(316 days)
BioDerm Sciences Wound Spray is intended to cleanse, rinsc and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, burns and ulcers (diabetic, venous 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 Spray is intended to clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor burns and abrasions.
BioDerm Wound Spray is an acidic zinc-saline wet dressing for external wound management. It aids the body in the healing process by providing a moist, acidic wound environment. The non-irritating components of BioDerm Wound Spray allow it to be used in the mouth, eyes and on mucous membrancs as well as on the skin.
BioDerm Wound Spray is similar in chemical composition to the previously cleared BioDerm Scicnces Wound Solution with the spray also containing 0.002% of some trace elements. A difference between these products is that the predicate device BioDerm Scicnccs Wound Solution is supplied sterile in injection bottles, while the current device is supplied non-sterile in pump-spray bottles. The dressing is applied by spraying onto the affected arca.
BioDerm Wound Spray is supplied in 100 ml spray bottles with a plunger activated pump applicator.
Here's an analysis of the provided text regarding the BioDerm Wound Spray, focusing on acceptance criteria and the supporting study:
The provided document, a 510(k) summary, is for a medical device called BioDerm Wound Spray. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or providing a detailed, statistically robust performance study with specific metrics and thresholds.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define numerical acceptance criteria or provide quantifiable device performance metrics in the way one would expect for a study designed to meet specific performance thresholds (e.g., sensitivity, specificity, accuracy for a diagnostic device).
Instead, the implied acceptance criterion is "effectiveness as an aid to the body's healing of burns and partial wounds" and "safe and effective as a wound cleanser or wet dressing." The reported device performance is simply that the study "demonstrated the effectiveness of BioDerm Wound Spray."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Effective as an aid to the body's healing of burns and partial wounds. | A study "demonstrated the effectiveness of BioDerm Wound Spray as an aid to the body's healing of burns, and partial wounds." |
| Safe and effective as a wound cleanser or wet dressing. | "When used as directed, BioDerm Wound Spray is safe and effective as a wound cleanser or wet dressing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The study was conducted "using a porcine model." The number of porcine subjects or wounds is not mentioned.
- Data Provenance: The study was "performed at the University of Miami (Department of Dermatology & Cutaneous Surgery)." It was a pre-clinical study using an animal model (porcine), not human patient data. It is inherently prospective within the animal model context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide information on experts used to establish ground truth. As an animal model study assessing healing, the evaluation criteria would likely be objective measurements (e.g., wound size reduction, epithelialization rates) or histological assessments, potentially by veterinary pathologists or researchers involved in wound healing.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method. Given it's a pre-clinical animal study, adjudication is less common than in human clinical trials, where subjective assessments might require reconciliation. Performance assessment would likely follow standardized experimental protocols.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study described is a pre-clinical animal model study, not involving human readers or assessment of AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance)
Not applicable. BioDerm Wound Spray is a physical product (a wet dressing/wound spray), not an AI algorithm or a diagnostic device that would have "standalone performance" in the typical sense of algorithm-only evaluation.
7. The Type of Ground Truth Used
The ground truth or outcome measure for the animal study would relate to wound healing parameters. While not explicitly detailed, common measures in porcine burn/wound models include:
- Rate of wound closure/epithelialization
- Measurement of wound area
- Histological evaluation of tissue regeneration, collagen deposition, inflammation
- Clinical observation of wound condition
This is closer to objective biological observations/outcomes data rather than expert consensus or pathology reports in a diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. BioDerm Wound Spray is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this is a physical product, not an AI/ML model that requires a training set and associated ground truth.
Summary Takeaway:
The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a wound care product. The "performance study" mentioned is a pre-clinical animal model study designed to show the utility of the product, not to meet specific, quantifiable performance acceptance criteria commonly seen for diagnostic devices or AI solutions. The details about the study are very limited in the summary provided.
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042084
JUN 1 5 2005
510(k) summary as described in § 807.92
510(k) Summary
| Submitter: | BioDerm Sciences, Inc. |
|---|---|
| Enterprise Center | |
| 9 Industrial Park Drive, Suite 1N | |
| Oxford, Mississippi 38655 | |
| Phone: (301) 216-3912 | |
| Contact Person: | Ed Gubish Ph. D. egubish@biodermsciences.comChief Scientific Officer |
| Preparation Date: | May 26, 2005 |
| Proprietary Device Name: | BioDerm Wound Spray |
| Classification Name: | Liquid Bandage |
| Predicate Devices: |
BioDerm Wound Solution Dermagran wound cleanser with zinc Restore Wound Cleanser
Description:
BioDerm Wound Spray is an acidic zinc-saline wet dressing for external wound management. It aids the body in the healing process by providing a moist, acidic wound environment. The non-irritating components of BioDerm Wound Spray allow it to be used in the mouth, eyes and on mucous membrancs as well as on the skin.
BioDerm Wound Spray is similar in chemical composition to the previously cleared BioDerm Scicnces Wound Solution with the spray also containing 0.002% of some trace elements. A difference between these products is that the predicate device BioDerm Scicnccs Wound Solution is supplied sterile in injection bottles, while the current device is supplied non-sterile in pump-spray bottles. The dressing is applied by spraying onto the affected arca.
BioDerm Wound Spray is supplied in 100 ml spray bottles with a plunger activated pump applicator.
Intended Use (Prescription):
BioDerm Sciences Wound Spray is intended to cleanse, rinse and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial
Confidential BioDerm Sciences, Inc.
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and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It is and thickness wounds, carrior with a sterile dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
Intended Use (OTC): BioDerm Sciences Wound Spray is intended to clean, rinse mendou Ose (Oren Blow wounds such as minor lacerations, minor cuts, minor cuts, minor burns and abrasions.
BioDerm Wound Spray can also be used as a wound cleanser to remove foreign matter, bacteria and tissue debris.
BioDerm Wound Spray 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 aners, or for any wound for which the dermis has been severcly damaged or is missing.
Comparison of Technological Characteristics:
A number of wet dressings have been cleared for marketing by the FDA. All have in A numor of we we a caline 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 Wound Spray is supplied non-sterile.
A broad range of chemical compositions is currently available. The chemical composition of BioDerm Wound Spray is within the range of chemical compositions of these predicate devices and is substantially equivalent in terms of its safety and effectiveness. (Sec Table 1)
Performance:
A study of various formulations 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 effectiveness of BioDerm Wound Spray as an aid to the body's healing of burns, and partial wounds.
Conclusions:
When used as directed, BioDerm Wound Spray is safe and offective as a wound cleanser or wet dressing.
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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 the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 1 2007
Edward R. Gubish, Ph.D. Chief Scientific Officer BioDerm Sciences Inc. Enterprise Center 9 Industrial Park Drive, Suite 1N Oxford, Mississippi 38665
K042084 Re: Trade Name: BioDerm Sciences Wound Spray Regulatory Class: Unclassified Product Code: FRO Dated: May 17, 2005 Received: May 18, 2005
Dear Dr. Gubish:
This letter corrects our substantially equivalent letter of June 15, 2005.
We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section 910(x) prematics is substantially equivalent (for the device relevenced above and nave decembly marketed predicate devices marketed
indications for use stated in the enclosure) to the of the Modical Device indicalloris for use stated in the encreases of the enactment and of the Medical Device in in interstate commerce prior to may 20, 1770, and 11 accordance with the provisions of
Amendments or to devices that have been reclassified in accordance corrected of a Amendinents of to devices that ha re over (Act) that do not require approval of a
the Federal Food, Drug, and Cosmetic Act (Act) that do not requires website the the the Federal Food, Drug, and Cosment Act (100), market the device, subject to the general
premarket approval (PMA). You may, therefore, market the Act include prematket approval (1 Mr.). "Totale general controls provisions of the Act include controls provisions of the Act. "The general of devices, good manufacturing practice, the requiremond for anitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (sec above) into entist regulations affecting your
(PMA), it may be subject to additional controls. Existing major regulations affecting your (PMA), if may be subject to additional controllar controlly of itle 21, Parts 800 to 898. In the Federal device can be found in the Code of Federal Regulations, Courter, Concerning your device in the Federal Register.
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Page 2 - 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 510(k) premarket 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: TBD
Device Name: BioDcrm Sciences Wound Spray
Indications for Use:
BioDcrm Sciences Wound Spray is intended to cleanse, rinsc and externally manage dermal lesions such as lacerations, post-operative (surgical) wounds, partial and full-thickness wounds, burns and ulcers (diabetic, venous stasis, pressure). It may also be used in conjunction with a dressing that absorbs fluids (i.e. gauze, gel, alginate, foam, hydrocolloid).
X Prescription Use (Part 21 CFR 801 Subpart D) 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 K042084
Confidential BioDerm Sciences, Inc.
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Ko42084
Indications for Use
510(k) Number: TBD
Device Name: BioDerm Sciences Wound Spray
Indications for Use:
BioDerm Sciences Wound Spray is intended to clean, rinse and externally manage skin wounds such as minor lacerations, minor cuts, minor burns and abrasions.
Prescription Use (Part 21 CFR 801 Subpart D) 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 Gene., Restorative |
and Neurological Devices
510(k) Number
_特殊 | 上一
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N/A