(274 days)
No
The device description focuses on the material properties and antimicrobial barrier function of a wound dressing, with no mention of AI or ML technologies.
Yes
The device is indicated for use on various types of wounds, including burns, ulcers, and surgical sites, to facilitate healing and provide an antimicrobial barrier, which are therapeutic actions.
No
The device description and intended use indicate that ACTICOAT FLEX 7 is a wound dressing designed to cover and protect wounds, and provide an antimicrobial barrier. It does not mention any capability to identify, measure, or determine the presence or nature of a disease or condition, which are characteristics of a diagnostic device.
No
The device description clearly states it is a "dressing" consisting of a "flexible, low adherent polyester layer coated with nanocrystalline silver." This describes a physical, hardware-based medical device, not software.
Based on the provided information, the ACTICOAT FLEX 7 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use on various types of wounds (partial and full-thickness, burns, grafts, ulcers, surgical sites). This is a direct application to the body for therapeutic purposes (wound care and antimicrobial barrier).
- Device Description: The description details a dressing with a physical structure and a silver coating that acts as an antimicrobial barrier. This is a topical application, not a test performed on samples taken from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample (blood, urine, tissue, etc.), or provide information about a patient's health status based on in vitro testing.
- Performance Studies: The performance studies focus on biocompatibility and effects on wound healing in an animal model, which are relevant to a wound dressing, not an IVD.
In Vitro Diagnostics (IVDs) are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. The ACTICOAT FLEX 7 does not fit this definition.
N/A
Intended Use / Indications for Use
ACTICOAT FLEX 7 is indicated for use on partial and full-thickness wounds for up to 7 days.
This includes:
First and second-degree burns,
To cover grafts, Surgical sites, Venous ulcers, Pressure ulcers
Diabetic ulcers.
Product codes
FRO
Device Description
The ACTICOAT FLEX 7 dressing consists of a flexible, low adherent polyester layer coated with nanocrystalline silver.
The ACTICOAT FLEX 7 is a highly conformable dressing, nanocrystalline silver provides an effective barrier to microbial contamination The antimicrobial barrier properties of the ACTICOAT FLEX 7 dressings remain effective for up to 7 days. The antimicrobial barrier properties and the ability of the dressing to allow fluid to pass through without impairment, (in-vitro data) has shown ACTICOAT FLEX 7 to be compatible with negative pressure wound therapy (NPWT) for a period of up to 3 days.
The dressing is low adherent, which helps to minimise wound trauma at dressing changes.
The silver coating is derived from a silver target which 99.99% silver. The coating which is applied to the dressing is predominantly silver with a small number of oxygen atoms trapped within the coating structure. The coatings are highly porous and consist of equiaxed nanocrystals organised into coarse columnar structures. These unique physical structures, in combination with the oxygen atoms/molecules that are trapped in the crystal lattice, contribute to the enhanced solubility of the films.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility of ACTICOAT FLEX 7 has been demonstrated through appropriate in vivo and in vitro tests including cytotoxicity, sensitization, subchronic toxicity, and genotoxicity. All tests were performed on the finished device according to the Biological Evaluation of Medical Devices Standard ISO 10993 Part 1:2003. These studies indicated that ACTICOAT FLEX 7 dressings are safe for their intended use.
In addition, the effects of the device on wound healing have been evaluated in an animal model (minipigs), and it was demonstrated that the device had no deleterious effects on wound healing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Dossier Reference: K083143
Page 289 of 297
K083113
pg 1 of 5
JUL 2 2 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
- Trade (Proprietary) Name
ACTICOAT FLEX 7 Dressing
2. Common/Classification Name
Common Name: Silver Coated Dressing
Classification Name: Dressing
Classification Code: FRO
3. Applicant's Name & Address
Smith & Nephew, Inc. 970 Lake Carillon Drive St. Petersburg, Florida 33716 Phone: 727-392-1261 Fax: 727-399-3468
4. Contact Information
Terry McMahon Director, Regulatory Affairs and Compliance Phone: 727-399-3785 Email: terry.mcmahon@smith-nephew.com
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K083113
pg 2 of 5
5. Device Classification and Panel
A final classification for "dressing" has not been implemented by the General and Plastic Surgery Devices Panel. At this time, however, classification code FRO is unclassified.
6. Predicate Device
Silvelon (K981299).
The ACTICOAT FLEX 7 dressing cover by this submission is substantial equivalent to other legally marketed burn and wound dressing. The ACTICOAT FLEX 7 dressing is substantial cquivalent to Argentum International LLC's Silvelon Contact Wound Dressing (K981299).
7. Other Similar Devices
ACTICOAT FLEX 7 is similar in form and function to Acticoat 7 dressings (K001519). The subject device has all features has all the features and benefits associated with a conformable dressing as well as the added benefit of an antimicrobial barrier dressing.
8. Performance Standards
No applicable performance standards have been established under Section 514 of the FD&C Act. Biocompatibility tests were done in conformance with relevant requirements of AAMI/ISO-10993. Additional standards applicable to the device include the following: ISO 13485, AAMI/ISO 11137-1, AAMI/ISO 11137-2 and ISO 15843.
9. Intended Use
ACTICOAT FLEX 7 is indicated for use on partial and full-thickness wounds for up to 7 days.
This includes:
First and second-degree burns,
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K083113
pg 305
To cover grafts, Surgical sites, Venous ulcers, Pressure ulcers
Diabetic ulcers.
10. Device Description
The ACTICOAT FLEX 7 dressing consists of a flexible, low adherent polyester layer coated with nanocrystalline silver.
The ACTICOAT FLEX 7 is a highly conformable dressing, nanocrystalline silver provides an effective barrier to microbial contamination The antimicrobial barrier properties of the ACTICOAT FLEX 7 dressings remain effective for up to 7 days. The antimicrobial barrier properties and the ability of the dressing to allow fluid to pass through without impairment, (in-vitro data) has shown ACTICOAT FLEX 7 to be compatible with negative pressure wound therapy (NPWT) for a period of up to 3 days.
The dressing is low adherent, which helps to minimise wound trauma at dressing changes.
The silver coating is derived from a silver target which 99.99% silver. The coating which is applied to the dressing is predominantly silver with a small number of oxygen atoms trapped within the coating structure. The coatings are highly porous and consist of equiaxed nanocrystals organised into coarse columnar structures. These unique physical structures, in
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- smith&nephew
Page 292 of 297
Rg 475
combination with the oxygen atoms/molecules that are trapped in the crystal lattice, contribute to the enhanced solubility of the films.
11. Biocompatability
The biocompatibility of ACTICOAT FLEX 7 has been demonstrated through appropriate in vivo and in vitro tests including cytotoxicity, sensitization, subchronic toxicity, and genotoxicity. All tests were performed on the finished device according to the Biological Evaluation of Medical Devices Standard ISO 10993 Part 1:2003. These studies indicated that ACTICOAT FLEX 7 dressings are safe for their intended use.
In addition, the effects of the device on wound healing have been evaluated in an animal model (minipigs), and it was demonstrated that the device had no deleterious effects on wound healing.
12. Summary of Substantial Equivalence
The subject device is substantially equivalent to the predicate devices Silverlon Contact Wound and Acticoat Silver Coated Silver dressings. This subject device has similar characteristics and it provides similar functions as the predicate devices. The silver coating and process used to produce the nanocrystalline silver coating for the subject are identical to the coating and coating process used in the manufacture of Acticoat 7. The indications and instructions for use are similar.
Like the subject device the Silverlon Contact Wound product consists of an absorbent material and the dressing release silver ions into and around site when activated by moisture. Both products are provided sterile to the user, and both have antimicrobial effect.
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28 3113
The technological subject device and the predicate devices have similar design, matcrials and manufacturing methods and do not raise any new issues of safety and effectiveness.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2009
Smith & Nephew % Terry McMahon 970 Lake Carillon Drive Suite 110 St. Petersburg, Florida 33716
Re: K083113
Trade/Device Name: ACTICOAT FLEX 7 Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 14, 2009 Received: May 18, 2009
Dear Terry McMahon:
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 (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.
6
Page 2 - Terry McMahon
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
houbare Buchund
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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smith&nephew
Bage 288 of 297
Indications for Use
510(k) Number (if known):K083113
Device Name: ACTICOAT FLEX 7 Dressing
Indications For Use:
ACTICOAT FLEX 7 is indicated for use on partial and full thickness wounds for up to 7 days.
This includes: first and second-degree burns, as a protective covering of grafts, surgical sites, venous ulcers, pressure ulcers, diabetic ulcers.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Voubarabuehum.
Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
Page 1 of 1
510(k) Number_