(111 days)
No
The summary describes a negative pressure wound therapy system with dressing kits and focuses on fluid removal and pressure delivery, with no mention of AI or ML.
Yes.
The device is indicated for promoting wound healing by removing fluids, exudate, and infectious materials from various wound types, aligning with the definition of a therapeutic device.
No
The device is a negative pressure wound therapy (NPWT) system designed to promote wound healing by removing fluids. It does not perform any diagnostic functions.
No
The device description explicitly lists physical components (gauze dressing, film, ViewPad) and the intended use describes a suction device (negative pressure wound therapy), indicating a hardware-based system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that applies negative pressure to a wound to remove fluids and promote healing. This is a therapeutic intervention applied directly to the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The components listed (gauze dressing, film, ViewPad) are all materials used in wound care and negative pressure therapy, not reagents, instruments, or software used for in vitro testing.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
Therefore, the Avance NPWT system and its associated gauze dressing kits are a medical device used for wound therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
Product codes
OMP
Device Description
The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:
- Antimicrobial gauze dressing ●
- . Avance Transparent Film or Avance Film with Safetac technology
- . Avance ViewPad
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
No clinical data was required to support substantial equivalence.
Bench testing has been performed to demonstrate that the line additions to the Avance NPWT System do not negatively affect the ability of the NPWT system to transport fluid away from the wound and that pressure is delivered in an acceptable manner. The subject Avance Gauze Dressing Kits performed as intended in the test setups, and all predefined acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
Venturi Gauze Wound Care Sets with Portal Drain (K151263)
Reference Device(s)
Avance Foam Dressing Kits with ViewPad (K141847), Avance Foam Dressing Kits with Transfer Pad (K122132)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures in profile facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002
November 3, 2016
Molnlycke Health Care, Us LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross. Georgia 30092
Re: K161948
Trade/Device Name: Avance Gauze Dressing Kits Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: July 13, 2016 Received: July 15, 2016
Dear Megan Bevill:
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 Actinclude requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161948
Device Name Avance Gauze Dressing Kits
Indications for Use (Describe)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
| Date Prepared: | October 31, 2016 |
|---|---|
| Applicant: | Mölnlycke Health Care US, LLC |
| 5550 Peachtree Parkway, Suite 500 | |
| Norcross, GA 30092 | |
| Registration number: 3004763499 | |
| Owner/Operator Number: 8030877 | |
| Official Correspondent: | Megan Bevill |
| Manager, Regulatory Affairs | |
| Tel: 470-375-0049 | |
| Fax: 678-245-7746 | |
| email: megan.bevill@molnlycke.com | |
| Trade/Proprietary Names: | Avance Gauze Dressing Kits |
| Common Name: | NPWT Dressing Kits |
| Regulation Name: | Powered Suction Pump |
| Device Class: | Class II |
| Regulation Number: | 21 CFR 878.4780 |
| Product Code: | OMP |
| Predicate Device Information: | Venturi Gauze Wound Care Sets with Portal Drain (K151263) |
| Reference Device Information: | Avance Foam Dressing Kits with ViewPad (K141847) |
| Avance Foam Dressing Kits with Transfer Pad (K122132) |
Reason for 510(k) Submission:
This premarket notification has been prepared to obtain clearance for the following line additions to Mölnlycke's Avance Negative Pressure Wound Therapy (NPWT) System: Avance Gauze Dressing Kits.
Description of Devices:
The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:
- Antimicrobial gauze dressing ●
- . Avance Transparent Film or Avance Film with Safetac technology
- . Avance ViewPad
Indications for Use:
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
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Technological Characteristics:
| Feature | Avance Gauze Dressing Kits | Venturi Gauze Wound Care Sets with Portal Drain |
|---|---|---|
| 510(k) | ||
| clearance | Subject device | K151263 |
| Manufacturer | Mölnlycke Health Care | Talley Group Ltd. |
| Common name | NPWT Dressing Kit | NPWT Dressing Kit |
| Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 |
| Class name | Powered Suction Pump | Powered Suction Pump |
| Class | II | II |
| Product code | OMP | OMP |
| Functionality | ||
| within NPWT | ||
| system | The Avance Gauze Dressing Kits contain all dressing | |
| components necessary to administer NPWT using gauze as | ||
| a wound filler material. | The Venturi Gauze Wound Care Sets with Portal Drain | |
| contain all dressing components necessary to administer | ||
| NPWT using gauze as a wound filler material. | ||
| Indication for | ||
| use | The Avance NPWT system, with associated products, are | |
| indicated for patients who would benefit from a suction | ||
| device (negative pressure wound therapy), as it may promote | ||
| wound healing via the removal of fluids, including irrigation | ||
| and body fluids, wound exudate and infectious materials. | ||
| Examples of appropriate wound types include: chronic, | ||
| acute, traumatic, sub-acute and dehisced wounds, ulcers | ||
| (such as pressure or diabetic), partial-thickness burns, flaps | ||
| and grafts. | Venturi Gauze Wound Care Sets with Portal Drain are | |
| intended to be used with the Talley Group range of negative | ||
| pressure wound therapy pumps. The Talley Group NPWT | ||
| pumps are indicated for use for patients with acute or chronic | ||
| wounds that may be benefitted by the application of continual | ||
| negative pressure to the wound for removal of fluids, | ||
| including wound exudate, irrigation fluids, and infectious | ||
| materials. | ||
| Kit | ||
| Components | • Antimicrobial gauze wound filler | |
| • Avance ViewPad | ||
| • Avance Transparent Film or Avance Film with | ||
| Safetac technology | • Antimicrobial gauze wound filler | |
| • Portal drain assembly | ||
| • Adhesive film dressing | ||
| • 20 mL saline | ||
| • Wound ruler | ||
| Single use or | ||
| Reusable | Single use | Single use |
| Sterility | Individually packaged, sterilized and labelled components co- | |
| packed into non-sterile plastic pouch to form the dressing kit | Individually packaged, sterilized and labelled components co- | |
| packed into non-sterile plastic pouch to form the dressing kit |
All technological differences between the predicate devices have been accounted for within the submission through defailed device comparisons, nonclinical testing, and other means. Technological differences have been shown to raise of safety or effectiveness.
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Non-Clinical Testing:
The kit components have been shown to be biocompatible for their intended use, in accordance with ISO 10993.
Bench testing has been performed to demonstrate that the line additions to the Avance NPWT System do not negatively affect the ability of the NPWT system to transport fluid away from the wound and that pressure is delivered in an acceptable manner. The subject Avance Gauze Dressing Kits performed as intended in the test setups, and all predefined acceptance criteria were met.
Clinical Data:
No clinical data was required to support substantial equivalence.
Conclusion:
The subject devices are substantially equivalent to the predicate and reference devices with respect to design, technological characteristics, intended use, and conformance to standard requirements.