(413 days)
BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, 15 and 200 as racerations, post operative (cargenous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. BioDerm Sciences Wound Cream is supplied in 100 g aluminum tubes. A metal seal at the tip of the tube must be broken in order to use the contents, thus rendering the packaging tamper-resistant. The dressing is applied by squeezing the cream from the tube onto the affected skin.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the BioDerm Sciences Wound Cream:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | No sensitization demonstrated in tests with guinea pigs. |
| * Non-toxic | No toxicity observed in mice receiving intraperitoneal injections. |
| * No adverse side effects | The identical product has been marketed in Europe for fourteen years under the name "NAWA, Medical Elektrolyt-Salbe S" with satisfactory performance and no reports of adverse side effects. |
| Effectiveness: | A study using a porcine model demonstrated the effectiveness of the solutions contained in the BioDerm Wound Cream as an aid to the body's healing of burns and partial thickness wounds. |
| * Aids in healing (burns, partial thickness wounds) | The porcine model study showed effectiveness in aiding the healing of burns and partial thickness wounds. The device aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. |
| * Provides moist, low pH wound environment | BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. The pH value is 3.0-3.4. (This is a characteristic, and the effectiveness study implies this characteristic contributes to the stated healing aid). |
| * Provides essential minerals | BioDerm Sciences Wound cream is an aqueous-based, acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals. BioDerm Sciences Wound Cream contains zinc chloride and iron chloride, and other trace elements. (Similar to pH, this is a characteristic that the effectiveness study implies contributes to efficacy). |
| Substantial Equivalence to Predicate Devices (Chemical Composition): | BioDerm Sciences Wound Cream is similar in chemical composition to the previously approved BioDerm Sciences Wound Solution. Although the zinc chloride and iron chloride contents are similar, the pH value is somewhat higher (ph 3.0-3.4 vs. 2.8); and other trace elements have been added, making it somewhat more comparable in content to BioDerm Sciences Wound Spray. Its chemical composition is within the range of chemical compositions of these predicate devices and is substantially equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Effectiveness Study: Not explicitly stated. The document mentions "a study of various formulations of with varying strength levels of the metallic salts... using a porcine model." It does not provide the number of pigs or wounds studied.
- Sample Size for Sensitization Study: Not explicitly stated. The document mentions "tests with guinea pigs."
- Sample Size for Toxicity Study: Not explicitly stated. The document mentions "mice receiving intraperitoneal injections."
- Data Provenance:
- Effectiveness Study: Prospective, conducted at the University of Miami (Department of Dermatology & Cutaneous Surgery).
- Sensitization Study: Not explicitly stated if prospective or retrospective, but implied prospective ("tests with guinea pigs").
- Toxicity Study: Not explicitly stated if prospective or retrospective, but implied prospective ("mice receiving intraperitoneal injections").
- Adverse Event Data: Retrospective (from 14 years of marketing in Europe as "NAWA, Medical Elektrolyt-Salbe S").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device. The studies described are animal studies (porcine, guinea pig, mouse) and a review of post-market surveillance data. There is no mention of expert human readers/reviewers establishing ground truth for the device's performance in these studies.
4. Adjudication Method for the Test Set
Not applicable. The studies are based on animal models for physiological outcomes (healing, sensitization, toxicity) and a review of past clinical performance, not on interpretation by multiple human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The studies mentioned are animal model studies and a summary of post-market data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described can be considered standalone performance evaluations of the device itself (the wound cream) without human intervention in its direct 'reading' or 'interpretation'. The device is a therapeutic product, not an diagnostic imaging or AI algorithm.
7. The Type of Ground Truth Used
- Effectiveness Study: Physiological outcomes in a porcine model (healing of burns and partial thickness wounds). The "ground truth" would be the observed healing parameters in the animals.
- Sensitization Study: Observed physiological reactions in guinea pigs (absence of sensitization).
- Toxicity Study: Observed physiological reactions in mice (absence of toxicity).
- Adverse Events: Clinical outcomes and adverse event reports from 14 years of market experience in Europe. The "ground truth" here is the real-world safety profile based on reported incidents.
8. The Sample Size for the Training Set
Not applicable. The device is a wound cream, not an AI or machine learning algorithm that requires a training set. The "training" here would be the development and formulation process, informed by scientific principles and prior knowledge.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is not an AI/ML device.
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OCT 17 2005
K042352
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VII. 510(k) summary as described in § 807.92
510(k) Summary
BioDerm Sciences Wound Spray
Dermagran Wound Management System
| Submitter: | BioDerm Sciences, Inc.Enterprise Center9 Industrial Park Drive, Suite 1NOxford, Mississippi 38655Phone: (301) 216-3912Fax (301) 216-3919 | |
|---|---|---|
| Contact Person: | Ed Gubish Ph. D. egubish@healthpathways.comChief Scientific Officer | |
| Preparation Date: | June 30, 2005 | |
| Proprietary Device Name: | BioDerm Sciences Wound Cream | |
| Classification Name: | Wound Dressing | |
| Predicate Device: | BioDerm Sciences Wound Solution | K040683 |
| BioDerm Sciences Wound Spray | K042084 |
BioDerm Sciences Wound cream is an aqueous-based, Description: acidic zinc/iron-saline cream for external wound management. It aids the body in the healing process by providing a moist, low pH wound environment and providing essential minerals.
BioDcrm Sciences Wound cream is similar in chemical composition to the previously approved BioDerm Sciences Wound Solution. Although the zinc chloride and iron chloride contents are similar, the pH value is somewhat higher (ph 3.0-3.4 vs. 2.8); and other trace elements have been added, making it somewhat more comparable in content to BioDerm Sciences Wound Spray. Unlike BioDerm Sciences Wound Solution and Spray, this product is applied as a cream. BioDerm Sciences Wound Cream is supplied in 100 g aluminum tubes. A metal seal at the tip of the tube must be broken in order to use the contents, thus rendering the packaging tamper-resistant. The dressing is applied by squeezing the cream from the tube onto the affected skin.
BioDerm Sciences Wound cream is intended for external Intended Use: management of minor abrasions, lacerations, cuts, scalds, and 14 and 2nd burns. It can be used in conjunction with a conventional dressing that absorbs fluids (i.c. gauze, gcl, alginate, foam, hydrocolloid).
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BioDcrm Sciences Wound cream 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 burns, or for any wound for which the dermis has been severely damaged or is missing.
Comparison of Technological Characteristics:
The FDA has cleared a number of wet dressings for marketing. All have in common that they are saline solutions based on sodium chloride or metallic salts with a pH less than or equal to 7 (i.e. acidic). They may or may not contain additives such as nutrients. BioDerm Sciences Wound Cream contains similar proportions and amounts of zinc chloride and iron chloride as the predicate devices BioDerm Sciences Wound Solution and Wound Spray. Like the Dermagran Wound Management System, which is essentially a lanolin-based ointment containing zinc chloride and other nutrients, the water-based BioDerm Sciences Wound Cream is applicd and used as a wound cover or filler.
A broad range of chemical compositions is currently available. The chemical composition of BioDerm Sciences Wound Cream is within the range of chemical compositions of these predicate devices and is substantially equivalent in terms of its safety and effectivencss. (See Table 2)
Performance:
A study of various formulations of with varying strength levels of the metallic salts, performed at the University of Miami (Department of Dermatology & Cutaneous Surgery) using a porcine model demonstrated the effectivencss of the solutions contained in the BioDerm Wound Cream as an and to the body's healing of burns, and partial thickness wounds. No sensitization was demonstrated in tests with guinea pigs and no toxicity was observed in mice receiving intraperitoneal injections. The identical product has been marketed in Europe for fourteen years under the name "NAWA, Medical Elektrolyt-Salbe S" with satisfactory performance and no reports of adverse side effects. The Elektrolyt-Salbe is registered as Klasse IIa with registration number: DE/CA65/622-2678.1N4/8.
Conclusions:
When used as directed, BioDerm Scicnces Wound Cream is safe and effective as a wound 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 shows the logo for the Department of Health and Human Services (HHS). The logo consists of the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure, with three curved lines forming the body and head.
Public Health Service
OCT 17 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Edward R. Gubish, Ph.D. Chief Scientific Officer BioDerm Sciences, Inc. 101 Orchard Ridge Drive, Suite 1N Gaithersburg, Maryland 20878
Re: K042352
Trade/Device Name: BioDerm Sciences Wound Cream Regulatory Class: Unclassified Product Code: FRO Dated: September 27, 2005 Received: September 28, 2005
Dear Dr. Gubish:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becament in d the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in 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, de Moos that have been i that do not require approval of a premarket approval application (PMA). and Cosmetter resert ince) and the device, subject to the general controls provisions of the Act. The I ou may, diererey, mains 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 such 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 r lease of actived and I Drimination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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.
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Page 2- Edward R. Gubish, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your a finding of substantial equivalence of your device to a legally premated 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 If you attire 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 other general international and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson ్రాల్య Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K042352
Devicc Name: BioDerm Sciences Wound Cream
Indications for Use:
BioDerm Sciences Wound Cream is intended to externally manage dermal lessions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, 15 and 200 as racerations, post operative (cargenous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
X Prescription Usc (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.)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Kod2352
N/A