(121 days)
No
The description focuses on the physical properties and function of a silicone sealant for wound dressings, with no mention of AI or ML technologies.
No.
The device's intended use is to prevent leakage, maintain a seal for wound dressings, and facilitate negative pressure wound therapy by filling uneven skin surfaces around a wound. It acts as an accessory to dressings, not as a primary treatment device.
No
The device is described as a soft silicone sealant used to prevent leakage and improve the seal of wound dressings, particularly in negative pressure wound therapy. Its function is to fill uneven skin surfaces and mold around wounds, acting as an accessory to wound dressings, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "soft silicone sealant," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Mepiseal is to be applied to periwound skin to prevent leakage and aid in sealing wound dressings, including those used in Negative Pressure Wound Therapy (NPWT). This is a topical application and directly interacts with the patient's skin and the wound environment.
- Device Description: The device is described as a soft silicone sealant for use on periwound skin. It functions as a seal for wound dressings.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Its function is purely mechanical and supportive for wound care.
- Bench Testing: The performance studies described are bench tests evaluating its sealing capabilities and compatibility with NPWT systems. These are functional tests, not diagnostic performance evaluations.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. Mepiseal's function is external and supportive to wound management.
N/A
Intended Use / Indications 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 Avance Dressing Kits that include Avance Film with Safetac Technology and Avance Transparent Film.
Product codes (comma separated list FDA assigned to the subject device)
OMP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periwound skin
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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
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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)
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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). | 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, LLC
5550 Peachtree Parkway, Suite 500
Norcross, GA 30092
Registration number: 3004763499
Owner/Operator Number: 8030877 | Rationale for
inclusion | Subject of submission | Primary predicate | Reference device |
| Official Correspondent: | Megan Bevill
Manager, Regulatory Affairs
Tel: 470-375-0049
Fax: 678-245-7746
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
use/Intended
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.
(Mepiseal is part of the Avance NPWT System,
with the following indications:)
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 exudates 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. | 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 exudates 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. | The SNaP SecuRing functions to improve the seal
of the dressing around the wound.
(The SNaP SecuRing is part of the SNaP Wound
Care System, with the following indications:)
The SNaP Wound Care System is indicated for
patients who would benefit from a suction device,
particularly as the device may promote wound
healing through the removal of excess exudates,
infectious material and tissue debris. The SNaP
Wound Care System is indicated for removal of
small amounts of exudate from chronic, acute,
traumatic, subacute and dehisced wounds, partial-
thickness burns, ulcers (such as diabetic, venous
or pressure), surgically closed incisions, flaps and
grafts. |
| Predicate Device Name(s): | Avance® Foam Dressing Kits (K141847)
SNAP SecuRing, a component of SNAP Wound Care System (K132080) | NPWT system
includes device
to augment seal | Subject of this submission | No | Yes |
| Sealant material | Soft silicone | No sealant included | Hydrocolloid | | |
| Sealant
application
method | Supplied in two-component applicator; product is
dispensed through mixer in applicator onto
periwound skin a covered with dressing | No sealant included | Supplied as soft, moldable ring; manipulated to
desired shape with hands, then applied to
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
situation | Use on difficult to dress/seal wounds, including
those with uneven skin surfaces and those in
challenging anatomical locations | No sealant included; no current solution for difficult
to dress/seal wounds | Use on uneven skin surfaces and challenging body
contours |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------|
| Single use or
Reusable | 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.