory Director Telephone: + 44(0)1270 500019 Fax:- + 44(0)1270 500045 Email: jonathan.ranfield@medtrade.co.uk
2. · · Date Summary prepared:
24th" June 2014
3. Device Information :-
| Proprietary Name: | Bondiloxs Topical Hemostatic Dressing |
|---|---|
| Common Name: | Bondiloxs Topical Hemostatic Dressing |
| Trade Names: | Not yet defined |
| Product Code: | FRO |
| Classification Name: | Dressing, Wound, Drug |
| Classification: | Unclassified |
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Image /page/5/Picture/0 description: The image shows the logo for Medtrade, a company that specializes in innovative medical products. The logo features the word "Medtrade" in a simple, sans-serif font, with the words "Innovative Medical Products" underneath in a smaller font. A curved line arches over the word "Medtrade", adding a dynamic element to the design.
4. Predicate Devices:
CELOX Gauze PRO 510(k) # K113560, manufactured by Medtrade Products Ltd.
5. Device Description :-
Bondiloxs Topical Hemostatic Dressing is a sterile non-woven dressing comprising of chitosan fibres which aids the gelling and absorbency potential of the dressing.
Bondiloxs Topical Hemostatic Dressing achieves the principle intended action of hemostasis by the providing a physical barrier to stop bleeding. By applying the Bondiloxs Topical Hemostatic Dressing directly onto a wound and together with firm pressure the gel-like plug on dressing's surface creates a physical barrier which controls blood flow through the dressing to stop bleeding.
The dressing promotes localized clotting formation to help stop bleeding.
The Bondiloxs Topical Hemostatic Dressing is packed in a foil/foil pouch. The pouch provide an integral barrier that maintains dressing sterility post irradiation vet allows easy opening and aseptic dressing removal by the end user.
The Bondiloxs Topical Hemostatic Dressing is available in various sizes ranging up to a maximum of 15cm x 15cm and is available in a flat dressing or z-folded for fast and intuitive application.
6. Indication for Use :-
Under the supervision of a healthcare professional Bondiloxs Topical Hemostatic Dressing is 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 surqical procedures and for temporary external treatment for controlling moderate to severe bleeding.
7. Substantial Equivalence: -
The Bondiloxs Topical Hemostatic Dressings has identical indications for use to the legally marketed Medtrade Products CELOX Gauze Pro (510(k) # K113560)
Which is a chitosan based dressing.
The following tabulations which summarises the description, Indications for use, and general information, and the substantial equivalence information provides a succinct and direct comparison of equivalence between Bondiloxs Topical Hemostatic Dressings and the approved predicate device listed above.
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Summary of Comparison of Bondiloxs Topical Hemostatic Dressing and the Predicate Device
.
| Bondiloxs Topical HemostaticDressings | CELOX Gauze PRO (510(k) #K113560) | |
|---|---|---|
| Description | Bondiloxs Topical HemostaticDressing is sterile non-wovendressing comprising of chitosanfibres and lactic acid which aids thegelling and absorbency potential ofthe dressing. | The device consists of a chitosanHaemostatic granules adhered ontoa base fabric (non woven gauze)using a hot melt adhesive. |
| PhysicalComposition | Chitosan fibres and lactic acid non-woven, soft, non fibrous absorbentdressing | Chitosan Granules on Sheet |
| Indications forUse /RX only) | Under the supervision of ahealthcare professional BondiloxsTopical Hemostatic Dressing isindicated for use as a temporarytopical dressing for bleeding controlassociated with minor wounds,including control of minor externalbleeding and exudate from suturesand/or surgical procedures and fortemporary external treatment forcontrolling moderate to severebleeding. | Under the supervision of ahealthcare professional CELOXGauze PRO for moderate to severeexternal bleeding wounds (Rx) isintended for temporary externaltreatment for controlling moderate tosevere bleeding. |
·
:
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Image /page/7/Picture/0 description: The image shows the logo for Medtrade, a company that specializes in innovative medical products. The logo features the word "Medtrade" in a simple, sans-serif font, with the tagline "Innovative Medical Products" written in a smaller font below it. A curved line extends over the word "Medtrade", adding a modern and dynamic touch to the logo.
. .
,
| Bondiloxs Topical HemostaticDressings | CELOX Gauze PRO (510(k) #K113560) | |
|---|---|---|
| Indications forUse /RX only)(Continue) | Under the supervision of ahealthcare professional CELOXGauze PRO for minor externalbleeding from wounds andprocedures (Rx) is intended for useas a temporary topical dressing forbleeding control associated withminor wounds, including control ofminor external bleeding and exudatefrom sutures and/or surgicalprocedures. |
- Sales of the same
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| Bondiloxs Topical HemostaticDressings | CELOX Gauze PRO (510(k) #K113560) | |
|---|---|---|
| Product Code | FRO | FRO |
| For single useonly | Yes | Yes |
| Method ofsterilisation | Gamma Irradiation in accordancewith ISO 11137 | Gamma Irradiation in accordancewith ISO 11137 |
| Sterilityassurance level | 1x10-6 | 1x10-6 |
| Biocompatibilitytesting completedin accordancewith ISO 10993 | Yes | Yes |
| Mode of Action | Bondiloxs Topical HemostaticDressing achieves the principleintended action of hemostasis bythe providing a physical barrier tostop bleeding | CELOX Gauze PRO achieves theprinciple intended action ofhemostasis by the providing aphysical barrier to stop bleeding. |
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Image /page/9/Picture/0 description: The image shows the logo for Medtrade, a company that produces innovative medical products. The logo consists of the word "Medtrade" in a simple, sans-serif font, with the tagline "Innovative Medical Products" written in a smaller font below. The word "Medtrade" is enclosed by a curved line above and below the word.
8. Manufacturing :-
Bondiloxs Topical Hemostatic Dressing is manufactured according to the product specifications and under good manufacturing practices (GMP). A risk analysis has been performed in accordance with BS EN ISO 14971 to identify possible failure mode during manufacturing and design. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode.
Bondiloxs Topical Hemostatic Dressings meets all the established specifications prior to release to ensure the device is safe, effective and correctly labelled for its intended use.
Bondiloxs Topical Hemostatic Dressings are terminally sterilised by gamma irradiation to a sterility assurance level (SAL) of 10°.
9. Non-Clinical Performance Data:-
Performance data for the Bondiloxs Topical Hemostatic Dressing has been established using in-vivo testing (Hemostatic properties) and bench testing in accordance to relevant standards where applicable (including absorbency, tensile strength, gelling properties, pack integrity (dye penetration and burst test) and sterility testing.
The in-vivo studies were designed and conducted to establish the hemostatic efficacy of the Bondiloxs Topical Hemostatic Dressing in different injury types, including: Epigastric artery wound model with both heparinised and nonheparinised conditions. Liver cruciate model (represents mild to moderate bleeding), liver dissection model (to assess hemostatic efficacy for moderate bleeding), Epigastric sever model (to assess hemostatic efficacy for mild topical bleeding) and Saphenous femoral 2.7mm punch (to assess hemostatic efficacy for moderate to major bleeding).
The Bondiloxs Topical Hemostatic Dressing is restricted to external, topical (dermal) use and the various animal models were used to assess the ability of the device to control different severities of bleeding.
Shelf Life has been determined using stability studies at ambient conditions (real time aging 25°C/60% RH) and in an environment in which the temperature and relative humidity have been controlled at 40°C/75% RH.
The biocompatibility of Bondiloxs Topical Hemostatic Dressing has been demonstrated through assessment according to BS EN ISO 10993-1 (Biological Evaluation of Medical Devices) and appropriate testing these include cytotoxicity, sensitization and irritation. The biocompatibility testing for the Bondiloxs Topical Hemostatic Dressing has demonstrated that the device is safe for the indications of use.
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Sterilisation validation has been performed in compliance with harmonised standards (ISO 11137-1: 2006 - Sterilization of healthcare products - Radiation -Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices).
The biocompatibility and performance testing including the in vivo testing for the Bondiloxs Topical Hemostatic Dressing has demonstrated that the device is safe and effective for the indications of use.
10. Clinical Performance Data:
Based upon the substantial equivalence determination for the predicate device (CELOX Gauze Pro (510(k) # K113560 no clinical data is required for evaluation of the Bondiloxs Topical Hemostatic Dressing.
11. Conclusion
The indication for use and performance testing for the Bondiloxs Topical Hemostatic Dressing is substantially equivalent to the predicate device; CELOX Gauze Pro (510(k) # K113560) manufactured by Medtrade Products Ltd.
The Bondiloxs Topical Hemostatic Dressing is indicated for topical application as for the control of temporary external bleeding associated with minor to severely bleeding wounds.
The biocompatibility and performance testing for the Bondiloxs Topical Hemostatic Dressing has demonstrated that the device is as safe and effective as the predicate devices and raises no new issues of safety or effectiveness.
N/A