(283 days)
OTC: DONASORB™ is intended for use in management of minor cuts, minor abrasions, minor lacerations and minor burns.
Rx: DONASORB™ is intended for use by prescription for the management of partial and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, abrasions, surgical wounds, graft sites, skin tears, and first and second degree burns. DONASORB™ is not indicated for use on third degree burns.
DONASORB™ is a moist hydrogel sheet containing the antimicrobial ionic silver in the form of silver chloride which is intended to be a primary wound contact dressing to manage wound moisture. The base matrix of the subject device is composed of crosslinked polyacrylate sheet incorporating antimicrobial ionic silver in a silver chloride reservoir. Ionic silver in the form of silver chloride in the sheet inhibits the growth of broad spectrum microbes on or within the dressing. The Device is a sterile single use dressing supplied on PVC (Poly Vinyl Chloride) transparent carrier sheet, packed in a medical grade heat sealed aluminum foil pouch. Five single piece pouches are packed in a Mono-carton along with a package insert. Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. It is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first. It is available in sterile sheets of 2x2 cm, 2x4 cm, 4x8 cm, 8x8 cm and 10x10 cm sizes.
This document describes the DONASORB™ Silver Wound Dressing, a medical device, and the testing conducted to demonstrate its performance and safety. It's important to note that this is a 510(k) premarket notification, meaning the device is seeking clearance by demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. Therefore, the "acceptance criteria" and "study" described are primarily focused on equivalence and bench testing, not necessarily a comparative effectiveness study against a gold standard for treatment outcomes.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail sense with numerical thresholds typically seen for AI device performance. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device (AcryDerm Silver Antimicrobial Barrier Wound Dressing) and conformity to established testing standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bacterial Barrier Property (Prevent bacterial penetration) | DONASORB™ was evaluated for its effective barrier property. |
| Antimicrobial Efficiency (Inhibit microbial growth on/within dressing) | DONASORB™ was evaluated for its antimicrobial efficiency to inhibit the growth of microorganisms. Tests used 3 Gram positive, 3 Gram negative, and 2 fungi organisms with repeated inoculation over 24 hours. |
| Duration of Effectiveness | Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. Recommended use is up to 2 days or until saturated. |
| Biocompatibility/Safety (ISO 10993 compliance) | Demonstrated to be substantially similar to its predicate (AcryDerm) in: In Vitro Cytotoxicity Study, Acute Toxicity Test, Intracutaneous Irritation/Reactivity Study, Skin Sensitization testing, and Sub chronic toxicity test. |
| Sterility | Provided as a sterile single use device. |
| Manufacturing Standards | Will be manufactured according to product specifications under good manufacturing practices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of number of dressings or units tested for the bacterial barrier, antimicrobial efficacy, and biocompatibility studies. These were bench tests, not clinical studies on patient samples. For the antimicrobial efficacy, the "sample" refers to the types of microorganisms tested (3 Gram positive, 3 Gram negative, and 2 fungi organisms).
- Data Provenance: The document does not specify country of origin for the test data directly, but the submitter (Virchow Biotech PVT LTD) is located in India. The tests performed are described as "bench testing," meaning they were conducted in a laboratory setting. These were prospective bench tests specifically designed to evaluate the DONASORB™ device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the "test set" does not involve human interpretation or subjective assessment that would require expert consensus for ground truth. The tests are laboratory-based, objective measurements (e.g., microbial growth inhibition, penetration rates, cytotoxicity).
4. Adjudication Method for the Test Set
This information is not applicable. The tests are objective laboratory tests, and thus no adjudication method like 2+1 or 3+1 is required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI or diagnostic imaging devices where human readers interpret results, and the study would compare human performance with and without AI assistance on a set of cases. The DONASORB™ is a wound dressing, and its performance is evaluated through bench testing and biocompatibility assessments, not through human reader interpretation of output.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a "standalone" performance evaluation in the context of an algorithm or AI device was not done. The term "standalone" performance typically applies to AI algorithms operating independently of human intervention. DONASORB™ is a physical medical device (wound dressing), not an algorithm or AI. Its performance (e.g., antimicrobial efficacy, barrier property) is inherent to the dressing itself.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established through objective laboratory measurements and established scientific testing standards.
- Bacterial Barrier Property: Likely determined by measuring the passage of bacteria through the dressing material under controlled conditions, with the "ground truth" being the measured presence or absence and quantity of bacteria on the "wound" side of the dressing.
- Antimicrobial Efficacy: Determined by measuring the inhibition or reduction of microbial growth on or within the dressing compared to controls, with the "ground truth" being the observed microbial counts.
- Biocompatibility/Safety (ISO 10993): "Ground truth" established by compliance with the well-defined methodologies and acceptance criteria outlined in the ISO 10993 series of standards for biological evaluation of medical devices. This includes observing cellular responses (cytotoxicity), tissue reactions (irritation, sensitization), and systemic effects (acute and subchronic toxicity).
8. The Sample Size for the Training Set
Not applicable. The DONASORB™ is a physical medical device (wound dressing), not an AI/ML algorithm or system that requires a "training set" for model development.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the DONASORB™ device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 22, 2016
Virchow Biotech PVT LTD Mr. Bruce Gibbons Project Head 5903 SE Milwaukie Avenue Portland, OR 97202
Re: K153565
Trade/Device Name: DONASORB Silver Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: August 13, 2016 Received: August 22, 2016
Dear Mr. Gibbons:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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/Resourcesfor You/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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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)
Device Name
DONASORBTM
Indications for Use (Describe)
OTC: DONASORB™ is intended for use in management of minor abrasions, minor lacerations and minor burns.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of infornation 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
PSC Publishing Services (601) 443-6740
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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)
Device Name
DONASORBTM
Indications for Use (Describe)
Rx: DONASORB™ is intended for use by prescription for the management of partial and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, surgical wounds, graft sites, skin tears, and first and second degree burns.
DONASORBTM is not indicated for use on third degree burns.
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)
-1
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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 estiniate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
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5.2 510(k) Summary for OTC:
Submitter's Details 5.2.1
| Name of the 510(k) sponsor: | VIRCHOW BIOTECH PVT LTD |
|---|---|
| Address: | Plot No: 318 & 320, |
| 3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd, | |
| Madhapur, Hyderabad, | |
| Telangana, | |
| India-500 081. | |
| Contact Person: | BRUCE GIBBINS PhD, |
| 5903 SE Milwaukie Avenue, | |
| Portland OR 97202. | |
| Contact No: 503-781-7565 | |
| Email: blgibbins@gmail.com |
5.2.2 Device Name
| Proprietary name of device: | DONASORB™ |
|---|---|
| Generic Name/Common Name | Silver Wound Dressing |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/orBiologic |
| Product Code: | FRO |
| Regulatory Class: | Unclassified |
Legally Marketed Predicate Devices: 5.2.3
AcryDerm Silver Antimicrobial Barrier Wound Dressing (K991818).
Device Description 5.2.4
DONASORB™ is a moist hydrogel sheet containing the antimicrobial ionic silver in the form of silver chloride which is intended to be a primary wound contact dressing to manage wound moisture. The base matrix of the subject device is composed of crosslinked polyacrylate sheet incorporating antimicrobial ionic silver in a silver chloride reservoir. Ionic silver in the form of silver chloride in the sheet inhibits the growth of broad spectrum microbes on or within the dressing.
{5}------------------------------------------------
The Device is a sterile single use dressing supplied on PVC (Poly Vinyl Chloride) transparent carrier sheet, packed in a medical grade heat sealed aluminum foil pouch. Five single piece pouches are packed in a Mono-carton along with a package insert. Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. It is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first. It is available in sterile sheets of 2x2 cm, 2x4 cm, 4x8 cm, 8x8 cm and 10x10 cm sizes.
5.2.5 Mechanism of Action
Primary function of the DONASORB™ device is to manage wound exudates. The antimicrobial action of the dressing is intended to inhibit or kill microbes to prevent them from colonizing the dressing and entering the wound. The device acts a barrier between the wound and the surrounding environment.
Statement of Intended Use 5.2.6
DONASORB is is a hydrophilic dressing that aids in the management of wound exudate. The device contains ionic silver in the form of silver chloride minimize the bacterial growth on or within the dressing. These characteristics constitute the device as an effective barrier to bacterial penetration.
5.2.7 Indications for Use:
OTC: DONASORB™ is intended for use in management of minor cuts, minor abrasions, minor lacerations and minor burns.
5.2.8 Device Technological Characteristics and Substantial Equivalence
DONASORB™ is an antimicrobial barrier dressing containing silver chloride substantially equivalent to AcryDerm Silver Antimicrobial Wound Dressing (hereafter referred as AcryDerm); cleared under 510k number K991818 by AcryMed Inc.
DONASORB™ is a sterile, single use cross-linked polyacrylate hydrogel sheet containing ionic silver in a silver chloride reservoir similar to its predicate device AcryDerm. The subject device is substantially equivalent to predicate device in its
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composition, indication for use and functionality, and does not raise any additional risks in terms of safety and performance. The inactive ingredients of the device may be similar to the predicate.
Assessment of Performance Data and Safety 5.2.9
Both the Device (DONASORB™) and Predicate (AcryDerm Silver Antimicrobial Barrier Wound Dressing) are composed of cross-linked polyacrylate sheet with the incorporation of antimicrobial ionic silver in a silver chloride reservoir. DONASORB™ was evaluated for its effective barrier property (Bacterial barrier property testing) in the prevention of bacterial penetration through the dressing and the antimicrobial efficiency (Antimicrobial efficacy test) of the device to inhibit the growth of microorganisms. The tests that were performed simulates the clinical conditions of use, using 3 Gram positive, 3 Gram negative and 2 fungi organisms. At time points more than 24 hours, dressing was challenged with repeated inoculation.
Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. Based on the test results, it is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first.
As per the regulatory requirement, safety of DONASORB™ has been evaluated in accordance with ISO 10993. The study design included comparative testing of DONASORB™ with predicate device AcryDerm for In Vitro Cytotoxicity Study, Acute Toxicity Test, Intracutaneous Irritation/Reactivity Study, Skin Sensitization testing, and Sub chronic toxicity test. The studies have demonstrated DONASORB™ to be substantially similar to its predicate.
Sterilization: DONASORB™ will be provided as a sterile single use device.
5.2.10 Manufacturing
DONASORB™ will be manufactured according to the product specification under the good manufacturing practices that ensures the device is safe and effective for its intended use.
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5.1 510(k) Summary for Rx:
5.1.1 Submitter's Details
| Name of the 510(k) sponsor: | VIRCHOW BIOTECH PVT LTD |
|---|---|
| Address: | Plot No: 318 & 320,3rd Floor, Swamy Ayyapa Co-Op Housing Society Ltd,Madhapur, Hyderabad,Telangana,India-500 081. |
| Contact Person: | BRUCE GIBBINS PhD,5903 SE Milwaukie Avenue,Portland OR 97202.Contact No: 503-781-7565Email: blgibbins@gmail.com |
5.1.2 Device Name
| Proprietary name of device: | DONASORBTM |
|---|---|
| Generic Name/Common Name | Silver Wound Dressing |
| Classification Name: | Dressing, Wound and Burn, Hydrogel w/Drug and/orBiologic |
| Product Code: | FRO |
| Regulatory Class: | Unclassified |
5.1.3 Legally Marketed Predicate Devices:
AcryDerm Silver Antimicrobial Barrier Wound Dressing (K991818).
5.1.4 Device Description
DONASORB™ is a moist hydrogel sheet containing the antimicrobial ionic silver in the form of silver chloride which is intended to be a primary wound contact dressing to manage wound moisture. The base matrix of the subject device is composed of crosslinked polyacrylate sheet incorporating antimicrobial ionic silver in a silver chloride reservoir. Ionic silver in the form of silver chloride in the sheet inhibits the growth of broad spectrum microbes on or within the dressing.
The Device is a sterile single use dressing supplied on PVC (Poly Vinyl Chloride) transparent carrier sheet, packed in a medical grade heat sealed aluminum foil pouch. Five single piece pouches are packed in a Mono-carton along with a package insert.
{8}------------------------------------------------
Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. It is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first. It is available in sterile sheets of 2x2 cm, 2x4 cm, 4x8 cm, 8x8 cm, 8x8 cm and 10x10 cm sizes.
5.1.5 Mechanism of Action
Primary function of the DONASORB™ device is to manage wound exudate. The antimicrobial action of the dressing is intended to inhibit or kill microbes to prevent them from colonizing the dressing and entering the wound. The device acts a barrier between the wound and the surrounding environment.
5.1.6 Statement of Intended Use
DONASORB™ is a hydrophilic dressing that aids in the management of wound exudate. The device contains ionic silver in the form of silver chloride to prevent or minimize bacterial growth on or within the dressing. These characteristics constitute the device as an effective barrier to bacterial penetration.
5.1.7 Indications for Use:
- DONASORB™ is intended for use by prescription for the management of partial Rx: and full thickness wounds such as pressure ulcers, vascular ulcers, diabetic wounds, lacerations, abrasions, surgical wounds, graft sites, skin tears, and first and second degree burns.
DONASORB™ is not indicated for use on third degree burns.
5.1.8 Device Technological Characteristics and Substantial Equivalence
DONASORB™ is an antimicrobial barrier dressing containing silver chloride substantially equivalent to AcryDerm Silver Antimicrobial Wound Dressing (hereafter referred as AcryDerm); cleared under 510k number K991818 by AcryMed Inc.
DONASORB™ is a sterile, single use cross-linked polyacrylate base matrix hydrogel sheet containing antimicrobial ionic silver in a silver chloride reservoir similar to its predicate device AcryDerm. The subject device is substantially equivalent to predicate
{9}------------------------------------------------
device in its composition, indication for use and functionality, and does not raise any additional risks in terms of safety and performance. The inactive ingredients of the device may be similar to the predicate.
5.1.9 Assessment of Performance Data and Safety
Both the Device (DONASORB™) and Predicate (AcryDerm Silver Antimicrobial Barrier Wound Dressing) are composed of cross-linked polyacrylate sheet with the incorporation of antimicrobial ionic silver in a silver chloride reservoir. DONASORB™ was evaluated for its effective barrier property (Bacterial barrier property testing) in the prevention of bacterial penetration through the dressing and the antimicrobial efficiency (Antimicrobial efficacy test) of the device to inhibit the growth of microorganisms. The tests that were performed simulates the clinical conditions of use, using 3 Gram positive, 3 Gram negative and 2 fungi organisms. At time points more than 24 hours, dressing was challenged with repeated inoculation.
Barrier and Antimicrobial Effectiveness was demonstrated to last for up to 2 days per bench testing. Based on the test results, it is recommend to use DONASORB™ for up to 2 days or should be removed gently when completely saturated with wound fluids; whichever occurs first.
As per the regulatory requirement, safety of DONASORB™ has been evaluated in accordance with ISO 10993. The study design includes comparative testing of DONASORBI™ with predicate device AcryDerm for In Vitro Cytotoxicity Study, Acute Toxicity Test, Intracutaneous Irritation/Reactivity Study, Skin Sensitization testing, and Sub chronic toxicity test. The studies have demonstrated DONASORB™ to be substantially similar to its predicate.
Sterilization: DONASORB™ will be provided as a sterile single use device.
5.1.10 Manufacturing
DONASORB™ will be manufactured according to the product specification under the good manufacturing practices that ensures the device as safe and effective for its intended use.
N/A