(240 days)
OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
ExSept WC Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept WC Skin and Wound Cleanser has a 30 month shelf life.
The provided text describes a medical device, the "ExSept WC Skin and Wound Cleanser," and its regulatory clearance process (510(k) submission). However, it does not include the detailed information requested regarding specific acceptance criteria, a structured study with a test set, ground truth establishment, or performance metrics in the format of the questions provided.
The document primarily focuses on establishing substantial equivalence to predicate devices based on intended use, mechanism of action (mechanical cleansing), and general safety/efficacy. It mentions "numerous in-vitro and in-vivo studies" and "stability studies" but does not provide details about their methodology, specific acceptance criteria, or quantitative results.
Therefore, I cannot populate most of the requested fields. Here's a breakdown of what can be extracted and what is missing:
Information NOT present in the provided text:
- A table of acceptance criteria and the reported device performance: No specific quantitative acceptance criteria or performance metrics are detailed.
- Sample size used for the test set and the data provenance: No information on a specific test set, its size, or origin.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of ground truth experts.
- Adjudication method for the test set: Not applicable as no test set data is provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable as this is not an AI/imaging device.
- If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable as this is a wound cleanser, not an algorithm.
- The type of ground truth used: Not explicitly stated beyond general "efficacy, safety and biocompatibility."
- The sample size for the training set: No information on a training set.
- How the ground truth for the training set was established: Not applicable.
Information that can be inferred or directly stated:
| Category | Information from the Text |
|---|---|
| Acceptance Criteria & Performance | Acceptance Criteria (Inferred from 510(k) Context): The device must demonstrate substantial equivalence to legally marketed predicate devices (ExSept WC, SilvaKlenz, Dermacyn, Anasept) in terms of: 1. Intended Use: Cleansing and removal of dirt, debris, and foreign material from various wound types and skin. 2. Mechanism of Action: Mechanical cleansing. 3. Safety: Biocompatibility and lack of adverse effects compared to predicates. 4. Efficacy: Ability to perform cleaning functions as intended. 5. Shelf Life: 30 months (explicitly stated). Reported Device Performance: The submission states: - "Numerous in-vitro and in-vivo studies have been performed to demonstrate the efficacy, safety and biocompatibility of the ExSept WC Skin and Wound Cleanser for the indications for use." - "Stability studies show a shelf life of 30 months for the ExSept WC Skin and Wound Cleanser, when stored at room temperature." - Conclusion: "ExSept WC Skin and Wound Cleanser will perform as intended as a wound cleanser. ExSept WC Skin and Wound Cleanser is substantially equivalent in its actions and functions as the marketed devices ExSept WC, SilvaKlenz, Dermacyn and Anasept." |
| Sample Size (Test Set) | Not specified. The document refers to "numerous in-vitro and in-vivo studies" generally, not a specific test set. |
| Data Provenance (Test Set) | Not specified. |
| Number & Qualifications of Experts for Ground Truth (Test Set) | Not applicable/specified. The document does not detail expert involvement in establishing ground truth for a specific test set. |
| Adjudication Method (Test Set) | Not applicable/specified. |
| MRMC Comparative Effectiveness Study | No. This is a wound cleanser, not an AI-assisted diagnostic device. |
| Standalone Performance (Algorithm Only) | No. This is a wound cleanser, not an algorithm. |
| Type of Ground Truth Used | The document vaguely refers to "efficacy, safety and biocompatibility" studies. For equivalence, the "ground truth" is that the device performs comparably to established predicate devices based on these characteristics. Specific markers for "efficacy" and "safety" (e.g., wound healing rates, infection rates, skin irritation scores) are implied but not detailed as "ground truth." |
| Sample Size (Training Set) | Not applicable/specified. This is not an AI/machine learning device that uses a "training set." |
| How Ground Truth for Training Set was Established | Not applicable/specified. |
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K082858 ExSept WC Skin and Wound Cleanser
510(k) Summary
27 2009 MAY
| Sponsor: | Alcavis International8322 Helgerman CourtGaithersburg, MD 20877 |
|---|---|
| Contact Person: | Gary J. MishkinVice President, Research and DevelopmentTele: (301) 330-7597Fax: (301) 330-6432 |
| Date Prepared: | September 25, 2008 |
| Device Name: | Proprietary Name: ExSept WC Skin and Wound CleanserCommon Name: Wound CleanserClassification Name: Dressing, Wound, Drug |
| Predicate Devices: | ExSept WC Wound Cleaner, K061467SilvaKlenz Skin and Wound Cleanser, K063069Dermacyn Wound Cleanser, K042729Anasept Animicrobial Skin and Wound Cleanser, K073547 |
Device Description: ExSept WC Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept WC Skin and Wound Cleanser has a 30 month shelf life.
Intended Use:
1
OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
Professional Use: Under supervision of healthcare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
- Substantial Equivalence: ExSept WC Skin and Wound Cleanser is substantially equivalent in the cleansing functions and intended uses to the predicate devices ExSept WC, SilvaKlenz, Dermacyn
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K082858
Page 2 of 2
K082858 ExSept WC Skin and Wound Cleanser
and Anasept. All predicate devices use a mechanical action to remove foreign material and other debris from the wounds and surrounding skin.
- Testing: Numerous in-vitro and in-vivo studies have been performed to demonstrate the efficacy, safety and biocompatibility of the ExSept WC Skin and Wound Cleanser for the indications for use. Stability studies show a shelf life of 30 months for the ExSept WC Skin and Wound Cleanser, when stored at room temperature.
Conclusion: Based upon the information in the 510(k) submission, ExSept WC Skin and Wound Cleanser will perform as intended as a wound cleanser. ExSept WC Skin and Wound Cleanser is substantially equivalent in its actions and functions as the marketed devices ExSept WC, SilvaKlenz, Dermacyn and Anasept.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
MAY 27 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alcavis International, Incorporated % Mr. Gary J. Mishkin Vice President, Research and Development 8322 Helgerman Court Gaithersburg, Maryland 20877
Re: K082858
Trade/Device Name: ExSept WC Skin and Wound Cleanser Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: II Product Code: FQH Dated: April 17, 2009 Received: April 20, 2009
Dear Mr. Mishkin:
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 application (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.
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); medical device reporting
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Page 2-Mr. Mishkin
(reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/industry/support/index.html.
Sincerely yours.
F-R Pete D. Rummmo mfit
Mark N. Mallem O.K.
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K082858 ExSept WC Skin and Wound Cleanser
Indications for Use
510(k) Number (if known):K082858
Device Name: ExSept WC Skin and Wound Cleanser
Indications For Use:
- OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin.
- Professional Use: Under supervision of healthcare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
Prescription Use X ( Part 21 CFR 801 Subpart D) Over-The-Counter Use _ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXM
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K062656
Page 1 of 10
§ 880.5475 Jet lavage.
(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.