(80 days)
BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and fullthickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
BioDerm Wound Solution can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.
Bio Derm Wound Solution is an acidic zinc-saline wet dressing for external wound management. It provides an acidic, moist environment that aids the body in the healing process. The non-toxic nature of the solution allow it to be used in the mouth, eyes and on mucous membranes as well as on the skin.
BioDerm Wound Solution is supplied sterile in 50 ml injection bottles with Teflon septums. The solution is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tab which must be removed to get the syringe through the septum. The pull-tab supplies whether the bottle has been opened or not. The contents must be used within five days after opening.
Here's an analysis of the provided 510(k) summary for the BioDerm Wound Solution, focusing on acceptance criteria and supporting studies:
Acceptance Criteria and Device Performance for BioDerm Wound Solution
Based on the provided K040683 510(k) summary, the device is a wound cleanser and wet dressing. The acceptance criteria are primarily focused on the compositional range compared to legally marketed predicate devices, and its performance as an aid to wound healing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| P-Value (chemical composition): Within the range of essential chemical components of predicate devices (acidic saline solutions with a pH ≤ 7, potentially with metallic salts or other additives). Predicate devices identified: Saljet Single Dose Sterile Saline Topical Solution (K993969), 20 ml Normal Saline Topical Solution, 0.9% w/v Sodium Chloride (K972185), Hypertonic saline wet dressing - sterile (K941999). | "BioDerm Wound Solution is within the range of essential chemical components of the predicate devices." (See Table 1 - Note: Table 1 itself is not included in the provided text, but the statement confirms compliance). This implies the device's composition (acidic zinc-saline) falls within the accepted range of other cleared saline-based wound dressings. |
| Performance (clinical efficacy/safety): Safe and effective as a wound cleanser and wet dressing when used as directed, aiding in the healing of incision, grafts, burns, partial and full-thickness wounds. | "A study of various formulations... performed at the University of Miami... using a porcine model evaluated BioDerm Wound Solution as an aid to healing of incision, grafts, burns, partial and full-thickness wounds." The conclusion states: "When used as directed, BioDerm Wound Solution is safe and effective as a wound cleanser or wet dressing." (Appendices B-E are referenced but not provided). |
| Sterility: Supplied sterile. | "BioDerm Wound Solution is supplied sterile." |
| Intended Use: To cleanse, irrigate, and externally manage dermal lesions (lacerations, post-operative wounds, grafts, partial and full-thickness wounds, burns, ulcers) in conjunction with a sterile dressing. | The "Indications for Use" section explicitly states this intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "a porcine model" for performance testing. However, it does not specify the sample size (number of animals or wounds) used in this study.
- Data Provenance: The study was conducted at the "University of Miami (Department of Dermatology & Cutaneous Surgery)." The data provenance is pre-clinical (animal model) rather than human clinical data. It is prospective in nature, as it describes a planned evaluation of various formulations. The country of origin is the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications.
- Given it's a porcine model, the "ground truth" would likely be established by veterinarians, histopathologists, or dermatologists experienced in animal models of wound healing, who would assess wound progression, histological changes, and healing metrics. However, this information is not provided.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method for the test set. For animal studies, this is less common than for human clinical trials or image-based diagnostic studies. Outcomes would typically be assessed by the research team involved in the study.
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
- No, an MRMC comparative effectiveness study was not done. This device is a wound cleanser, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not done. This device is a physical product (liquid solution), not an algorithm.
7. The Type of Ground Truth Used
- The type of ground truth used for the performance study was based on observations and measurements of wound healing in a porcine model. This would likely include:
- Clinical assessment: Visual inspection of wound size reduction, re-epithelialization, inflammation, etc.
- Histopathology: Microscopic examination of tissue samples from the wounds to assess new tissue formation, collagen deposition, cellular infiltration, and other healing markers.
- Potentially other objective measurements: Such as wound tensile strength or biochemical markers, although not explicitly stated.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI. The "various formulations" evaluated in the study could be considered analogous to different experimental groups, but not a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, there is no training set for this type of device.
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K040 683
Dermagran wound cleanser with zinc
510(k) Summary
| Submitter: | BioDerm Sciences, Inc.101 Orchard Ridge Drive, Suite 1NGaithersburg, Maryland 20878Tel. (301) 216-3912Fax (301) 216-3919 |
|---|---|
| Contact Person: | Ed Gubish Ph. D. egubish@healthpathways.comPresident, BioSciences Corp. |
| Preparation Date: | May 27, 2004 |
| Proprietary Device Name: | BioDerm Wound Solution |
| Classification Name: | Liquid Bandage |
| Predicate Devices: | |
| Saljet Single Dose Sterile Saline Topical Solution | K993969 |
| 20 ml Normal Saline Topical Solution, 0.9% w/v Sodium Chloride | K972185 |
| Hypertonic saline wet dressing - sterile | K941999 |
Description:
Bio Derm Wound Solution is an acidic zinc-saline wet dressing for external wound management. Biollerm Wound Solution is an actore zinc-saline were the body in the healing process. The nonIt provides an acidic, moist environment that aids the book in the mouth aves If provides an acidic, moist environment that allow it to be used in the mouth, eyes and on mucous membranes as well as on the skin.
BioDerm Wound Solution is supplied sterile in 50 ml injection bottles with Tellon septents from the BioDeffi Wound Solution is supplied steries is applied by withdrawing the contents from the injection bottle with a syringe. The crimp caps have a pull-tal which must be removed or got The injection bothe with a sytting. The onlip supp whether the bottle has been opened or not. The contents must be used within five days after opening.
Intended Use:
BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage BioDerm Sciences Wound Bolution is interative (surgical) wounds, grafts, practial and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to full-thickness wounds, ourils and dicers (Graoone, Toloos fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
BioDerm Wound Solution can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.
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KC40683 page 2 of 2
BioDerm Wound Solution is contraindicated for use when patients are known to have had allergic reactions to this dressing or its components. It is not suitable for use on third degree allergic reactions to this thessing of its components. We are a love a missing.
Comparison of Technological Characteristics:
A number of wet dressings have been cleared for marketing by the FDA. All have in common A number of wel dressings nave been on sodium chloride or metallics salts with a pH less than or that they are same southous based on socialin additives such as nutrients. Dressings
equal to 7 (i.e. acidic). They may or may not contain as that as also intended for use equal to 7 (1.6. actire). They may of thay not coilant also intended for use as wound dressings are sterile. BioDerm Wound Solution is supplied sterile.
A broad range of chemical compositions is currently available. The chemical compositions of these predicate A broad range of chemical compositions is can chary of chemical compositions of these predicate BioDerm Wound Solution is willin the raige of enchiential ve " (See Table 1)
Performance:
A study of various formulations of with varying strength levels of the metalic salts, performed at A study of various tonimations of milli rarying ology & Cutaneous Surgery) using a porcine
the University of Miami (Department of Dermatology & Cutaneous in the healing of the University of Miami (Department of BioDerm Wound Solution as an aid to healing of incision, grafts, burns, partial and full-thickness wounds. (Appendices B-E)
Conclusions:
When used as directed, BioDerm Wound Solution is safe and effective as a wound cleanser or wet dressing.
Other Information:
This product is intended for sale by or on the order of a physician (or properly licensed practitioner).
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Image /page/2/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 image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2007
Edward R. Gubish, Ph.D. President BioDerm Sciences, Inc. 101 Orchard Ridge Drive, Suite 1N Gaithersburg, MD 20878
Re: K040683
Trade Name: BioDerm Sciences Wound Solution Regulatory Class: Unclassified Product Code: FRO Dated: March 9, 2004 Received: March 16, 2004
Dear Mr. Gubish:
This letter corrects our substantially equivalent letter of June 4, 2004.
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 (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.
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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Page 2 - Mr. Edward R. Gubish, Ph.D.
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); 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.
This letter will allow you to continue marketing your device as described in your Section Fins leaser warket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number: K040683
Device Name: BioDerm Sciences Wound Solution
Indications for Use:
BioDerm Sciences Wound Solution is intended to cleanse, irrigate and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, grafts, partial and fullthickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is meant to be used in conjunction with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence/of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040683
Page I of _ l
Confidential BioDerm Sciences, Inc. 4
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