(342 days)
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasis ulcers, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds. It has not been evaluated in third degree burns.
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-density polyethylene (HDPE) mesh. The sustained release of silver actively protects the wound site from bacterial and fungal contamination. The dressing will be sold in a variety of sizes.
The provided text does not describe a study to prove the device meets acceptance criteria in the traditional sense of a clinical trial with specific performance metrics. Instead, it is a 510(k) submission summary for the ACTICOAT® Primary Antimicrobial Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against predefined acceptance criteria through a specific study.
The primary "acceptance criterion" in a 510(k) submission is the demonstration of substantial equivalence to a legally marketed predicate device. This is achieved by comparing the new device's intended use, technological characteristics (design, materials), and safety/effectiveness data to those of the predicate.
Here's how to address the questions based on the provided document:
1. A table of acceptance criteria and the reported device performance
As mentioned, there are no explicit "acceptance criteria" and "reported device performance" in the context of a prospective study for this specific 510(k) submission. The document's closest equivalent is a comparison for substantial equivalence.
| Acceptance Criterion (for 510(k) Equivalence) | Reported Device Performance / Characteristics |
|---|---|
| Intended Use (Wound Dressing) | Yes (Matches predicate) |
| Design: HDPE Skin Contact Layer | Yes (Matches predicate) |
| Design: Absorbable | No (Differs from one predicate, matches another) |
| Design: Antimicrobial silver coating | Yes (Present, distinguishes it from one predicate) |
| Materials (HDPE & Polyurethane backing) | HDPE (Matches predicate) |
| Biocompatibility | Demonstrated through in vivo and in vitro tests |
| Safety and Effectiveness | Substantially equivalent (based on comparison and biocompatibility) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable (N/A). The document does not describe a "test set" in the context of a clinical performance study. The "in vitro testing" mentioned is for antimicrobial effectiveness and biocompatibility, not for assessing wound healing performance against a specific set of test cases.
- Data Provenance: N/A for a clinical performance test set. The biocompatibility and antimicrobial effectiveness data would likely be from laboratory studies, but the document does not specify their origin or whether they were retrospective/prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A. There is no mention of a test set with an established ground truth by experts in this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set requiring adjudication is described.
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
- N/A. This is not an AI-assisted device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A for clinical performance. For the antimicrobial claim, the "ground truth" would be established by in vitro microbiological testing (e.g., zone of inhibition, bacterial kill rates) against known pathogenic microorganisms, as stated by "based on in vitro testing. Data on file." This type of ground truth is laboratory-based and uses established microbiological assay methods.
- For biocompatibility, the ground truth is established through standard in vivo and in vitro toxicology tests (e.g., cytotoxicity, irritation, sensitization), as mentioned.
8. The sample size for the training set
- N/A. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- N/A. This is not an AI/machine learning device.
Summary of the document's approach:
The ACTICOAT® Primary Antimicrobial Dressing's 510(k) submission relies on:
- Substantial Equivalence: Comparing its intended use and technological characteristics to legally marketed predicate devices (ACTICOAT® Composite dressing and N'Terface dressing). The key difference highlighted is the antimicrobial silver coating, which is also present in one of the predicate devices.
- In vitro testing: To support the antimicrobial claims ("effective barrier to bacterial and fungal penetration") and biocompatibility.
- Previous testing on individual components: For biocompatibility, leveraging existing data for its constituent materials.
The document does not describe a new clinical study to evaluate the device's performance against specific acceptance criteria for wound healing outcomes in humans. Its clearance is based on its similarity to existing devices and positive laboratory findings.
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Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The sequence starts with the capital letter 'K', followed by the numbers '992221'. The numbers are written in a simple, slightly rounded style, and the entire sequence appears to be written with a dark pen or marker on a white background.
510K Summary of Safety and Efficacy ACTICOAT® Primary Antimicrobial Dressing
May 17, 2000
Westaim Biomedical, Inc Submitter 1. One Hampton Rd. Suite 302 Exeter, NH 03833
Steve Chartier Manager, Regulatory and Clinical Affairs (603) 775-7300
Device Name 2.
| Proprietary Name: | ACTICOAT® Primary Antimicrobial Dressing |
|---|---|
| Common Name: | Dressing |
| Classification Name: | Dressing |
| Regulatory Class: | Unclassified |
Intended Use 3.
The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and The Acticoat® Frimary Antimiorobial Broomy 10 the dressing may help reduce infections in fungal perfetration. The battler of the areasing ulcers, venous stasis ulcers, partial and Tull Thickness wounds informating "accuration" sites and surgical wounds. It may be used over grafted and partial thickness wounds.
Device Description 4.
Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-Acticulate phinaly antimisrobial droosings of the sustained release of silver actively protects the wound site from bacterial and fungal1 contamination.
The dressing will be sold in a variety of sizes the size used will depend on the size of the size of the The dressing will be sold in a valiety in alle the largest will be a 4" x 48" roll.
How Supplied
| 2" x 2" | (5cm x 5 cm) |
|---|---|
| 4" x 4" | (10 cm x 10 cm) |
| 4" x 8" | (10 cm x 20 cm) |
| 8" x 16" | (20 cm x 40 cm) |
| 16" x 16" | (40 cm x 40 cm) |
| 4" x 48" | (10 cm x 120 cm) |
1 based on in vitro testing. Data on file.
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5. Predicate Device Comparison
Acticoat® Primary Antimicrobial Dressing is the identical skin contact layer that is used in the Acticoat® Composite dressing (K983883). The absorbent outer laver has been This configuration allows the user to choose an appropriate secondary omitted. dressing.
This product is also similar to N'Terface dressing distributed by Winfield Laboratories. (K820298 and K973538). Both products are manufactured from HDPE and intended for use as a primary dressing to minimize damage to the wound bed during dressing changes. The only difference between these two products is that the Acticoat® dressing has an antimicrobial coating.
The table below compares the features and characteristics of the ACTICOAT® Primary antimicrobial dressing to the predicate products.
Comparison of the ACTICOAT® Contact Layer Dressing to Predicate Products
| ActicoatAntimicrobialContact LayerDressing | Acticoat®CompositeDressing(K983883) | Winfield LabsN'Terface(K820198 &K973538) | |
|---|---|---|---|
| INTENDED USE | |||
| Wound Dressing | Yes | Yes | Yes |
| DESIGN | |||
| HDPE Skin ContactLayer | Yes | Yes | Yes |
| Absorbable | No | Yes | No |
| Antimicrobial silvercoating | YES | Yes | NO |
| MATERIALS | |||
| HDPE | HDPE &PolyurethanebackingAbsorbentmaterial | HDPE |
6. Biocompatibilitv
biocompatibility of Acticoat® Primary Antimicrobial Dressing has been The demonstrated through appropriate in vivo and in vitro tests as well as previous tests on individual components.
Premarket Notification ACTICOAT® Primary Antimicrobial Dressing Westaim Biomedical Inc.
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Public Health Service
JUN - 7 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Steve Chartier Manager, Regulatory and Clinical Affairs Westaim Biomedical, Inc. One Hampton Road, Suite 302 Exeter, New Hampshire 03833
Re: K992221
Trade Name: ACTICOAT® Primary Antimicrobial Dressing Regulatory Class: Unclassified Product Code: MGP Dated: April 13, 2000 Received: April 14, 2000
Dear Mr. Chartier:
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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 - Mr. Steve Chartier
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,
Dmna R. Lochner
Celia M. Witten, Ph.D., M.D. 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 Device Name: ACTICOAT® Primary Antimicrobial Dressing K 992221
The Acticoat® silver coated contact layer dressing is an effective barrier to bacterial and fungal penetration. The barner function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasio unes, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor siten and surgical wounds. It may be used over debrided and grafted partial thickness wounds.
It has not been evaluated in third degree burns.
'based on invitro testing. Data on file.
(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)
Dona R. Lochner.
of General Restorative Devices 510(k) Number_K
Prescription Use (Per 21 CFR §801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
N/A