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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) summary for the Mepiseal Soft Silicone Sealant. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of typical AI/ML device performance.

The "Performance Data" section states: "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."

This indicates functional testing of the sealing ability and compatibility with an NPWT system, not a study assessing diagnostic performance (like sensitivity, specificity, or AUC) which would be typical for an AI/ML device. Therefore, I cannot provide details for most of your requested points, as they are not applicable to the type of device described (a silicone sealant) or the type of data presented (bench testing for physical functionality).

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance:

Based on the provided text, the acceptance criteria implicitly relate to the device's ability to create and maintain a seal for negative pressure wound therapy systems and not interfere with fluid transport. The "reported device performance" is a qualitative statement of meeting these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Capable of sealing air leaks in the Avance NPWT system.	"Mepiseal is capable of sealing air leaks in the Avance NPWT system."
Does not interfere with the Avance NPWT system's ability to transport fluid away from the wound.	"Mepiseal... does not otherwise interfere with the system's ability to transport fluid away from the wound."
Performance is acceptable under both soft silicone films (Avance Film with Safetac Technology) and acrylic films (Avance Transparent Film).	"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."

2. Sample sized used for the test set and the data provenance: Not applicable. This was bench testing, not a clinical study or AI/ML performance evaluation test set with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML system or diagnostic accuracy was not established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device or a diagnostic device where human reader improvement would be measured.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" here would be the physical principles of sealing and fluid transport, verified through bench test measurements.

8. The sample size for the training set: Not applicable. There is no training set for an AI/ML algorithm.

9. How the ground truth for the training set was established: Not applicable. There is no training set for an AI/ML algorithm.

In summary, the provided document describes a medical device (a silicone sealant) and its associated bench testing results for a 510(k) submission, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML performance studies (e.g., sample sizes for training/test sets, expert ground truth establishment, MRMC studies) is not present and not relevant to this specific premarket notification.

Summary

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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 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

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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

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Indications for Use

510(k) Number (if known) K152741

Device Name Mepiseal® Soft Silicone Sealant

Indications for Use (Describe)

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)

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510(k) SUMMARY

	This 510(k) summary information is being submitted in accordancewith 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)clearance	Subject of submission	K141847	K132080
Applicant:	Mölnlycke Health Care US, LLC5550 Peachtree Parkway, Suite 500Norcross, GA 30092Registration number: 3004763499Owner/Operator Number: 8030877	Rationale forinclusion	Subject of submission	Primary predicate	Reference device
Official Correspondent:	Megan BevillManager, Regulatory AffairsTel: 470-375-0049Fax: 678-245-7746email: 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 foruse/Intendeduse	Mepiseal is intended to be used on periwound skinin conjunction with a wound dressing to preventleakage and premature loosening of the dressing.It is designed to fill uneven skin surfaces and moldaround wounds in challenging anatomicallocations. When used under NPWT dressings,Mepiseal serves as a sealant to help create andmaintain a seal, which enables delivery of effectivenegative pressure wound therapy.When used under NPWT dressings to aid in sealformation, Mepiseal is compatible with the AvanceDressing Kits that include Avance Film withSafetac Technology and Avance Transparent Film.(Mepiseal is part of the Avance NPWT System,with the following indications:)The Avance NPWT system, with associatedproducts are indicated for patients who wouldbenefit from a suction device (negative pressurewound therapy), as it may promote wound healingvia the removal of fluids, including irrigation andbody fluids, wound exudates and infectiousmaterials. Examples of appropriate wound typesinclude: chronic, acute, traumatic, sub-acute anddehisced wounds, ulcers (such as pressure ordiabetic), partial-thickness burns, flaps and grafts.	The Avance NPWT system, with associatedproducts are indicated for patients who wouldbenefit from a suction device (negative pressurewound therapy), as it may promote wound healingvia the removal of fluids, including irrigation andbody fluids, wound exudates and infectiousmaterials. Examples of appropriate wound typesinclude: chronic, acute, traumatic, sub-acute anddehisced wounds, ulcers (such as pressure ordiabetic), partial-thickness burns, flaps and grafts.	The SNaP SecuRing functions to improve the sealof the dressing around the wound.(The SNaP SecuRing is part of the SNaP WoundCare System, with the following indications:)The SNaP Wound Care System is indicated forpatients who would benefit from a suction device,particularly as the device may promote woundhealing through the removal of excess exudates,infectious material and tissue debris. The SNaPWound Care System is indicated for removal ofsmall amounts of exudate from chronic, acute,traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venousor pressure), surgically closed incisions, flaps andgrafts.
Predicate Device Name(s):	Avance® Foam Dressing Kits (K141847)SNAP SecuRing, a component of SNAP Wound Care System (K132080)	NPWT systemincludes deviceto augment seal	Subject of this submission	No	Yes
Sealant material	Soft silicone	No sealant included	Hydrocolloid
Sealantapplicationmethod	Supplied in two-component applicator; product isdispensed through mixer in applicator ontoperiwound skin a covered with dressing	No sealant included	Supplied as soft, moldable ring; manipulated todesired shape with hands, then applied toperiwound 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:

Intended Use/Indication for Use:

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.

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Technological Characteristics:

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Sealant usesituation	Use on difficult to dress/seal wounds, includingthose with uneven skin surfaces and those inchallenging anatomical locations	No sealant included; no current solution for difficultto dress/seal wounds	Use on uneven skin surfaces and challenging bodycontours
Single use orReusable	Single Use	Single Use	Single Use
Sterility	Non-sterile, controlled bioburden	Sterile	Unknown

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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.

Regulation Number and Section

§ 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.