(57 days)
The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a moist healing environment, manage exudate, and protect the wound from contamination. The dressing is indicated for the management of the following types of wounds:
Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous & arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers.
Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns.
Other indications include; a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain, chest tube, or sump drain, as well as a secondary or cover dressing for packed wounds.
The device has not changed from those approved under Bioderm, Inc. K982778 and consist of square, hydrophilic foam pads for wound care and square foam pads with a slit to fit around tracheostomy or gastrostomy tubes. The device provides a means to absorb exudate from draining wounds.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Bioderm Foam Wound Dressing:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices, particularly those seeking 510(k) clearance, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a legally marketed predicate device. This often involves showing that the new device has the same technological characteristics and similar performance. In this case, the acceptance criteria are related to the biological safety and non-toxicity of the materials.
| Acceptance Criteria (from predicate/general safety standards) | Reported Device Performance (Bioderm Foam Wound Dressing) |
|---|---|
| Non-irritant (Primary Dermal Irritation) | Considered a non-irritant |
| Non-sensitizing (Kilgman Maximization Study) | Exhibit no reaction to the challenge (0% sensitization), Grade I reaction (weak allergic potential, not considered significant) |
| No significant systemic toxicity (Systemic Injection Test) | Considered negative; no significantly greater biological reaction than control |
| Not toxic with repeated intravenous administration (14 Day Repeated Intravenous Toxicity Study) | Not toxic based on clinical observations and histopathological assessment |
| Non-cytotoxic (Cytotoxicity - Agar Diffusion Test) | No biological reactivity (Grade 0); considered non-cytotoxic |
| Non-hemolytic (Hemolysis Rabbit Blood) | Considered non-hemolytic at 0.12% Hemolysis |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document details non-clinical laboratory tests, primarily on biological samples rather than human clinical data.
- Primary Skin Irritation: Albino rabbits (specific number not given, but typically a small group for such tests).
- Kilgman Maximization Study: Not specified, but generally performed on a small group of animals (e.g., guinea pigs).
- Systemic Injection Test: Albino Swiss mice (specific number not given, but generally a small group).
- 14 Day Repeated Intravenous Toxicity Study: Not specified, but typically a small group of animals (e.g., rabbits, rodents).
- Cytotoxicity-Agar Diffusion Test: L929 mammalian cells (in vitro).
- Hemolysis Rabbit Blood: Rabbit blood (in vitro).
Data Provenance: These are pre-clinical (animal and in-vitro) studies. The sponsor is Rynel Ltd. Inc., Boothbay, Maine, and the test facility is Toxicon Laboratories. The country of origin for the animals/biological material is not explicitly stated but is presumed to be local to the test facility (USA). All tests appear to be prospective in nature, as they were specifically conducted for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
For these non-clinical biological tests, the "ground truth" is established by adherence to standard laboratory protocols and interpretations by qualified laboratory personnel. The document does not specify the number or qualifications of individual experts who "established the ground truth" in the way clinical studies might for image interpretation. Instead, the validity relies on:
- Accredited Test Facility: Toxicon Laboratories.
- Standardized Protocols: Reference to standards like USP XXIII for cytotoxicity.
- Expert Interpretation: Implied expertise of the scientists and technicians at Toxicon Laboratories in conducting and interpreting these specific toxicology and biocompatibility assays.
4. Adjudication Method for the Test Set
Not applicable for these types of non-clinical laboratory tests. Adjudication methods like "2+1" (two readers agree, third resolves discrepancy) are relevant for human interpretation tasks (e.g., radiology reads), not for direct biological assay results.
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 submission is for a foam wound dressing, not a diagnostic imaging AI algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant to this device's clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (wound dressing), not an algorithm or AI-based device.
7. The Type of Ground Truth Used
The ground truth for these tests is based on direct biological and chemical measurements and observations according to established laboratory protocols and scientific standards, aimed at assessing biocompatibility and safety. This is distinct from expert consensus, pathology (though histopathology was used in one test), or outcomes data in a clinical trial.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model. There is no "training set" in the context of device development described here.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reason as above.
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| FROM | CHIP WORTHLEY |
|---|---|
| ------ | --------------- |
| FAX NO 708 690 8309 | |
|---|---|
| MAY 18 1999 |
| K990955 | |
|---|---|
| -- | --------- |
| BIODERM, INC. | |
|---|---|
| -- | --------------- |
| MAY 7,1999 04:08 PM P 2 | |
|---|---|
| -- | ------------------------- |
| 510(k) SUMMARY PER 807.92 | |
|---|---|
| -- | --------------------------- |
| (a) (1) | |
|---|---|
| -- | --------- |
| Submitters Name: | George Worthley |
|---|---|
| Submitters Address: | PO Box 4882Wheaton, Illinois 60189 |
| Submitters Phone: | (630) 690-8339 |
| Contact Person: | George Worthley |
| Date Prepared: | May 7, 1999 |
| (a) (2) | |
|---|---|
| -- | --------- |
| Device Trade Name: | Bioderm Foam Wound Dressing |
|---|---|
| Device Common Name: | Wound Dressing |
| Classification Name: | 79 FRO Dressing |
| (a) (3) | |
|---|---|
| -- | --------- |
| Predicate Device: | Hydrasorb (K976230) |
|---|---|
| ------------------- | --------------------- |
| (a) (4) | |
|---|---|
| -- | --------- |
| Device Description: | The device has not changed from those approved under Bioderm, Inc. K982778 and consist of square, hydrophilic foam pads for wound care and square foam pads with a slit to fit around tracheostomy or gastrostomy tubes. The device provides a means to absorb exudate from draining wounds. |
|---|---|
| --------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| (a) (5) | |
|---|---|
| -- | --------- |
| Revised Indications for Use Statement | |
|---|---|
| 520(k): | K990955 |
| Device Name: | Bioderm Foam Wound Dressing |
| Indications for Use: |
The Bioderm, Inc. foam dressing is an external wound dressing designed to help maintain a
moist healing environment, manage exudate, and protect the wound from contamination. The
dressing is indicated for the management of the following types of wounds:
Partial and full-thickness wounds, moderate to heavily exudating wounds such as; lower
extremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed etiology (venous &
arterial) and post surgical incisions, pressure sores, and diabetic foot ulcers.
Partial thickness wounds such as; donor sites, abrasions, lacerations, and superficial burns.
Other indications include; a drainage dressing for tracheostomy, G-tube, J-tube, Penrose drain,
chest tube, or sump drain, as well as a secondary or cover dressing for packed wounds.
| (1.) | |
|---|---|
| -- | ------ |
: :
:
. . . . . . . . . . . . . .
{1}------------------------------------------------
| SUMMARY (CONTINUED) | |
|---|---|
| (a) (6) | |
| Technological Characteristics: | This device has the same design, material, and chemical composition as the predicate device indicated in paragraph (a) (3) above. |
| (b) (1): | |
| Nonclinical Testing: | |
| Test Article: | Hydrophilic Polyurethane Foam HPF-L0562 & L0562-6 (Formerly Coded HPF/L52) |
| Sponsor: | Rynel Ltd. Inc., Boothbay, Maine |
| Test Facility: | Toxicon Laboratories |
| Primary Skin Irritation | |
| The test article, HPF-L0562, was tested for its potential to produce primary dermal irritation after a single topical 24 hour application to the skin of albino rabbits. The test article is considered a non-irritant | |
| Kilgman Maximization Study (Sodium Chloride Extract) | |
| Based on the standards set by the study protocol, HPF-L0562, exhibited no reaction to the challenge (0% sensitization). Therefore, as defined by the scoring system of Kilgman, this is a Grade I reaction and the test article is classified as having a weak allergic potential. A Grade I sensitization rate is not considered significant according to Magnusson and Kligman (1969, 1970) | |
| Systemic Injection Test | |
| This test is considered negative based on standards set by the study protocol. The extract of the test article, HPF/L62, did not show a significantly greater biological reaction than the control extract, when tested in albino Swiss mice, | |
| 14 Day Repeated Intravenous Toxicity Study-Subchronic | |
| The results indicate that the test article, HPF-L0562, is not toxic according to the procedure described in the study protocol when administered by the intravenous injection each weekday (5 days/week) for 14 days. The lack of toxicity was based upon clinical observations and histopathological assessment of selected tissue. | |
| Cytotoxicity-Agar Diffusion Test | |
| No biological reactivity (Grade 0) was observed in the L929 mammalian cells by 48 hours post exposure to the test article. The observed cellular response obtained from the positive control article (Grade 4) and the negative (Grade 0) confirmed the suitability of the test system. The test article is considered non-cytotoxic and meets the requirements of the Agar Diffusion Test, USP XXIII, | |
| Hemolysis Rabbit Blood | |
| The test article, HPF/L62, is considered non-hemolytic at 0.12% Hemolysis, under the experimental conditions employed. | |
| (2.) |
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
MAY 1 8 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Worthley President Bioderm, Inc. P.O. Box 4882 Wheaton, Illinois 60189
Re: K990955 Trade Name: Foam Wound Dressing Regulatory Class: Unclassifed Product Code: KMF Dated: March 16, 1999 Received: March 22, 1999
Dear Mr. Worthley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food. Drug, and Cosmetic Act (Act) and the following limitations:
-
- This device may not be labeled for use on third degree burns.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
-
- This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.
The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).
The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
{3}------------------------------------------------
Page 2 - Mr. George Worthley
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.
Sincerely yours,
Image /page/3/Picture/5 description: The image shows a handwritten letter 'f' in black ink on a white background. The letter is written in a cursive style, with a long, curved stroke extending above and below the horizontal bar. The stroke below the bar is slightly longer than the stroke above the bar. The letter is slightly tilted to the left.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
| Bioderm, Inc. · | Altachment # 1. | 5/1/99 | |||
|---|---|---|---|---|---|
| Revised Indications for Use Statement | |||||
| 610(k) Number (fr Known): K990955 | |||||
| Device Name: Bioderm Foam Wound Dressing | ****************************************************************************************************************************************************************************** | . | |||
| Indications for Use: | |||||
| The Bloderm, Inc. foam dressing is an external wound dressing designed to help maintain a | |||||
| molst healing environment, manage exudate, and protect the wound from contamination. Thedressing is Indicated for the local management of the following types of wounds: | |||||
| Partial and full-thickness wounds, moderate to neavily exudating wounds such as: lower | |||||
| autremity ulcers including; venous stasis ulcers, arterial ulcers, or mixed ettology (venous & | |||||
| arterial) and post surpical Incisions. pressure sores and diabetic foot ulcers. | |||||
| Partial thickness wounds such as; donor sites, abrasions, lacerations, superficial burns, | |||||
| Other Indications Include; a drainage drassing for tracheostomy, G-tube, J-lub, Penrose drain, | |||||
| chest lube, or surap drain, as well as a secondary or cover dressing for packed wounds. | |||||
| (DO NOT WRITE BELOW THIS LINE-USE ANOTHER PAGE IF NEEDED) | |||||
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |||||
| Prescription Use | OR | Over the Counter Use | |||
| (Per 21 CFR 801.109) | |||||
| (Optional Formal 1-2-96) | |||||
| (Division Sign Of | |||||
| Division of Gel | |||||
| 510(k) Number | |||||
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.