Avance Abdominal Dressing Kit

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 17, 2016 Molnlycke Health Care Us, LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092 Re: K161939 Trade/Device Name: Avance Abdominal Dressing Kit Regulation Number: 21 CFR 878.3300 Regulation Name: Mesh, Surgical, Non-Absorbable, Large Abdominal Regulatory Class: Class II Product Codes: OXJ, OMP Dated: October 14, 2016 Received: October 17, 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 Act include 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 {1}------------------------------------------------ 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 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, Jennifer R. # Stevenson -A 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K161939 Device Name Avance Abdominal Dressing Kit #### Indications for Use (Describe) The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ### 510(k) SUMMARY This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92(c). | Date Prepared: | November 16, 2016 | |----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Mölnlycke Health Care US, LLC<br>5550 Peachtree Parkway, Suite 500<br>Norcross, GA 30092<br>Registration number: 3004763499<br>Owner/Operator Number: 8030877 | | Official Correspondent: | Megan Bevill<br>Manager, Regulatory Affairs<br>Tel: 470-375-0049<br>Fax: 678-245-7746<br>email: megan.bevill@molnlycke.com | | Trade/Proprietary Names: | Avance Abdominal Dressing Kit | | Common Name: | NPWT Dressing Kit | | Regulation Name: | Surgical Mesh | | Device Class: | Class II | | Regulation Number: | 21 CFR 878.3300 | | Product Code: | OXJ, OMP | | Predicate Device Information:<br>Reference Device Information: | Avance Abdominal Dressing Kit (K130852)<br>Avance Foam Dressing Kits (K141847) | #### Reason for 510(k) Submission: This premarket notification has been prepared to obtain clearance for the following line addition to Mölnlycke's Avance Negative Pressure Wound Therapy (NPWT) System: Avance Abdominal Dressing Kit. #### Description of Device: The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer. #### Indication for Use: The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories. {4}------------------------------------------------ # Technological Characteristics: | Feature | Avance Abdominal Dressing Kit | Avance Abdominal Dressing Kit | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) clearance | Subject device | K130852 | | Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | | Common name | NPWT Dressing Kit | NPWT Dressing Kit | | Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | | Class name | Mesh, Surgical, Non-Absorbable, Large Abdominal<br>Wall Defects | Mesh, Surgical, Non-Absorbable, Large Abdominal<br>Wall Defects | | Class | II | II | | Product code | OXJ, OMP | OXJ, OMP | | Functionality within NPWT system | The Avance Abdominal Dressing Kit contains all<br>components necessary to dress an abdominal<br>wound in preparation for administering NPWT. | The Avance Abdominal Dressing Kit contains all<br>components necessary to dress an abdominal<br>wound in preparation for administering NPWT. | | Indication for use | The Avance Foam Abdominal Dressing Kit is<br>indicated for temporary bridging of abdominal wall<br>openings where primary closure is not possible<br>and/or repeat abdominal entries may be required.<br>Its intended use is with patients who have open<br>abdominal wounds with exposed viscera and<br>organs, and including but not limited to patients with<br>abdominal compartment syndrome. It is intended<br>for use in acute hospital settings (trauma, general<br>and plastic surgery wards) and should ideally be<br>applied in the operating theatre. The dressing kit is<br>intended for use together with the Avance Max<br>NPWT pump and its accessories. | The Avance Foam Abdominal Dressing Kit is<br>indicated for temporary bridging of abdominal wall<br>openings where primary closure is not possible<br>and/or repeat abdominal entries may be required.<br>Its intended use is with patients who have open<br>abdominal wounds with exposed viscera and<br>organs, and including but not limited to patients with<br>abdominal compartment syndrome. | | Dressing kit components | ● Avance ViewPad (1 pc)<br>● Avance Abdominal Foam (2 pcs)<br>● Avance Transparent Film (4 pcs)<br>● Avance Organ Contact Layer (1 pc) | ● Avance Transfer Pad (I pc)<br>● Avance Abdominal Foam (2 pcs)<br>● Avance Film with Safetac technology (4 pcs)<br>● Avance Organ Contact Layer (1 pc) | | Single use or Reusable | Single use | Single use | | Sterility | EtO | EtO | All technological differences between the subject and peen accounted for within the submission through detailed device comparisons, nonclinical testing, and other means. Technological differences have been shown to raise of safety or effectiveness. {5}------------------------------------------------ #### Non-Clinical Testing: The subject device has been evaluated in accordance with ISO 10993-1 and have been shown to meet the criteria for their intended use. Bench testing has been performed to demonstrate that the line addition to the Avance NPWT System does not negatively affect the ability of the NPWT system to transport fluid away from the wound. The subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met. ## Clinical Data: No clinical data was required to support substantial equivalence. #### Conclusion: The subject device is substantially equivalent to the predicate and reference devices with respect to design, technological characteristics, intended use, and conformance to standard requirements.