Mepiseal Soft Silicone Sealant

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 22, 2016 Molnlycke Health Care, US LLC Megan Bevill Manager, Regulatory Affairs 5550 Peachtree Parkway Suite 500 Norcross. Georgia 30092 Re: K152741 Trade/Device Name: Mepiseal Soft Silicone Sealant Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 22, 2015 Received: September 23, 2015 Dear Ms. 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 {1}------------------------------------------------ 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. 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/Resourcesfor You/Industry/default.htm. 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/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 yours, # 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152741 Device Name Mepiseal® Soft Silicone Sealant #### Indications for Use (Describe) Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy. When used under Negative Wound Therapy (NPWT) dressings to aid in seal formation, Mepiseal is compatible with Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | 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<br>with the requirements of 21 CFR 807.92(c). | Feature | Mepiseal Soft Silicone Sealant | Avance Foam Dressing Kits | SNaP SecuRing | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | January 19, 2015 | 510(k)<br>clearance | Subject of submission | K141847 | K132080 | | 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 | Rationale for<br>inclusion | Subject of submission | Primary predicate | Reference device | | Official Correspondent: | Megan Bevill<br>Manager, Regulatory Affairs<br>Tel: 470-375-0049<br>Fax: 678-245-7746<br>email: megan.bevill@molnlycke.com | Manufacturer | Mölnlycke Health Care | Mölnlycke Health Care | Spiracur | | Trade/Proprietary Names: | Mepiseal® Soft Silicone Sealant | Common name | NPWT Dressing | NPWT Dressing Kits | NPWT Dressing Kits | | Common Name: | NPWT Dressing | Regulation | 21 CFR 878.4780 | 21 CFR 878.4780 | 21 CFR 878.4683 | | Regulation Name: | Powered Suction Pump | Class name | Powered Suction Pump | Powered Suction Pump | Non-powered Suction Pump | | Device Class: | Class II | Class | II | II | II | | Regulation Number: | 21 CFR 878.4780 | Product code | OMP | OMP | OKO | | Product Code: | OMP | Indication for<br>use/Intended<br>use | Mepiseal is intended to be used on periwound skin<br>in conjunction with a wound dressing to prevent<br>leakage and premature loosening of the dressing.<br>It is designed to fill uneven skin surfaces and mold<br>around wounds in challenging anatomical<br>locations. When used under NPWT dressings,<br>Mepiseal serves as a sealant to help create and<br>maintain a seal, which enables delivery of effective<br>negative pressure wound therapy.<br><br>When used under NPWT dressings to aid in seal<br>formation, Mepiseal is compatible with the Avance<br>Dressing Kits that include Avance Film with<br>Safetac Technology and Avance Transparent Film.<br><br>(Mepiseal is part of the Avance NPWT System,<br>with the following indications:)<br><br>The Avance NPWT system, with associated<br>products are indicated for patients who would<br>benefit from a suction device (negative pressure<br>wound therapy), as it may promote wound healing<br>via the removal of fluids, including irrigation and<br>body fluids, wound exudates and infectious<br>materials. Examples of appropriate wound types<br>include: chronic, acute, traumatic, sub-acute and<br>dehisced wounds, ulcers (such as pressure or<br>diabetic), partial-thickness burns, flaps and grafts. | The Avance NPWT system, with associated<br>products are indicated for patients who would<br>benefit from a suction device (negative pressure<br>wound therapy), as it may promote wound healing<br>via the removal of fluids, including irrigation and<br>body fluids, wound exudates and infectious<br>materials. Examples of appropriate wound types<br>include: chronic, acute, traumatic, sub-acute and<br>dehisced wounds, ulcers (such as pressure or<br>diabetic), partial-thickness burns, flaps and grafts. | The SNaP SecuRing functions to improve the seal<br>of the dressing around the wound.<br><br>(The SNaP SecuRing is part of the SNaP Wound<br>Care System, with the following indications:)<br><br>The SNaP Wound Care System is indicated for<br>patients who would benefit from a suction device,<br>particularly as the device may promote wound<br>healing through the removal of excess exudates,<br>infectious material and tissue debris. The SNaP<br>Wound Care System is indicated for removal of<br>small amounts of exudate from chronic, acute,<br>traumatic, subacute and dehisced wounds, partial-<br>thickness burns, ulcers (such as diabetic, venous<br>or pressure), surgically closed incisions, flaps and<br>grafts. | | Predicate Device Name(s): | Avance® Foam Dressing Kits (K141847)<br>SNAP SecuRing, a component of SNAP Wound Care System (K132080) | NPWT system<br>includes device<br>to augment seal | Subject of this submission | No | Yes | | Sealant material | Soft silicone | No sealant included | Hydrocolloid | | | | Sealant<br>application<br>method | Supplied in two-component applicator; product is<br>dispensed through mixer in applicator onto<br>periwound skin a covered with dressing | No sealant included | Supplied as soft, moldable ring; manipulated to<br>desired shape with hands, then applied to<br>periwound skin and covered with dressing | | | #### Reason for 510(k) Submission: This premarket notification has been prepared to obtain clearance for a line addition to Mölnlycke's Wound Care product offering: the Mepiseal Soft Silicone Sealant. #### Description of Device: The subject device is a soft silicone sealant intended to be used on periwound skin in conjunction with a wound dressing and is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. Mepiseal serves the same function as the soft silicone layer of any wound dressing, to maintain the seal of the dressing around the wound. It is considered an accessory to the wound dressing and can be used under conventional wound dressings and under Negative Pressure Wound Therapy (NPWT) dressings. #### Intended Use/Indication for Use: Mepiseal is intended to be used on periwound skin in conjunction with a wound dressing to prevent leakage and premature loosening of the dressing. It is designed to fill uneven skin surfaces and mold around wounds in challenging anatomical locations. When used under NPWT dressings, Mepiseal serves as a sealant to help create and maintain a seal, which enables delivery of effective negative pressure wound therapy. When used under NPWT dressings to aid in seal formation, Mepiseal is compatible with the Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film. {4}------------------------------------------------ # Technological Characteristics: {5}------------------------------------------------ | Sealant use<br>situation | Use on difficult to dress/seal wounds, including<br>those with uneven skin surfaces and those in<br>challenging anatomical locations | No sealant included; no current solution for difficult<br>to dress/seal wounds | Use on uneven skin surfaces and challenging body<br>contours | |---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------| | Single use or<br>Reusable | Single Use | Single Use | Single Use | | Sterility | Non-sterile, controlled bioburden | Sterile | Unknown | {6}------------------------------------------------ #### Performance Data: Bench testing has been performed to demonstrate that Mepiseal is capable of sealing air leaks in the Avance NPWT system and does not otherwise interfere with the system's ability to transport fluid away from the wound. Mepiseal's performance has been evaluated under both soft silicone films and acrylic films (Avance Film with Safetac Technology and Avance Transparent Film) and found to be acceptable. #### 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.